A Phase 2 interventional study of mRNA-1647 and Placebo in Cytomegalovirus Infection, sponsored by ModernaTX, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by ModernaTX, Inc. · Phase 2, Interventional, and Prevention
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity of 3 dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A planned interim analysis of safety and immunogenicity through Month 3 (1 month after the second dose) of Part 1 of the study informed the selection of the middle dose level for further development. Part 2 of the study is designed to further evaluate the safety and immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of CMV-seronegative and CMV-seropositive female population, which includes the target population for the pivotal Phase 3 efficacy trial.
359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.
This study's enrollment of 315 is above the median of 60 across 233 interventional studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →ModernaTX, Inc. is the lead sponsor of 112 studies on the registry; 14 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 32 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive mRNA-1647 vaccine at Dose Level A by intramuscular (IM) injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Participants will receive mRNA-1647 vaccine at Dose Level B by IM injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Participants will receive mRNA-1647 vaccine at Dose Level C by IM injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.
Other: Placebo
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
0.9% sodium chloride (normal saline) injection
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs were selected signs and symptoms occurring after vaccination administration during a specified post-vaccination follow-up period. The occurrence and intensity of the selected signs and symptoms was actively solicited from the participant during a specified post-vaccination follow-up period (day of vaccination and 6 subsequent days), using a predefined checklist in the electronic diary. The following local ARs were solicited: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the vaccination arm. The following systemic ARs were solicited: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, fever, and chills. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to Day 175 (7 days following last dose administration)
Number of Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Time frame: Up to Day 196 (28 days following last dose administration)
Number of Participants With Medically Attended Adverse Events (MAAEs)
An MAAE is an AE that lead to a visit to a healthcare practitioner (HCP). This would include visits to study clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up), and visits to HCPs external to the clinical site (for example, urgent care, primary care physician). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Time frame: Up to Day 336 (6 months following last dose administration)
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, in the view of either the Investigator or the Sponsor, resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Time frame: Up to Day 504 (1 year following last dose administration)
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity (AMI) analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Geometric Mean Ratio (GMR) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) Over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z \* the lower limit of quantification (LLOQ) for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Time frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Anti-Glycoprotein B (gB)-Specific Immunoglobulin G (IgG) and Anti-Pentamer-specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-pentameric gH/gL/UL128/UL130/UL131A glycoprotein complex (Pentamer)-specific IgG binding was measured with ELISA. The GMT measures the level of inhibition of anti-gB-specific IgG (anti-gB) and anti-Pentamer-specific IgG (anti-Pentamer) against cytomegalovirus. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Anti-gB-specific IgG and Anti-Pentamer-specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Number Analyzed = participants who were evaluable at specified timepoints.
Time frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z \* the LLOQ for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Time frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Time frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
mRNA-1647-P202 was a 2-part study. For Part 1, participants were randomized to receive 1 of 3 dose levels (50, 100, 150 micrograms \[ug\]) of the mRNA-1647 vaccine and placebo in CMV-seronegative and CMV-seropositive male and female participants. For Part 2, new female participants (that is, did not participate in Part 1) who were either CMV-seronegative or CMV-seropositive were randomized to receive either the mRNA-1647 vaccine (100 ug) or placebo.
| Milestone | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Started | 45 | 73 | 45 | 55 | 18 | 36 | 18 | 25 |
| Received at least 1 dose of study drug | 45 | 73 | 45 | 55 | 18 | 36 | 18 | 25 |
| Safety set | 45 | 72 | 45 | 53 | 18 | 37 | 18 | 27 |
| Full analysis set (fas) | 45 | 68 | 45 | 55 | 15 | 34 | 17 | 23 |
| Part 1 participants | 45 | 45 | 45 | 45 | 18 | 18 | 18 | 18 |
| Part 2 (female participants only) | 0 | 28 | 0 | 10 | 0 | 18 | 0 | 7 |
| Completed | 34 | 52 | 35 | 47 | 15 | 28 | 13 | 18 |
| Not completed | 11 | 21 | 10 | 8 | 3 | 8 | 5 | 7 |
| Withdrew: Withdrawal by subject | 6 | 14 | 6 | 4 | 0 | 5 | 3 | 4 |
| Withdrew: Lost to follow-up | 4 | 6 | 3 | 4 | 3 | 3 | 2 | 2 |
| Withdrew: Participant no longer eligible | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Solicited ARs were selected signs and symptoms occurring after vaccination administration during a specified post-vaccination follow-up period. The occurrence and intensity of the selected signs and symptoms was actively solicited from the participant during a specified post-vaccination follow-up period (day of vaccination and 6 subsequent days), using a predefined checklist in the electronic diary. The following local ARs were solicited: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the vaccination arm. The following systemic ARs were solicited: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, fever, and chills. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
| Participants | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| After First Vaccination: Solicited Local ARs | 33 | 59 | 40 | 12 | 15 | 33 | 15 | 7 |
| After First Vaccination: Solicited Systemic ARs | 23 | 43 | 29 | 25 | 16 | 29 | 16 | 15 |
| After Second Vaccination: Solicited Local ARs | 34 | 55 | 36 | 8 | 14 | 30 | 12 | 1 |
| After Second Vaccination: Solicited Systemic ARs | 24 | 47 | 31 | 20 | 12 | 31 | 11 | 11 |
| After Third Vaccination: Solicited Local ARs | 23 | 50 | 28 | 8 | 12 | 26 | 9 | 1 |
| After Third Vaccination: Solicited Systemic ARs | 18 | 45 | 27 | 11 | 10 | 25 | 8 | 7 |
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
| Participants | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Unsolicited Adverse Events (AEs) | 16 | 31 | 18 | 21 | 10 | 16 | 6 | 10 |
An MAAE is an AE that lead to a visit to a healthcare practitioner (HCP). This would include visits to study clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up), and visits to HCPs external to the clinical site (for example, urgent care, primary care physician). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
| Participants | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Medically Attended Adverse Events (MAAEs) | 13 | 24 | 14 | 19 | 5 | 11 | 1 | 9 |
An SAE was defined as any untoward medical occurrence that, in the view of either the Investigator or the Sponsor, resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
| Participants | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Blood samples for antibody-mediated immunogenicity (AMI) analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| titer | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Baseline (Day 1): Epithelial Cell | 8.0 (NA to NA) | 8.0 (NA to NA) | 8.0 (NA to NA) | 8.0 (NA to NA) | 2250.0 (589.3 to 8591.3) | 4571.9 (2708.6 to 7717.2) | 7295.7 (4109.4 to 12952.5) | 5369.2 (2514.4 to 11465.1) |
| Day 29: Epithelial Cell | 1120.5 (684.0 to 1835.6) | 1664.0 (1032.9 to 2680.5) | 3802.0 (2712.8 to 5328.3) | 8.9 (7.2 to 11.0) | 27061.6 (7391.8 to 99073.1) | 77414.8 (47189.5 to 126999.8) | 102921.4 (55936.7 to 189371.3) | 8648.5 (4823.2 to 15507.8) |
| Day 56: Epithelial Cell | 875.8 (546.9 to 1402.5) | 742.0 (447.3 to 1230.8) | 1814.9 (1264.2 to 2605.3) | 8.3 (7.7 to 9.0) | 30228.3 (7729.8 to 118210.8) | 50596.3 (27015.5 to 94759.9) | 88938.9 (50342.7 to 157125.5) | 9365.9 (5447.7 to 16102.0) |
| Day 84: Epithelial Cell | 61759.1 (39400.1 to 96806.5) | 44745.1 (32240.9 to 62098.7) | 49581.0 (36690.2 to 67000.7) | 8.0 (NA to NA) | 104605.7 (67545.8 to 161998.9) | 85821.2 (53651.2 to 137280.7) | 115517.2 (72279.5 to 184619.6) | 8684.8 (5262.2 to 14333.5) |
| Day 168: Epithelial Cell | 8152.7 (4672.1 to 14226.2) | 10780.1 (7194.4 to 16152.9) | 9587.3 (7143.1 to 12867.7) | 9.8 (6.5 to 14.8) | 41511.4 (24866.9 to 69296.9) | 48035.5 (26414.1 to 87355.1) | 81979.3 (50734.4 to 132466.3) | 9709.3 (5046.5 to 18680.6) |
| Day 196: Epithelial Cell | 117022.3 (71908.7 to 190439.0) | 136935.3 (97637.3 to 192050.2) | 101113.5 (75956.7 to 134602.1) | 8.0 (NA to NA) | 87440.9 (49755.7 to 153669.1) | 86359.0 (52162.3 to 142974.4) | 105862.1 (57020.2 to 196540.7) | 7539.1 (5062.9 to 11226.4) |
| Day 336: Epithelial Cell | 20622.0 (13451.7 to 31614.3) | 18790.9 (13864.4 to 25467.9) | 28526.8 (18535.4 to 43904.1) | 9.7 (6.5 to 14.4) | 38787.8 (23499.4 to 64022.7) | 27083.3 (17644.7 to 41570.9) | 65788.7 (37545.8 to 115276.4) | 4992.1 (3096.2 to 8048.8) |
| Day 504: Epithelial Cell | 10145.3 (6364.0 to 16173.2) | 11658.5 (8180.6 to 16615.1) | 15762.9 (9572.3 to 25957.3) | 12.4 (7.0 to 22.2) | 23536.1 (14454.3 to 38324.3) | 18460.9 (11694.5 to 29142.5) | 51490.6 (23328.5 to 113649.7) | 5065.0 (2940.8 to 8723.6) |
| Baseline (Day 1): Fibroblast | 8.0 (NA to NA) | 8.0 (NA to NA) | 8.0 (NA to NA) | 8.0 (NA to NA) | 2507.4 (651.1 to 9655.4) | 4837.6 (2865.2 to 8167.7) | 6358.9 (3624.1 to 11157.7) | 3691.3 (1716.8 to 7936.6) |
| Day 29: Fibroblast | 66.2 (37.7 to 116.2) | 139.4 (92.6 to 209.7) | 156.0 (88.7 to 274.2) | 8.0 (NA to NA) | 5686.3 (1679.5 to 19252.2) | 11371.6 (7988.2 to 16188.2) | 20364.9 (13679.1 to 30318.5) | 6021.3 (3968.9 to 9135.2) |
| Day 56: Fibroblast | 33.8 (19.8 to 57.7) | 75.3 (43.7 to 129.5) | 84.2 (51.2 to 138.5) | 8.0 (NA to NA) | 5448.5 (1547.6 to 19181.8) | 9808.0 (6008.7 to 16009.6) | 11983.0 (7109.1 to 20198.5) | 6229.1 (4330.7 to 8959.7) |
| Day 84: Fibroblast | 4395.3 (3194.6 to 6047.3) | 3981.2 (3126.7 to 5069.2) | 4596.5 (3437.6 to 6146.1) | 8.0 (NA to NA) | 10410.2 (6923.1 to 15653.7) | 10130.3 (7609.8 to 13484.8) | 12868.2 (9234.1 to 17932.5) | 7503.9 (5606.8 to 10042.9) |
| Day 168: Fibroblast | 346.4 (219.5 to 546.6) | 562.4 (353.6 to 894.7) | 517.8 (354.4 to 756.5) | 9.0 (7.1 to 11.5) | 7447.4 (3921.5 to 14143.7) | 10185.5 (6627.2 to 15654.3) | 16061.7 (11656.7 to 22131.2) | 6155.0 (4272.1 to 8867.9) |
| Day 196: Fibroblast | 2758.2 (1957.6 to 3886.3) | 3811.4 (2962.7 to 4903.3) | 3761.2 (2849.3 to 4965.0) | 8.0 (NA to NA) | 9013.2 (5366.4 to 15138.0) | 9170.7 (6588.8 to 12764.2) | 13122.9 (9167.8 to 18784.3) | 5392.2 (3498.0 to 8312.3) |
| Day 336: Fibroblast | 1065.0 (664.7 to 1706.2) | 1168.7 (807.0 to 1692.3) | 1227.0 (829.7 to 1814.8) | 9.8 (6.5 to 14.8) | 8442.3 (5216.3 to 13663.4) | 8793.6 (5463.8 to 14152.7) | 11657.2 (7701.7 to 17644.2) | 4946.9 (3263.5 to 7498.5) |
| Day 504: Fibroblast | 486.3 (234.5 to 1008.7) | 582.3 (355.1 to 955.1) | 817.1 (526.6 to 1267.8) | 11.6 (7.1 to 19.0) | 7023.2 (4003.5 to 12320.5) | 7447.5 (4216.6 to 13153.9) | 9860.9 (6933.7 to 14023.9) | 5546.9 (3761.0 to 8181.0) |
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| Ratio | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Day 29: Epithelial Cell | 140.06 (85.50 to 229.45) | 207.99 (129.12 to 335.06) | 475.24 (339.10 to 666.04) | 1.11 (0.90 to 1.38) | 12.03 (7.30 to 19.83) | 17.13 (10.09 to 29.10) | 12.82 (5.24 to 31.37) | 1.69 (0.87 to 3.29) |
| Day 56: Epithelial Cell | 109.47 (58.36 to 175.31) | 92.75 (55.92 to 153.85) | 226.86 (158.03 to 328.67) | 1.04 (0.96 to 1.12) | 13.43 (7.55 to 23.90) | 14.61 (8.03 to 26.59) | 11.89 (6.07 to 23.29) | 1.74 (0.79 to 3.85) |
| Day 84: Epithelial Cell | 7719.89 (4952.02 to 12100.81) | 5593.13 (4030.12 to 7762.34) | 6197.62 (4586.28 to 8375.09) | 1.00 (NA to NA) | 46.49 (13.06 to 165.46) | 22.34 (13.11 to 38.05) | 17.06 (9.58 to 30.37) | 1.65 (0.80 to 3.40) |
| Day 168: Epithelial Cell | 1019.09 (584.01 to 1778.27) | 1347.51 (899.30 to 2019.11) | 1198.41 (892.89 to 1608.47) | 1.22 (0.81 to 1.85) | 18.99 (5.32 to 67.77) | 10.10 (5.21 to 19.61) | 10.82 (5.68 to 20.62) | 1.88 (0.65 to 5.40) |
| Day 196: Epithelial Cell | 14627.79 (8988.59 to 23804.88) | 17116.91 (12204.67 to 24006.27) | 12639.18 (9494.59 to 16825.27) | 1.00 (NA to NA) | 40.35 (7.45 to 218.58) | 17.97 (10.61 to 30.44) | 12.88 (7.37 to 22.49) | 1.45 (0.63 to 3.33) |
| Day 336: Epithelial Cell | 2577.75 (1681.46 to 3951.78) | 2348.86 (1733.06 to 3183.48) | 3565.85 (2316.93 to 5488.01) | 1.21 (0.82 to 1.80) | 17.75 (4.83 to 65.24) | 5.27 (3.02 to 9.20) | 8.58 (3.99 to 18.45) | 1.07 (0.44 to 2.62) |
| Day 504: Epithelial Cell | 1268.16 (795.51 to 2021.65) | 1457.31 (1022.57 to 2076.89) | 1970.37 (1195.53 to 3244.66) | 1.55 (0.87 to 2.77) | 10.77 (3.16 to 36.74) | 3.97 (2.29 to 6.90) | 6.88 (2.90 to 16.31) | 0.95 (0.36 to 2.51) |
| Day 29: Fibroblast | 8.27 (4.71 to 14.52) | 17.42 (11.58 to 26.22) | 19.50 (11.09 to 34.28) | 1.00 (NA to NA) | 2.27 (1.40 to 3.66) | 2.42 (1.80 to 3.25) | 2.87 (1.76 to 4.67) | 1.84 (0.94 to 3.59) |
| Day 56: Fibroblast | 4.22 (2.48 to 7.21) | 9.41 (5.47 to 16.19) | 10.53 (6.40 to 17.32) | 1.00 (NA to NA) | 2.19 (1.43 to 3.29) | 2.13 (1.59 to 2.86) | 1.68 (1.04 to 2.73) | 1.81 (0.84 to 3.90) |
| Day 84: Fibroblast | 549.41 (399.33 to 755.91) | 497.65 (390.84 to 633.65) | 574.56 (429.70 to 768.26) | 1.00 (NA to NA) | 4.15 (1.33 to 12.94) | 2.23 (1.52 to 3.27) | 2.06 (1.29 to 3.27) | 2.25 (1.02 to 4.97) |
| Day 168: Fibroblast | 43.29 (27.44 to 68.32) | 70.30 (44.19 to 111.83) | 64.73 (44.31 to 94.57) | 1.13 (0.88 to 1.44) | 3.37 (0.96 to 11.80) | 1.65 (1.28 to 2.12) | 2.22 (1.10 to 4.46) | 2.55 (0.77 to 8.38) |
| Day 196: Fibroblast | 344.78 (244.70 to 485.79) | 476.43 (370.34 to 612.91) | 470.15 (356.16 to 620.63) | 1.00 (NA to NA) | 4.20 (1.06 to 16.74) | 1.67 (1.21 to 2.32) | 2.02 (1.07 to 3.82) | 1.90 (0.80 to 4.48) |
| Day 336: Fibroblast | 133.12 (86.09 to 213.28) | 146.08 (100.88 to 211.54) | 153.38 (103.71 to 226.85) | 1.23 (0.81 to 1.85) | 3.82 (1.13 to 12.87) | 1.53 (1.20 to 1.94) | 1.80 (0.84 to 3.84) | 1.71 (0.61 to 4.50) |
| Day 504: Fibroblast | 60.79 (29.31 to 126.09) | 72.79 (44.38 to 119.38) | 103.13 (65.82 to 158.48) | 1.45 (0.89 to 2.38) | 3.18 (0.97 to 10.41) | 1.29 (1.03 to 1.61) | 1.39 (0.72 to 2.65) | 2.20 (0.85 to 5.72) |
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z \* the lower limit of quantification (LLOQ) for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
| percentage of participants | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Day 29: ≥2-Fold Increase - Epithelial Cell | 95.5 (84.5 to 99.4) | 93.8 (84.8 to 98.3) | 100 (90.7 to 100.0) | 2.0 (NA to 10.4) | 100.0 (78.2 to 100.0) | 93.9 (79.8 to 99.3) | 84.6 (54.6 to 98.1) | 9.5 (1.2 to 30.4) |
| Day 29: ≥3-Fold Increase - Epithelial Cell | 95.5 (84.5 to 99.4) | 92.2 (82.7 to 97.4) | 100.0 (90.7 to 100.0) | 2.0 (NA to 10.4) | 93.3 (68.1 to 99.8) | 87.9 (71.8 to 96.6) | 84.6 (54.6 to 98.1) | 9.5 (1.2 to 30.4) |
| Day 29: ≥4-Fold Increase - Epithelial Cell | 95.5 (84.5 to 99.4) | 92.2 (82.7 to 97.4) | 100.0 (90.7 to 100.0) | 2.0 (NA to 10.4) | 86.7 (59.5 to 98.3) | 84.8 (68.1 to 94.9) | 84.6 (54.6 to 98.1) | 9.5 (1.2 to 30.4) |
| Day 56: ≥2-Fold Increase - Epithelial Cell | 97.4 (86.2 to NA) | 93.8 (82.8 to 98.7) | 100.0 (90.0 to 100.0) | 2.4 (NA to 12.9) | 100.0 (78.2 to 100.0) | 92.0 (74.0 to 99.0) | 100.0 (71.5 to 100.0) | 17.6 (3.8 to 43.4) |
| Day 56: ≥3-Fold Increase - Epithelial Cell | 97.4 (86.2 to NA) | 89.6 (77.3 to 96.5) | 100.0 (90.0 to 100.0) | 0 (0.0 to 8.6) | 100.0 (78.2 to 100.0) | 84.0 (63.9 to 95.5) | 90.9 (58.7 to 99.8) | 5.9 (0.1 to 28.7) |
| Day 56: ≥4-Fold Increase - Epithelial Cell | 94.7 (82.3 to 99.4) | 87.5 (74.8 to 95.3) | 100.0 (90.0 to 100.0) | 0 (0.0 to 8.6) | 80.0 (51.9 to 95.7) | 84.0 (63.9 to 95.5) | 90.9 (58.7 to 99.8) | 5.9 (0.1 to 28.7) |
| Day 84: ≥2-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (93.6 to 100.0) | 100.0 (90.3 to 100.0) | 0 (0.0 to 7.7) | 100.0 (78.2 to 100.0) | 100.0 (88.1 to 100.0) | 100.0 (75.3 to 100.0) | 15.8 (3.4 to 39.6) |
| Day 84: ≥3-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (93.6 to 100.0) | 100.0 (90.3 to 100.0) | 0 (0.0 to 7.7) | 100.0 (78.2 to 100.0) | 100.0 (88.1 to 100.0) | 100.0 (75.3 to 100.0) | 5.3 (0.1 to 26.0) |
| Day 84: ≥4-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (93.6 to 100.0) | 100.0 (90.3 to 100.0) | 0 (0.0 to 7.7) | 100.0 (78.2 to 100.0) | 93.1 (77.2 to 99.2) | 100.0 (75.3 to 100.0) | 5.3 (0.1 to 26.0) |
| Day 168: ≥2-Fold Increase - Epithelial Cell | 96.9 (83.8 to NA) | 100.0 (90.3 to 200.0) | 100.0 (87.7 to 100.0) | 3.1 (NA to 16.2) | 100.0 (76.8 to 100.0) | 100.0 (82.4 to 100.0) | 90.0 (55.5 to 99.7) | 21.4 (4.7 to 50.8) |
| Day 168: ≥3-Fold Increase - Epithelial Cell | 96.9 (83.8 to NA) | 100.0 (90.3 to 100.0) | 100.0 (87.7 to 100.0) | 3.1 (NA to 16.2) | 85.7 (57.2 to 95.2) | 78.9 (54.4 to 93.9) | 90.0 (55.5 to 99.7) | 14.3 (1.8 to 42.8) |
| Day 168: ≥4-Fold Increase - Epithelial Cell | 96.9 (83.8 to NA) | 100.0 (90.3 to 100.0) | 100.0 (87.7 to 100.0) | 3.1 (NA to 16.2) | 85.7 (57.2 to 98.2) | 63.2 (38.4 to 83.7) | 90.0 (55.5 to 99.7) | 7.1 (0.2 to 33.9) |
| Day 196: ≥2-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (91.2 to 100.0) | 100.0 (87.2 to 100.0) | 0 (0.0 to 9.5) | 100.0 (75.3 to 100.0) | 95.8 (78.9 to 99.9) | 100.0 (71.5 to 100.0) | 16.7 (3.6 to 41.4) |
| Day 196: ≥3-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (91.2 to 100.0) | 100.0 (87.2 to 100.0) | 0 (0.0 to 9.5) | 100.0 (75.3 to 100.0) | 91.7 (73.0 to 99.0) | 90.1 (58.7 to 99.8) | 11.1 (1.4 to 34.7) |
| Day 196: ≥4-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (91.2 to 100.0) | 100.0 (87.2 to 100.0) | 0 (0.0 to 9.5) | 84.6 (54.6 to 98.1) | 91.7 (73.0 to 99.0) | 81.8 (45.2 to 97.7) | 5.6 (0.1 to 27.3) |
| Day 336: ≥2-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (91.0 to 100.0) | 100.0 (87.2 to 100.0) | 2.9 (NA to 15.3) | 92.9 (66.1 to 99.8) | 83.3 (58.6 to 96.4) | 83.3 (51.6 to 97.9) | 6.3 (0.2 to 30.2) |
| Day 336: ≥3-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (91.0 to 100.0) | 100.0 (87.2 to 100.0) | 2.9 (NA to 15.3) | 85.7 (57.2 to 98.2) | 61.1 (35.7 to 82.7) | 83.3 (51.6 to 97.9) | 6.3 (0.2 to 30.2) |
| Day 336: ≥4-Fold Increase - Epithelial Cell | 100.0 (87.2 to 100.0) | 100.0 (91.0 to 100.0) | 100.0 (87.2 to 100.0) | 2.9 (NA to 15.3) | 85.7 (57.2 to 98.2) | 55.6 (30.8 to 78.5) | 75.0 (42.8 to 94.5) | 6.3 (0.2 to 30.2) |
| Day 504: ≥2-Fold Increase - Epithelial Cell | 100.0 (84.6 to 100.0) | 100.0 (90.3 to 100.0) | 100.0 (85.2 to 100.0) | 5.6 (0.7 to 18.7) | 92.9 (66.1 to 99.8) | 64.7 (38.3 to 85.8) | 81.8 (48.2 to 97.7) | 6.7 (0.2 to 31.9) |
| Day 504: ≥3-Fold Increase - Epithelial Cell | 100.0 (84.6 to 100.0) | 100.0 (90.3 to 100.0) | 100.0 (85.2 to 100.0) | 5.6 (0.7 to 18.7) | 78.6 (49.2 to 95.3) | 64.7 (38.3 to 85.8) | 63.9 (30.8 to 89.1) | 6.7 (0.2 to 31.9) |
| Day 504: ≥4-Fold Increase - Epithelial Cell | 100.0 (84.6 to 100.0) | 100.0 (90.3 to 100.0) | 100.0 (85.2 to 100.0) | 5.6 (0.7 to 18.7) | 50.0 (23.0 to 77.0) | 58.8 (32.9 to 81.5) | 54.5 (23.4 to 83.3) | 6.7 (0.2 to 31.9) |
| Day 29: ≥2-Fold Increase - Fibroblast | 63.6 (47.8 to 77.6) | 84.4 (73.1 to 92.2) | 81.6 (65.7 to 92.3) | 0 (0.0 to 7.0) | 46.7 (21.3 to 73.4) | 51.5 (33.5 to 69.2) | 69.2 (38.6 to 90.9) | 19.0 (5.4 to 41.9) |
| Day 29: ≥3-Fold Increase - Fibroblast | 61.4 (45.5 to 75.6) | 78.1 (66.0 to 87.5) | 76.3 (59.8 to 88.6) | 0 (0.0 to 7.0) | 20.0 (4.3 to 48.1) | 33.3 (18.0 to 51.8) | 38.5 (13.9 to 68.4) | 14.3 (3.0 to 36.3) |
| Day 29: ≥4-Fold Increase - Fibroblast | 54.5 (38.8 to 69.6) | 73.4 (60.9 to 83.7) | 73.7 (56.9 to 86.6) | 0 (0.0 to 7.0) | 13.3 (1.7 to 40.5) | 21.2 (9.0 to 38.9) | 23.1 (5.0 to 53.8) | 14.3 (3.0 to 36.3) |
| Day 56: ≥2-Fold Increase - Fibroblast | 50.0 (33.4 to 66.6) | 66.7 (51.6 to 79.6) | 77.1 (59.9 to 89.6) | 0 (0.0 to 8.6) | 40.0 (16.3 to 67.7) | 36.0 (18.0 to 57.5) | 27.3 (6.0 to 61.0) | 23.5 (6.8 to 49.9) |
| Day 56: ≥3-Fold Increase - Fibroblast | 44.7 (28.6 to 61.7) | 62.5 (47.4 to 76.0) | 68.6 (50.7 to 83.1) | 0 (0.0 to 8.6) | 33.3 (11.8 to 61.6) | 28.0 (12.1 to 49.4) | 27.3 (6.0 to 61.0) | 23.5 (6.8 to 49.9) |
| Day 56: ≥4-Fold Increase - Fibroblast | 28.9 (15.4 to 45.9) | 58.3 (43.2 to 72.4) | 65.7 (47.8 to 80.9) | 0 (0.0 to 8.6) | 20.0 (4.3 to 48.1) | 20.0 (6.8 to 40.7) | 18.2 (2.3 to 51.8) | 11.8 (1.5 to 36.4) |
| Day 84: ≥2-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (93.6 to 100.0) | 100.0 (90.3 to 100.0) | 0 (0.0 to 7.7) | 53.3 (26.6 to 78.7) | 55.2 (35.7 to 73.6) | 53.8 (25.1 to 80.8) | 31.6 (12.6 to 56.6) |
| Day 84: ≥3-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (93.6 to 100.0) | 100.0 (90.3 to 100.0) | 0 (0.0 to 7.7) | 26.7 (7.8 to 55.1) | 27.6 (12.8 to 48.2) | 15.4 (1.9 to 45.4) | 26.3 (9.1 to 51.2) |
| Day 84: ≥4-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (93.6 to 100.0) | 100.0 (90.3 to 100.0) | 0 (0.0 to 7.7) | 26.7 (7.8 to 55.1) | 13.8 (3.9 to 31.7) | 15.4 (1.9 to 45.4) | 15.8 (3.4 to 39.6) |
| Day 168: ≥2-Fold Increase - Fibroblast | 96.9 (83.8 to NA) | 97.2 (85.5 to NA) | 100.0 (87.7 to 100.0) | 3.1 (NA to 16.2) | 42.9 (17.7 to 71.1) | 26.3 (9.1 to 51.2) | 40.0 (12.2 to 73.8) | 30.8 (9.1 to 61.4) |
| Day 168: ≥3-Fold Increase - Fibroblast | 90.6 (75.0 to 98.0) | 97.2 (85.5 to NA) | 100.0 (87.7 to 100.0) | 3.1 (NA to 16.2) | 28.6 (8.4 to 58.1) | 15.8 (3.4 to 39.6) | 30.0 (6.7 to 65.2) | 30.8 (9.1 to 61.4) |
| Day 168: ≥4-Fold Increase - Fibroblast | 90.6 (75.0 to 98.0) | 94.4 (81.3 to 99.3) | 100.0 (87.7 to 100.0) | 3.1 (NA to 16.2) | 14.3 (1.8 to 42.8) | 10.5 (1.3 to 33.1) | 10.0 (0.3 to 44.5) | 23.1 (5.0 to 53.8) |
| Day 196: ≥2-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (91.2 to 100.0) | 100.0 (87.2 to 100.0) | 0 (0.0 to 9.5) | 53.8 (25.1 to 80.8) | 37.5 (18.8 to 59.4) | 36.4 (10.9 to 69.2) | 35.3 (14.2 to 61.7) |
| Day 196: ≥3-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (91.2 to 100.0) | 100.0 (87.2 to 100.0) | 0 (0.0 to 9.5) | 23.1 (5.0 to 53.8) | 20.8 (7.1 to 42.2) | 27.3 (6.0 to 61.0) | 23.5 (6.8 to 49.9) |
| Day 196: ≥4-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (91.2 to 100.0) | 100.0 (87.2 to 100.0) | 0 (0.0 to 9.5) | 15.4 (1.9 to 45.4) | 16.7 (4.7 to 37.4) | 18.2 (2.3 to 51.8) | 17.6 (3.8 to 43.4) |
| Day 336: ≥2-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (91.0 to 100.0) | 100.0 (87.2 to 100.0) | 2.9 (NA to 15.3) | 57.1 (28.9 to 82.3) | 27.8 (9.7 to 53.5) | 33.3 (9.9 to 65.1) | 25.0 (7.3 to 52.4) |
| Day 336: ≥3-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (91.0 to 100.0) | 100.0 (87.2 to 100.0) | 2.9 (NA to 15.3) | 21.4 (4.7 to 50.8) | 11.1 (1.4 to 34.7) | 33.3 (9.9 to 65.1) | 25.0 (7.3 to 52.4) |
| Day 336: ≥4-Fold Increase - Fibroblast | 100.0 (87.2 to 100.0) | 100.0 (91.0 to 100.0) | 100.0 (87.2 to 100.0) | 2.9 (NA to 15.3) | 14.3 (1.8 to 42.8) | 0 (0.0 to 18.5) | 33.3 (9.9 to 65.1) | 18.8 (4.0 to 45.6) |
| Day 504: ≥2-Fold Increase - Fibroblast | 90.9 (70.8 to 98.9) | 97.2 (85.5 to NA) | 100.0 (85.2 to 100.0) | 8.3 (1.8 to 22.5) | 42.9 (17.7 to 71.1) | 23.5 (6.8 to 49.9) | 27.3 (6.0 to 61.0) | 40.0 (16.3 to 67.7) |
| Day 504: ≥3-Fold Increase - Fibroblast | 90.9 (70.8 to 98.9) | 91.7 (77.5 to 98.2) | 100.0 (85.2 to 100.0) | 5.6 (0.7 to 18.7) | 14.3 (1.8 to 42.8) | 0 (0.0 to 19.5) | 9.1 (0.2 to 41.3) | 26.7 (7.8 to 55.1) |
| Day 504: ≥4-Fold Increase - Fibroblast | 90.9 (70.8 to 98.9) | 91.7 (77.5 to 98.2) | 100.0 (85.2 to 100.0) | 5.6 (0.7 to 18.7) | 14.3 (1.8 to 42.8) | 0 (0.0 to 19.5) | 9.1 (0.2 to 41.3) | 20.0 (4.3 to 48.1) |
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-pentameric gH/gL/UL128/UL130/UL131A glycoprotein complex (Pentamer)-specific IgG binding was measured with ELISA. The GMT measures the level of inhibition of anti-gB-specific IgG (anti-gB) and anti-Pentamer-specific IgG (anti-Pentamer) against cytomegalovirus. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| titer | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Baseline (Day 1): Anti-gB | 17.50 (NA to NA) | 18.20 (16.83 to 19.68) | 17.50 (NA to NA) | 17.50 (NA to NA) | 1146.61 (367.95 to 3573.08) | 2631.32 (1611.38 to 4296.84) | 2981.12 (1649.35 to 5388.25) | 2948.18 (1683.25 to 5163.69) |
| Day 29: Anti-gB | 19.05 (17.53 to 20.70) | 21.73 (18.85 to 25.06) | 19.65 (17.79 to 21.71) | 17.50 (NA to NA) | 2121.17 (645.07 to 6974.73) | 4849.42 (2999.05 to 7841.45) | 6754.86 (3799.57 to 12008.74) | 3494.48 (2417.72 to 5050.78) |
| Day 56: Anti-gB | 17.82 (17.18 to 18.49) | 24.44 (19.20 to 31.12) | 18.53 (17.06 to 20.12) | 19.95 (15.31 to 25.98) | 1998.18 (627.93 to 6358.51) | 4383.36 (2308.90 to 8321.64) | 5908.63 (3097.70 to 11270.27) | 4422.21 (3147.66 to 6212.85) |
| Day 84: Anti-gB | 339.83 (234.71 to 492.04) | 480.55 (360.83 to 639.99) | 347.45 (268.76 to 449.18) | 17.50 (NA to NA) | 3699.02 (2149.36 to 6365.94) | 4708.14 (3215.43 to 6893.83) | 8112.05 (5108.43 to 12881.71) | 3782.90 (2685.71 to 5328.32) |
| Day 168: Anti-gB | 83.84 (57.61 to 122.00) | 133.80 (90.44 to 197.94) | 107.28 (75.34 to 152.76) | 18.63 (16.40 to 21.17) | 3384.91 (1634.19 to 7011.21) | 5137.05 (3042.33 to 8674.05) | 10702.55 (6307.14 to 18161.07) | 3235.25 (2174.90 to 4812.58) |
| Day 196: Anti-gB | 1154.82 (848.30 to 1572.11) | 962.89 (680.53 to 1362.42) | 937.17 (686.85 to 1278.70) | 17.50 (NA to NA) | 4143.99 (2473.48 to 6942.73) | 4971.82 (3291.99 to 7508.85) | 10115.96 (5983.30 to 17103.06) | 3274.52 (2314.97 to 4631.80) |
| Day 336: Anti-gB | 296.60 (197.73 to 444.92) | 396.96 (269.50 to 584.72) | 261.98 (195.16 to 351.69) | 20.52 (14.85 to 28.35) | 3746.85 (1860.42 to 7546.09) | 4130.37 (2426.85 to 7029.68) | 8915.36 (5714.18 to 13909.90) | 3193.29 (2049.62 to 4975.11) |
| Day 504: Anti-gB | 170.25 (103.18 to 280.91) | 225.31 (128.30 to 395.70) | 156.47 (107.51 to 227.73) | 20.62 (14.78 to 28.79) | 2745.18 (1311.43 to 5784.14) | 3037.74 (1743.56 to 5292.56) | 7665.63 (5045.24 to 11646.99) | 3491.80 (2449.26 to 4978.11) |
| Baseline (Day 1): Anti-Pentamer | 24.0 (NA to NA) | 24.0 (NA to NA) | 24.0 (NA to NA) | 24.0 (NA to NA) | 334.7 (143.4 to 781.2) | 412.1 (283.7 to 598.7) | 496.3 (273.1 to 902.2) | 374.4 (225.8 to 620.7) |
| Day 29: Anti-Pentamer | 165.8 (113.1 to 243.1) | 148.9 (105.7 to 209.6) | 518.7 (381.3 to 705.7) | 24.5 (23.5 to 25.6) | 1905.20 (836.5 to 4339.2) | 4114.8 (2790.1 to 6068.5) | 4655.2 (3036.5 to 7136.8) | 377.7 (241.6 to 590.5) |
| Day 56: Anti-Pentamer | 110.1 (75.3 to 161.0) | 112.1 (76.2 to 164.9) | 278.3 (202.4 to 382.5) | 24.0 (NA to NA) | 1371.3 (627.0 to 2998.9) | 3017.4 (1699.1 to 5358.6) | 3476.4 (2259.2 to 5349.4) | 534.8 (327.2 to 874.2) |
| Day 84: Anti-Pentamer | 5750.0 (4006.7 to 8251.8) | 3165.2 (2112.9 to 4741.7) | 5841.8 (4481.9 to 7614.3) | 24.0 (NA to NA) | 3378.1 (2377.3 to 4800.3) | 4159.7 (2770.0 to 6246.7) | 4556.1 (3063.5 to 6775.9) | 469.9 (294.3 to 750.1) |
| Day 168: Anti-Pentamer | 573.1 (387.6 to 847.3) | 597.0 (393.9 to 905.0) | 661.6 (468.8 to 933.6) | 26.2 (21.9 to 31.5) | 2139.1 (1240.2 to 3689.7) | 2447.0 (1485.4 to 4031.0) | 2831.4 (1932.1 to 4149.3) | 456.6 (242.1 to 861.4) |
| Day 196: Anti-Pentamer | 5572.6 (3871.2 to 8021.9) | 3709.7 (2273.7 to 6052.5) | 6512.6 (4542.7 to 9336.7) | 24.0 (NA to NA) | 3349.3 (2009.3 to 5582.8) | 2891.7 (2014.5 to 4150.8) | 3239.1 (2121.4 to 4945.8) | 369.8 (220.3 to 620.7) |
| Day 336: Anti-Pentamer | 1230.0 (810.2 to 1867.5) | 1623.5 (1127.0 to 2338.7) | 1458.9 (943.3 to 2255.9) | 28.0 (20.5 to 38.2) | 1629.3 (993.9 to 2670.8) | 2314.9 (1364.4 to 3927.3) | 2177.7 (1715.9 to 2763.9) | 508.8 (262.8 to 985.2) |
| Day 504: Anti-Pentamer | 508.9 (313.1 to 827.2) | 815.9 (553.1 to 1203.6) | 796.5 (496.9 to 1276.6) | 27.1 (21.1 to 34.8) | 1020.9 (618.6 to 1684.8) | 1361.5 (919.0 to 2017.0) | 1644.4 (1232.2 to 2194.4) | 381.6 (214.1 to 680.2) |
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Number Analyzed = participants who were evaluable at specified timepoints.
| Ratio | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Day 29: Anti-gB | 1.088 (1.002 to 1.183) | 1.194 (1.044 to 1.365) | 1.123 (1.016 to 1.241) | 1.000 (NA to NA) | 1.850 (1.283 to 2.666) | 1.873 (1.522 to 2.305) | 2.128 (1.529 to 2.962) | 1.242 (0.794 to 1.943) |
| Day 56: Anti-gB | 1.018 (0.981 to 1.057) | 1.326 (1.089 to 1.615) | 1.059 (0.975 to 1.150) | 1.140 (0.875 to 1.485) | 1.743 (1.243 to 2.443) | 1.746 (1.449 to 2.104) | 1.954 (1.349 to 2.831) | 1.361 (0.777 to 2.386) |
| Day 84: Anti-gB | 19.419 (13.412 to 28.116) | 26.259 (19.197 to 35.919) | 19.854 (15.357 to 25.668) | 1.000 (NA to NA) | 3.226 (1.552 to 6.705) | 1.969 (1.495 to 2.593) | 2.863 (1.877 to 4.368) | 1.310 (0.796 to 2.158) |
| Day 168: Anti-gB | 4.791 (3.292 to 6.971) | 7.132 (4.867 to 10.451) | 6.130 (4.305 to 8.729) | 1.065 (0.937 to 1.210) | 3.397 (1.441 to 8.012) | 1.535 (1.225 to 1.924) | 3.408 (1.578 to 7.359) | 1.208 (0.580 to 2.515) |
| Day 196: Anti-gB | 65.990 (48.474 to 89.835) | 51.684 (33.457 to 79.840) | 53.552 (39.249 to 73.069) | 1.000 (NA to NA) | 4.210 (1.489 to 11.904) | 1.746 (1.392 to 2.192) | 3.466 (1.748 to 6.869) | 1.217 (0.684 to 2.165) |
| Day 336: Anti-gB | 16.949 (11.299 to 25.424) | 21.273 (13.981 to 32.368) | 14.971 (11.152 to 20.097) | 1.172 (0.848 to 1.620) | 3.761 (1.475 to 9.589) | 1.308 (0.704 to 2.431) | 3.009 (1.740 to 5.205) | 1.251 (0.595 to 2.628) |
| Day 504: Anti-gB | 9.728 (5.896 to 16.052) | 12.875 (7.331 to 22.611) | 8.941 (6.144 to 13.013) | 1.179 (0.844 to 1.645) | 2.764 (1.171 to 6.529) | 1.006 (0.529 to 1.914) | 2.535 (1.370 to 4.691) | 1.413 (0.748 to 2.668) |
| Day 29: Anti-Pentamer | 6.91 (4.71 to 10.13) | 6.20 (4.41 to 8.73) | 21.61 (15.89 to 29.40) | 1.02 (0.98 to 1.07) | 5.69 (3.32 to 9.77) | 10.00 (6.66 to 15.00) | 8.01 (4.19 to 15.34) | 1.09 (0.84 to 1.40) |
| Day 56: Anti-Pentamer | 4.59 (3.14 to 6.71) | 4.67 (3.17 to 6.87) | 11.59 (8.43 to 15.94) | 1.00 (NA to NA) | 4.10 (2.51 to 6.69) | 7.41 (5.02 to 10.93) | 6.60 (3.33 to 13.07) | 1.15 (0.83 to 1.59) |
| Day 84: Anti-Pentamer | 239.58 (166.94 to 343.82) | 131.88 (88.04 to 197.57) | 243.41 (186.74 to 317.26) | 1.00 (NA to NA) | 10.09 (4.21 to 24.20) | 9.82 (6.96 to 13.85) | 10.21 (5.09 to 20.46) | 1.22 (0.90 to 1.66) |
| Day 168: Anti-Pentamer | 23.88 (16.15 to 35.31) | 24.88 (16.41 to 37.71) | 27.56 (19.53 to 38.90) | 1.09 (0.91 to 1.31) | 6.24 (2.46 to 15.79) | 4.84 (3.28 to 7.15) | 5.39 (2.32 to 12.54) | 0.94 (0.67 to 1.30) |
| Day 196: Anti-Pentamer | 232.19 (161.30 to 334.25) | 154.57 (94.74 to 252.19) | 271.36 (189.28 to 389.03) | 1.00 (NA to NA) | 8.81 (3.09 to 25.09) | 6.30 (4.50 to 8.81) | 6.84 (3.66 to 12.79) | 0.99 (0.74 to 1.31) |
| Day 336: Anti-Pentamer | 51.25 (33.76 to 77.81) | 67.64 (46.96 to 97.45) | 60.79 (39.31 to 93.99) | 1.17 (0.85 to 1.59) | 4.75 (2.05 to 11.01) | 4.97 (2.84 to 8.96) | 4.43 (2.39 to 8.23) | 1.38 (0.85 to 2.26) |
| Day 504: Anti-Pentamer | 21.20 (13.04 to 34.47) | 34.00 (23.05 to 50.15) | 33.19 (20.70 to 53.19) | 1.13 (0.88 to 1.45) | 2.98 (1.47 to 6.02) | 2.86 (1.83 to 4.48) | 3.12 (1.59 to 6.12) | 1.08 (0.73 to 1.60) |
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| titer | Seronegative mRNA-1647 - Total | Seropositive mRNA-1647 - Total |
|---|---|---|
| Baseline (Day 1): Epithelial Cell | 8.0 (8 to 8) | 4320.2 (2826.0 to 6604.4) |
| Day 29: Epithelial Cell | 1831.4 (1389.5 to 2414.0) | 63523.6 (41451.0 to 97350.0) |
| Day 56: Epithelial Cell | 1012.5 (771.5 to 1328.7) | 49108.9 (29931.2 to 80574.4) |
| Day 84: Epithelial Cell | 49657.3 (40590.4 to 60749.5) | 96749.5 (73584.9 to 127206.3) |
| Day 168: Epithelial Cell | 9491.4 (7416.5 to 12146.6) | 51869.1 (37732.0 to 71302.9) |
| Day 196: Epithelial Cell | 119972.6 (97209.9 to 148065.5) | 90790.0 (66884.6 to 123239.5) |
| Day 336: Epithelial Cell | 21792.6 (17628.4 to 26940.5) | 38677.5 (29211.0 to 51211.9) |
| Day 504: Epithelial Cell | 12230.4 (9633.5 to 15527.2) | 26187.0 (19029.4 to 36036.8) |
| Baseline (Day 1): Fibroblast | 8.0 (NA to NA) | 4421.5 (2902.5 to 6735.4) |
| Day 29: Fibroblast | 114.7 (86.1 to 152.7) | 10857.7 (7600.8 to 15510.2) |
| Day 56: Fibroblast | 60.5 (44.4 to 82.3) | 8615.0 (5603.4 to 13245.1) |
| Day 84: Fibroblast | 4252.5 (3634.6 to 4974.1) | 10775.2 (8944.2 to 12981.0) |
| Day 168: Fibroblast | 467.1 (363.4 to 600.3) | 10226.2 (7702.8 to 13576.2) |
| Day 196: Fibroblast | 3460.1 (2941.4 to 4070.3) | 9909.0 (7954.2 to 12344.1) |
| Day 336: Fibroblast | 1153.8 (919.1 to 1448.4) | 9373.9 (7269.0 to 12088.3) |
| Day 504: Fibroblast | 610.5 (447.6 to 832.6) | 7860.4 (5883.2 to 10502.2) |
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| Ratio | Seronegative mRNA-1647 - Total | Seropositive mRNA-1647 - Total |
|---|---|---|
| Day 29: Epithelial Cell | 228.93 (173.68 to 301.75) | 14.76 (10.42 to 20.91) |
| Day 56: Epithelial Cell | 126.56 (96.43 to 166.09) | 13.63 (9.64 to 19.29) |
| Day 84: Epithelial Cell | 6207.16 (5073.80 to 7593.69) | 25.47 (16.56 to 39.18) |
| Day 168: Epithelial Cell | 1186.42 (927.07 to 1518.32) | 12.61 (7.70 to 20.65) |
| Day 196: Epithelial Cell | 14996.58 (12151.23 to 18508.18) | 20.73 (12.44 to 34.53) |
| Day 336: Epithelial Cell | 2724.07 (2203.55 to 3367.56) | 8.86 (5.39 to 14.56) |
| Day 504: Epithelial Cell | 1528.80 (1204.19 to 1940.90) | 6.40 (3.92 to 10.44) |
| Day 29: Fibroblast | 14.33 (10.76 to 19.08) | 2.47 (2.00 to 3.05) |
| Day 56: Fibroblast | 7.56 (5.55 to 10.29) | 2.04 (1.66 to 2.49) |
| Day 84: Fibroblast | 531.57 (454.45 to 621.77) | 2.58 (1.81 to 3.67) |
| Day 168: Fibroblast | 58.39 (45.43 to 75.04) | 2.23 (1.46 to 3.40) |
| Day 196: Fibroblast | 432.51 (367.67 to 508.79) | 2.24 (1.49 to 3.37) |
| Day 336: Fibroblast | 144.22 (114.88 to 181.05) | 2.14 (1.40 to 3.27) |
| Day 504: Fibroblast | 76.31 (55.95 to 104.08) | 1.77 (1.17 to 5.70) |
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z \* the LLOQ for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
| percentage of participants | Seronegative mRNA-1647 - Total | Seropositive mRNA-1647 - Total |
|---|---|---|
| Day 29: ≥2-Fold Increase - Epithelial Cell | 95.9 (91.3 to 98.5) | 93.4 (84.1 to 98.2) |
| Day 29: ≥3-Fold Increase - Epithelial Cell | 95.2 (90.4 to 98.1) | 88.5 (77.8 to 95.3) |
| Day 29: ≥4-Fold Increase - Epithelial Cell | 95.2 (90.4 to 98.1) | 85.2 (73.8 to 93.0) |
| Day 56: ≥2-Fold Increase - Epithelial Cell | 96.7 (91.8 to 99.1) | 96.1 (86.5 to 99.5) |
| Day 56: ≥3-Fold Increase - Epithelial Cell | 95.0 (89.5 to 98.2) | 90.2 (78.6 to 96.7) |
| Day 56: ≥4-Fold Increase - Epithelial Cell | 93.4 (87.4 to 97.1) | 84.3 (71.4 to 93.0) |
| Day 84: ≥2-Fold Increase - Epithelial Cell | 100.0 (96.9 to 100.0) | 100.0 (93.7 to 100.0) |
| Day 84: ≥3-Fold Increase - Epithelial Cell | 100.0 (96.9 to 100.0) | 100.0 (93.7 to 100.0) |
| Day 84: ≥4-Fold Increase - Epithelial Cell | 100.0 (96.9 to 100.0) | 96.5 (87.9 to 99.6) |
| Day 168: ≥2-Fold Increase - Epithelial Cell | 99.0 (94.3 to NA) | 97.7 (87.7 to NA) |
| Day 168: ≥3-Fold Increase - Epithelial Cell | 99.0 (94.3 to NA) | 83.7 (69.3 to 93.2) |
| Day 168: ≥4-Fold Increase - Epithelial Cell | 99.0 (94.3 to NA) | 76.7 (61.4 to 88.2) |
| Day 196: ≥2-Fold Increase - Epithelial Cell | 100.0 (96.2 to 100.0) | 97.9 (88.9 to NA) |
| Day 196: ≥3-Fold Increase - Epithelial Cell | 100.0 (96.2 to 100.0) | 93.8 (82.8 to 98.7) |
| Day 196: ≥4-Fold Increase - Epithelial Cell | 100.0 (96.2 to 100.0) | 87.5 (74.8 to 95.3) |
| Day 336: ≥2-Fold Increase - Epithelial Cell | 100.0 (96.1 to 100.0) | 86.4 (72.6 to 94.8) |
| Day 336: ≥3-Fold Increase - Epithelial Cell | 100.0 (96.1 to 100.0) | 75.0 (59.7 to 86.8) |
| Day 336: ≥4-Fold Increase - Epithelial Cell | 100.0 (96.1 to 100.0) | 70.5 (54.8 to 83.2) |
| Day 504: ≥2-Fold Increase - Epithelial Cell | 100.0 (95.5 to 100.0) | 78.6 (63.2 to 89.7) |
| Day 504: ≥3-Fold Increase - Epithelial Cell | 100.0 (95.5 to 100.0) | 69.0 (52.9 to 82.4) |
| Day 504: ≥4-Fold Increase - Epithelial Cell | 100.0 (95.5 to 100.0) | 54.8 (38.7 to 70.2) |
| Day 29: ≥2-Fold Increase - Fibroblast | 77.4 (69.7 to 83.9) | 54.1 (40.8 to 66.9) |
| Day 29: ≥3-Fold Increase - Fibroblast | 72.6 (64.6 to 79.7) | 31.1 (19.9 to 44.3) |
| Day 29: ≥4-Fold Increase - Fibroblast | 67.8 (59.6 to 75.3) | 19.7 (10.6 to 31.8) |
| Day 56: ≥2-Fold Increase - Fibroblast | 64.5 (55.2 to 73.0) | 35.3 (22.4 to 49.9) |
| Day 56: ≥3-Fold Increase - Fibroblast | 58.7 (49.4 to 67.6) | 29.4 (17.5 to 43.8) |
| Day 56: ≥4-Fold Increase - Fibroblast | 51.2 (42.0 to 60.4) | 19.6 (9.8 to 33.1) |
| Day 84: ≥2-Fold Increase - Fibroblast | 100.0 (96.9 to 100.0) | 54.4 (40.7 to 67.6) |
| Day 84: ≥3-Fold Increase - Fibroblast | 100.0 (96.9 to 100.0) | 24.6 (14.1 to 37.8) |
| Day 84: ≥4-Fold Increase - Fibroblast | 100.0 (96.9 to 100.0) | 17.5 (8.7 to 29.9) |
| Day 168: ≥2-Fold Increase - Fibroblast | 97.9 (92.7 to 99.7) | 34.9 (21.0 to 50.9) |
| Day 168: ≥3-Fold Increase - Fibroblast | 95.8 (89.7 to 98.9) | 23.3 (11.8 to 38.6) |
| Day 168: ≥4-Fold Increase - Fibroblast | 94.8 (88.3 to 98.3) | 11.6 (3.9 to 25.1) |
| Day 196: ≥2-Fold Increase - Fibroblast | 100.0 (96.2 to 100.0) | 41.7 (27.6 to 56.8) |
| Day 196: ≥3-Fold Increase - Fibroblast | 100.0 (96.2 to 100.0) | 22.9 (12.0 to 37.3) |
| Day 196: ≥4-Fold Increase - Fibroblast | 100.0 (96.2 to 100.0) | 16.7 (7.5 to 30.2) |
| Day 336: ≥2-Fold Increase - Fibroblast | 100.0 (96.1 to 100.0) | 38.6 (24.4 to 54.5) |
| Day 336: ≥3-Fold Increase - Fibroblast | 100.0 (96.1 to 100.0) | 20.5 (9.8 to 35.3) |
| Day 336: ≥4-Fold Increase - Fibroblast | 100.0 (96.1 to 100.0) | 13.6 (5.2 to 27.4) |
| Day 504: ≥2-Fold Increase - Fibroblast | 96.3 (89.6 to 99.2) | 31.0 (17.6 to 47.1) |
| Day 504: ≥3-Fold Increase - Fibroblast | 93.8 (86.2 to 98.0) | 7.1 (1.5 to 19.5) |
| Day 504: ≥4-Fold Increase - Fibroblast | 93.8 (86.2 to 98.0) | 7.1 (1.5 to 19.5) |
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| titer | Seronegative mRNA-1647 - Total | Seropositive mRNA-1647 - Total |
|---|---|---|
| Baseline (Day 1): Anti-gB | 17.79 (17.22 to 18.38) | 2230.11 (1518.78 to 3274.58) |
| Day 29: Anti-gB | 20.35 (18.94 to 21.85) | 4246.74 (2852.16 to 6323.21) |
| Day 56: Anti-gB | 20.43 (18.47 to 22.59) | 3710.50 (2328.94 to 5911.61) |
| Day 84: Anti-gB | 402.71 (338.18 to 479.54) | 5002.29 (3862.97 to 6477.63) |
| Day 168: Anti-gB | 107.35 (86.61 to 133.05) | 5319.40 (3744.81 to 7556.07) |
| Day 196: Anti-gB | 1006.64 (833.96 to 1215.07) | 5569.16 (4230.24 to 7331.86) |
| Day 336: Anti-gB | 323.30 (261.11 to 400.30) | 4939.18 (3561.20 to 6850.36) |
| Day 504: Anti-gB | 188.26 (140.15 to 252.89) | 3746.71 (2640.32 to 5316.70) |
| Baseline (Day 1): Anti-Pentamer | 24.0 (NA to NA) | 410.0 (305.1 to 550.8) |
| Day 29: Anti-Pentamer | 212.8 (171.0 to 264.9) | 3495.7 (2587.4 to 4723.0) |
| Day 56: Anti-Pentamer | 145.0 (116.1 to 181.0) | 2466.9 (1705.9 to 3567.5) |
| Day 84: Anti-Pentamer | 4362.6 (3487.8 to 5456.6) | 4020.6 (3182.2 to 5079.9) |
| Day 168: Anti-Pentamer | 606.9 (487.5 to 755.4) | 2423.0 (1837.5 to 3195.1) |
| Day 196: Anti-Pentamer | 4901.2 (3809.7 to 6305.5) | 3088.3 (2452.5 to 3888.9) |
| Day 336: Anti-Pentamer | 1452.0 (1159.3 to 1818.7) | 2035.9 (1570.6 to 2369.1) |
| Day 504: Anti-Pentamer | 712.8 (556.0 to 913.9) | 1299.6 (1032.0 to 1636.6) |
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
| Ratio | Seronegative mRNA-1647 - Total | Seropositive mRNA-1647 - Total |
|---|---|---|
| Day 29: Anti-gB | 1.143 (1.068 to 1.223) | 1.919 (1.650 to 2.231) |
| Day 56: Anti-gB | 1.144 (1.052 to 1.243) | 1.788 (1.547 to 2.067) |
| Day 84: Anti-gB | 22.533 (18.754 to 27.073) | 2.442 (1.1911 to 3.120) |
| Day 168: Anti-gB | 5.976 (4.838 to 7.383) | 2.393 (1.712 to 3.346) |
| Day 196: Anti-gB | 56.010 (45.056 to 69.628) | 2.593 (1.867 to 3.603) |
| Day 336: Anti-gB | 17.984 (14.394 to 22.469) | 2.297 (1.523 to 3.467) |
| Day 504: Anti-gB | 10.758 (8.009 to 14.451) | 1.795 (1.188 to 2.712) |
| Day 29: Anti-Pentamer | 8.87 (7.12 to 11.04) | 8.30 (6.27 to 11.00) |
| Day 56: Anti-Pentamer | 6.04 (4.84 to 7.54) | 6.07 (4.63 to 7.95) |
| Day 84: Anti-Pentamer | 181.77 (145.33 to 227.36) | 9.98 (7.36 to 13.53) |
| Day 168: Anti-Pentamer | 25.29 (20.31 to 31.48) | 5.39 (3.75 to 7.75) |
| Day 196: Anti-Pentamer | 204.22 (158.74 to 262.73) | 7.03 (5.06 to 9.76) |
| Day 336: Anti-Pentamer | 60.50 (48.30 to 75.78) | 4.75 (3.32 to 6.79) |
| Day 504: Anti-Pentamer | 29.70 (23.17 to 38.08) | 2.97 (2.17 to 4.06) |
Collected over 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Seronegative mRNA-1647 (50 ug) | 0/45 (0%) | 0/45 (0%) | 40/45 (88.9%) |
| Seronegative mRNA-1647 (100 ug) | 0/72 (0%) | 1/72 (1.4%) | 67/72 (93.1%) |
| Seronegative mRNA-1647 (150 ug) | 0/45 (0%) | 0/45 (0%) | 44/45 (97.8%) |
| Seronegative Placebo | 0/53 (0%) | 0/53 (0%) | 38/53 (71.7%) |
| Seropositive mRNA-1647 (50 ug) | 0/18 (0%) | 0/18 (0%) | 18/18 (100%) |
| Seropositive mRNA-1647 (100 ug) | 0/37 (0%) | 1/37 (2.7%) | 36/37 (97.3%) |
| Seropositive mRNA-1647 (150 ug) | 0/18 (0%) | 0/18 (0%) | 18/18 (100%) |
| Seropositive Placebo | 0/27 (0%) | 0/27 (0%) | 20/27 (74.1%) |
| Event | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Follicular thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/45 | 0/72 | 0/45 | 0/53 | 0/18 | 1/37 | 0/18 | 0/27 |
| AnxietyPsychiatric disorders | 0/45 | 1/72 | 0/45 | 0/53 | 0/18 | 0/37 | 0/18 | 0/27 |
| DepressionPsychiatric disorders | 0/45 | 1/72 | 0/45 | 0/53 | 0/18 | 0/37 | 0/18 | 0/27 |
| Event | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo |
|---|---|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 37/45 | 62/72 | 44/45 | 18/53 | 17/18 | 36/37 | 17/18 | 5/27 |
| FatigueGeneral disorders | 26/45 | 50/72 | 37/45 | 24/53 | 17/18 | 28/37 | 15/18 | 9/27 |
| HeadacheNervous system disorders | 26/45 | 48/72 | 30/45 | 29/53 | 14/18 | 33/37 | 15/18 | 15/27 |
| MyalgiaMusculoskeletal and connective tissue disorders | 23/45 | 52/72 | 29/45 | 11/53 | 14/18 | 29/37 | 15/18 | 5/27 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/45 | 39/72 | 20/45 | 10/53 | 12/18 | 27/37 | 9/18 | 2/27 |
| ChillsGeneral disorders | 14/45 | 39/72 | 28/45 | 8/53 | 10/18 | 25/37 | 13/18 | 0/27 |
| VomitingGastrointestinal disorders | 12/45 | 24/72 | 15/45 | 5/53 | 7/18 | 17/37 | 8/18 | 4/27 |
| Injection site lymphadenopathyGeneral disorders | 9/45 | 27/72 | 16/45 | 6/53 | 6/18 | 16/37 | 8/18 | 3/27 |
| PyrexiaGeneral disorders | 5/45 | 13/72 | 10/45 | 1/53 | 4/18 | 9/37 | 8/18 | 0/27 |
| Injection site indurationGeneral disorders | 5/45 | 13/72 | 14/45 | 0/53 | 3/18 | 6/37 | 2/18 | 0/27 |
Randomized Set: all participants who were randomized in the study, regardless of the participant's treatment status in the study. Participants were included in the treatment group to which they were randomized.
| Age, Continuous(years) | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 29.6 ± 7.07 | 28.6 ± 6.88 | 28.7 ± 6.10 | 28.0 ± 6.67 | 34.3 ± 4.54 | 30.8 ± 6.53 | 33.1 ± 6.41 | 27.8 ± 6.32 | 29.4 ± 6.71 |
| Sex: Female, Male(Participants) | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 21 | 50 | 24 | 37 | 12 | 29 | 12 | 21 | 206 |
| Male | 24 | 23 | 21 | 18 | 6 | 7 | 6 | 4 | 109 |
| Ethnicity (NIH/OMB)(Participants) | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 12 | 11 | 10 | 1 | 7 | 1 | 8 | 55 |
| Not Hispanic or Latino | 40 | 60 | 34 | 45 | 17 | 29 | 17 | 17 | 259 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Seronegative mRNA-1647 (50 ug) | Seronegative mRNA-1647 (100 ug) | Seronegative mRNA-1647 (150 ug) | Seronegative Placebo | Seropositive mRNA-1647 (50 ug) | Seropositive mRNA-1647 (100 ug) | Seropositive mRNA-1647 (150 ug) | Seropositive Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
| Black or African American | 6 | 7 | 3 | 5 | 2 | 7 | 2 | 1 | 33 |
| White | 39 | 64 | 37 | 47 | 15 | 27 | 14 | 22 | 265 |
| More than one race | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 0 | 7 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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