A Phase 3 interventional study of Moderna COVID-19 Vaccine in SARS-CoV-2 Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 51 sites in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Prevention
The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine.
This study will evaluate the efficacy of the Moderna COVID-19 vaccine against SARS-CoV-2 infection, as well as its effect on peak nasal viral load as a measure of infection and a proxy of infectiousness, in adults aged 18-29.
In the Main study, up to 12,000 participants will be randomized 1:1 to Immediate Vaccination Group 1 (at Months 0 and 1) or Standard of Care Group 2, with vaccination given at Months 4 and 5 if not received off-study previously. Up to an additional 6,000 participants will be enrolled into the Vaccine Declined Group 3 and will also be offered vaccine at Months 4 and 5.
Additional study visits for Group 1 will occur at Months 2 and 4; for Groups 2 and 3, at Months 0 and 2. Study visits may include medical history, vaccine injections, blood collection, nasal swab, SARS-CoV-2 screening, COVID-19 symptom check, and questionnaires.
In addition to the main study participants, the study will also evaluate infectiousness following close contacts with main study participants. Study procedures for close contacts include questionnaires and blood samples; for those who become SARS-CoV-2 infected, study procedures will also include nasal swabs.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,923 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Inclusion criteria for Main cohort, Vaccine Declined Group General and Demographic Criteria
Exclusion criteria for Main cohort, Vaccine Declined Group
Inclusion criteria for Prospective Close Contact (PCC) cohort
Inclusion criteria for Case-ascertained Close Contact (CACC) cohort
Prolonged close physical proximity with Main Cohort participant within a residence/vehicle/enclosed space without maintaining social distance,
Medical staff, first responders, or other care persons who cared for the index case without appropriate personal protective equipment.
Further information on the definition of close contact can be found in the CoVPN 3006 Study Specific Procedures (SSP).
Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29.
Biological: Moderna COVID-19 Vaccine
Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141.
Biological: Moderna COVID-19 Vaccine
Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study
A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.
Also known as: mRNA-1273
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection
Incidence of SARS-CoV-2 infection diagnosed by study PCR among baseline negative participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.
Time frame: Measured through Month 4 study visit
Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load
As a measure of infection and a proxy of infectiousness, mean observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.
Time frame: Measured through Month 4 study visit
Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load
As a measure of infection and a proxy of infectiousness, median observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.
Time frame: Measured through Month 4 study visit
Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms
Incidence of study PCR-confirmed SARS-CoV-2 infection and concurrent symptoms captured by daily or weekly symptom reporting (at least one of the following: hospitalization, fever, chills, cough, shortness of breath, difficulty breathing, tiredness/fatigue, muscle aches, joint aches, body aches, headache, change in sense of taste, change in sense of smell, sore throat, nasal congestion, runny nose, nausea, vomiting, diarrhea, oral ulcers and clinical or radiographical evidence of pneumonia) among baseline negative participants. Exposure starting from first study PCR and censored at last PCR/outside vaccination. Participants without concurrent symptom data were assumed not symptomatic and were additionally censored at SARS-CoV-2 infection. Exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.
Time frame: Measured through Month 4 study visit
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity
Incidence of SARS-CoV-2 infection diagnosed by study PCR among FAS-P participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.
Time frame: Measured through Month 4 study visit
Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection
Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment
Time frame: Measured through Month 4 study visit
Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection
Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment
Time frame: Measured through Month 4 study visit
Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms
Evaluated by SARS-CoV-2 infection confirmed by PCR among participants who were SARS-CoV-2 seronegative at enrollment; reporting at least 2 of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome
Time frame: Measured through Month 4 study visit
Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time
Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection who were SARS-CoV-2 seronegative at enrollment
Time frame: Measured through Month 4 study visit
Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)
Evaluated by SARS-CoV-2 infection diagnosed by PCR
Time frame: Measured through Month 4 study visit
Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load)
Evaluated by peak viral load in nasal samples from diagnosed participants
Time frame: Measured through Month 4 study visit
Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events)
Evaluated by number of secondary transmission events in close-contact cohorts
Time frame: Measured through Month 4 study visit
Immunogenicity of Moderna COVID-19 Vaccine
Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
Time frame: Measured through Month 2
Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease
Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
Time frame: Measured through Month 2
Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection
SARS-CoV-2 infection by PCR or periodic serology
Time frame: Measured through Month 4 study visit
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease
SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
Time frame: Measured through Month 4 study visit
Effect of Moderna COVID-19 Vaccine on Viral Load
Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
Time frame: Measured through Month 4 study visit
Effect of Moderna COVID-19 Vaccine on Secondary Transmission
Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
Time frame: Measured through Month 4 study visit
| Milestone | Immediate Vaccination | Standard of Care | Vaccine Declined |
|---|---|---|---|
| Started | 725 | 728 | 470 |
| Full analysis set (fas) | 725 | 728 | 470 |
| Full analysis set with study pcr (fas-p) | 701 | 646 | 454 |
| Fas-p with outside vaccination censored incidence rate follow-up | 563 | 622 | 452 |
| Baseline negative | 600 | 549 | 311 |
| Baseline negative with outside vaccination censored incidence rate follow-up | 489 | 531 | 311 |
| Fas-p viral load | 22 | 23 | 44 |
| Completed | 571 | 450 | 255 |
| Not completed | 154 | 278 | 215 |
| Withdrew: Lost to follow-up | 78 | 125 | 46 |
| Withdrew: Withdrawal by subject | 39 | 76 | 12 |
| Withdrew: Participant unable to adhere to visit schedule | 6 | 13 | 17 |
| Withdrew: Participant is unwilling or unable to comply with required study | 24 | 47 | 16 |
| Withdrew: Protocol violation | 0 | 5 | 11 |
| Withdrew: Study terminated by sponsor | 4 | 3 | 34 |
| Withdrew: Early study closure | 3 | 7 | 79 |
| Withdrew: Other (unable to receive payment visa status) | 0 | 2 | 0 |
Incidence of SARS-CoV-2 infection diagnosed by study PCR among baseline negative participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.
| events per 100 person years | Immediate Vaccination | Standard of Care | Vaccine Declined |
|---|---|---|---|
| Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection | 12.2 (6.1 to 21.9) | 31.8 (20.3 to 47.2) | 89.6 (65.4 to 119.9) |
As a measure of infection and a proxy of infectiousness, mean observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.
| Cycle Thresholds | Immediate Vaccination | Standard of Care | Vaccine Declined |
|---|---|---|---|
| Lab:Corteva, Target:N1 | 25.8 (17.0 to 37.2) | 20.2 (14.6 to 35.8) | 22.3 (12.8 to 37.2) |
| Lab:Corteva, Target:N2 | 26.3 (17.3 to 38.2) | 20.7 (15.0 to 37.0) | 22.8 (13.2 to 37.5) |
| Lab:UW/Northwell, Target:N1 | 34.4 (31.3 to 37.5) | 28.8 (18.0 to 39.1) | 24.4 (16.0 to 38.3) |
| Lab:UW/Northwell, Target:N2 | 34.1 (34.1 to 34.1) | 30.5 (21.1 to 38.6) | 26.2 (18.8 to 34.9) |
As a measure of infection and a proxy of infectiousness, median observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.
| Cycle Thresholds | Immediate Vaccination | Standard of Care | Vaccine Declined |
|---|---|---|---|
| Lab:Corteva, Target:N1 | 23.9 (21.3 to 29.1) | 19.6 (16.9 to 21.6) | 21.0 (17.3 to 25.9) |
| Lab:Corteva, Target:N2 | 24.3 (21.9 to 29.5) | 20.0 (17.6 to 22.1) | 21.3 (18.2 to 26.2) |
| Lab:UW/Northwell, Target:N1 | 34.4 (32.9 to 35.9) | 29.4 (22.8 to 34.6) | 22.5 (19.0 to 29.2) |
| Lab:UW/Northwell, Target:N2 | 34.1 (34.1 to 34.1) | 31.2 (24.8 to 36.3) | 25.7 (22.1 to 31.1) |
Incidence of study PCR-confirmed SARS-CoV-2 infection and concurrent symptoms captured by daily or weekly symptom reporting (at least one of the following: hospitalization, fever, chills, cough, shortness of breath, difficulty breathing, tiredness/fatigue, muscle aches, joint aches, body aches, headache, change in sense of taste, change in sense of smell, sore throat, nasal congestion, runny nose, nausea, vomiting, diarrhea, oral ulcers and clinical or radiographical evidence of pneumonia) among baseline negative participants. Exposure starting from first study PCR and censored at last PCR/outside vaccination. Participants without concurrent symptom data were assumed not symptomatic and were additionally censored at SARS-CoV-2 infection. Exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.
| events per 100 person years | Immediate Vaccination | Standard of Care | Vaccine Declined |
|---|---|---|---|
| Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | 4.5 (1.2 to 11.4) | 18.5 (10.1 to 31.1) | 53.8 (35.5 to 78.3) |
Incidence of SARS-CoV-2 infection diagnosed by study PCR among FAS-P participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.
| events per 100 person years | Immediate Vaccination | Standard of Care | Vaccine Declined |
|---|---|---|---|
| Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity | 11.7 (6.0 to 20.4) | 28.3 (18.3 to 41.8) | 76.0 (57.4 to 98.7) |
Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment
No measurements were reported for this outcome.
Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment
No measurements were reported for this outcome.
Evaluated by SARS-CoV-2 infection confirmed by PCR among participants who were SARS-CoV-2 seronegative at enrollment; reporting at least 2 of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome
No measurements were reported for this outcome.
Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection who were SARS-CoV-2 seronegative at enrollment
No measurements were reported for this outcome.
Evaluated by SARS-CoV-2 infection diagnosed by PCR
No measurements were reported for this outcome.
Evaluated by peak viral load in nasal samples from diagnosed participants
No measurements were reported for this outcome.
Evaluated by number of secondary transmission events in close-contact cohorts
No measurements were reported for this outcome.
Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
No measurements were reported for this outcome.
Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
No measurements were reported for this outcome.
SARS-CoV-2 infection by PCR or periodic serology
No measurements were reported for this outcome.
SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
No measurements were reported for this outcome.
Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
No measurements were reported for this outcome.
Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
No measurements were reported for this outcome.
Collected over No adverse event information was collected during the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Vaccination | — | — | — |
| Standard of Care | — | — | — |
| Vaccine Declined | — | — | — |
Baseline Negative
| Age, Continuous(years) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| Median | 21 (18 to 29) | 21 (18 to 29) | 22 (18 to 29) | 21 (18 to 29) |
| Age, Customized(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| 18 - 22 years | 449 | 402 | 157 | 1008 |
| 23 - 26 years | 122 | 128 | 84 | 334 |
| 27 - 29 years | 29 | 19 | 70 | 118 |
| Sex/Gender, Customized(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| Man | 254 | 248 | 126 | 628 |
| Woman | 321 | 282 | 175 | 778 |
| Transgender Man | 3 | 1 | 1 | 5 |
| Transgender Woman | 0 | 1 | 0 | 1 |
| Gender Nonconforming/Gender Variant | 3 | 7 | 3 | 13 |
| Genderqueer | 3 | 1 | 0 | 4 |
| Other | 1 | 2 | 1 | 4 |
| Multiple | 10 | 7 | 1 | 18 |
| Unknown | 5 | 0 | 4 | 9 |
| Sex: Female, Male(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| Female | 341 | 294 | 184 | 819 |
| Male | 259 | 255 | 127 | 641 |
| Race/Ethnicity, Customized(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| Hispanic or Latino | 106 | 99 | 71 | 276 |
| Not Hispanic or Latino | 490 | 448 | 237 | 1175 |
| Race/Ethnicity, Customized(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 1 | 6 |
| Asian | 97 | 93 | 11 | 201 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 1 | 4 |
| Black or African American | 47 | 49 | 47 | 143 |
| White | 358 | 334 | 203 | 895 |
| More than one race | 52 | 43 | 26 | 121 |
| Other | 19 | 13 | 8 | 40 |
| Prefer not to answer | 23 | 13 | 14 | 50 |
| Region of Enrollment(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| USA | 600 | 549 | 311 | 1460 |
| Residence(Participants) | Immediate Vaccination | Standard of Care | Vaccine Declined | Total |
|---|---|---|---|---|
| Dormitory or campus housing | 87 | 78 | 21 | 186 |
| Fraternity or sorority house | 9 | 10 | 0 | 19 |
| Apartment building or condo | 285 | 258 | 146 | 689 |
| Stand-alone house (non-fraternity or sorority) | 190 | 178 | 128 | 496 |
| Shelter | 0 | 1 | 2 | 3 |
| RV / Trailer | 4 | 3 | 3 | 10 |
| Staying with friends / Couch surfing | 4 | 3 | 2 | 9 |
| No residence | 0 | 0 | 2 | 2 |
| Other | 21 | 18 | 6 | 45 |
14 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)