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CompletedNCT04064905Updated Aug 21, 2024Results posted

Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults

A Phase 1 interventional study of mRNA-1893 and Placebo in Zika Virus, sponsored by ModernaTX, Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants

02

Conditions studied

  • Zika Virus

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Keywords

  • mRNA-1893
  • zika vaccine
  • Moderna
03

In context

Zika Virus Infection

65 studies on the registry are indexed under Zika Virus Infection; 5 are open to participants now.

This study's enrollment of 120 is above the median of 85 across 36 interventional studies indexed under Zika Virus Infection.

Browse Zika Virus Infection studies →

Lead sponsor

ModernaTX, Inc. is the lead sponsor of 117 studies on the registry; 16 are open to participants now.

Of its 63 completed or terminated interventional studies of FDA-regulated products, 35 (56%) have results posted.

Browse ModernaTX, Inc. studies →All Moderna, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Agrees to comply with the study procedures and provides written informed consent
  • 18 to 49 years of age
  • In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete diary cards, return for follow-up visits, be available for safety telephone calls).
  • Is in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, and physical examination at screening.
  • Negative urine pregnancy test at the Screening visit and at the day of each vaccination for females of childbearing potential.
  • Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months following the last vaccination.
  • For flavivirus-seropositive group, has positive flavivirus test results (including dengue, West Nile, and Zika) as determined by enzyme-linked immunosorbent assay (ELISA) or other commercially available serological assay.
  • For flavivirus-seronegative group, has negative flavivirus test results (including dengue, West Nile, and Zika) as determined by ELISA or other commercially available serological assay.

Exclusion criteria

Exclusion Criteria:

  • Has any acute or chronic, Clinically Significant disease in the opinion of the investigator.
  • Has received a vaccine for dengue, Japanese encephalitis, tick-borne encephalitis, West Nile, Yellow Fever, or Zika.
  • Has a neurologic disorder
  • Has a body mass index that is ≤ 18 or ≥ 35 kg/m2.
  • Has elevated liver function tests
  • Has clinical laboratory test results (hematology, serum chemistry, or coagulation) with a toxicity score of Grade ≥ 1 at Screening.
  • Has a bleeding disorder that would contraindicate IM injections or phlebotomy.
  • Reports a diagnosis of congenital or acquired immunodeficiency (including HIV infection), or autoimmune disease.
  • Has a history of hypersensitivity or severe reactions to previous vaccinations or any component of the study vaccine.
  • Has a history of idiopathic urticaria.
  • Reports a previous diagnosis of hematologic malignancy or pre-malignancy or a diagnosis of any other malignancy within the previous 10 years (excluding nonmelanoma skin cancer).
  • Has a medical, psychiatric, or occupational condition that, in the opinion of the investigator, might pose an additional risk to the participant due to participation in the study or would interfere with the evaluation of the study vaccines or the interpretation of study results.
  • Is acutely ill or febrile on the day of screening (Day 0) or randomization (Day 1).
  • Has a history of inflammatory arthritis.
  • Has a history of febrile disease with arthritis or arthralgia within 2 weeks of administration of any study vaccine.
  • Has received an investigational or nonregistered product (drug or vaccine) within 30 days before the first dose of study vaccine or has plans for administration during the study period.
  • Has received or is scheduled to receive an inactivated vaccine within the period from 14 days before, or through 14 days after, administration of any study vaccination.
  • Has received or is scheduled to receive a live virus vaccine administered within the period from 28 days before, or through 28 days after, any dose of study vaccine.
  • Has received chronic administration (defined as > 14 total days) of immunosuppressants or other immune-modifying drugs within 6 months before the first study vaccine dose.
  • Has received immunoglobulins and/or blood products within the 3 months before the first study vaccine dose or has plans for administration during the study period.
  • Has a positive test result at the Screening Visit for hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or 2 antibodies.
  • Has donated > 450 mL of whole blood or blood products within 30 days of enrollment or plans to do so during the study period.
  • Is an immediate family member or household member of study personnel.
  • Previously participated in an investigational study involving LNPs.
  • Has a positive urine drug screen result at Screening for any of the following nonprescription drugs of abuse: amphetamines, benzodiazepines, cocaine, methadone, opiates, and phencyclidine.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    mRNA-1893

    Biological: mRNA-1893

  • Placebo comparator
    Placebo

    0.9% sodium chloride

    Other: Placebo

Interventions

  • BiologicalmRNA-1893

    Zika vaccine

  • OtherPlacebo

    0.9% sodium chloride

06

What researchers measure

Primary outcomes

  1. Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination

    Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

    Time frame: Up to Day 7 after first vaccination (up to 8 days)

  2. Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination

    Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

    Time frame: Up to Day 7 after second vaccination (Day 29 to Day 36)

  3. 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. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

    Time frame: Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)

  4. Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)

    An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

    Time frame: Day 1 to the end of study visit (up to Day 392)

Secondary outcomes

  1. Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

    GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

    Time frame: Day 1, 29, 57, Month 7 and 13

  2. Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

    GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

    Time frame: Day 1, 29, 57, Month 7 and 13

  3. Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

    GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

    Time frame: Day 1, 29, 57, Month 7 and 13

  4. Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13

    Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.

    Time frame: Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13.

  5. Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test

    Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.

    Time frame: Day 29, Day 57, Month 7, and Month 13

  6. Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test

    Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.

    Time frame: Day 29, Day 57, Month 7, and Month 13

07

Results

Posted Jun 17, 2024

Participant flow

Participant flow — Overall Study
MilestonePlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Started2424242424
Received first vaccination2424242424
Received second vaccination2423232424
Completed2421232022
Not completed03142
Withdrew: Lost to follow-up03142

Outcome measures

PrimaryNumber of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination

Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

Time frame:
Up to Day 7 after first vaccination (up to 8 days)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
ParticipantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Local ARs- Erythema (Redness)00012
Local ARs- Pain112121714
Local ARs- Swelling (Hardness)00001
Systemic ARs- Arthralgia12201
Systemic ARs- Chills01002
Systemic ARs- Fatigue38534
Systemic ARs- Fever01010
Systemic ARs- Headache47533
Systemic ARs- Myalgia25316
Systemic ARs- Nausea04330
Systemic ARs- Rash01000
PrimaryNumber of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination

Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

Time frame:
Up to Day 7 after second vaccination (Day 29 to Day 36)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
ParticipantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Local ARs- Erythema (Redness)00122
Local ARs- Pain28111514
Local ARs- Swelling (Hardness)00213
Systemic ARs- Arthralgia24497
Systemic ARs- Chills3151114
Systemic ARs- Fatigue36101013
Systemic ARs- Fever113711
Systemic ARs- Headache458913
Systemic ARs- Myalgia1741015
Systemic ARs- Nausea22145
Systemic ARs- Rash00010
PrimaryNumber 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. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

Time frame:
Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events (AEs)
ParticipantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Number of Participants With Unsolicited Adverse Events (AEs)1412131510
PrimaryNumber of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)

An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

Time frame:
Day 1 to the end of study visit (up to Day 392)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)
ParticipantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
SAEs30001
AESI00000
SecondaryGeometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

Time frame:
Day 1, 29, 57, Month 7 and 13
Reported as:
Geometric mean · Titer
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
TiterPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Day 19.1 (7.0 to 11.8)10.1 (7.2 to 14.1)8.9 (7.1 to 11.3)9.1 (7.0 to 11.9)8.0 (NA to NA)
Day 299.1 (6.9 to 12.0)13.6 (7.8 to 23.8)19.8 (11.5 to 33.8)54.6 (29.4 to 101.3)29.2 (17.2 to 49.3)
Day 579.3 (6.8 to 12.5)200.5 (121.1 to 331.9)267.2 (161.6 to 441.8)393.0 (273.1 to 565.7)230.0 (148.9 to 355.3)
Month 78.9 (7.1 to 11.1)42.7 (23.0 to 79.3)68.0 (39.7 to 116.3)174.8 (114.6 to 266.7)116.7 (75.4 to 180.6)
Month 139.0 (7.1 to 11.4)41.0 (21.7 to 77.4)47.8 (23.9 to 95.6)100.8 (56.3 to 180.4)100.2 (64.5 to 155.7)
SecondaryGeometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

Time frame:
Day 1, 29, 57, Month 7 and 13
Reported as:
Geometric mean · Titer
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
TiterPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Day 18.0 (NA to NA)8.0 (NA to NA)8.0 (NA to NA)8.0 (NA to NA)8.0 (NA to NA)
Day 298.0 (NA to NA)8.5 (7.5 to 9.5)14.4 (9.9 to 21.0)45.9 (23.4 to 89.9)27.6 (15.5 to 49.2)
Day 578.0 (NA to NA)195.6 (108.4 to 352.8)303.4 (195.5 to 470.9)454.2 (333.0 to 619.6)273.6 (195.3 to 383.2)
Month 78.0 (NA to NA)38.2 (20.0 to 73.0)66.7 (38.5 to 115.4)170.1 (112.1 to 258.0)137.7 (94.6 to 200.5)
Month 138.0 (NA to NA)35.0 (18.4 to 66.5)48.3 (23.0 to 101.7)112.3 (63.6 to 198.4)113.2 (77.7 to 164.9)
SecondaryGeometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

Time frame:
Day 1, 29, 57, Month 7 and 13
Reported as:
Geometric mean · Titer
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
TiterPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Day 117.0 (1.5 to 188.2)32.2 (2.5 to 417.7)15.2 (2.0 to 115.7)17.4 (1.5 to 203.9)8.0 (NA to NA)
Day 2917.8 (1.4 to 226.8)147.9 (6.2 to 3507.8)88.1 (3.6 to 2166.7)130.6 (13.0 to 1306.4)38.2 (3.7 to 398.6)
Day 5718.6 (1.3 to 270.5)224.1 (43.5 to 1153.5)150.9 (6.2 to 3699.1)190.5 (19.2 to 1887.2)100.9 (5.4 to 1886.3)
Month 715.2 (2.0 to 116.9)68.8 (3.6 to 1231.4)74.2 (4.0 to 1362.9)196.3 (18.3 to 2102.4)53.2 (3.7 to 774.9)
Month 1315.9 (1.8 to 142.9)77.6 (3.6 to 1670.2)45.6 (1.7 to 1237.6)60.9 (0.6 to 6248.0)59.6 (3.9 to 922.0)
SecondaryPercentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13

Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.

Time frame:
Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13.
Reported as:
Number · percentage of participants
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
percentage of participantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Day 1 (baseline) to Day 29012.547.875.066.7
Day 1 to Day 57090.995.5100.095.7
Day 1 to Month 7066.781.8100.095.7
Day 1 to Month 13060.061.994.195.2
SecondaryNumber of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test

Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.

Time frame:
Day 29, Day 57, Month 7, and Month 13
Reported as:
Count of participants · Participants
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
ParticipantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Day 290181413
Day 57017182019
Month 7012151719
Month 13010111417
SecondaryNumber of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test

Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.

Time frame:
Day 29, Day 57, Month 7, and Month 13
Reported as:
Count of participants · Participants
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
ParticipantsPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Day 29: >= 2-fold increase03332
Day 29: >= 4-fold increase02232
Day 57: >= 2-fold increase04333
Day 57: >= 4-fold increase03333
Month 7: >= 2-fold increase02332
Month 7: >= 4-fold increase01232
Month 13: >= 2-fold increase02222
Month 13: >= 4-fold increase01222

Adverse events

Collected over Day 1 to the end of study visit (up to Day 392). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/24 (0%)3/24 (12.5%)17/24 (70.8%)
mRNA-1893 10 mcg0/24 (0%)0/24 (0%)21/24 (87.5%)
mRNA-1893 30 mcg0/24 (0%)0/24 (0%)21/24 (87.5%)
mRNA-1893 100 mcg0/24 (0%)0/24 (0%)22/24 (91.7%)
mRNA-1893 250 mcg0/24 (0%)1/24 (4.2%)20/24 (83.3%)
Most frequent serious events
Most frequent serious events
EventPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
NephrolithiasisRenal and urinary disorders0/240/240/240/241/24
DiverticulitisInfections and infestations1/240/240/240/240/24
Hand fractureInjury, poisoning and procedural complications1/240/240/240/240/24
Adjustment disorder with depressed moodPsychiatric disorders1/240/240/240/240/24
AnxietyPsychiatric disorders1/240/240/240/240/24
Most frequent other events
Showing 10 of 111
Most frequent other events
EventPlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcg
Injection site painGeneral disorders3/2414/2416/2420/2417/24
MyalgiaMusculoskeletal and connective tissue disorders2/2412/247/2411/2416/24
FatigueGeneral disorders5/249/2411/2411/2414/24
ChillsGeneral disorders3/242/246/2411/2414/24
HeadacheNervous system disorders8/2412/2412/2411/2413/24
PyrexiaGeneral disorders1/242/244/248/2411/24
ArthralgiaMusculoskeletal and connective tissue disorders3/246/245/249/248/24
NauseaGastrointestinal disorders2/245/243/246/246/24
Upper respiratory tract infectionInfections and infestations4/240/242/240/240/24
Viral infectionInfections and infestations0/240/240/243/240/24

Baseline characteristics

The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo).

Age, Categorical
Age, Categorical(Participants)PlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcgTotal
<=18 years000000
Between 18 and 65 years2424242424120
>=65 years000000
Sex: Female, Male
Sex: Female, Male(Participants)PlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcgTotal
Female161811141170
Male8613101350
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcgTotal
Hispanic or Latino6585529
Not Hispanic or Latino181916191991
Unknown or Not Reported000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcgTotal
American Indian or Alaska Native010001
Asian000101
Black or African American42911228
White202114221289
Other001001
Flavivirus Serostatus
Flavivirus Serostatus(Participants)PlacebomRNA-1893 10 mcgmRNA-1893 30 mcgmRNA-1893 100 mcgmRNA-1893 250 mcgTotal
Seropositive4444420
Seronegative2020202020100
08

Study locations

4 sites
  • Meridan Clinical Research
    Omaha, Nebraska 68134, United States
  • Benchmark Research
    Austin, Texas 78705, United States
  • Benchmark Research
    Fort Worth, Texas 76135, United States
  • Ponce School of Medicine - CAIMED Center
    Ponce, 00716, Puerto Rico
09

References and documents

Publications

  • Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19. PubMed 36682364 ↗

Study documents

  • Study protocol · Mar 17, 2020
  • Statistical analysis plan · May 25, 2021
  • Informed consent form · Jul 12, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Mar 2021, 19 months.

Results were first posted in Jun 2024, 3 years 2 months after primary completion.

Of 17 phase 1 interventional studies under Zika Virus Infection, half reached primary completion within 13 months of starting (the median); a quarter within 8 and three quarters within 25. This study's 19 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2019
First posted
Aug 22, 2019
StartActual
Jul 30, 2019
Primary completionActual
Mar 22, 2021
CompletionActual
Mar 22, 2021
Results first posted
Jun 17, 2024
Last update
Aug 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04064905
Lead sponsor
ModernaTX, Inc.
Collaborators
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Aug 22, 2019
Start date
Jul 30, 2019
Primary completion
Mar 22, 2021
Completion
Mar 22, 2021
Results posted
Jun 17, 2024
Last update
Aug 21, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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