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mRNA-1893

Phase 2

Zika Virus | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Sep 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment928
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04917861A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus AreasPHASE2 COMPLETED 808Jun 7, 2021Jul 26, 2024Sep 25, 202511 United States, Puerto Rico
NCT04064905Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative AdultsPHASE1 COMPLETED 120Jul 30, 2019Mar 22, 2021Aug 21, 20244 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to 7 days post-vaccination

Solicited ARs (local and systemic) were collected in the electronic diary. Local ARs included: pain, erythema (redness), swelling/induration (hardness). Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, body temperature (potentially fever), and chills. A summary of all serious adverse events (SAEs) and all nonserious adverse events (AEs) ("Other"), regardless of causality, is in Reported "Adverse Events" section.

Number of Participants With Unsolicited Adverse Events (AEs)
Up to 28 days post-vaccination

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. Unsolicited AEs were AEs that were not included in the protocol-defined solicited ARs. A treatment-emergent adverse event (TEAE) was defined 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.

Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period

An SAE was defined as any AE that resulted in death, was 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. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

Number of Participants With Medically Attended AEs (MAAEs)
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period

An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. Note that the generation of the tables for the MAAE data for the Main Study occurred after the start of the Extension Period. Therefore, some of the MAAE data for this outcome measure may appear both in the Main Study and the Extension Period. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50)
Day 57

Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ=91; ULOQ=24814. 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.

GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80)
Day 57

Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=24814. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.

Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50
Day 57

Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.

Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80
Day 57

Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Up to Day 7 after first vaccination (up to 8 days)

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.

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Up to Day 7 after second vaccination (Day 29 to Day 36)

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.

Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)
Day 1 to the end of study visit (up to Day 392)

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.

Secondary Endpoints
GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80
Days 1, 8, 29, and 36
GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN)
Days 1, 8, 29, 36, and 57
Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80
Days 8, 29, 36, and 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1893 Low Dose (2-Dose Regimen)EXPERIMENTALParticipants will receive mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
mRNA-1893 High Dose (2-Dose Regimen)EXPERIMENTALParticipants will receive mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
mRNA-1893 High Dose (1-Dose Regimen)EXPERIMENTALParticipants will receive placebo matching to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There will be 28-day (-3/+7 days) interval between vaccinations.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matching to mRNA-1893 administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
mRNA-1893EXPERIMENTAL -
Interventions
NameTypeDescription
mRNA-1893BIOLOGICALSolution for injection
PlaceboBIOLOGICAL0.9% sodium chloride solution for injection
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites11

Key Inclusion Criteria: * Understands and agrees to comply with the study procedures and provides written informed consent. * According to investigator assessment, is in good general health and can comply with study procedures. * Female participants of childbearing potential may be enrolled in the ...

Countries:United StatesPuerto Rico
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