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mRNA-1893

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment928

FDA Designations

No designations recorded

Clinical trial landscape

mRNA-1893 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT04917861A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus AreasZika Virus
COMPLETED808 Analytics
PHASE2COMPLETED
A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
Zika VirusUnlock trial analytics

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 to 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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Frequently asked questions about mRNA-1893

What is mRNA-1893 used for?

mRNA-1893 is an investigational vaccine being developed for the prevention of Zika virus infection. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The vaccine is designed to elicit an immune response against the Zika virus in healthy adults.

Who makes mRNA-1893?

mRNA-1893 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ stock exchange. Moderna is conducting clinical trials to evaluate the safety, tolerability, and immunogenicity of this investigational Zika vaccine candidate.

What phase is mRNA-1893 in?

mRNA-1893 is in Phase 2 clinical development. Two clinical trials have been completed, including a Phase 1 study and a Phase 2 study. The vaccine remains investigational and has not received FDA approval. It is being studied for the prevention of Zika virus infection in healthy adults.

What clinical trials is mRNA-1893 in?

mRNA-1893 has been evaluated in two completed clinical trials. NCT04064905 was a Phase 1 study in healthy flavivirus seropositive and seronegative adults, enrolling 120 participants in the United States and Puerto Rico. NCT04917861 was a Phase 2 study in adults living in endemic and non-endemic flavivirus areas, enrolling 808 participants.

How does mRNA-1893 work?

mRNA-1893 is an mRNA-based vaccine that encodes Zika virus antigens to stimulate the immune system to produce protective antibodies. It is designed to induce a targeted immune response against the Zika virus, potentially providing immunity against infection. The vaccine is administered to healthy adults in clinical trials.