A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas

ModernaTX, Inc.808 enrolled

Overview

This clinical study will evaluate the safety, tolerability, and reactogenicity of 2 dose levels of messenger RNA (mRNA)-1893 Zika vaccine in comparison to a placebo control in healthy participants who are flavivirus-seronegative and in participants who are flavivirus-seropositive.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

808

Conditions

Zika Virus

Interventions

mRNA-1893BIOLOGICAL

Solution for injection

PlaceboBIOLOGICAL

0.9% sodium chloride solution for injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 study if the participant: has a negative pregnancy test at the Eligibility Visit and on the day of the first investigational product (IP) injection; has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first IP injection; has agreed to continue adequate contraception through 3 months following the last IP injection; and is not currently breastfeeding. Key Exclusion Criteria: * Participant is acutely ill or febrile (temperature ≥38.0°Celsius/100.4°Farenheight) on the day of the first or second vaccination. * Participant had prior administration of a ZIKV vaccine candidate during a clinical study investigation. * Participant had prior administration of a marketed dengue vaccine or dengue vaccine candidate under clinical study investigation. * Participant has a body mass index (BMI) from ≤18 or ≥35 kilograms (kg)/square meter (m\^2). * Participant has a history of myocarditis, pericarditis, or myopericarditis. * Participant has a history of a diagnosis or condition that, in the judgement of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. "Clinically unstable" is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing work-up of an undiagnosed illness that could lead to a new diagnosis or condition. * Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that in the opinion of the investigator, might pose a risk due to participation in the study or could interfere with the interpretation of study results. * Participant has as a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine, including an mRNA vaccine or any components of an mRNA vaccine. * Participant has received or plans to receive a nonstudy vaccine (including authorized or approved vaccines for the prevention of COVID-19) ≤28 days prior to the first IP injection or within 28 days prior to or after any IP injection. Licensed influenza vaccine received within 14 days prior to the first IP injection or plans to receive a licensed influenza vaccine 14 days prior to through 14 days following each IP injection are not exclusionary. * Participant has received systemic immunoglobulins or blood products within 3 months prior to the day of enrollment. * Participant has donated ≥450 milliliters (mL) of blood products within 28 days of the Day 1 Visit. * Participant has participated in an interventional clinical study within 28 days prior to the day of enrollment or plans to do so while enrolled in this study.

Locations (11)

Meridian Clinical Research (Sioux City, IA)

Sioux City, Iowa, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Benchmark Research - Fort Worth

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

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.

Time frame: Up to 7 days post-vaccination

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. 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.

Time frame: Up to 28 days post-vaccination

Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)

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.

Time frame: Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period

Data from ClinicalTrials.gov

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Secondary Outcomes

GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80

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.

Time frame: Days 1, 8, 29, and 36

GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN)

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=28; ULOQ=11589. 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: 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

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=248. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.