Clinical trial NCT04917861: A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
Official title: A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose Confirmation Study to Evaluate the Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Adults Aged 18 Through 65 Years and Living in Endemic and Non-Endemic Flavivirus Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Zika Virus
Keywords: Flavivirus
mRNA-1893
Zika vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 36 (7 days after each vaccination)
measure: Number Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 57 (28 days after each vaccination)
measure: Number of Medically Attended Adverse Events (MAAEs)
timeFrame: Day 1 throughout the entire study duration (up to Day 700)
measure: Number of Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
timeFrame: Day 1 throughout the entire study duration (up to Day 700)
measure: Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAb) in All Participants, Initially Flavivirus Seronegative, and Initially Flavivirus Seropositive Participants, as Measured by Plaque Reduction Neutralization Test (PRNT)
timeFrame: Day 57
measure: Percentage of Participants With Seroconversion, as Measured by PRNT
timeFrame: Day 1 to Day 57
Secondary outcomes:
measure: GMT of ZIKV-Specific nAbs in All Participants, as Measured by PRNT
timeFrame: Days 1, 8, 29, and 36
measure: GMT of ZIKV-Specific nAbs in All Participants, as Measured by Microneutralization (MN)
timeFrame: Days 1, 8, 29, 36 and 57
measure: GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by PRNT
timeFrame: Days 1, 8, 29, and 36
measure: GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by MN
timeFrame: Days 1, 8, 29, 36, and 57
measure: GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by PRNT
timeFrame: Days 1, 8, 29, and 36
measure: GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by MN
timeFrame: Days 1, 8, 29, 36, and 57
measure: Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs in All Participants, as Measured by PRNT
timeFrame: Days 8, 29, 36, and 57
measure: GMFR of ZIKV-Specific nAbs in All Participants, as Measured by MN
timeFrame: Days 8, 29, 36, and 57
measure: GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by PRNT
timeFrame: Days 8, 29, and 36
measure: GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by MN
timeFrame: Days 8, 29, 36, and 57
measure: Percentage of Participants With Seroconversion, as Measured by PRNT
timeFrame: Day 1 to Days 8, 29, and 36
measure: Percentage of Participants With Seroconversion, as Measured by MN
timeFrame: Day 1 to Days 8, 29, 36, and 57
measure: Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by PRNT
timeFrame: Days 8, 29, and 36
measure: Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by MN
timeFrame: Days 8, 29, 36, and 57
measure: Percentage of Initially Seropositive Participants With a 2-Fold or 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by PRNT
timeFrame: Days 8, 29, and 36
measure: Percentage of Initially Seropositive Participants With a 2-Fold or 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN
timeFrame: Days 8, 29, 36, and 57
Other outcomes:
Locations:
city: Sioux City
country: United States
facility: Meridian Clinical Research (Sioux City, IA)
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth
state: Texas
city: Guayama
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation, Inc.
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation, Inc.
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center, Inc.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC
city: San Juan
country: Puerto Rico
facility: Carribean Medical Research
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
References: