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

Zika Virus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04917861
• Other study ID #: mRNA-1893-P201
• Secondary ID: HHSO100201600029
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 8, 2021
• Est. completion date: July 23, 2024

Study information

• Verified date: September 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 809
• Est. completion date: July 23, 2024
• Est. primary completion date: July 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Zika Virus
• Zika Virus Infection

Intervention

Biological:
• mRNA-1893
Solution for injection
• Placebo
0.9% sodium chloride solution for injection

Locations

Country	Name	City	State
Puerto Rico	Clinical Research Puerto Rico, Inc.	Guayama
Puerto Rico	Ponce Medical School Foundation, Inc.	Ponce
Puerto Rico	Ponce Medical School Foundation, Inc.	Ponce
Puerto Rico	Carribean Medical Research	San Juan
Puerto Rico	Clinical Research Puerto Rico, Inc.	San Juan
Puerto Rico	GCM Medical Group, PSC	San Juan
Puerto Rico	Latin Clinical Trial Center, Inc.	San Juan
Puerto Rico	University of Puerto Rico	San Juan
United States	Benchmark Research - Fort Worth	Fort Worth	Texas
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Meridian Clinical Research (Sioux City, IA)	Sioux City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 36 (7 days after each vaccination)
Primary	Number Unsolicited Adverse Events (AEs)		Up to Day 57 (28 days after each vaccination)
Primary	Number of Medically Attended Adverse Events (MAAEs)		Day 1 throughout the entire study duration (up to Day 700)
Primary	Number of Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)		Day 1 throughout the entire study duration (up to Day 700)
Primary	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)		Day 57
Primary	Percentage of Participants With Seroconversion, as Measured by PRNT	Seroconversion is defined as either an increase in ZIKV-specific nAb titer from below the lower limit of quantification (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 (as measured by PRNT).	Day 1 to Day 57
Secondary	GMT of ZIKV-Specific nAbs in All Participants, as Measured by PRNT		Days 1, 8, 29, and 36
Secondary	GMT of ZIKV-Specific nAbs in All Participants, as Measured by Microneutralization (MN)		Days 1, 8, 29, 36 and 57
Secondary	GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by PRNT		Days 1, 8, 29, and 36
Secondary	GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by MN		Days 1, 8, 29, 36, and 57
Secondary	GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by PRNT		Days 1, 8, 29, and 36
Secondary	GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by MN		Days 1, 8, 29, 36, and 57
Secondary	Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs in All Participants, as Measured by PRNT		Days 8, 29, 36, and 57
Secondary	GMFR of ZIKV-Specific nAbs in All Participants, as Measured by MN		Days 8, 29, 36, and 57
Secondary	GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by PRNT		Days 8, 29, and 36
Secondary	GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by MN		Days 8, 29, 36, and 57
Secondary	Percentage of Participants With Seroconversion, as Measured by PRNT	Seroconversion is defined as either 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 (as measured by PRNT).	Day 1 to Days 8, 29, and 36
Secondary	Percentage of Participants With Seroconversion, as Measured by MN	Seroconversion is defined as either 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 (as measured by MN).	Day 1 to Days 8, 29, 36, and 57
Secondary	Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by PRNT	Seroresponse is defined as an increase in ZIKV-specific nAb titer (as measured by PRNT) from below the LLOQ to greater than or equal to the LLOQ).	Days 8, 29, and 36
Secondary	Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by MN	Seroresponse is defined as an increase in ZIKV-specific nAb titer (as measured by MN) from below the LLOQ to greater than or equal to the LLOQ).	Days 8, 29, 36, and 57
Secondary	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		Days 8, 29, and 36
Secondary	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		Days 8, 29, 36, and 57