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

Primary Purpose

Zika Virus

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
mRNA-1893
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zika Virus focused on measuring Flavivirus, mRNA-1893, Zika vaccine, Moderna

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Meridian Clinical Research (Sioux City, IA)
  • Johnson County Clin-Trials
  • Benchmark Research - Fort Worth
  • Clinical Research Puerto Rico, Inc.
  • Ponce Medical School Foundation, Inc.
  • Ponce Medical School Foundation, Inc.
  • Clinical Research Puerto Rico, Inc.
  • Latin Clinical Trial Center, Inc.
  • GCM Medical Group, PSC
  • Carribean Medical Research
  • University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

mRNA-1893 Low Dose (2-Dose Regimen)

mRNA-1893 High Dose (2-Dose Regimen)

mRNA-1893 High Dose (1-Dose Regimen)

Placebo

Arm Description

Participants 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).

Participants 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).

Participants 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.

Participants 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).

Outcomes

Primary Outcome Measures

Number of Solicited Local and Systemic Adverse Reactions (ARs)
Number Unsolicited Adverse Events (AEs)
Number of Medically Attended Adverse Events (MAAEs)
Number of Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
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)
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).

Secondary Outcome Measures

GMT of ZIKV-Specific nAbs in All Participants, as Measured by PRNT
GMT of ZIKV-Specific nAbs in All Participants, as Measured by Microneutralization (MN)
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by PRNT
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by MN
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by PRNT
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by MN
Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs in All Participants, as Measured by PRNT
GMFR of ZIKV-Specific nAbs in All Participants, as Measured by MN
GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by PRNT
GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by MN
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).
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).
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).
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).
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
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

Full Information

First Posted
June 2, 2021
Last Updated
September 13, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04917861
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
July 23, 2024 (Anticipated)
Study Completion Date
July 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus
Keywords
Flavivirus, mRNA-1893, Zika vaccine, Moderna

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
809 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1893 Low Dose (2-Dose Regimen)
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
mRNA-1893 High Dose (2-Dose Regimen)
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
mRNA-1893 High Dose (1-Dose Regimen)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants 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).
Intervention Type
Biological
Intervention Name(s)
mRNA-1893
Other Intervention Name(s)
Zika vaccine
Intervention Description
Solution for injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride solution for injection
Primary Outcome Measure Information:
Title
Number of Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 36 (7 days after each vaccination)
Title
Number Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 57 (28 days after each vaccination)
Title
Number of Medically Attended Adverse Events (MAAEs)
Time Frame
Day 1 throughout the entire study duration (up to Day 700)
Title
Number of Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
Time Frame
Day 1 throughout the entire study duration (up to Day 700)
Title
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)
Time Frame
Day 57
Title
Percentage of Participants With Seroconversion, as Measured by PRNT
Description
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).
Time Frame
Day 1 to Day 57
Secondary Outcome Measure Information:
Title
GMT of ZIKV-Specific nAbs in All Participants, as Measured by PRNT
Time Frame
Days 1, 8, 29, and 36
Title
GMT of ZIKV-Specific nAbs in All Participants, as Measured by Microneutralization (MN)
Time Frame
Days 1, 8, 29, 36 and 57
Title
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by PRNT
Time Frame
Days 1, 8, 29, and 36
Title
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by MN
Time Frame
Days 1, 8, 29, 36, and 57
Title
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by PRNT
Time Frame
Days 1, 8, 29, and 36
Title
GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by MN
Time Frame
Days 1, 8, 29, 36, and 57
Title
Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs in All Participants, as Measured by PRNT
Time Frame
Days 8, 29, 36, and 57
Title
GMFR of ZIKV-Specific nAbs in All Participants, as Measured by MN
Time Frame
Days 8, 29, 36, and 57
Title
GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by PRNT
Time Frame
Days 8, 29, and 36
Title
GMFR of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants and Initially Flavivirus Seropositive Participants, as Measured by MN
Time Frame
Days 8, 29, 36, and 57
Title
Percentage of Participants With Seroconversion, as Measured by PRNT
Description
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).
Time Frame
Day 1 to Days 8, 29, and 36
Title
Percentage of Participants With Seroconversion, as Measured by MN
Description
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).
Time Frame
Day 1 to Days 8, 29, 36, and 57
Title
Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by PRNT
Description
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).
Time Frame
Days 8, 29, and 36
Title
Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by MN
Description
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).
Time Frame
Days 8, 29, 36, and 57
Title
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
Time Frame
Days 8, 29, and 36
Title
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
Time Frame
Days 8, 29, 36, and 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Meridian Clinical Research (Sioux City, IA)
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Benchmark Research - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Clinical Research Puerto Rico, Inc.
City
Guayama
ZIP/Postal Code
00784
Country
Puerto Rico
Facility Name
Ponce Medical School Foundation, Inc.
City
Ponce
ZIP/Postal Code
00713
Country
Puerto Rico
Facility Name
Ponce Medical School Foundation, Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Carribean Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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