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

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ClinicalTrials.gov Identifier: NCT04917861
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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

Condition or disease Intervention/treatment Phase
Zika Virus Biological: mRNA-1893 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 8, 2021
Estimated Primary Completion Date : September 17, 2023
Estimated Study Completion Date : September 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Arm Intervention/treatment
Experimental: mRNA-1893 Low Dose (2-Dose Regimen)
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).
Biological: mRNA-1893
Solution for injection
Other Name: Zika vaccine

Experimental: mRNA-1893 High Dose (2-Dose Regimen)
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).
Biological: mRNA-1893
Solution for injection
Other Name: Zika vaccine

Experimental: mRNA-1893 High Dose (1-Dose Regimen)
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.
Biological: mRNA-1893
Solution for injection
Other Name: Zika vaccine

Biological: Placebo
0.9% sodium chloride solution for injection

Placebo Comparator: Placebo
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).
Biological: Placebo
0.9% sodium chloride solution for injection




Primary Outcome Measures :
  1. Number of Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after each vaccination) ]
  2. Number Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each vaccination) ]
  3. Number of Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 throughout the entire study duration (up to Day 700) ]
  4. 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) ]
  5. 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 ]
  6. Percentage of Participants With Seroconversion, as Measured by PRNT [ Time Frame: Day 1 to Day 57 ]
    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 :
  1. GMT of ZIKV-Specific nAbs in All Participants, as Measured by PRNT [ Time Frame: Days 1, 8, 29, and 36 ]
  2. GMT of ZIKV-Specific nAbs in All Participants, as Measured by Microneutralization (MN) [ Time Frame: Days 1, 8, 29, 36 and 57 ]
  3. GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by PRNT [ Time Frame: Days 1, 8, 29, and 36 ]
  4. GMT of ZIKV-Specific nAbs in Initially Flavivirus Seronegative Participants, as Measured by MN [ Time Frame: Days 1, 8, 29, 36, and 57 ]
  5. GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by PRNT [ Time Frame: Days 1, 8, 29, and 36 ]
  6. GMT of ZIKV-Specific nAbs in Initially Flavivirus Seropositive Participants, as Measured by MN [ Time Frame: Days 1, 8, 29, 36, and 57 ]
  7. Geometric Mean Fold-Rise (GMFR) of ZIKV-Specific nAbs in All Participants, as Measured by PRNT [ Time Frame: Days 8, 29, 36, and 57 ]
  8. GMFR of ZIKV-Specific nAbs in All Participants, as Measured by MN [ Time Frame: Days 8, 29, 36, and 57 ]
  9. 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 ]
  10. 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 ]
  11. Percentage of Participants With Seroconversion, as Measured by PRNT [ Time Frame: Day 1 to Days 8, 29, and 36 ]
    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).

  12. Percentage of Participants With Seroconversion, as Measured by MN [ Time Frame: Day 1 to Days 8, 29, 36, and 57 ]
    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).

  13. Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by PRNT [ Time Frame: Days 8, 29, and 36 ]
    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).

  14. Percentage of Initially Seronegative Participants With a Seroresponse, as Measured by MN [ Time Frame: Days 8, 29, 36, and 57 ]
    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).

  15. 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 ]
  16. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of 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 vaccine ≤28 days prior to the first IP injection or plans to receive a nonstudy vaccine 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. Any COVID-19 vaccine (regardless of type of vaccine) that becomes available to participant during the study is not exclusionary; efforts should be made to space IP injections and COVID-19 vaccinations by at least 7 days and preferably 14 days, but COVID-19 vaccinations should not be delayed.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917861


Contacts
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Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com

Locations
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United States, Iowa
Meridian Clinical Research (Sioux City, IA) Recruiting
Sioux City, Iowa, United States, 51106
United States, Kansas
Johnson County Clin-Trials Recruiting
Lenexa, Kansas, United States, 66219
United States, Texas
Benchmark Research - Fort Worth Recruiting
Fort Worth, Texas, United States, 76135
Puerto Rico
Clinical Research Puerto Rico, Inc. Recruiting
Guayama, Puerto Rico, 00784
Ponce Medical School Foundation, Inc. Active, not recruiting
Ponce, Puerto Rico, 00713
Ponce Medical School Foundation, Inc. Recruiting
Ponce, Puerto Rico, 00716
Clinical Research Puerto Rico, Inc. Recruiting
San Juan, Puerto Rico, 00909
Latin Clinical Trial Center, Inc. Recruiting
San Juan, Puerto Rico, 00909
GCM Medical Group, PSC Recruiting
San Juan, Puerto Rico, 00917
Carribean Medical Research Recruiting
San Juan, Puerto Rico, 00918
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04917861    
Other Study ID Numbers: mRNA-1893-P201
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
Flavivirus
mRNA-1893
Zika vaccine
Moderna
Additional relevant MeSH terms:
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Zika Virus Infection
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs