- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064905
Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults
April 20, 2021 updated by: ModernaTX, Inc.
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults
This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ponce, Puerto Rico, 00716
- Ponce School of Medicine - CAIMED Center
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Nebraska
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Omaha, Nebraska, United States, 68134
- Meridan Clinical Research
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Texas
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Austin, Texas, United States, 78705
- Benchmark Research
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Fort Worth, Texas, United States, 76135
- Benchmark Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Agrees to comply with the study procedures and provides written informed consent
- 18 to 49 years of age
- In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete diary cards, return for follow-up visits, be available for safety telephone calls).
- Is in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, and physical examination at screening.
- Negative urine pregnancy test at the Screening visit and at the day of each vaccination for females of childbearing potential.
- Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months following the last vaccination.
- For flavivirus-seropositive group, has positive flavivirus test results (including dengue, West Nile, and Zika) as determined by ELISA or other commercially available serological assay.
- For flavivirus-seronegative group, has negative flavivirus test results (including dengue, West Nile, and Zika) as determined by ELISA or other commercially available serological assay.
Exclusion Criteria:
- Has any acute or chronic, Clinically Significant disease in the opinion of the investigator.
- Has received a vaccine for dengue, Japanese encephalitis, tick-borne encephalitis, West Nile, Yellow Fever, or Zika.
- Has a neurologic disorder
- Has a body mass index that is ≤ 18 or ≥ 35 kg/m2.
- Has elevated liver function tests
- Has clinical laboratory test results (hematology, serum chemistry, or coagulation) with a toxicity score of Grade ≥ 1 at Screening.
- Has a bleeding disorder that would contraindicate IM injections or phlebotomy.
- Reports a diagnosis of congenital or acquired immunodeficiency (including HIV infection), or autoimmune disease.
- Has a history of hypersensitivity or severe reactions to previous vaccinations or any component of the study vaccine.
- Has a history of idiopathic urticaria.
- Reports a previous diagnosis of hematologic malignancy or pre-malignancy or a diagnosis of any other malignancy within the previous 10 years (excluding nonmelanoma skin cancer).
- Has a medical, psychiatric, or occupational condition that, in the opinion of the investigator, might pose an additional risk to the participant due to participation in the study or would interfere with the evaluation of the study vaccines or the interpretation of study results.
- Is acutely ill or febrile on the day of screening (Day 0) or randomization (Day 1).
- Has a history of inflammatory arthritis.
- Has a history of febrile disease with arthritis or arthralgia within 2 weeks of administration of any study vaccine.
- Has received an investigational or nonregistered product (drug or vaccine) within 30 days before the first dose of study vaccine or has plans for administration during the study period.
- Has received or is scheduled to receive an inactivated vaccine within the period from 14 days before, or through 14 days after, administration of any study vaccination.
- Has received or is scheduled to receive a live virus vaccine administered within the period from 28 days before, or through 28 days after, any dose of study vaccine.
- Has received chronic administration (defined as > 14 total days) of immunosuppressants or other immune-modifying drugs within 6 months before the first study vaccine dose.
- Has received immunoglobulins and/or blood products within the 3 months before the first study vaccine dose or has plans for administration during the study period.
- Has a positive test result at the Screening Visit for hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or 2 antibodies.
- Has donated > 450 mL of whole blood or blood products within 30 days of enrollment or plans to do so during the study period.
- Is an immediate family member or household member of study personnel.
- Previously participated in an investigational study involving LNPs.
- Has a positive urine drug screen result at Screening for any of the following nonprescription drugs of abuse: amphetamines, benzodiazepines, cocaine, methadone, opiates, and phencyclidine.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
0.9% sodium chloride
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0.9% sodium chloride
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Experimental: mRNA-1893
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Zika vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Frequency and grade of each solicited local and systemic reactogenicity adverse event (AE)
Time Frame: 7-day follow-up period after each vaccination
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7-day follow-up period after each vaccination
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Frequency and grade of any unsolicited AEs
Time Frame: 28-day follow-up period after each vaccination
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28-day follow-up period after each vaccination
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Frequency of any medically attended adverse event (MAAE), serious adverse event (SAE), and adverse event of special interest (AESI)
Time Frame: Day 1 to the end of study (EOS) Visit at Month 13
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Day 1 to the end of study (EOS) Visit at Month 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric mean titer (GMT) of serum neutralizing antibodies (nAb) against zika virus (ZIKV) as measured by Plaque Reduction Neutralization Test (PRNT)
Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13
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Day 1, Day 29, Day 57, Month 7, and Month 13
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GMT of nAb in initially seronegative participants against ZIKV as measured by PRNT
Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13
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Day 1, Day 29, Day 57, Month 7, and Month 13
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GMT of nAb in initially seropositive participants against ZIKV as measured by PRNT
Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13
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Day 1, Day 29, Day 57, Month 7, and Month 13
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Percentage of participants who seroconverted
Time Frame: Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13
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A seroconversion is defined as a change of PRNT from below the LOQ to a PRNT equal to or above 1:10, or a multiplication by at least 4 in subjects with pre-existing PRNT titers
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Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13
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Proportion of initially seronegative participants with a seroresponse as measured by PRNT
Time Frame: Day 29, Day 57, Month 7, and Month 13
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Day 29, Day 57, Month 7, and Month 13
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Proportion of initially seropositive participants with a 2-fold or 4-fold increase in nAb titers as compared with baseline as measured by PRNT
Time Frame: Day 29, Day 57, Month 7, and Month 13
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Day 29, Day 57, Month 7, and Month 13
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2019
Primary Completion (Actual)
March 22, 2021
Study Completion (Actual)
March 22, 2021
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 20, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Actual)
April 22, 2021
Last Update Submitted That Met QC Criteria
April 20, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mRNA-1893-P101
- BARDA HHS010020160029C (Other Grant/Funding Number: Biomedical Advanced Research & Development Authority (BARDA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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