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Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064905
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • Frequency and grade of each solicited local and systemic reactogenicity adverse event (AE) [ Time Frame: 7-day follow-up period after each vaccination ]
  • Frequency and grade of any unsolicited AEs [ Time Frame: 28-day follow-up period after each vaccination ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Frequency and grade of each solicited local and systemic reactogenicity AE [ Time Frame: 7-day follow-up period after each vaccination ]
  • Frequency and grade of any unsolicited AEs [ Time Frame: 28-day follow-up period after each vaccination ]
  • Frequency of any MAAE, SAE, and AESI [ Time Frame: Day 1 to the EOS Visit at Month 13 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
    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
  • Proportion of initially seronegative participants with a seroresponse as measured by PRNT [ Time Frame: Day 29, Day 57, Month 7, and Month 13 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • GMT of nAb against ZIKV as measured by PRNT [ Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13 ]
  • 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 ]
  • 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 ]
  • 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 ]
    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
  • Proportion of initially seronegative participants with a seroresponse as measured by PRNT [ Time Frame: Day 29, Day 57, Month 7, and Month 13 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults
Official Title  ICMJE 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
Brief Summary This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Observer blind
Primary Purpose: Prevention
Condition  ICMJE Zika Virus
Intervention  ICMJE
  • Biological: mRNA-1893
    Zika vaccine
  • Other: Placebo
    0.9% sodium chloride
Study Arms  ICMJE
  • Experimental: mRNA-1893
    Intervention: Biological: mRNA-1893
  • Placebo Comparator: Placebo
    0.9% sodium chloride
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04064905
Other Study ID Numbers  ICMJE mRNA-1893-P101
BARDA HHS010020160029C ( Other Grant/Funding Number: Biomedical Advanced Research & Development Authority (BARDA) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Biomedical Advanced Research and Development Authority
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP