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

NCT04064905 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: mRNA-1893-P101BARDA HHS010020160029C
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 4

Brief Summary

This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants

Conditions

Zika Virus

Keywords

mRNA-1893; zika vaccine; Moderna

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination

  Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

  Up to Day 7 after first vaccination (up to 8 days)

• Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination

  Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

  Up to Day 7 after second vaccination (Day 29 to Day 36)

• Number of Participants With Unsolicited Adverse Events (AEs)

  An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

  Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)

• Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)

  An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

  Day 1 to the end of study visit (up to Day 392)

Secondary Outcomes (6)

• Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

  Day 1, 29, 57, Month 7 and 13

• Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

  Day 1, 29, 57, Month 7 and 13

• Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)

  Day 1, 29, 57, Month 7 and 13

• Percentage of Participants Who Seroconverted From 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

  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.

• Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test

  Day 29, Day 57, Month 7, and Month 13

Study Arms (2)

mRNA-1893

EXPERIMENTAL

Biological: mRNA-1893

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride

Other: Placebo

Interventions

mRNA-1893 BIOLOGICAL

Zika vaccine

mRNA-1893

Placebo OTHER

0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agrees to comply with the study procedures and provides written informed consent
• 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 enzyme-linked immunosorbent assay (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (4)

Meridan Clinical Research

Omaha, Nebraska, 68134, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Ponce School of Medicine - CAIMED Center

Ponce, 00716, Puerto Rico

Location

Related Publications (1)

• Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19.

  PMID: 36682364 DERIVED

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Observer blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: July 30, 2019
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: August 21, 2024
• Results First Posted: June 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (3)