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Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date pushed from Aug 28, 2026 to Sep 18, 2026
  2. Re-verified, no change to tracked fields
  3. Interventions: Saline (Drug), cH15/3 (Biological), cH4/3 (Biological), cH5/1N1 (Biological), cH8/1N1 (Biological) to Saline (Drug), cH15/3 (Biological), cH4/3 (Biological), cH5/1N1 (Biological), cH8/1N1 (Biological) Eligibility criteria expanded, about 41 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 41 words
  4. Start date pushed from Aug 7, 2026 to Aug 28, 2026v10
  5. 2 versions Re-verified since Aug 27, 2026, no change to tracked fieldsv8-v9
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Jul 17, 2026 to Aug 7, 2026v7
  2. 5 versions Re-verified since Jul 16, 2026, no change to tracked fieldsv2-v6
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1, randomized, controlled, dose-ranging clinical trial to assess the safety and immunogenicity of novel influenza A Group 1 and influenza A Group 2 mRNA chimeric hemagglutinin (HA) vaccine candidates given as intramuscular injections alone and in combination. A total of 60 healthy men and non-pregnant, non-breastfeeding women aged 18 through 59 years will be enrolled in one of 6 study arms. The 6 arms will consist of: 1) Sequential influenza A Group 1 mRNA chimeric hemagglutinin: cH8/1 (25 µg) followed by cH5/1 (25 µg), 2) Sequential influenza A Group 2 mRNA chimeric hemagglutinin: cH15/3 (25 µg) followed by cH4/3 (25 µg), 3) Sequential combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH8/1 + cH15/3 (25 µg) followed by cH5/1 + cH4/3 (25 µg), 4) A single dose of combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH8/1 + cH15/3 (50 µg) followed by placebo, 5) A single dose of combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH5/1 + cH4/3 (50 µg) followed by placebo, 6) Sequential combined influenza A Group 1 and Group 2 mRNA chimeric hemagglutinin: cH8/1 + cH15/3 (50 µg) followed by cH5/1 + cH4/3 (50 µg). The primary objectives are to evaluate safety and immunogenicity: 1) To assess the safety and reactogenicity of one or two doses of monovalent or bivalent Group 1 and 2 study products and 2) To describe the Group 1 and 2 anti-HA stalk IgG antibody responses of one or two doses of monovalent or bivalent Group 1 and 2 study products by ELISA.
Trial Details
NCT Number NCT07703514
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Influenza
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov