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Long-term Follow-up Study to Evaluate Safety and Immunogenicity of CHIKV VLP Single or Booster Vaccination

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 11% 800 → 715 participants
See other at-risk trials from Bavarian Nordic

Record History

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  1. Enrollment reduced: 800 → 715 participantsv9 Show 7 more changesShow less
    • Primary completion moved earlier from Apr 2028 to Feb 2028
    • Study completion moved earlier from Aug 2028 to Feb 2028
    • Trial arms changed: 7 → 6
    • Secondary endpoints: details revised at 3 of 4 entries
    • Eligibility criteria expanded, about 4 words
    • Study description shortened, about 1 word
    • Study title expanded, about 1 word
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 24 of 24 sites
    v8
  3. Primary endpoints revised (2)v7 Show 4 more changesShow less
    • Interventions: PXVX0317 vaccine booster (Biological), Placebo booster (Biological) to CHIKV VLP vaccine booster (Biological), Placebo booster (Biological)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 20 words
  4. Site contacts updated at 1 of 24 sitesv6
  5. Study sites: 21 to 24v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 9 to 21
    • Eligibility criteria expanded, about 202 words
    • Secondary endpoints: 3 to 4
    v4
  2. Study sites: 6 to 9v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Study completion date: May 2028 to Aug 2028
    • Start date changed from estimate of Aug 2023 to Aug 30, 2023
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3 or 4 years post-initial CHIKV VLP vaccination.
Trial Details
NCT Number NCT06007183
Lead Sponsor Bavarian Nordic
Conditions
(from sponsor)		 Chikungunya Virus Infection
Related terms Chikungunya Fever
Enrollment 715 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov