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Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Jul 27, 2026 → Nov 30, 2027
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

  1. Primary completion pushed from Jul 27, 2026 to Nov 30, 2027 Completion pushed from May 4, 2027 to Nov 30, 2027 · Eligibility criteria expanded, about 59 words · Site details revised at 5 of 9 sites Show 3 more changesShow less
    • Completion pushed from May 4, 2027 to Nov 30, 2027
    • Eligibility criteria expanded, about 59 words
    • Site details revised at 5 of 9 sites
  2. Study sites: 7 to 9v13
  3. Site details revised at 1 of 7 sitesv12
  4. Site details revised at 1 of 7 sitesv11
  5. Site details revised at 1 of 7 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites revised (7)v9 See this version in full on ClinicalTrials.gov ↗
  2. Site details revised at 1 of 7 sitesv8
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2025 to Sep 14, 2025 · Site details revised at 7 of 7 sitesv7 Show 2 more changesShow less
    • Start date changed from estimate of Dec 1, 2025 to Sep 14, 2025
    • Site details revised at 7 of 7 sites
  4. Re-verified, no change to tracked fieldsv6
  5. Primary endpoints revised (10) Interventions: Hiltonol (Biological) to CD40.HIVRI.Env (VRIPRO) (Biological), Hiltonol Poly-ICLC-adjuvant (Biological) · Eligibility criteria expanded, about 125 words · Secondary endpoints: 28 to 20 · 1 morev5 Show 4 more changesShow less
    • Interventions: Hiltonol (Biological) to CD40.HIVRI.Env (VRIPRO) (Biological), Hiltonol Poly-ICLC-adjuvant (Biological)
    • Eligibility criteria expanded, about 125 words
    • Secondary endpoints: 28 to 20
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Start date: May 23, 2025 to Dec 1, 2025v4
  7. Study sites: 3 to 7v3
  8. Start date: Feb 4, 2025 to May 23, 2025 Interventions: Hiltonol (Biological), Hiltonol (Biological) to Hiltonol (Biological)v2 Show 1 more changeShow less
    • Interventions: Hiltonol (Biological), Hiltonol (Biological) to Hiltonol (Biological)
  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 clinical schedule will consist of 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24.40 volunteers without HIV and in overall good health, aged 18 to 60 years, who previously participated in the HVTN 706 trial.
Trial Details
NCT Number NCT06665646
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions HIV Infections
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov