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Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients

Study acronym: VIHVAC-B
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis to ANRS, Emerging Infectious Diseases Study completion date changed from estimate of Dec 2008 to Sep 2012 · Trial status: Recruiting to Completed · Enrollment target: estimated 420 to confirmed 437 · 2 morev4 Show all 6 changesShow less
    • Study completion date changed from estimate of Dec 2008 to Sep 2012
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 420 to confirmed 437
    • Site details revised
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Dec 2008v3
  4. Trial status: Not Yet Recruiting to Recruiting Completion date: Dec 2008 · Interventions: Vaccin GenHevac-B Pasteur (Biological) to GenHevac B Pasteur (Biological), GenHevac B Pasteur (Biological), GenHevac B Pasteur (Biological) · Study description expanded, about 13 words · 3 morev2 Show all 7 changesShow less
    • Completion date: Dec 2008
    • Interventions: Vaccin GenHevac-B Pasteur (Biological) to GenHevac B Pasteur (Biological), GenHevac B Pasteur (Biological), GenHevac B Pasteur (Biological)
    • Study description expanded, about 13 words
    • Site details revised
    • Study arms: 0 to 3
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer. However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.
Trial Details
NCT Number NCT00480792
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: MCM Vaccines B.V.
Conditions HIV Infections
Enrollment 437 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov