HIV InfectionsPhase 3VIHVAC-BNCT00480792
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
A Phase 3 study testing GenHevac B Pasteur in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- GenHevac B Pasteur
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both
- Criteria
- HIV infection
- T CD4 count cell level above 200 per mm3
- Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)
- unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit
- Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3
- Pregnancy test negative at the screening and inclusion visits
Who cannot join
- Any injection of the vaccine against Hepatitis B in the medical history
- Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients
- Any vaccine received one month before the inclusion
- History of intolerance to any component of GenHevac-B
- Evolutive opportunistic infection treated the month before the screening visit
- Severe and acute pyretic infection or unexplained fever the week before inclusion
Show all 15Show fewer
- Evolutive hemopathy or solid-organ cancer
- Prothrombin factor equal or below 50 percent and/or platelets equal or below 50 000 per mm3
- Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during above 7 days) in the last 6 months before the screening visit
- Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months
- Splenectomy
- Decompensated cirrhosis (Child Pugh B or C)
- Kidney deficient function (creatinine clearance below 50 ml per mn)
- Other immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
- Any participation to another clinical trial plan until Week 28
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B
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.
Read the detailed description
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3
Intervention:
- Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
- Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
- Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
- Conditions
- HIV Infections
- Being tested
- GenHevac B Pasteur
- Keywords
- Hepatitis B vaccination, GenHevac-B Pasteur, HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenHevac B PasteurBiological
Also called Sanofi Pasteur MSD
Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6
GenHevac B PasteurBiological
Also called Sanofi Pasteur MSD
Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6
GenHevac B PasteurBiological
Also called Sanofi Pasteur MSD
GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6 Receives: Biological: GenHevac B Pasteur |
| B | Experimental | GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6 Receives: Biological: GenHevac B Pasteur |
| C | Experimental | GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6 Receives: Biological: GenHevac B Pasteur |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.
Measured: two months after the last injection;week 28, month 18, month 30 and month 42
Secondary outcomes (1)
According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion
Measured: two months after the last injection; week 28, month 18, month 30 and month 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- MCM Vaccines B.V.
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD, Principal investigator, CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris FrFabrice Carrat, MD, Study chair, Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480792
- Sponsor's protocol ID
- ANRS HB 03 VIHVAC-B
- Other IDs
- 2006-003940-50
- Acronym
- VIHVAC-B
- Status last verified
- Jul 2013
- First submitted
- 30 May 2007
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Launay O, Rosenberg AR, Rey D, Pouget N, Michel ML, Reynes J, Neau D, Raffi F, Piroth L, Carrat F; ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group. Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 May 1;176(5):603-10. doi: 10.1001/jamainternmed.2016.0741.
PubMed 27064975Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdiere N, Slama L, Martin K, Lortholary O, Carrat F; ANRS HB03 VIHVAC-B Trial. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 2011 Apr 13;305(14):1432-40. doi: 10.1001/jama.2011.351.
PubMed 21486976
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B
- ClinicalTrials.gov ID
- NCT00480792
- Acronym / sponsor ID
- VIHVAC-B / ANRS HB 03 VIHVAC-B
- Conditions
- HIV Infections
- Keywords
- Hepatitis B vaccination, GenHevac-B Pasteur, HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- MCM Vaccines B.V.
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3
Intervention:
- Arm A: GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6
- Arm B: GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6
- Arm C: GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Biological: GenHevac B PasteurGenHevac-B 20 microgramme Intramuscular use at M0, M1, M6 |
| B | Experimental | Biological: GenHevac B PasteurGenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6 |
| C | Experimental | Biological: GenHevac B PasteurGenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both
- Criteria
- HIV infection
- T CD4 count cell level above 200 per mm3
- Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)
Key exclusion criteria (15 listed)
- Any injection of the vaccine against Hepatitis B in the medical history
- Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients
- Any vaccine received one month before the inclusion
- History of intolerance to any component of GenHevac-B
- Evolutive opportunistic infection treated the month before the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenHevac B PasteurAlso: Sanofi Pasteur MSDIntra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6 | Biological | A |
| GenHevac B PasteurAlso: Sanofi Pasteur MSDIntra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6 | Biological | B |
| GenHevac B PasteurAlso: Sanofi Pasteur MSDGenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6 | Biological | C |
Primary outcome
HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml.
Time frame: two months after the last injection;week 28, month 18, month 30 and month 42
1 secondary outcome
According to the vaccine administration (IM or ID) comparison of AbHBs titers,permanence of the humoral response,intensity of clinical and biological events and predicting factors related to seroconversion
Time frame: two months after the last injection; week 28, month 18, month 30 and month 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 27064975Launay O, Rosenberg AR, Rey D, Pouget N, Michel ML, Reynes J, Neau D, Raffi F, Piroth L, Carrat F; ANRS HB03 VIHVAC-B (Trial Comparing 3 Strategies of Vaccination Against the Virus of Hepatitis B in HIV-Infected Patients) Group. Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 May 1;176(5):603-10. doi: 10.1001/jamainternmed.2016.0741.
- Derived from this study: PubMed 21486976Launay O, van der Vliet D, Rosenberg AR, Michel ML, Piroth L, Rey D, Colin de Verdiere N, Slama L, Martin K, Lortholary O, Carrat F; ANRS HB03 VIHVAC-B Trial. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 2011 Apr 13;305(14):1432-40. doi: 10.1001/jama.2011.351.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile Launay, MD principal investigator
CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr
Fabrice Carrat, MD study chair
Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GenHevac B Pasteur in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml. (time frame: two months after the last injection;week 28, month 18, month 30 and month 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.