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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003940-50 | EudraCT Number |
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| Name | Class |
|---|---|
| MCM Vaccines B.V. | INDUSTRY |
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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.
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3
Intervention:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | GenHevac-B 20 microgramme Intramuscular use at M0, M1, M6 |
|
| B | Experimental | GenHevac-B 40 microgramme Intramuscular use at M0, M1, M2, M6 |
|
| C | Experimental | GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenHevac B Pasteur | Biological | Intra-muscular injection 20 microgramme Intramuscular use at M0, M1, M6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | two months after the last injection;week 28, month 18, month 30 and month 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | two months after the last injection; week 28, month 18, month 30 and month 42 |
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Inclusion Criteria:
Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, MD | CIC de vaccinologie Cochin-Pasteur 27, rue du Fb Saint Jacques 75014 Paris Fr | Principal Investigator |
| Fabrice Carrat, MD | Inserm U707 27, rue de Chaligny 75571 Paris cedex 12 Fr | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cochin CIC de vaccinologie | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27064975 | Derived | 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. | |
| 21486976 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C075656 | GenHevac B Pasteur |
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| GenHevac B Pasteur | Biological | Intra-muscular injection 40 microgramme intramuscular use at M0, M1,M2, M6 |
|
|
| GenHevac B Pasteur | Biological | GenHevac-B 4 microgramme Intradermal use at M0, M1, M2, M6 |
|
|
| Derived |
| Launay 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |