Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected … (NCT00480792) | Clinical Trial Compass
CompletedPhase 3
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
France437 participantsStarted 2007-06
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both
Criteria
Inclusion 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
Exclusion Criteria:
* 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
* 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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: two months after the last injection;week 28, month 18, month 30 and month 42