Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Completed · Phase 4
Conditions studied: HIV Infection, Hepatitis B
In brief
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.
Key facts
- Study ID
- NCT00106964
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 371
- Starts
- 2004-01-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 12 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented HIV+
- Age 12 to < 25 years
- History of no or one hepatitis B vaccination
- Not pregnant.
- Females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
You may not qualify if…
- History of > 1 hepatitis B vaccination
- Serologic evidence of past or present hepatitis B infection: anti-hepatitis B surface antigen (HBsAg), HBs-Ag or anti- hepatitis B core antigen (HBcAg)
- Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or aluminum.
- Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
- Presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
- Anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
- Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
- Receipt of immune globulin product or plasma product within 6 months preceding randomization
- Receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
- Known or suspected diseases of the immune system, other than HIV, or treatment for a malignancy within 3 months of randomization.
- Other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
Where it is running
- Childrens Hosp of Los Angeles — Los Angeles, California, United States
- University of California at San Francisco — San Francisco, California, United States
- Children's Hosp Natinal Med Center — Washington D.C., District of Columbia, United States
- Tulane Med Center — New Orleans, Louisiana, United States
- Federal University of Minas Gerais — Belo Horizonte, Minas Gerais, Brazil
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP — Ribeirão Preto, São Paulo, Brazil
- Instituto de Infectologia Emilio Ribas — São Paulo, São Paulo, Brazil
- Hospital dos Sevidores do Estado — Rio de Janeiro, Brazil
- Ippmg-Ufrj — Rio de Janeiro, Brazil
- Tygerberg Hospital — Bellville, Cape Town, South Africa
- Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital — Johannesburg, Gauteng, South Africa
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.