HIV Infection Clinical Trial
Official title:
A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth
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.
Status | Completed |
Enrollment | 371 |
Est. completion date | June 2009 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 24 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Minas Gerais | Belo Horizonte | MG |
Brazil | Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP | Ribeirao Preto | SP |
Brazil | Hospital dos Sevidores do Estado | Rio de Janeiro | |
Brazil | Ippmg-Ufrj | Rio de Janeiro | |
Brazil | Instituto de Infectologia Emilio Ribas | Sao Paulo | SP |
South Africa | Tygerberg Hospital | Bellville | Cape Town |
South Africa | Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital | Johannesburg | Gauteng |
United States | Childrens Hosp of Los Angeles | Los Angeles | California |
United States | Tulane Med Center | New Orleans | Louisiana |
United States | University of California at San Francisco | San Fransisco | California |
United States | Children's Hosp Natinal Med Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA) |
United States, Brazil, South Africa,
Flynn PM, Cunningham CK, Rudy B, Wilson CM, Kapogiannis B, Worrell C, Bethel J, Monte D, Bojan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens. J A — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sero-response to Hepatitis B Surface Antigen | The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL. | Week 28 | No |
Secondary | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity. | Baseline through Week 72 | Yes |
Secondary | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity. | Baseline through Week 72 | Yes |
Secondary | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator. | Baseline through Week 72 | Yes |
Secondary | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown. | Entry through Week 72 | No |
Secondary | Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM | Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL. | Week 28 | No |
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