Phase 4
Completed N=371
Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Source: ClinicalTrials.gov NCT00106964 ↗Enrolled (actual)
371
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Sero-response to Hepatitis B Surface Antigen — 60; 73.2; 75.4 percentage of participants who resonded — p=0.0440
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sero-response to Hepatitis B Surface Antigen |
60; 73.2; 75.4 | 0.0440 sig |
| SECONDARY Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY |
7; 5; 9; 0; 1; 2 | — |
| SECONDARY Response Rates in HIV+ Youth Within Each Study Arm by Study Duration |
27.87; 19.23; 22.22; 3.28; 7.69; 11.11 | 0.5822 |
| SECONDARY Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM |
73.2; 60; 75.4 | 0.0853 |
Eligibility Criteria
Inclusion Criteria
- Documented HIV+
- Age 12 to 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.
Data sourced from ClinicalTrials.gov (NCT00106964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.