Phase 2
N=123
Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00107042 ↗Enrolled (actual)
123
Serious AEs
3.3%
Results posted
Dec 2012
Primary outcome: Primary: Qualitative Seroresponsiveness to Hepatitis B Surface Antigen — 41; 52; 6; 3 Participants — p=0.2954
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombivax (Biological); Twinrix (Biological)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative Seroresponsiveness to Hepatitis B Surface Antigen |
41; 52; 6; 3 | 0.2954 |
| PRIMARY Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) |
6; 4 | — |
| PRIMARY Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Quantitative Vaccine Response |
2.29; 2.58 | 0.0608 |
| SECONDARY Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window. |
34; 41; 43; 32; 51; 24 | 0.1667 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. |
41; 52; 6; 3 | 0.2068 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT |
42; 51; 5; 4 | 0.5524 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE |
61; 32; 7; 2 | 0.4646 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER |
36; 57; 2; 7 | 0.3390 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY |
21; 72; 6; 3 | 0.0102 sig |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE |
8; 66; 19; 1; 2; 6 | 0.4241 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES |
19; 17; 1; 1 | 0.9390 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES |
19; 38; 3; 4 | 0.6181 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline |
62; 31; 4; 5 | 0.1943 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES |
76; 16; 6; 3 | 0.2542 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY |
87; 6; 6; 3 | 0.0161 sig |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) |
59; 7; 23; 3; 3; 1 | 0.8945 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS |
59; 26; 7; 3; 0; 5 | 0.0042 sig |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS |
78; 13; 1; 4; 0; 4 | 0.0003 sig |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS |
72; 14; 6; 6; 1; 1 | 0.5503 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL |
58; 35; 4; 5 | 0.3010 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA |
78; 15; 5; 4 | 0.0501 |
| SECONDARY Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE |
89; 4; 8; 1 | 0.3846 |
| SECONDARY Immunogenicity to Hep B 18 Months After First Immunization |
30; 44; 7; 6 | 0.3827 |
| SECONDARY Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination |
98.08; 1.92 | — |
| SECONDARY Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination |
91.49; 8.51 | — |
| SECONDARY Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination) |
98.11; 1.89 | — |
| SECONDARY As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen |
85.4; 93.6; 14.6; 6.4 | 0.2938 |
| SECONDARY Assessment of Youth Understanding of Vaccine Trial and Informed Consent |
5.18; 5.1 | — |
Summary
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).
Eligibility Criteria
Inclusion Criteria
- HIV negative youth age 12-17 years (No serologic evidence of HIV infection).
- Negative hepatitis B serology. (No serologic evidence of hepatitis B surface antigen (HBSAg), hepatitis B surface antibody (HBsAb or anti-HBs) and hepatitis B core antibody (HBcAb or anti-HBc)).
- Either no prior hepatitis B immunizations or unknown or incomplete hepatitis B immunization status.
- Willing to participate in HIV risk-reduction counseling and computer assisted measurement of behaviors.
- Parent or legal guardian willing to provide written permission
- Females of childbearing potential must have a negative pregnancy test at screening and should agree to avoid pregnancy through the end of the vaccine phase of the study. Females who are engaging in sexual intercourse must be willing to practice a reliable method of birth control through the end of the vaccine-phase of the study (approximately 6 months). The decision of what is "reliable" is at the discretion of the site investigator.
Exclusion Criteria
- Presence of any serious illness requiring treatment with systemic medications, excluding treatment for asthma.
- Previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
- Pregnancy
- Current immunomodulator therapy
- Receipt of immunosuppressor therapy (more than 10 mg/day of prednisone or equivalent for >1 week) in the 6 months preceding entry or anticipated long-term corticosteroid therapy in the above dose and duration. Short term (< 7 days) steroid use for the treatment of asthma is not an exclusion.
- Receipt of any vaccine within 2 weeks preceding study entry.
Data sourced from ClinicalTrials.gov (NCT00107042). 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.