Hepatitis B
Conditions
Keywords
Hepatitis B, HIV vaccine trial
Brief 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).
Detailed description
Hepatitis B (HBV) prophylactic immunization has been recommended for at-risk adolescents for more than 10 years although universal coverage has not been achieved. Vaccine response in healthy adolescents has generally been reported to be excellent. But, data from the study Reaching for Excellence in Adolescent Care and Health (REACH) that studied HIV-negative adolescents who were at-risk of acquiring Hepatitis B infection through sexual or needle sharing behaviors has demonstrated a much lower than expected vaccine response rate in this population using standard vaccine dosing. Some data suggest that factors such as gender or body mass index might be responsible for the differences in response to the vaccine observed in individuals. The reason for the diminished vaccine response in this population is unclear. If in fact, Hepatitis B vaccine response is diminished in this population, then efforts to determine correlates of response and to improve the response are warranted. The proposed trial will evaluate 2 licensed vaccine products given in a two-dose schedule in 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, participation in such trials will require ability to understand and willingness to volunteer for such trials, ability to return for multiple vaccinations and blood draws to assess vaccine response, and willingness to participate in HIV prevention education. A hepatitis B vaccine trial will provide a licensed vaccine to youth in whom the vaccine is indicated and will allow preliminary assessment of youth's willingness to participate in a vaccine trial that involves blood draws for immunologic assessment. Tools that will be necessary for HIV vaccine trials in youth include a youth-friendly simplified vaccine trial education component with a required written test for the participant, a standardized risk reduction education program, and a computer-assisted assessment of youth behaviors. These tools can be finalized and field tested in youth participating in the hepatitis B vaccine trial without promoting a false sense of protection from HIV. Secondary objectives of this trial will include assessment of a number of ancillary tools crucial for future HIV vaccine trials. This Hepatitis B vaccine trial will also serve as a HIV vaccine preparedness trial for youth at risk for both Hepatitis B and HIV. Design: This is a phase II, randomized, single-blinded trial of two hepatitis B immunization regimens in 150 HIV-negative, hepatitis B core antibody, hepatitis B surface antigen and surface antibody negative youth. Vaccinations will be given in a two-dose regimen at 0 and six months (75 subjects in each arm) and the primary outcome will be seroresponsiveness one month after the 6-month dose. Safety and tolerability will also be assessed.
Interventions
BIOLOGICALRecombivax
Participants receive doses of Recombivax at weeks 0 and 24.
BIOLOGICALTwinrix
Participants receive doses of Twinrix at weeks 0 and 24.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Seroresponsiveness to Hepatitis B Surface Antigen | Week (Wk) 28 (One month after the second immunization) | Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows: Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL. |
| Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) | Week 12, Week 24, Week 28, Week 76 | Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as Any vs. None. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported. |
| Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Week 12, Week 24, Week 28, Week 76 | Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as Any vs. None. The number of participants with at least one SAE is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT | Week 28 | Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a Responder if serum antibody level is \>= 10 mIU/mL and a Non- Responder if a serum a'body level is \< 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum a'body level is \< 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination | Week 76 | Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Quantitative Vaccine Response | Week 28 | The Log10 titer was used as the quantitative vaccine response. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| Immunogenicity to Hep B 18 Months After First Immunization | Week 76 | Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76 |
| Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination | Week 28 | Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response. |
| Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination) | Week 28 and Week 76 | Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. |
| As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen | Week 28 | The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis. |
| Assessment of Youth Understanding of Vaccine Trial and Informed Consent | Screening | Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Week 28 | Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Age of participants' first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
| 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. | Week 28 | The Log10 titer at Week 28 was used as the quantitative continuous vaccine response. |
| Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. | Week 28 | Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was started in February 2004 and was completed in July 2008. A total of 11 sites, all in the United States and Puerto Rico, participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24 | 60 |
| Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24 | 63 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disallowed medications | 0 | 2 |
| Overall Study | Inadvertent enrollment | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Moved out of area | 5 | 3 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | vaccinated outside window | 1 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | Recombivax | Twinrix | Total |
|---|---|---|---|
| Age, Continuous | 15.02 years STANDARD_DEVIATION 1.43 | 15.22 years STANDARD_DEVIATION 1.71 | 15.12 years STANDARD_DEVIATION 1.58 |
| Age, Customized 12 - 14 years | 18 participants | 23 participants | 41 participants |
| Age, Customized 15 - 17 years | 42 participants | 40 participants | 82 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 14 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 37 Participants | 43 Participants | 80 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Female | 19 Participants | 27 Participants | 46 Participants |
| Sex: Female, Male Male | 41 Participants | 36 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 60 | 4 / 63 |
| serious Total, serious adverse events | 2 / 60 | 2 / 63 |
Outcome results
Primary
Qualitative Seroresponsiveness to Hepatitis B Surface Antigen
Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows: Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL.
Time frame: Week (Wk) 28 (One month after the second immunization)
Population: Participants were included if they were vaccinated at least once (Intent-to-Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Qualitative Seroresponsiveness to Hepatitis B Surface Antigen | Responder | 41 Participants |
| Recombivax | Qualitative Seroresponsiveness to Hepatitis B Surface Antigen | Non-responder | 6 Participants |
| Twinrix | Qualitative Seroresponsiveness to Hepatitis B Surface Antigen | Responder | 52 Participants |
| Twinrix | Qualitative Seroresponsiveness to Hepatitis B Surface Antigen | Non-responder | 3 Participants |
Comparison: The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.p-value: 0.2954Fisher Exact
Comparison: Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here.95% CI: [74.26, 95.17]95% confidence interval
Comparison: Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here.95% CI: [84.88, 98.86]95% confidence interval
Primary
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))
Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as Any vs. None. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.
Time frame: Week 12, Week 24, Week 28, Week 76
Population: The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Recombivax | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) | 6 participants |
| Twinrix | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) | 4 participants |
Primary
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)
Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as Any vs. None. The number of participants with at least one SAE is reported.
Time frame: Week 12, Week 24, Week 28, Week 76
Population: The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Asthenia | 1 participants |
| Recombivax | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Forearm fracture | 1 participants |
| Recombivax | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Road traffic accident | 0 participants |
| Recombivax | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Anxiety | 0 participants |
| Twinrix | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Anxiety | 1 participants |
| Twinrix | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Asthenia | 0 participants |
| Twinrix | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Road traffic accident | 1 participants |
| Twinrix | Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) | Forearm fracture | 0 participants |
Secondary
Assessment of Youth Understanding of Vaccine Trial and Informed Consent
Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.
Time frame: Screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recombivax | Assessment of Youth Understanding of Vaccine Trial and Informed Consent | 5.18 Number of correct answers | Standard Deviation 1.24 |
| Twinrix | Assessment of Youth Understanding of Vaccine Trial and Informed Consent | 5.1 Number of correct answers | Standard Deviation 1.32 |
Secondary
As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen
The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.
Time frame: Week 28
Population: Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen | Responded (>=10mIU/ml) | 85.4 percentage of participants |
| Recombivax | As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen | Not responded (< 10mIU/ml) | 14.6 percentage of participants |
| Twinrix | As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen | Responded (>=10mIU/ml) | 93.6 percentage of participants |
| Twinrix | As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen | Not responded (< 10mIU/ml) | 6.4 percentage of participants |
p-value: 0.2938Fisher Exact
95% CI: [70.83, 94.43]95 % confidence interval
95% CI: [82.46, 98.66]95% confidence interval
Secondary
Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination
Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.
Time frame: Week 28
Population: The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination | POSITIVE (1 month post 2nd vaccination) | 98.08 percentage of participants |
| Recombivax | Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination | NEGATIVE (1 month post 2nd vaccination) | 1.92 percentage of participants |
95% CI: [89.74, 99.95]Exact 95% CI
Secondary
Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)
Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.
Time frame: Week 28 and Week 76
Population: Subjects in the Twinrix arm who had week 28 \&/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered Positive. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was Negative.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination) | Positive: overall | 98.11 percentage of participants |
| Recombivax | Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination) | Negative: overall | 1.89 percentage of participants |
95% CI: [89.93, 99.95]Exact 95% confidence interval
Secondary
Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination
Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.
Time frame: Week 76
Population: Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination | Positive (12 months post 2nd vaccination) | 91.49 percentage of participants |
| Recombivax | Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination | Negative (12 months post 2nd vaccination) | 8.51 percentage of participants |
95% CI: [79.62, 97.63]Exact 95 % confidence interval
Secondary
Immunogenicity to Hep B 18 Months After First Immunization
Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76
Time frame: Week 76
Population: Participants who had a week 76 Hepatitis B antibody titer were included in this analysis.~One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Immunogenicity to Hep B 18 Months After First Immunization | Responded (>= 10mIU/ml) | 30 Participants |
| Recombivax | Immunogenicity to Hep B 18 Months After First Immunization | Not responded (< 10mIU/ml) | 7 Participants |
| Twinrix | Immunogenicity to Hep B 18 Months After First Immunization | Responded (>= 10mIU/ml) | 44 Participants |
| Twinrix | Immunogenicity to Hep B 18 Months After First Immunization | Not responded (< 10mIU/ml) | 6 Participants |
p-value: 0.3827Fisher Exact
95% CI: [68.84, 92.04]
95% CI: [75.69, 95.47]
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.
Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. | Responder | 41 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. | Non-Responder | 6 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. | Responder | 52 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. | Non-Responder | 3 Participants |
p-value: 0.206895% CI: [0.6, 10.76]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE
Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE | Responder | 61 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE | Non-Responder | 7 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE | Responder | 32 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE | Non-Responder | 2 Participants |
p-value: 0.464695% CI: [0.36, 9.36]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Age of participants' first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Responder | 59 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Non-responder | 3 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Responder | 7 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Non-responder | 3 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Responder | 23 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) | Non-responder | 1 Participants |
p-value: 0.894595% CI: [0.12, 11.83]Univariate regression, logistic
p-value: 0.01995% CI: [0.02, 0.7]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline | Responder | 62 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline | Non-responder | 4 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline | Responder | 31 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline | Non-responder | 5 Participants |
p-value: 0.194395% CI: [0.1, 1.6]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL | Responder | 58 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL | Non-responder | 4 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL | Responder | 35 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL | Non-responder | 5 Participants |
p-value: 0.30195% CI: [0.12, 1.92]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES | Responder | 76 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES | Non-responder | 6 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES | Responder | 16 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES | Non-responder | 3 Participants |
p-value: 0.254295% CI: [0.1, 1.86]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA | Responder | 78 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA | Non-responder | 5 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA | Responder | 15 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA | Non-responder | 4 Participants |
p-value: 0.050195% CI: [0.06, 1]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE | Responder | 89 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE | Non-responder | 8 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE | Responder | 4 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE | Non-responder | 1 Participants |
p-value: 0.384695% CI: [0.04, 3.61]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum a'body level is \< 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER | Responder | 36 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER | Non-Responder | 2 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER | Responder | 57 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER | Non-Responder | 7 Participants |
p-value: 0.33995% CI: [0.09, 2.3]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY | Responder | 21 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY | Non-Responder | 6 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY | Responder | 72 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY | Non-Responder | 3 Participants |
p-value: 0.010295% CI: [1.58, 29.78]Univariate regression, logistic
p-value: 0.011895% CI: [1.56, 34.95]Multivariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Responder | 8 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Non-Responder | 1 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Responder | 66 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Non-Responder | 2 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Responder | 19 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE | Non-Responder | 6 Participants |
p-value: 0.424195% CI: [0.04, 3.84]Univariate regression, logistic
p-value: 0.268595% CI: [0.34, 50.76]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY | Responder | 87 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY | Non-responder | 6 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY | Responder | 6 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY | Non-responder | 3 Participants |
p-value: 0.016195% CI: [0.03, 0.69]Univariate regression, logistic
p-value: 0.022295% CI: [0.02, 0.74]Multivariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT
Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a Responder if serum antibody level is \>= 10 mIU/mL and a Non- Responder if a serum a'body level is \< 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT | Responder | 42 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT | Non-Responder | 5 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT | Responder | 51 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT | Non-Responder | 4 Participants |
p-value: 0.552495% CI: [0.38, 6.01]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES | Responder | 19 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES | Non-responder | 1 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES | Responder | 17 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES | Non-responder | 1 Participants |
p-value: 0.93995% CI: [0.05, 15.44]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES | Responder | 19 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES | Non-responder | 3 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES | Responder | 38 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES | Non-responder | 4 Participants |
p-value: 0.618195% CI: [0.3, 7.39]Univariate regression, logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Responder | 72 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Non-responder | 6 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Responder | 14 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Non-responder | 1 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Responder | 6 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS | Non-responder | 1 Participants |
p-value: 0.550395% CI: [0.05, 4.86]Univariate regression, logistic
p-value: 0.890495% CI: [0.13, 10.46]Univariate Regression, Logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Responder | 78 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Non-responder | 4 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Responder | 13 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Non-responder | 0 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Responder | 1 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS | Non-responder | 4 Participants |
p-value: 0.000395% CI: [0, 0.19]Univariate regression, logistic
p-value: 195% CI: [0, 10.01]Univariate regression, Logistic
Secondary
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS
Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is \>= 10 mIU/mL and a Non- Responder if a serum antibody level is \< 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time frame: Week 28
Population: Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was \> 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Responder | 59 Participants |
| Recombivax | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Non-responder | 3 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Responder | 26 Participants |
| Twinrix | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Non-responder | 0 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Responder | 7 Participants |
| Black/African American | Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS | Non-responder | 5 Participants |
p-value: 0.004295% CI: [0.01, 0.48]Univariate regression, logistic
p-value: 0.6893Univariate regression, Logistic
Secondary
Quantitative Vaccine Response
The Log10 titer was used as the quantitative vaccine response.
Time frame: Week 28
Population: Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recombivax | Quantitative Vaccine Response | 2.29 Log10 titer (mIU/ml) | Standard Deviation 0.82 |
| Twinrix | Quantitative Vaccine Response | 2.58 Log10 titer (mIU/ml) | Standard Deviation 0.65 |
Comparison: Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.p-value: 0.0608Wilcoxon (Mann-Whitney)
Comparison: Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here.95% CI: [2.05, 2.53]95% confidence interval
Comparison: Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here.95% CI: [2.4, 2.76]95% confidence interval
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.
The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.
Time frame: Week 28
Population: The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recombivax | 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. | Study Arm: Recombivax | 34 Participant |
| Recombivax | 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. | Study Arm: Twinrix | 41 Participant |
| Recombivax | 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. | Site Effect: Other Site | 43 Participant |
| Recombivax | 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. | Site Effect: Baltimore | 32 Participant |
| Recombivax | 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. | Age: 15 - 17 years | 51 Participant |
| Recombivax | 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. | Age: 12 - 14 years | 24 Participant |
| Recombivax | 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. | Gender: Female | 29 Participant |
| Recombivax | 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. | Gender: Male | 46 Participant |
| Recombivax | 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. | Hispanic Ethnicity: No | 23 Participant |
| Recombivax | 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. | Hispanic Ethnicity: Yes | 52 Participant |
| Recombivax | 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. | Racial Background: White | 6 Participant |
| Recombivax | 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. | Racial Background: Other/Mixed Race | 47 Participant |
| Recombivax | 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. | Racial Background: Black/African American | 22 Participant |
| Recombivax | 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. | Tanner Stage for Females: Stage 5 | 17 Participant |
| Recombivax | 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. | Tanner Stage for Females: Stages 1 - 4 | 12 Participant |
| Recombivax | 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. | Tanner Stage for Males: Stage 5 | 15 Participant |
| Recombivax | 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. | Tanner Stage for Males: Stages 1 - 4 | 31 Participant |
| Recombivax | 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. | BMI at Baseline: Normal and Underweight (<25.0) | 49 Participant |
| Recombivax | 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. | BMI at Baseline: Overweight and Obese (>=25.0) | 26 Participant |
| Recombivax | 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. | Ever Smoked Cigarettes: No | 59 Participant |
| Recombivax | 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. | Ever Smoked Cigarettes: Yes | 16 Participant |
| Recombivax | 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. | Sexual Identity: Straight (Heterosexual) | 67 Participant |
| Recombivax | 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. | Sexual Identity: Gay, Bi, Not Sure or Undecided | 8 Participant |
| Recombivax | 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. | Age First Sex Not Forced: Never | 44 Participant |
| Recombivax | 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. | Age First Sex Not Forced: <=14 Years | 8 Participant |
| Recombivax | 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. | Age First Sex Not Forced: 15-17 Years | 17 Participant |
| Recombivax | 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. | Total Lifetime Sex Partners: 0 Partners | 44 Participant |
| Recombivax | 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. | Total Lifetime Sex Partners: 1-5 Partners | 19 Participant |
| Recombivax | 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. | Total Lifetime Sex Partners: >= 6 Partners | 10 Participant |
| Recombivax | 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. | Total Lifetime Male Sex Partners: 0 Partners | 58 Participant |
| Recombivax | 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. | Total Lifetime Male Sex Partners: 1-5 Partners | 10 Participant |
| Recombivax | 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. | Total Lifetime Male Sex Partners: >= 6 Partners | 5 Participant |
| Recombivax | 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. | Total Lifetime Female Sex Partners: 0 Partners | 57 Participant |
| Recombivax | 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. | Total Lifetime Female Sex Partners: 1-5 Partners | 11 Participant |
| Recombivax | 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. | Total Lifetime Female Sex Partners: >= 6 Partners | 5 Participant |
| Recombivax | 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. | Ever Drank Alcohol: No | 45 Participant |
| Recombivax | 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. | Ever Drank Alcohol: Yes | 30 Participant |
| Recombivax | 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. | Ever Smoked Marijuana: No | 58 Participant |
| Recombivax | 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. | Ever Smoked Marijuana: Yes | 17 Participant |
| Recombivax | 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. | Ever Used Drugs not Prescribed: No | 71 Participant |
| Recombivax | 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. | Ever Used Drugs not Prescribed: Yes | 4 Participant |
Comparison: This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.1667Regression, Linear
Comparison: This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.989Regression, Linear
Comparison: This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.2796Regression, Linear
Comparison: This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.008Regression, Linear
Comparison: This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.2543Regression, Linear
Comparison: This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.p-value: 0.3661Regression, Linear
Comparison: This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.p-value: 0.9812Regression, Linear
Comparison: This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.7766Regression, Linear
Comparison: This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.2492Regression, Linear
Comparison: This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (\<25.0) vs. Overweight and Obsese (\>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.0877Regression, Linear
Comparison: This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.p-value: 0.0117Regression, Linear
Comparison: This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.7899Regression, Linear
Comparison: This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.0607Regression, Linear
Comparison: This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. \<= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. \<= 14 year olds is presented.p-value: 0.167Regression, Linear
Comparison: This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. \<= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented.p-value: 0.8682Regression, Linear
Comparison: This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.p-value: 0.4219Regression, Linear
Comparison: This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.p-value: 0.002Regression, Linear
Comparison: This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.p-value: 0.1659Regression, Linear
Comparison: This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.p-value: 0Regression, Linear
Comparison: This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.p-value: 0.4701Regression, Linear
Comparison: This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.p-value: 0.7572Regression, Linear
Comparison: This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.8657Regression, Linear
Comparison: This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.0917Regression, Linear
Comparison: This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.p-value: 0.3788Regression, Linear