Hepatitis B, HIV Infection
Conditions
Keywords
Hepatitis B vaccines, HIV-infected adolescents, Hepatitis B infection (negative)
Brief summary
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.
Detailed description
Suboptimal response to hepatitis B vaccination in HIV+ adults and children has been well documented in the literature. Given the importance of preventing hepatitis B virus (HBV) co-infection in HIV+ youth and the poor response rates in this population, this study will attempt to improve the immediate and long-term sero-response rates by undertaking a randomized, open-label trial of three hepatitis B vaccination schemas, as follows: 1. standard adult dosing of HBV-only vaccine: Engerix-B 20 mcg at Entry, Week 4 and Week 24 2. increased adult dosing of HBV-only vaccine: Engerix-B 40 mcg at Entry, Week 4 and Week 24 3. standard adult dosing of combined HBV/hepatitis A virus (HAV) vaccine: Twinrix 720 enzyme immunoassay (EIA) HAV Ag plus 20 mcg HBsAg at Entry, Week 4 and Week 24. This study will also describe the safety of administration of an increased dose of the hepatitis B vaccine in this population. In general, patients undergoing dialysis who have received the dosing regimen recommended for immunocompromised individuals have tolerated the vaccine series well. Design: This is a stratified, block-randomized, open-label trial of three hepatitis B vaccination schemas in HIV-infected and HBV-uninfected youth. Once randomized, there will be a total of 6 study visits in a 72 week period. Vaccination will occur at Entry, Week 4 and Week 24. Primary sero-response will be evaluated at Week 28 and sustainability of response will be evaluated at Weeks 48 and 72 for those who achieve a primary antibody response of \>= 10 IU/ml. Primary non-responders (antibody response of \< 10 IU/ml) will be provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48 and evaluated for responsiveness at Week 72.
Interventions
BIOLOGICALEngerix-B 20 mcg
A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.
BIOLOGICALEngerix-B 40 mcg
A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.
BIOLOGICALTwinrix 720 EIA HAV Ag plus 20 mcg HBsAg
Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml: A single dose of 1 mL will be administered in the deltoid muscle.
Sponsors
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
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Documented HIV+ * Age 12 to \< 25 years * History of no or one hepatitis B vaccination * Not pregnant. * Females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
Exclusion criteria
* History of \> 1 hepatitis B vaccination * Serologic evidence of past or present hepatitis B infection: anti-hepatitis B surface antigen (HBsAg), HBs-Ag or anti- hepatitis B core antigen (HBcAg) * Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or aluminum. * Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam. Presence of any known grade \>= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables. * Anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed. * Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization. * Receipt of immune globulin product or plasma product within 6 months preceding randomization * Receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization. * Known or suspected diseases of the immune system, other than HIV, or treatment for a malignancy within 3 months of randomization. * Other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sero-response to Hepatitis B Surface Antigen | Week 28 | The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Baseline through Week 72 | The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity. |
| Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Baseline through Week 72 | The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity. |
| Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Baseline through Week 72 | The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator. |
| Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | Entry through Week 72 | Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown. |
| Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM | Week 28 | Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL. |
Countries
Brazil, South Africa, United States
Participant flow
Recruitment details
This is a multi-site study. Accrual was open between April 2006 and January 2008. Participants were enrolled in the United States, South Africa, Brazil, and the Bahamas.
Pre-assignment details
Subjects were randomized into one of three arms using blocks of six and stratified by absolute CD4 count (less than 500 and 500 cells/mL or greater) and previous hepatitis B virus (HBV) vaccination (0,1). The randomization was restricted so that the percentage of subjects with CD4 count \< = 200 cells/mL would not exceed 15% of subjects on any arm.
Participants by arm
| Arm | Count |
|---|---|
| 1: Engerix 20 mcg Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24. | 118 |
| 2: Engerix 40 mcg 40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24. | 126 |
| 3: Twinrix 20 mcg 20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24. | 127 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 0 |
| Overall Study | Did not meet eligibility criteria | 0 | 2 | 2 |
| Overall Study | Failure to adhere | 2 | 0 | 0 |
| Overall Study | Incarceration | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 6 | 2 |
| Overall Study | Pregnancy | 2 | 3 | 2 |
| Overall Study | Required disallowed medication | 0 | 1 | 0 |
| Overall Study | Site Funding Terminated | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 1: Engerix 20 mcg | 2: Engerix 40 mcg | 3: Twinrix 20 mcg | Total |
|---|---|---|---|---|
| Age, Continuous | 20.56 years STANDARD_DEVIATION 3.42 | 20.96 years STANDARD_DEVIATION 3.25 | 20.20 years STANDARD_DEVIATION 3.5 | 20.57 years STANDARD_DEVIATION 3.4 |
| Age, Customized 12-13 years | 8 participants | 3 participants | 8 participants | 19 participants |
| Age, Customized 14-15 years | 5 participants | 11 participants | 10 participants | 26 participants |
| Age, Customized 16-19 years | 25 participants | 18 participants | 20 participants | 63 participants |
| Age, Customized >20 years | 80 participants | 94 participants | 89 participants | 263 participants |
| Region of Enrollment Bahamas | 10 participants | 8 participants | 7 participants | 25 participants |
| Region of Enrollment Brazil | 52 participants | 58 participants | 58 participants | 168 participants |
| Region of Enrollment South Africa | 4 participants | 6 participants | 13 participants | 23 participants |
| Region of Enrollment United States | 52 participants | 54 participants | 49 participants | 155 participants |
| Sex: Female, Male Female | 73 Participants | 74 Participants | 80 Participants | 227 Participants |
| Sex: Female, Male Male | 45 Participants | 52 Participants | 47 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 118 | 25 / 126 | 25 / 127 |
| serious Total, serious adverse events | 0 / 118 | 0 / 126 | 0 / 127 |
Outcome results
Primary
Sero-response to Hepatitis B Surface Antigen
The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.
Time frame: Week 28
Population: Participants who completed a Week 28 visit with a Hepatitis B serology result were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1: Engerix 20 mcg | Sero-response to Hepatitis B Surface Antigen | 60 percentage of participants who resonded |
| 2: Engerix 40 mcg | Sero-response to Hepatitis B Surface Antigen | 73.2 percentage of participants who resonded |
| 3: Twinrix 20 mcg | Sero-response to Hepatitis B Surface Antigen | 75.4 percentage of participants who resonded |
p-value: 0.044Chi-squared
p-value: 0.0157Chi-squared
Secondary
Response Rates in HIV+ Youth Within Each Study Arm by Study Duration
Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.
Time frame: Entry through Week 72
Population: Population analyzed were those who had an antibody titer measured at Week 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Engerix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | <= 20 weeks | 27.87 percentage of participants who responded |
| 1: Engerix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | 21 - 44 weeks | 3.28 percentage of participants who responded |
| 1: Engerix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | > 20 weeks | 4.92 percentage of participants who responded |
| 1: Engerix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | > 44 weeks | 63.93 percentage of participants who responded |
| 2: Engerix 40 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | > 44 weeks | 60.26 percentage of participants who responded |
| 2: Engerix 40 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | <= 20 weeks | 19.23 percentage of participants who responded |
| 2: Engerix 40 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | > 20 weeks | 12.82 percentage of participants who responded |
| 2: Engerix 40 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | 21 - 44 weeks | 7.69 percentage of participants who responded |
| 3: Twinrix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | > 44 weeks | 62.96 percentage of participants who responded |
| 3: Twinrix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | 21 - 44 weeks | 11.11 percentage of participants who responded |
| 3: Twinrix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | > 20 weeks | 3.70 percentage of participants who responded |
| 3: Twinrix 20 mcg | Response Rates in HIV+ Youth Within Each Study Arm by Study Duration | <= 20 weeks | 22.22 percentage of participants who responded |
p-value: 0.5822Regression, Cox
p-value: 0.8698Regression, Cox
Secondary
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY
The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.
Time frame: Baseline through Week 72
Population: All enrolled participants were included in this analysis. The following no. of participants experienced at least one Grade 2 or higher abnormal labs by study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Absolute Neutrophil Count | 7 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Hemoglobin | 0 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Platelets | 0 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | White Blood Cell count | 3 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | White Blood Cell count | 2 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Absolute Neutrophil Count | 5 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Platelets | 2 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Hemoglobin | 1 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | White Blood Cell count | 7 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Hemoglobin | 2 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Platelets | 1 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY | Absolute Neutrophil Count | 9 Events |
Secondary
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED
The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.
Time frame: Baseline through Week 72
Population: All enrolled participants were included in this analysis of AEs that were definitely related to study drug. There were no AEs above Grade 2 considered to be definitely related to study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Injection Site Pain, Grade 1 | 1 event |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Myalgia, Grade 2 | 1 event |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Injection Site Pain, Grade 1 | 0 event |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Myalgia, Grade 2 | 0 event |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Injection Site Pain, Grade 1 | 1 event |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED | Myalgia, Grade 2 | 1 event |
Secondary
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.
Time frame: Baseline through Week 72
Population: All enrolled participants were included in this analysis of all AEs that were possibly or probably related to study drug. There were no AEs above Grade 3 considered to be possibly or probably related to study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Asthenia, Grade 1 | 0 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Arthralgia, Grade 3 | 1 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Headache, Grade 1 | 1 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Headache, Grade 2 | 2 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Somnolence, Grade 1 | 0 Events |
| 1: Engerix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Syncope Vasovagal, Grade 1 | 0 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Syncope Vasovagal, Grade 1 | 0 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Asthenia, Grade 1 | 0 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Headache, Grade 2 | 0 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Somnolence, Grade 1 | 0 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Arthralgia, Grade 3 | 0 Events |
| 2: Engerix 40 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Headache, Grade 1 | 0 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Arthralgia, Grade 3 | 0 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Headache, Grade 1 | 0 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Syncope Vasovagal, Grade 1 | 1 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Headache, Grade 2 | 0 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Asthenia, Grade 1 | 1 Events |
| 3: Twinrix 20 mcg | Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED | Somnolence, Grade 1 | 1 Events |
Secondary
Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM
Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.
Time frame: Week 28
Population: All participants who had a Week 28 Hepatitis B serology result
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1: Engerix 20 mcg | Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM | 73.2 percentage of participants who responded |
| 2: Engerix 40 mcg | Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM | 60 percentage of participants who responded |
| 3: Twinrix 20 mcg | Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM | 75.4 percentage of participants who responded |
p-value: 0.085395% CI: [0.07, 1.19]Regression, Logistic
p-value: 0.024495% CI: [1.09, 3.63]Regression, Logistic