Trial Outcomes & Findings for Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine (NCT NCT00524576)
NCT ID: NCT00524576
Last Updated: 2018-09-07
Results Overview
Immune response defined as: * For initially seronegative subjects (anti-HBs antibody concentration \<3.3 milli-international unit per milliliter \[mIU/mL\] before vaccination) antibody concentration ≥ 10mIU/mL at post booster. * For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration.
COMPLETED
PHASE4
144 participants
30 days post-challenge dose
2018-09-07
Participant Flow
Participant milestones
| Measure |
Engerix 2 Doses + Challenge Dose
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
47
|
|
Overall Study
COMPLETED
|
97
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
Baseline characteristics by cohort
| Measure |
Engerix 2 Doses + Challenge Dose
n=97 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=47 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.5 years
STANDARD_DEVIATION 1.22 • n=5 Participants
|
19.3 years
STANDARD_DEVIATION 1.46 • n=7 Participants
|
19.4 years
STANDARD_DEVIATION 1.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post-challenge dosePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.
Immune response defined as: * For initially seronegative subjects (anti-HBs antibody concentration \<3.3 milli-international unit per milliliter \[mIU/mL\] before vaccination) antibody concentration ≥ 10mIU/mL at post booster. * For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=53 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=21 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
|
53 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 30 days post-challenge dosePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.
Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=53 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=21 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
≥ 3.3 mIU/mL
|
53 participants
|
21 participants
|
|
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
≥ 10 mIU/mL
|
53 participants
|
21 participants
|
|
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
≥ 100 mIU/mL
|
50 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 30 days post-challenge dosePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.
Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=53 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=21 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Concentration of Anti-HBs Antibodies
|
6214.1 mIU/mL
Interval 3213.1 to 12018.0
|
16564.3 mIU/mL
Interval 6394.9 to 42905.6
|
SECONDARY outcome
Timeframe: During the 4-day follow-up period (Day 0-3) after the challenge dosePopulation: Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=55 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=22 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Number of Participants Reporting Solicited Local Symptoms
Pain
|
22 participants
|
4 participants
|
|
Number of Participants Reporting Solicited Local Symptoms
Redness
|
11 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Local Symptoms
Swelling
|
9 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During the 4-day follow-up period (Day 0-3) after the challenge dosePopulation: Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=55 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=22 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Number of Participants Reporting Solicited General Symptoms
Fatigue
|
19 participants
|
7 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Fever ≥ 37.5 degree Celsius
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Gastrointestinal disorder
|
7 participants
|
4 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Headache
|
14 participants
|
4 participants
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period (Day 0-30) after the challenge dosePopulation: Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=55 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=22 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AE)
|
19 participants
|
5 participants
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period (Day 0-30) after the challenge dosePopulation: Analysis was performed on the Total Vaccinated Cohort. This table describes SAEs reported by all subjects except for those enrolled in the Australian center.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Engerix 2 Doses + Challenge Dose
n=55 Participants
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=22 Participants
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAE)
|
0 participants
|
0 participants
|
Adverse Events
Engerix 2 Doses + Challenge Dose
Engerix 3 Doses + Challenge Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Engerix 2 Doses + Challenge Dose
n=55 participants at risk
Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
Engerix 3 Doses + Challenge Dose
n=22 participants at risk
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
|
|---|---|---|
|
Nervous system disorders
Headache
|
30.9%
17/55 • Number of events 18 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
27.3%
6/22 • Number of events 6 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
|
General disorders
Pain
|
40.0%
22/55 • Number of events 22 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
18.2%
4/22 • Number of events 4 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
|
General disorders
Redness
|
20.0%
11/55 • Number of events 11 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
4.5%
1/22 • Number of events 1 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
|
General disorders
Swelling
|
16.4%
9/55 • Number of events 9 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
0.00%
0/22 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
|
General disorders
Fatigue
|
34.5%
19/55 • Number of events 19 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
31.8%
7/22 • Number of events 7 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
|
General disorders
Gastrointestinal disorder
|
12.7%
7/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
18.2%
4/22 • Number of events 4 • Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER