Trial Outcomes & Findings for Hepatitis B Challenge Dose in Adults (V232-059-10) (NCT NCT01251276)
NCT ID: NCT01251276
Last Updated: 2022-09-13
Results Overview
A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
Predose (Day 1) and 1 month after challenge dose (Month 1)
Results posted on
2022-09-13
Participant Flow
A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled
Study participants received 3 doses of Modified Process Hepatitis B Vaccine or ENGERIX-B™ vaccine in the Base Study (V232-059, NCT00440531). Two years after completion of the Base Study vaccinations, participants were eligible to receive one challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study.
Participant milestones
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
108
|
|
Overall Study
Vaccinated
|
96
|
108
|
|
Overall Study
COMPLETED
|
95
|
107
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Hepatitis B Challenge Dose in Adults (V232-059-10)
Baseline characteristics by cohort
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=108 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
63.7 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose (Day 1) and 1 month after challenge dose (Month 1)Population: Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation
A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=88 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=103 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Percentage of Seroresponders Before and After the Challenge Vaccination
Predose (Day 1); n=88, 102
|
45.5 Percentage of participants
Interval 34.8 to 56.4
|
58.8 Percentage of participants
Interval 48.6 to 68.5
|
|
Percentage of Seroresponders Before and After the Challenge Vaccination
Postdose (Month 1); n=88, 103
|
85.2 Percentage of participants
Interval 76.1 to 91.9
|
88.3 Percentage of participants
Interval 80.5 to 93.8
|
SECONDARY outcome
Timeframe: Up to Day 15 after challenge dosePopulation: Participants who received a challenge dose and had safety follow-up
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Percentage of Participants With One or More Adverse Experiences
|
39.6 Percentage of participants
|
45.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 7Population: Participants who received a challenge dose and had safety follow-up
The percentage of participants who discontinued the study due to an adverse experience was assessed.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 15 after challenge dosePopulation: Participants who received a challenge dose and had safety follow-up
The percentage of participants with one or more injection-site adverse experiences was assessed.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Percentage of Participants With One or More Injection-site Adverse Experiences
|
35.4 Percentage of participants
|
29.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 15 after challenge dosePopulation: Participants who received a challenge dose and had safety follow-up
The percentage of participants with one or more systemic adverse experiences was assessed.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Percentage of Participants With One or More Systemic Adverse Experiences
|
16.7 Percentage of participants
|
28.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 1 after challenge dosePopulation: Participants who received a challenge dose and had safety follow-up
A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 Participants
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 Participants
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Percentage of Participants With One or More Serious Adverse Experiences
|
0 Percentage of participants
|
0.9 Percentage of participants
|
Adverse Events
Modified Process Hepatitis B Vaccine in Base Study
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
ENGERIX-B™ Vaccine in Base Study
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 participants at risk
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 participants at risk
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/96 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
0.93%
1/107 • Number of events 1 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
Other adverse events
| Measure |
Modified Process Hepatitis B Vaccine in Base Study
n=96 participants at risk
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
ENGERIX-B™ Vaccine in Base Study
n=107 participants at risk
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
|
|---|---|---|
|
General disorders
Injection-site erythema
|
7.3%
7/96 • Number of events 7 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
4.7%
5/107 • Number of events 5 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
|
General disorders
Injection-site pain
|
32.3%
31/96 • Number of events 31 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
25.2%
27/107 • Number of events 27 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
|
General disorders
Injection-site swelling
|
7.3%
7/96 • Number of events 7 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
3.7%
4/107 • Number of events 4 • All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study sixty (60) days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER