Hepatitis B Challenge Dose in Adults (V232-059-10)
Study Details
Study Description
Brief Summary
The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Modified Process Hepatitis B Vaccine in Base Study Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
Biological: Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
Other Names:
|
Experimental: ENGERIX-B™ Vaccine in Base Study Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
Biological: Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Seroresponders Before and After the Challenge Vaccination [Predose (Day 1) and 1 month after challenge dose (Month 1)]
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.
Secondary Outcome Measures
- Percentage of Participants With One or More Adverse Experiences [Up to Day 15 after challenge dose]
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.
- Percentage of Participants Who Discontinued the Study Due to an Adverse Experience [Up to Month 7]
The percentage of participants who discontinued the study due to an adverse experience was assessed.
- Percentage of Participants With One or More Injection-site Adverse Experiences [Up to Day 15 after challenge dose]
The percentage of participants with one or more injection-site adverse experiences was assessed.
- Percentage of Participants With One or More Systemic Adverse Experiences [Up to Day 15 after challenge dose]
The percentage of participants with one or more systemic adverse experiences was assessed.
- Percentage of Participants With One or More Serious Adverse Experiences [Up to Month 1 after challenge dose]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
In general good health based on a medical history.
-
Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.
Exclusion Criteria:
-
Known history of previous Hepatitis B infection.
-
History of vaccination with any Hepatitis B vaccine within the last 2 years.
-
History of febrile illness.
-
Known or suspected hypersensitivity to any component of HBVaxPro.
-
Receipt of medication / vaccine that may interfere with study assessments.
-
Known or suspected immune impairment.
-
Pregnant women and nursing mothers.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V232-059-10
- rHB01C
- 2006-003649-18
Study Results
Participant Flow
Recruitment Details | A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 96 | 108 |
Vaccinated | 96 | 108 |
COMPLETED | 95 | 107 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 of all reporting groups |
Overall Participants | 96 | 108 | 204 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
63.8
(7.3)
|
63.6
(6.7)
|
63.7
(7.0)
|
Sex: Female, Male (Count of Participants) | |||
Female |
48
50%
|
63
58.3%
|
111
54.4%
|
Male |
48
50%
|
45
41.7%
|
93
45.6%
|
Outcome Measures
Title | Percentage of Seroresponders Before and After the Challenge Vaccination |
---|---|
Description | 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. |
Time Frame | Predose (Day 1) and 1 month after challenge dose (Month 1) |
Outcome Measure Data
Analysis Population Description |
---|
Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 88 | 103 |
Predose (Day 1); n=88, 102 |
45.5
47.4%
|
58.8
54.4%
|
Postdose (Month 1); n=88, 103 |
85.2
88.8%
|
88.3
81.8%
|
Title | Percentage of Participants With One or More Adverse Experiences |
---|---|
Description | 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. |
Time Frame | Up to Day 15 after challenge dose |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received a challenge dose and had safety follow-up |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 96 | 107 |
Number [Percentage of participants] |
39.6
41.3%
|
45.8
42.4%
|
Title | Percentage of Participants Who Discontinued the Study Due to an Adverse Experience |
---|---|
Description | The percentage of participants who discontinued the study due to an adverse experience was assessed. |
Time Frame | Up to Month 7 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received a challenge dose and had safety follow-up |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 96 | 107 |
Number [Percentage of participants] |
0
0%
|
0
0%
|
Title | Percentage of Participants With One or More Injection-site Adverse Experiences |
---|---|
Description | The percentage of participants with one or more injection-site adverse experiences was assessed. |
Time Frame | Up to Day 15 after challenge dose |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received a challenge dose and had safety follow-up |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 96 | 107 |
Number [Percentage of participants] |
35.4
36.9%
|
29.9
27.7%
|
Title | Percentage of Participants With One or More Systemic Adverse Experiences |
---|---|
Description | The percentage of participants with one or more systemic adverse experiences was assessed. |
Time Frame | Up to Day 15 after challenge dose |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received a challenge dose and had safety follow-up |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 96 | 107 |
Number [Percentage of participants] |
16.7
17.4%
|
28.0
25.9%
|
Title | Percentage of Participants With One or More Serious Adverse Experiences |
---|---|
Description | 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. |
Time Frame | Up to Month 1 after challenge dose |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received a challenge dose and had safety follow-up |
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 96 | 107 |
Number [Percentage of participants] |
0
0%
|
0.9
0.8%
|
Adverse Events
Time Frame | All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose | |||
---|---|---|---|---|
Adverse Event Reporting Description | The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up | |||
Arm/Group Title | Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | ||
Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/96 (0%) | 1/107 (0.9%) | ||
Psychiatric disorders | ||||
Bipolar disorder | 0/96 (0%) | 0 | 1/107 (0.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Modified Process Hepatitis B Vaccine in Base Study | ENGERIX-B™ Vaccine in Base Study | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 34/96 (35.4%) | 30/107 (28%) | ||
General disorders | ||||
Injection-site erythema | 7/96 (7.3%) | 7 | 5/107 (4.7%) | 5 |
Injection-site pain | 31/96 (32.3%) | 31 | 27/107 (25.2%) | 27 |
Injection-site swelling | 7/96 (7.3%) | 7 | 4/107 (3.7%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Senior Vice President, Global Clinical Development |
---|---|
Organization | Merck Sharp & Dohme Corp. |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- V232-059-10
- rHB01C
- 2006-003649-18