Hepatitis B Challenge Dose in Adults (V232-059-10)

A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01251276

Enrollment

204

Registered

2010-12-01

Start date

2010-11-30

Completion date

2011-04-12

Last updated

2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

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.

Interventions

BIOLOGICALModified 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Participant flow

Recruitment details

A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled

Pre-assignment details

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.

Participants by arm

Arm	Count
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	96
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	108
Total	204

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	1
Overall Study	Protocol Violation	1	0

Baseline characteristics

Characteristic	Modified Process Hepatitis B Vaccine in Base Study	ENGERIX-B™ Vaccine in Base Study	Total
Age, Continuous	63.8 Years STANDARD_DEVIATION 7.3	63.6 Years STANDARD_DEVIATION 6.7	63.7 Years STANDARD_DEVIATION 7
Sex: Female, Male Female	48 Participants	63 Participants	111 Participants
Sex: Female, Male Male	48 Participants	45 Participants	93 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	34 / 96	30 / 107
serious Total, serious adverse events	0 / 96	1 / 107

Outcome results

Primary

Percentage of Seroresponders Before and After the Challenge Vaccination

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)

Population: Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation

Arm	Measure	Group	Value (NUMBER)
Modified Process Hepatitis B Vaccine in Base Study	Percentage of Seroresponders Before and After the Challenge Vaccination	Predose (Day 1); n=88, 102	45.5 Percentage of participants
Modified Process Hepatitis B Vaccine in Base Study	Percentage of Seroresponders Before and After the Challenge Vaccination	Postdose (Month 1); n=88, 103	85.2 Percentage of participants
ENGERIX-B™ Vaccine in Base Study	Percentage of Seroresponders Before and After the Challenge Vaccination	Predose (Day 1); n=88, 102	58.8 Percentage of participants
ENGERIX-B™ Vaccine in Base Study	Percentage of Seroresponders Before and After the Challenge Vaccination	Postdose (Month 1); n=88, 103	88.3 Percentage of participants

Secondary

Percentage of Participants Who Discontinued the Study Due to an Adverse Experience

The percentage of participants who discontinued the study due to an adverse experience was assessed.

Time frame: Up to Month 7