Clinical trial NCT00440531: Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Official title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 540
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).


Eligibility criteria: Inclusion Criteria:

* Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

* Any adult with a history of previous hepatitis B infection
* A history of vaccination with any hepatitis B vaccine
* Recent (\<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
* Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
* Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
* Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
* Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
* Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
* Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
* Pregnant women, nursing mothers, and women planning to become pregnant within the study period
* Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Primary outcomes:
measure: The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
timeFrame: 7 months (1 month after third vaccination)
Secondary outcomes:
measure: The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
timeFrame: 7 months (1 month after third vaccination)
measure: The Total Number of Participants With One or More Injection-site Adverse Experiences
timeFrame: Days 1-5 After Any Vaccination
measure: The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C
timeFrame: Day 1-5 After Vaccination
measure: The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
timeFrame: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gilbert CL, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults >/=50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1.