Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

Hepatitis B Clinical Trial

Official title:

A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440531
• Other study ID #: V232-059
• Secondary ID: 2007_516
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2007
• Last updated: December 30, 2015
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
• Comparator: Modified Process Hepatitis B Vaccine (Experimental)
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
• Comparator: ENGERIX-B™ (currently licensed product)
ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)	The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).	7 months (1 month after third vaccination)	No
Secondary	The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)	The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).	7 months (1 month after third vaccination)	No
Secondary	The Total Number of Participants With One or More Injection-site Adverse Experiences		Days 1-5 After Any Vaccination	Yes
Secondary	The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C		Day 1-5 After Vaccination	Yes
Secondary	The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences		During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)	Yes

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site