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

NCT00440531 | Completed Phase 3 Results

• 2 other identifiers: V232-0592007_516
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

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™).

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)

  7 months (1 month after third vaccination)

• The Total Number of Participants With One or More Injection-site Adverse Experiences

  Days 1-5 After Any Vaccination

• The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C

  Day 1-5 After Vaccination

• 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)

Study Arms (3)

1

ACTIVE COMPARATOR

RECOMBIVAX HB™

Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)

2

EXPERIMENTAL

Modified Process Hepatitis B Vaccine

Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)

3

ACTIVE COMPARATOR

ENGERIX-B™

Biological: Comparator: ENGERIX-B™ (currently licensed product)

Interventions

Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) BIOLOGICAL

RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.

1

Comparator: Modified Process Hepatitis B Vaccine (Experimental) BIOLOGICAL

Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.

2

Comparator: ENGERIX-B™ (currently licensed product) BIOLOGICAL

ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.

3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22185811 DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 13, 2017
• Results First Posted: March 31, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share