A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Hepatitis B Infection Clinical Trial

Official title:

A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489099
• Other study ID #: V232-054
• Secondary ID: 2007_565
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2007
• Last updated: March 15, 2017
• Start date: June 2005
• Est. completion date: May 2006

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• In general good health

• Female participants have a negative pregnancy test just prior to vaccination on Day 1

Exclusion Criteria:

• History of Hepatitis B Infection or vaccination

• Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)

• Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1

• Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1

• Participation on prior study using an investigational drug or vaccine in prior 3 months

• Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids

• Pregnant or nursing women or women planning to become pregnant within the study period

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection

Intervention

Biological:
• V232 Modified Process Hepatitis B Vaccine: Lot A

• V232 Modified Process Hepatitis B Vaccine: Lot B

• V232 Modified Process Hepatitis B Vaccine: Lot C

• V232 Current Process Hepatitis B Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Seroprotection to Hepatitis B Surface Antigen		1 month after the third vaccination (Month 7)
Primary	Geometric Mean Titers to Hepatitis B Surface Antigen		1 month after the third vaccination (Month 7)
Secondary	Percentage of Participants with an Adverse Experience		Up to 15 days after any vaccination
Secondary	Percentage of Participants with an Injection-site Adverse Experience		Up to 15 days after any vaccination
Secondary	Percentage of Participants with a Systemic Adverse Experience		Up to 15 days after any vaccination
Secondary	Percentage of Participants with Fever (>=37.8°C, 100.0°F)		Up to 5 days after any vaccination