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NCT Number: NCT00489099

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)

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.

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Key information

Conditions

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

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V232 Modified Process Hepatitis B Vaccine: Lot A

Biological

V232 Modified Process Hepatitis B Vaccine: Lot B

Biological

V232 Modified Process Hepatitis B Vaccine: Lot C

Biological

V232 Current Process Hepatitis B Vaccine

Biological

Primary outcomes

  1. Number of Participants with Seroprotection to Hepatitis B Surface Antigen

    Time frame: 1 month after the third vaccination (Month 7)

  2. Geometric Mean Titers to Hepatitis B Surface Antigen

    Time frame: 1 month after the third vaccination (Month 7)

Secondary outcomes

  1. Percentage of Participants with an Adverse Experience

    Time frame: Up to 15 days after any vaccination

  2. Percentage of Participants with an Injection-site Adverse Experience

    Time frame: Up to 15 days after any vaccination

  3. Percentage of Participants with a Systemic Adverse Experience

    Time frame: Up to 15 days after any vaccination

  4. Percentage of Participants with Fever (>=37.8°C, 100.0°F)

    Time frame: Up to 5 days after any vaccination

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 21, 2007
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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