Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

NCT ID: NCT01463683

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 722 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-29
• Study Completion Date: 2012-11-06

Brief Summary

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.

Detailed Description

2XP HEPTAVAX™-II is manufactured using a modified process in which the composition of the amorphous aluminum hydroxyphosphate sulfate adjuvant has been modified by increasing the phosphate content by approximately 2-fold. Thus the modified process HEPTAVAX™-II is referred to as 2XP HEPTAVAX™-II.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V232-2XP SC

2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6

Group Type: EXPERIMENTAL

2XP HEPTAVAX™-II SC

Intervention Type: BIOLOGICAL

V232-1XP SC

1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6

Group Type: ACTIVE_COMPARATOR

1XP HEPTAVAX™-II SC

Intervention Type: BIOLOGICAL

V232-2XP IM

2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6

Group Type: EXPERIMENTAL

2XP HEPTAVAX™-II IM

Intervention Type: BIOLOGICAL

Interventions

2XP HEPTAVAX™-II SC

Intervention Type: BIOLOGICAL

1XP HEPTAVAX™-II SC

Intervention Type: BIOLOGICAL

2XP HEPTAVAX™-II IM

Intervention Type: BIOLOGICAL

Other Intervention Names

RECOMBIVAX HB; HBVAXPRO; RECOMBIVAX HB; HBVAXPRO

Eligibility Criteria

Inclusion Criteria

• Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main trial without participating in Future Biomedical Research.
• Participant is Japanese male or female, between 20 to 35 years of age on the day of the first study vaccination.
• Participant is determined to be in general good health based on the medical history taken on Day 1 prior to receiving the first injection of the vaccine. Any underlying chronic illness must be documented to be in stable condition.
• For females, a negative urine pregnancy test just prior to vaccination on Day 1.

Exclusion Criteria

• Participant has a history of previous hepatitis B infection.
• Participant has a history of vaccination with any hepatitis B vaccine.
• *Participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥ 37.8°C).
• Participant has a known or suspected hypersensitivity to any component of HEPTAVAX™-II vaccine and latex (e.g., aluminum, yeast).
• Participant has a 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, or is expected to require such blood-derived products during the study.
• *Participant has received licensed inactivated vaccines within 14 days prior or licensed live vaccines within 28 days prior to first injection with the study vaccine.
• Participant has received investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
• Use of immunosuppressive therapy. Participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 4 weeks prior to enrollment until 6 weeks post vaccination, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) per day for >2 weeks (except for use of topical or inhalation steroid therapy).
• Pregnant women, nursing mothers, and women planning to become pregnant within the study period. Women of childbearing age should employ an acceptable method of contraception during the study (e.g., condom, diaphragm, oral contraceptive, Intrauterine Device (IUD), or hormonal implants are considered acceptable).
• Participant has any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
• Participant has a coagulation disorder contraindicating intramuscular injection.
• Participant has immunocompromised condition (such as Human Immunodeficiency Virus (HIV) positive, leukemia, lymphoma, other cancers or disorders).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Kishino H, Takahashi K, Sawata M, Tanaka Y. Immunogenicity, safety, and tolerability of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young Japanese adults. Hum Vaccin Immunother. 2018 Jul 3;14(7):1773-1778. doi: 10.1080/21645515.2018.1452578. Epub 2018 Apr 12.

Reference Type: RESULT

PMID: 29553862 (View on PubMed)

Other Identifiers

V232-062

Identifier Type: -

Identifier Source: org_study_id