A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process

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

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
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.

Overall Status Completed
Start Date November 29, 2011
Completion Date November 6, 2012
Primary Completion Date November 6, 2012
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection Month 7
Percentage of Participants With Injection-site Adverse Events Up to 15 days after each vaccination
Percentage of Participants With Pyrexia Adverse Events Up to 15 days after each vaccination
Enrollment 722
Condition
Intervention

Intervention type: Biological

Intervention name: 2XP HEPTAVAX™-II SC

Arm group label: V232-2XP SC

Intervention type: Biological

Intervention name: 1XP HEPTAVAX™-II SC

Arm group label: V232-1XP SC

Intervention type: Biological

Intervention name: 2XP HEPTAVAX™-II IM

Arm group label: V232-2XP IM

Eligibility

Criteria:

Inclusion Criteria:

To receive the first study vaccination, Participants should meet all 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:

To receive the first study vaccination, Participants should not have any exclusion criteria. For items with an asterisk (*), if the Participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.

- 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).

Gender: All

Minimum age: 20 Years

Maximum age: 35 Years

Healthy volunteers: Accepts Healthy Volunteers

Verification Date

June 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: V232-2XP SC

Arm group type: Experimental

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

Arm group label: V232-1XP SC

Arm group type: Active Comparator

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

Arm group label: V232-2XP IM

Arm group type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov