Study of HBV-001 D1 in Healthy Adults

Hawaii Biotech

Status and phase: Completed; Phase 1

Conditions: Dengue Fever

Treatments: Biological: Placebo for DEN1-80E; Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00936429

HBV-001-C-101

Details and patient eligibility

About

This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.

Full description

This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females age 18 to 45.
• Body weight ≥ 110 pounds (50 kg).
• Satisfactory medical condition established by medical history and physical examination.
• Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.

Exclusion criteria

• Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
• Abuse of drugs or alcohol within 12 months prior to screening.
• Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Receipt of any vaccination within 30 days prior to screening.
• Receipt of blood products within 6 months of screening.
• Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
• History of flavivirus infection.
• No easy access to a fixed or mobile telephone.
• History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of > 1 year.
• Donation of ≥ 450 mL of blood within the previous 12 weeks.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 3 patient groups, including a placebo group

10 µg DEN1-80E + 3.5 mg Alhydrogel

Experimental group

Description:

Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.

Treatment:

Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)

50 µg DEN1-80E + 3.5 mg Alhydrogel

Experimental group

Description:

Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.

Treatment:

Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)

Placebo

Placebo Comparator group

Description:

Administration of placebo vaccine at Weeks 0, 4, and 8.

Treatment:

Biological: Placebo for DEN1-80E