Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults

Hawaii Biotech, Inc.1 site in 1 country16 target enrollmentJuly 2009

ConditionsDengue Fever

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Dengue Fever
Sponsor: Hawaii Biotech, Inc.
Enrollment: 16
Locations: 1
Primary Endpoint: To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

January 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hawaii Biotech, Inc.

Eligibility Criteria

Inclusion Criteria

•Males or females age 18 to
•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.

Outcomes

Primary Outcomes

To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data

Time Frame: Assessed at each study visit

Secondary Outcomes

To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses(Every 2 weeks during treatment)