Study of HBV-001 D1 in Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Dengue Fever
In brief
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.
Key facts
- Study ID
- NCT00936429
- Run by
- Hawaii Biotech, Inc.
- People needed
- 16
- Starts
- 2009-07-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2011-02-07
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Saint Louis University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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