A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)
Completed · Phase 1
Conditions studied: HIV Infections
In brief
Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e). Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.
Key facts
- Study ID
- NCT00000631
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 13
- Expected to finish
- 1992-12-01
- Last updated by the study team
- 2021-11-02
Who can join
Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Patients must have:
- Normal history and physical exam.
- Negative ELISA for HIV.
- Negative HIV p24 antigen test.
- Normal urinalysis.
- Prior Medication: Required:
- Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
- History of immunodeficiency or chronic illness.
- Hypersensitivity to insects.
- Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.
- Patients with the following prior conditions are excluded:
- History of immunodeficiency or chronic illness.
- Prior Medication:
- Excluded:
- Immunosuppressive medications.
- Prior Treatment:
- Excluded:
- Blood or blood product transfusion within the past 6 months.
- Risk Behavior: Excluded:
- Intravenous drug use.
- More than 2 sexual partners.
Where it is running
- Children's Hospital & Medical Center / Seattle ACTU — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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