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)
HIVAC-1e
+ gp160 Vaccine (MicroGeneSys)
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
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. Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Children's Hospital & Medical Center / Seattle ACTU
Seattle, United StatesOpen Children's Hospital & Medical Center / Seattle ACTU in Google Maps