Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.EnvPro is a recombinant, purified envelope protein vaccine with an aluminum hydroxide (alum) adjuvant. Aluminum hydroxide is licensed as an adjuvant in other vaccines, such as the hepatitis B vaccine. This study will examine the safety and tolerability of EnvPro with alum adjuvant in healthy, HIV uninfected adults. All participants in this study will receive vaccine injections in the upper arm muscle. Participants will receive a second vaccine injection eight weeks after the first injection. Blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 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.Any sex
Biological sex of participants that are eligible to enroll.Over 18 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: * HIV uninfected * Normal medical history and physical exam * Normal complete blood count * Normal liver function * Normal renal function * Normal serum creatine phosphokinase (CPK) * Availability for at least 1 year follow-up Exclusion Criteria: * History of immunosuppressive illness, chronic illness, or use of any immunosuppressive medications * Medical or psychiatric condition or occupational responsibilities which preclude compliance with the study * Live attenuated vaccines within 60 days of study entry * Use of experimental agents within 30 days of study entry
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