Clinical trial NCT00001056: A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose
Official title: A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
Vaccinia Virus
Viral Vaccines
HIV-1
HIV Envelope Protein gp160
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Immuno-US
First posted: 2001-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Detailed description: Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo. At each participating site, four volunteers receive vaccine and two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may be offered an additional booster of the same preparation at 12 months.

Eligibility criteria: Inclusion Criteria

Patients must be:

* Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
* Available for 2 years of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* History of positive PPD (tuberculin test) and abnormal chest x-ray.
* Positive syphilis serology (e.g., RPR).
* Positive for circulating hepatitis B surface antigen.

Patients with the following are excluded:

* They or their sexual partners have identifiable high-risk behavior for HIV infection.
* History of immunodeficiency or chronic illness.
* Evidence of psychological or psychiatric problems that may lead to noncompliance.

Prior Medication:

Excluded:

* Immunosuppressive medications.

Prior Treatment:

Excluded:

* Blood transfusions or cryoprecipitates within the past 6 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Univ. School of Medicine AVEG
state: Missouri
city: Rochester
country: United States
facility: Univ. of Rochester AVEG
state: New York
city: Nashville
country: United States
facility: Vanderbilt Univ. Hosp. AVEG
state: Tennessee
Study officials:
name: Belshe R
role: STUDY_CHAIR
References:
citation: Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163.