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 Accelerated Schedules - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Immuno-US
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000957

Purpose

To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; 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 ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Condition	Intervention	Phase
HIV Infections	Biological: gp160 Vaccine (Immuno-AG)	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Krestin PANVAC-V

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Double-Blind, Safety Study
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 Accelerated Schedules

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

30

Detailed Description:

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

Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Patients must be:

Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
Available for 1 year of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

They or their sexual partners have identifiable high-risk behavior for HIV infection.
Positive syphilis serology (e.g., VDRL).
Positive for circulating hepatitis B antigen.

Patients with the following prior conditions are excluded:

History of positive PPD (tuberculin test).
History of immunodeficiency or chronic illness.
Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

Immunosuppressive medications.

Prior Treatment:

Excluded:

Blood transfusions or cryoprecipitates within the past 6 months.

Risk Behavior: Excluded:

High-risk behavior for HIV infection.
History of intravenous drug use.
More than one sexual partner in the last 6 months.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000957

Locations

United States, Missouri
St Louis Univ School of Medicine
St. Louis, Missouri, United States, 63104
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Immuno-US

Investigators

Study Chair:

Belshe R

More Information

Publications:

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.

Gorse GJ, Schwartz DH, Graham BS, Matthews TJ, Stablein DM, Frey SE, Belshe RB, Clements ML, Wright PF, Eibl M, et al. HIV-1 recombinant gp160 vaccine given in accelerated dose schedules. NIAID AIDS Vaccine Clinical Trials Network. Clin Exp Immunol. 1994 Nov;98(2):178-84.

Gorse GJ, Patel GB, Newman FK, Mandava M, Belshe RB. Recombinant gp160 vaccination schedule and MHC HLA type as factors influencing cellular responses to HIV-1 envelope glycoprotein. NIAID AIDS Vaccine Clinical Trials Network. Vaccine. 1995 Sep;13(13):1170-9.

Study ID Numbers:	AVEG 004B
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000957
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Vaccines, Synthetic
Vaccinia Virus
Viral Vaccines
HIV-1
Drug Evaluation

HIV Envelope Protein gp160
Drug Administration Schedule
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Poxviridae Infections
Vaccinia
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
DNA Virus Infections
PS-K
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009