A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160 - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Protein Sciences Corporation
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000745

Purpose

To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160.

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

Condition	Intervention	Phase
HIV Infections	Biological: Hepatitis B Vaccine (Recombinant) Biological: gp160 Vaccine (MicroGeneSys)	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Hepatitis B Vaccines Krestin PANVAC-V

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Double-Blind, Safety Study
Official Title:	A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

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

Estimated Enrollment:

72

Detailed Description:

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

Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Subjects must have:

Normal history and physical exam.
Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
T4 count >= 800 cells/mm3.
Normal chest x-ray and urinalysis.
Negative surface antibody and core antibody for hepatitis B.
Negative hepatitis B surface antigen.
Negative HIV p24 antigen test.
Normal skin reactivity by Merieux test.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

Positive PPD.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).

Subjects with the following prior conditions are excluded:

History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
Prior hepatitis B vaccination.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Prior Medication:

Excluded:

Prior hepatitis B vaccine.

Prior Treatment:

Excluded:

Prior blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:

Any history of IV drug use.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000745

Locations

United States, Maryland
Univ of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, New York
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
United States, West Virginia
Marshall Universiy
Huntington, West Virginia, United States, 25701

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Protein Sciences Corporation

Investigators

Study Chair:	Belshe R
Study Chair:	Clements ML
Study Chair:	Couch R
Study Chair:	Dolin R
Study Chair:	Levine M
Study Chair:	Wright P

More Information

Publications:

Dolin R, Graham BS, Greenberg SB, Tacket CO, Belshe RB, Midthun K, Clements ML, Gorse GJ, Horgan BW, Atmar RL, et al. The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network. Ann Intern Med. 1991 Jan 15;114(2):119-27.

Archibald DW, Hebert CA, Sun D, Tacket CO. Salivary antibodies to human immunodeficiency virus type 1 in a phase I AIDS vaccine trial. J Acquir Immune Defic Syndr. 1990;3(10):954-8.

Westblom TU, Belshe RB, Gorse GJ, Anderson EL, Berry CF. Characteristics of a population volunteering for human immunodeficiency virus immunization. NIAID AIDS Clinical Trials Network. Int J STD AIDS. 1990 Mar;1(2):126-8.

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.

Tacket CO, Baqar S, Munoz C, Murphy JR. Lymphoproliferative responses to mitogens and HIV-1 envelope glycoprotein among volunteers vaccinated with recombinant gp160. AIDS Res Hum Retroviruses. 1990 Apr;6(4):535-42.

Viscidi R, Ellerbeck E, Garrison L, Midthun K, Clements ML, Clayman B, Fernie B, Smith G. Characterization of serum antibody responses to recombinant HIV-1 gp160 vaccine by enzyme immunoassay. NIAID AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1990 Nov;6(11):1251-6.

Orentas RJ, Hildreth JE, Obah E, Polydefkis M, Smith GE, Clements ML, Siliciano RF. Induction of CD4+ human cytolytic T cells specific for HIV-infected cells by a gp160 subunit vaccine. Science. 1990 Jun 8;248(4960):1234-7.

Clerici M, Berzofsky JA, Shearer GM, Tacket CO. Exposure to human immunodeficiency virus (HIV) type I indicated by HIV-specific T helper cell responses before detection of infection by polymerase chain reaction and serum antibodies [corrected] J Infect Dis. 1991 Jul;164(1):178-82.

Bollinger RC, Quinn TC, Liu AY, Stanhope PE, Hammond SA, Viveen R, Clements ML, Siliciano RF. Cytokines from vaccine-induced HIV-1 specific cytotoxic T lymphocytes: effects on viral replication. AIDS Res Hum Retroviruses. 1993 Nov;9(11):1067-77.

Polydefkis M, Koenig S, Flexner C, Obah E, Gebo K, Chakrabarti S, Earl PL, Moss B, Siliciano RF. Anchor sequence-dependent endogenous processing of human immunodeficiency virus 1 envelope glycoprotein gp160 for CD4+ T cell recognition. J Exp Med. 1990 Mar 1;171(3):875-87.

Study ID Numbers:	AVEG 003
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000745
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

HIV Envelope Protein gp160
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Study placed in the following topic categories:

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

Acquired Immunodeficiency Syndrome
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