A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)

NCT00001020 | Completed Phase 1

• 4 other identifiers: AVEG 006XVEU 006V0199g11537
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

AMENDED 11/17/93: To determine whether the pattern of response to MN rgp120 vaccine is altered by pre-exposure to IIIB rgp120. ORIGINAL DESIGN: To evaluate the safety (clinical and immunologic) of rgp120/HIV-1IIIB vaccine (gp120 vaccine) immunization in healthy HIV-1 seronegative adult subjects. To compare the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine. To determine whether gp120 vaccine immunization causes a significant immune response as defined by specific parameters (e.g., induction of neutralizing antibodies to the IIIB isolate of HIV-1, gp120 antigen-specific lymphocytic proliferation). Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Viral Vaccines; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

rgp120/HIV-1IIIB BIOLOGICAL

rgp120/HIV-1MN BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must have:
• Documented HIV seronegativity.
• Good general health.
• No high-risk behavior for HIV infection.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Postive PPD (unless a chest x-ray is negative and there is no suggestion of active or old pulmonary tuberculosis).
• Positive VDRL or HBsAG.
• No febrile illness within 1 week of study.
• Concurrent Medication:
• Excluded:
• Concomitant corticosteroids or other known immunosuppressive drugs.
• Other experimental agents.
• Patients with the following prior conditions are excluded:
• History of clinically significant cardiac, pulmonary, hepatic, renal, neurologic, or autoimmune disease.
• Prior Medication:
• Excluded:
• Other immunization within 4 weeks prior to study entry.
• Identifiable high-risk behavior for HIV infection.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Genentech, Inc.: collaborator

Study Sites (3)

St Louis Univ School of Medicine

St Louis, Missouri, 63104, United States

Location

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Related Publications (8)

• Clements ML, Belshe R, Duliege AM, Schwartz D, Gorse G, Izu A, Ammann A. Safety and immunogenicity of IIIB rgp120/HIV-1 vaccine in seronegative volunteers. The NIAID-sponsored AIDS Vaccine Clinical Trials Network. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo9 (abstract no MoB 0026)

  BACKGROUND

• Berman PW, Eastman DJ, Wilkes DM, Nakamura GR, Gregory TJ, Schwartz D, Gorse G, Belshe R, Clements ML, Byrn RA. Comparison of the immune response to recombinant gp120 in humans and chimpanzees. AIDS. 1994 May;8(5):591-601. doi: 10.1097/00002030-199405000-00004.

  PMID: 7520248 BACKGROUND

• VanCott TC, Bethke FR, Burke DS, Redfield RR, Birx DL. Lack of induction of antibodies specific for conserved, discontinuous epitopes of HIV-1 envelope glycoprotein by candidate AIDS vaccines. J Immunol. 1995 Oct 15;155(8):4100-10.

  PMID: 7561123 BACKGROUND

• Francis DP, Gregory T, McElrath MJ, Belshe RB, Gorse GJ, Migasena S, Kitayaporn D, Pitisuttitham P, Matthews T, Schwartz DH, Berman PW. Advancing AIDSVAX to phase 3. Safety, immunogenicity, and plans for phase 3. AIDS Res Hum Retroviruses. 1998 Oct;14 Suppl 3:S325-31.

  PMID: 9814961 BACKGROUND

• Schwartz DH, Cosentino LM, Shirai A, Conover J, Daniel S, Klinman DM. Lack of correlation between the number of circulating B cells and the concentration of serum antibodies reactive with the HIV-1 envelope glycoprotein. J Acquir Immune Defic Syndr (1988). 1994 May;7(5):447-53.

  PMID: 8158537 BACKGROUND

• Gorse GJ, Patel GB, Mandava M, Berman PW, Belshe RB. MN and IIIB recombinant glycoprotein 120 vaccine-induced binding antibodies to native envelope glycoprotein of human immunodeficiency virus type 1 primary isolates. National Institute of Allergy and Infectious Disease Aids Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1999 Jul 1;15(10):921-30. doi: 10.1089/088922299310638.

  PMID: 10408729 BACKGROUND

• Schwartz DH, Gorse G, Clements ML, Belshe R, Izu A, Duliege AM, Berman P, Twaddell T, Stablein D, Sposto R, et al. Induction of HIV-1-neutralising and syncytium-inhibiting antibodies in uninfected recipients of HIV-1IIIB rgp120 subunit vaccine. Lancet. 1993 Jul 10;342(8863):69-73. doi: 10.1016/0140-6736(93)91283-r.

  PMID: 8100910 BACKGROUND

• Gorse GJ, Patel GB, Newman FK, Belshe RB, Berman PW, Gregory TJ, Matthews TJ. Antibody to native human immunodeficiency virus type 1 envelope glycoproteins induced by IIIB and MN recombinant gp120 vaccines. The NIAID AIDS Vaccine Evaluation Group. Clin Diagn Lab Immunol. 1996 Jul;3(4):378-86. doi: 10.1128/cdli.3.4.378-386.1996.

  PMID: 8807200 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Clements M

  STUDY CHAIR

• Belshe R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1995
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

US (3)