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)

NCT ID: NCT00001020

Last Updated: 2012-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1995-02-28

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.

Detailed Description

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.

AMENDED 11/17/93: Selected subjects from VEU 006 or VEU 006 Rollover study will receive two injections of MN rgp120 vaccine, administered 28 days apart beginning 10-16 months after their last injection. Eight additional clinic visits will be required. Subjects are followed for at least 6 months.

ORIGINAL DESIGN: Twenty-eight subjects will be randomized to receive 100 or 300 mcg rgp120/HIV-1IIIB vaccine (gp120 vaccine) or matching placebo. For each dose level, 10 subjects will receive vaccine and four subjects will receive matching placebo. Injections are given intramuscularly at 0, 4, and 32 weeks. Each subject receiving treatment at the lower dose level must be monitored for unacceptable toxicity for at least 2 weeks following the initial immunization before his or her second dose is administered and before treatment at the higher dose level begins. Subjects are followed for at least 12 months.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

rgp120/HIV-1IIIB

Intervention Type: BIOLOGICAL

rgp120/HIV-1MN

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Patients must have:

• Documented HIV seronegativity.
• Good general health.
• No high-risk behavior for HIV infection.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clements M

Role: STUDY_CHAIR

Belshe R

Role: STUDY_CHAIR

Locations

St Louis Univ School of Medicine

St Louis, Missouri, United States

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, United States

Countries

United States

References

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)

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 7520248 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7561123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9814961 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8158537 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10408729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8100910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8807200 (View on PubMed)

Other Identifiers

VEU 006

Identifier Type: -

Identifier Source: secondary_id

V0199g

Identifier Type: -

Identifier Source: secondary_id

11537

Identifier Type: REGISTRY

Identifier Source: secondary_id

AVEG 006X

Identifier Type: -

Identifier Source: org_study_id