Completed

Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID00001020

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)

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-05-18

28

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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)

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 3 locations

1

St Louis Univ School of Medicine

St Louis, Missouri, United States, 63104

Status Unknown

2

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

3

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, United States, 981050371

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

N/A

Model

N/A

Primary Purpose

PREVENTION

Number of Arms

0

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Published Research Related To This Trial

Lack of induction of antibodies specific for conserved, discontinuous epitopes of HIV-1 envelope glycoprotein by candidate AIDS vaccines.

T C VanCott, F R Bethke, D S Burke...

https://pubmed.ncbi.nlm.nih.gov/7561123

Lack of correlation between the number of circulating B cells and the concentration of serum antibodies reactive with the HIV-1 envelope glycoprotein.

D H Schwartz, L M Cosentino, A Shirai...

https://pubmed.ncbi.nlm.nih.gov/8158537

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.

G J Gorse, G B Patel, M Mandava...

https://pubmed.ncbi.nlm.nih.gov/10408729

Induction of HIV-1-neutralising and syncytium-inhibiting antibodies in uninfected recipients of HIV-1IIIB rgp120 subunit vaccine.

D H Schwartz, G Gorse, M L Clements...

https://pubmed.ncbi.nlm.nih.gov/8100910

Antibody to native human immunodeficiency virus type 1 envelope glycoproteins induced by IIIB and MN recombinant gp120 vaccines. The NIAID AIDS Vaccine Evaluation Group.

G J Gorse, G B Patel, F K Newman...

https://pubmed.ncbi.nlm.nih.gov/8807200