Completed

Phase 2
Age: 16Years - 60Years
All Genders
Healthy Volunteers
ID00001031

A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

296

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

B

Biocine

Collaborating Sponsor

AI-Summary

What this Trial Is About

To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120 vaccine in alum in volunteers who are seronegative for HIV-1. AS PER AMENDMENT 07/02/97: To determine the ability of immunization with MN rgp120/HIV-1 in combination with alum or SF-2 rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp120/MN skin testing. The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to isolate. Thus, the identification of an immunogen that can elicit broadly neutralizing antibodies to HIV-1 is a major challenge in AIDS vaccine development. Two candidate vaccines, recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1, have shown immunogenicity and good tolerance in healthy immunocompetent adults. This study will expand testing into a larger population base, particularly targeting individuals at high risk for HIV infection.

CONDITIONS

Official Title

A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults

Who Can Participate

Age: 16Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Subjects must have:

  • Normal history and physical exam.
  • HIV negativity by ELISA.
  • CD4 count >= 400 cells/mm3.
  • No clinically significant medical disease.
  • No history of immunodeficiency, autoimmune disease, or use of immunosuppressive medication.
  • No prior HIV vaccines.
  • Classification in one of the eligible risk groups defined in the Disease Status field.

Eligible higher risk groups:

  • Heterosexual teenagers and young adults (ages 16-28 permitted) who have attended a clinic for sexually transmitted diseases in the last 3 months or have higher risk sexual behavior.
  • Homosexually active males who are practicing higher risk behavior (ages 18-60).
  • Injection drug users active within the past 3 years (ages 18-60).
  • Heterosexual partners of HIV seropositive individuals (ages 18-60).

Eligible lower risk groups:

  • Homosexually active males who are practicing lower risk behavior (ages 18-60).
  • Adult women and heterosexual adult men practicing lower risk sexual behavior (ages 18-60).

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior HIV vaccines.
  • Prior immunosuppressive medications.
  • Experimental agents within the past 30 days.
  • AS PER AMENDMENT 07/02/97: Use of systemic steroids in the past month (for volunteers undergoing DTH testing).

AS PER AMENDMENT 07/02/97:

  • History of eczema or allergic-type reactions to vaccines used in protocol 201 (for volunteers undergoing DTH testing).
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: 7 locations

1

UAB AVEG

Birmingham, Alabama, United States

Status Unknown

2

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States, 63104

Status Unknown

3

Univ. of Rochester AVEG

Rochester, New York, United States, 02115

Status Unknown

4

Univ. of Rochester ACTG CRS

Rochester, New York, United States, 14642

Status Unknown

5

JHU AVEG

Pittsburgh, Pennsylvania, United States

Status Unknown

6

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232

Status Unknown

7

UW - Seattle AVEG

Seattle, Washington, United States, 98195

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

A phase II study of two HIV type 1 envelope vaccines, comparing their immunogenicity in populations at risk for acquiring HIV type 1 infection. AIDS Vaccine Evaluation Group.

M J McElrath, L Corey, D Montefiori...

https://pubmed.ncbi.nlm.nih.gov/10875616

Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial.

K Harrison, D Vlahov, K Jones...

https://pubmed.ncbi.nlm.nih.gov/7552502