Search / Trial NCT00001031

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of December 03, 2023

Completed

Keywords

Vaccines, Synthetic Hiv 1 Hiv Envelope Protein Gp120 Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

Description

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. HIV-seronegative volunteers (including fou...

Gender

All

Eligibility criteria

  • 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).

Attachments

readout_NCT00001031_2023-12-03.pdf

4.5 MB

NCT00001031_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Rochester, New York, United States

Nashville, Tennessee, United States

Seattle, Washington, United States

Rochester, New York, United States

Pittsburgh, Pennsylvania, United States

Saint Louis, Missouri, United States

Birmingham, Alabama, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0