A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000832

Collaborator

(none)

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

Brief Summary

To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers.

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: MF59 Biological: rgp120/HIV-1 SF-2	Phase 1

Detailed Description

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Masking:

Double

Primary Purpose:

Prevention

Official Title:

A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

Actual Study Completion Date :

Jan 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Volunteers must have:

Normal history and physical exam.
HIV negativity.
Absolute CD4 count >= 400 cells/mm3.
Normal urine dipstick with esterase and nitrite.
Lower risk sexual behavior.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

Positive hepatitis B surface antigen.
Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.

Subjects with the following prior conditions are excluded:

History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
History of anaphylaxis or other serious adverse reactions to vaccines.
History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
Experimental agents within 30 days prior to study entry.
Prior HIV vaccines.

Prior Treatment:

Excluded:

Blood products or immunoglobulin within the past 6 months.

Identifiable high-risk behavior for HIV infection, including:

History of injection drug use within past 12 months.
Higher risk sexual behavior.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB AVEG	Birmingham	Alabama	United States	35294
2	St. Louis Univ. School of Medicine AVEG	Saint Louis	Missouri	United States	63104
3	Univ. of Rochester AVEG	Rochester	New York	United States	14642
4	JHU AVEG	Pittsburgh	Pennsylvania	United States