A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00000746

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters.

Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.

In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: rgp120/HIV-1 SF-2 Biological: Env 2-3 Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys)	Phase 1

Detailed Description

Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months.

Study Design

Study Type:

Interventional

Primary Purpose:

Prevention

Official Title:

A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines

Actual Study Completion Date :

Jul 1, 1994

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

Subjects must have:

Normal history and physical exam.
Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
History of smallpox vaccination more than 5 years prior to enrollment.
Normal urinalysis.
Absolute CD4 count = or > 500 cells/mm3.

Prior Medication: Required:

Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

Household contacts who are pregnant, < 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications.
Hepatitis B surface antigenemia.
Medical or psychiatric condition or occupational responsibilities that preclude compliance.

Subjects with the following prior conditions are excluded:

History of immunodeficiency or chronic illness.
Eczema within the past year.

Prior Medication:

Excluded:

Prior experimental HIV vaccine.
Immunoglobulin administration or use of experimental agent within the past 2 months.
History of immunosuppressive medications.