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

NCT ID: NCT00000746

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1994-07-31

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.

Detailed Description

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.

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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Study Design

• Primary Study Purpose: PREVENTION

Interventions

rgp120/HIV-1 SF-2

Intervention Type: BIOLOGICAL

Env 2-3

Intervention Type: BIOLOGICAL

HIVAC-1e

Intervention Type: BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

Prior Treatment:

Excluded:

• Blood or blood product transfusion within the previous 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corey L

Role: STUDY_CHAIR

Locations

JHU AVEG

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Clements ML, Corey L, Weinhold K, Schwartz D, Siliciano R, Matthews T, Hsieh R, Graham B, Keefer M, Gorse G, Zolla-Pazner S, Mascola J, Duliege A, Excler J, Tartaglia J, Paoletti E, Hu SL. HIV immunity induced by priming with canarypox or vaccinia-gp160 recombinants and boosting with rgp120. Inst of Hum Virol Annu Meet. 1996 Sept 7-13

Reference Type: BACKGROUND

Graham BS, Belshe RB, Clements ML, Dolin R, Corey L, Wright PF, Gorse GJ, Midthun K, Keefer MC, Roberts NJ Jr, et al. Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network. J Infect Dis. 1992 Aug;166(2):244-52. doi: 10.1093/infdis/166.2.244.

Reference Type: BACKGROUND

PMID: 1353102 (View on PubMed)

Other Identifiers

AVEG Protocol 008

Identifier Type: -

Identifier Source: secondary_id

10553

Identifier Type: REGISTRY

Identifier Source: secondary_id

AVEG 008

Identifier Type: -

Identifier Source: org_study_id