Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults

NCT ID: NCT00000904

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1999-08-31

Brief Summary

The purpose of this study is to find out whether three different anti-HIV vaccines are safe and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot get HIV from these vaccines.

There are two different ways a vaccine can protect the body from infection. First, a vaccine may help the immune system make antibodies, which are proteins that recognize invading viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy infected cells. The second type of vaccine is more powerful against HIV. In this study, doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing whether they help the body make immune cells.

Detailed Description

Previous studies in humans have shown that immunization with certain vaccine combinations (that is, ALVAC-HIV construct and an envelope subunit vaccine) can elicit CTL activity, antibody-dependent cellular toxicity (ADCC), neutralizing antibodies, and other antibody responses more often and at higher levels than either vaccine alone. This study examines improved vaccine candidates that can elicit broader, longer-lasting CTL activity in the majority of vaccine recipients.

Volunteers are randomized to one of four groups. Group I receives vCP205. Group II receives vCP1433. Group III receives vCP1452. Group IV receives an ALVAC rabies vaccine, as a control. Immunizations are administered at Months 0, 1, 3, and 6. At Months 3 and 6, patients in Groups I, II, and III also receive gp160 MN/LAI-2, the subunit boost vaccine. Group IV receives another placebo vaccine. Participants have regular clinic visits and blood is drawn to determine humoral and cellular immune responses to the vaccines. [AS PER AMENDMENT 10/23/98: A cell-mediated immunity substudy has been added at selected institutions following the fourth vaccination at 6 months; this study will assess the newer assays of CD8+ T cells and the kinetic response following immunization. The 6-month immunization may be rescheduled by up to 14 days to accommodate clinical, laboratory, or volunteer scheduling issues.] [AS PER AMENDMENT 6/17/99: Three study arms are added. Group V receives vCP1452 at Months 0,1,3, and 6. Group VI receives vCP205 at Months 0,1,3, and 6. Group VII receives placebo at Months 0,1,3, and 6. Patients in Groups V, VI, and VII do not receive the subunit boost, gp160 MN/LAI-2. Consenting volunteers enrolled in the three new groups at Johns Hopkins University undergo PET scanning as part of an ancillary study.]

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Viral Vaccines; HIV Antibodies; HIV Envelope Protein gp160; AIDS Vaccines; T-Lymphocytes, Cytotoxic; HIV Seronegativity; Antibody Formation; Risk-Taking; Avipoxvirus; Genetic Vectors; Immunization; HIV Preventive Vaccine

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)

Intervention Type: BIOLOGICAL

gp160 MN/LAI-2

Intervention Type: BIOLOGICAL

ALVAC(1)120(B,MN)GNP (vCP1433)

Intervention Type: BIOLOGICAL

ALVAC-HIV MN120TMG (vCP205)

Intervention Type: BIOLOGICAL

ALVAC-RG Rabies Glycoprotein (vCP65)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are 18-60 years old.
• Are HIV-negative and are in good health.
• Have a CD4 count of at least 400 cells/mm3.
• Test negative for hepatitis B.
• Agree to use effective methods of birth control for 1 month before and during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Are at high risk for being infected with HIV (risky sex behavior or injection drug use within 12 months prior to study entry).
• Have a serious medical condition, or if you have had chronic sickness, diseases of the immune system, or cancer that was not cured through surgery.
• Have a serious psychiatric condition or if you have been suicidal.
• Have a work commitment that would keep you from completing the study.
• Have syphilis or tuberculosis.
• Are allergic to eggs, neomycin, vaccines, or have ever had severe allergic reactions.
• Have taken certain medicines, including medicines that affect the immune system or experimental medicines.
• Have participated in another HIV vaccine trial.
• Have received any vaccines within 2 weeks of study entry.
• Have received a blood transfusion within 6 months prior to study entry.
• Are pregnant or breast-feeding.

• 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

David Schwartz

Role: STUDY_CHAIR

Johns Hopkins Bloomberg School of Public Health

Clayton Harro

Role: STUDY_CHAIR

Johns Hopkins Bloomberg School of Public Health

Locations

UAB AVEG

Birmingham, Alabama, United States

JHU AVEG

Baltimore, Maryland, United States

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States

Univ. of Rochester AVEG

Rochester, New York, United States

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States

UW - Seattle AVEG

Seattle, Washington, United States

Countries

United States

References

Fang ZY, Limbach K, Tartaglia J, Spearman P. A canarypox HIV vaccine candidate elicits efficient gag-env pseudovirion formation from human muscle cells. 36th Annual Meeting, Infectious Diseases Society of America. 1998 Nov 12-15 [Poster 710]

Reference Type: BACKGROUND

Bures R, Gaitan A, Zhu T, Graziosi C, McGrath KM, Tartaglia J, Caudrelier P, El Habib R, Klein M, Lazzarin A, Stablein DM, Deers M, Corey L, Greenberg ML, Schwartz DH, Montefiori DC. Immunization with recombinant canarypox vectors expressing membrane-anchored glycoprotein 120 followed by glycoprotein 160 boosting fails to generate antibodies that neutralize R5 primary isolates of human immunodeficiency virus type 1. AIDS Res Hum Retroviruses. 2000 Dec 10;16(18):2019-35. doi: 10.1089/088922200750054756.

Reference Type: BACKGROUND

PMID: 11153085 (View on PubMed)

Other Identifiers

AVEG 034A

Identifier Type: -

Identifier Source: secondary_id

10583

Identifier Type: REGISTRY

Identifier Source: secondary_id

AVEG 034

Identifier Type: -

Identifier Source: org_study_id