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

2014-08-27 03:59:54 | BioPortfolio


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.


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.]

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention


HIV Infections


ALVAC(2)120(B,MN)GNP (vCP1452), gp160 MN/LAI-2, ALVAC(1)120(B,MN)GNP (vCP1433), ALVAC-HIV MN120TMG (vCP205), ALVAC-RG Rabies Glycoprotein (vCP65)


Univ of Alabama at Birmingham
United States




National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:59:54-0400

Clinical Trials [52 Associated Clinical Trials listed on BioPortfolio]

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers

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PubMed Articles [5 Associated PubMed Articles listed on BioPortfolio]

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Generation and characterization of a bivalent protein boost for future clinical trials: HIV-1 subtypes CR01_AE and B gp120 antigens with a potent adjuvant.

The RV144 Phase III clinical trial with ALVAC-HIV prime and AIDSVAX B/E subtypes CRF01_AE (A244) and B (MN) gp120 boost vaccine regime in Thailand provided a foundation for the future development of i...

Bioengineered intravaginal isolate of Lactobacillus plantarum expresses algal lectin scytovirin demonstrating anti-HIV-1 activity.

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Interdomain Stabilization Impairs CD4 Binding and Improves Immunogenicity of the HIV-1 Envelope Trimer.

The HIV-1 envelope (Env) spike is a trimer of gp120/gp41 heterodimers that mediates viral entry. Binding to CD4 on the host cell membrane is the first essential step for infection but disrupts the nat...

Mapping of neutralizing antibody epitopes on the envelope of viruses obtained from plasma samples exhibiting broad cross-clade neutralization potential against HIV-1.

Several broadly neutralizing antibodies (bNAbs) that can target HIV strains with large degrees of variability have recently been identified. However, efforts to induce synthesis of such bNAbs that can...

Medical and Biotech [MESH] Definitions

An envelope protein of the human immunodeficiency virus that is encoded by the HIV env gene. It has a molecular weight of 160,000 kDa and contains numerous glycosylation sites. It serves as a precursor for both the HIV ENVELOPE PROTEIN GP120 and the HIV ENVELOPE PROTEIN GP41.

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