Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

NCT00027261 | Completed Phase 1

• 2 other identifiers: HVTN 03910200
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Vaccines, Synthetic; HIV-1; AIDS Vaccines; CD8-Positive T-Lymphocytes; HIV Seronegativity; Avipoxvirus; Dose-Response Relationship, Immunologic; HIV Preventive Vaccine

Interventions

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants may be eligible for this study if they:
• Are between the ages of 18 and 60.
• Are in good general health.
• Have a CD4 count of 400 or more cells/mm3.
• Do not have hepatitis C or active hepatitis B.
• Have had a negative HIV blood test within 8 weeks prior to enrollment.
• Use approved methods of contraception.
• Have access to a participating site and are available for follow-up for 18 months.
• Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
• Give written informed consent.

You may not qualify if:

• Participants may not be eligible for this study if they:
• Are pregnant or breast-feeding.
• Have received a live vaccine within 30 days prior to enrollment.
• Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
• Have used experimental research agents within 30 days prior to enrollment.
• Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
• Have received blood products 120 days before HIV screening.
• Have received immunoglobulin 60 days before HIV screening.
• Have a history of serious harmful reactions to vaccines.
• Have a history of disease of the immune system.
• Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
• Are using or have used (within past 6 months) drugs that interfere with the immune system.
• Have a history of type I or type II diabetes.
• Have thyroid disease.
• Have unstable asthma.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (13)

Alabama Vaccine CRS

Birmingham, Alabama, 35294, United States

Location

San Francisco Vaccine and Prevention CRS

San Francisco, California, 94102, United States

Location

UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.

San Francisco, California, United States

Location

Project Brave HIV Vaccine CRS

Baltimore, Maryland, United States

Location

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, United States

Location

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, 02115, United States

Location

Saint Louis Univ Health Sciences Ctr

St Louis, Missouri, 63110, United States

Location

NY Blood Ctr./Union Square CRS

New York, New York, 10021, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Infectious Diseases Physicians, Inc.

Annandale, Virginia, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Goepfert PA, Horton H, McElrath MJ, Gurunathan S, Ferrari G, Tomaras GD, Montefiori DC, Allen M, Chiu YL, Spearman P, Fuchs JD, Koblin BA, Blattner WA, Frey S, Keefer MC, Baden LR, Corey L; NIAID HIV Vaccine Trials Network. High-dose recombinant Canarypox vaccine expressing HIV-1 protein, in seronegative human subjects. J Infect Dis. 2005 Oct 1;192(7):1249-59. doi: 10.1086/432915. Epub 2005 Aug 31.

  PMID: 16136469 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Paul Goepfert

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2001
• First Posted: November 30, 2001
• Study Completion: December 1, 2005
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (13)