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

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00027261

Purpose

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.

Condition	Intervention	Phase
HIV Infections HIV Seronegativity	Biological: ALVAC(2)120(B,MN)GNP (vCP1452)	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Double-Blind, Safety/Efficacy Study
Official Title:	A Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine (vCP1452) in Healthy, HIV-1 Uninfected Adult Participants

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

110

Detailed Description:

To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured.

All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
Are currently taking preventive anti-TB therapy.
Have a seizure disorder.
Have a bleeding disorder that was diagnosed by a physician.
Have had their spleen removed.
Have angioedema with serious episodes.
Have active syphilis.
Have hypertension.
Have mental problems that would interfere with the protocol.
Have any other problems that, in the judgment of the investigator, would interfere with the study.
Have a body mass index less than 20.
Are allergic or sensitive to egg products.
Have active tuberculosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027261

Locations

United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
United States, District of Columbia
Johns Hopkins Bloomberg School of Public Health
Washington, District of Columbia, United States, 20037
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, United States, 212011192
United States, Massachusetts
Harvard University / Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Fenway Community Health
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis Univ Health Sciences Ctr
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia Univ
New York, New York, United States, 10032
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
New York Blood Center
New York, New York, United States, 10021
United States, Rhode Island
Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
United States, Virginia
Univ of Marlyand / Infectious Diseases Physicians
Fairfax, Virginia, United States
United States, Washington
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, United States, 98109

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Paul Goepfert

More Information

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Click here for more information on preventive HIV vaccines This link exits the ClinicalTrials.gov site

Publications of Results:

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. Epub 2005 Aug 31.

Study ID Numbers:	HVTN 039
Study First Received:	November 29, 2001
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00027261
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Vaccines, Synthetic
HIV-1
AIDS Vaccines
CD8-Positive T-Lymphocytes

HIV Seronegativity
Avipoxvirus
Dose-Response Relationship, Immunologic
HIV Preventive Vaccine

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009