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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027261
Recruitment Status : Completed
First Posted : November 30, 2001
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Seronegativity Biological: ALVAC(2)120(B,MN)GNP (vCP1452) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Masking: Double
Primary Purpose: Prevention
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
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027261

United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102
UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
San Francisco, California, United States
United States, Maryland
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
United States, Massachusetts
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States, 02115
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis Univ Health Sciences Ctr
St. Louis, Missouri, United States, 63110
United States, New York
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10021
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642
United States, Rhode Island
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
United States, Virginia
Infectious Diseases Physicians, Inc.
Annandale, Virginia, United States
United States, Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Paul Goepfert

Publications of Results:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00027261     History of Changes
Other Study ID Numbers: HVTN 039
10200 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: November 30, 2001    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
AIDS Vaccines
CD8-Positive T-Lymphocytes
HIV Seronegativity
Dose-Response Relationship, Immunologic
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs