We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001072
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
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.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
March 17, 2014
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00001072 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers

To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.

The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.

The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.

Volunteers are randomized to one of seven groups to receive immunizations with either ALVAC-HIV vCP300 or ALVAC-RG vCP65 (control), plus simultaneous or sequential boosting with rgp120/HIV-1SF2 or placebo. Immunizations are given at 0, 1, 6, and 9 months or 0, 1, 3, and 6 months. Volunteers are followed for at least 24 months.

Interventional
Phase 1
Masking: Double
Primary Purpose: Prevention
HIV Infections
  • Biological: ALVAC-HIV MN120TMGNP (vCP300)
  • Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
  • Biological: rgp120/HIV-1 SF-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
January 1999
Not Provided

Inclusion Criteria

Volunteers must have:

  • Normal history and physical exam.
  • ELISA and Western blot negative for HIV.
  • CD4 count >= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Lower risk sexual behavior.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
  • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
  • Allergy to egg products or neomycin.

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • Prior immunization against rabies.
  • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

  • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
  • Experimental agents within 30 days prior to study entry.
  • Prior HIV vaccines.
  • Prior rabies immunization.

Prior Treatment:

Excluded:

  • Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as
  • injection drug use within past 12 months.
  • higher or intermediate risk sexual behavior.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001072
AVEG 026
10576 ( Registry Identifier: DAIDS ES Registry Number )
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Keefer M
Study Chair: Evans T
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP