A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00001076 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 18, 2012
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | November 2, 1999 | |||
First Posted Date ICMJE | August 31, 2001 | |||
Last Update Posted Date | May 18, 2012 | |||
Study Start Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00001076 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules | |||
Official Title ICMJE | A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules | |||
Brief Summary | To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2 vaccine in HIV-negative volunteers. Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205. |
|||
Detailed Description | Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205. Volunteers are randomized to receive immunization with either ALVAC-HIV vCP205 or ALVAC-RG rabies glycoprotein (vCP65) at days 0, 7, 14, and 21, followed by boost with rgp120/HIV-1 SF2 at days 28 and 84. A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo. |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Masking: Double Primary Purpose: Prevention |
|||
Condition ICMJE | HIV Infections | |||
Intervention ICMJE |
|
|||
Study Arms | Not Provided | |||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
34 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | December 1997 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria Volunteers must have:
Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded:
Volunteers with the following prior conditions are excluded:
Prior Medication: Excluded:
Prior Treatment: Excluded:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00001076 | |||
Other Study ID Numbers ICMJE | AVEG 029 10579 ( Registry Identifier: DAIDS ES Registry Number ) |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |