Back to resultsSafety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
Primary Purpose
HIV Infections, HIV Seronegativity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALVAC(2)120(B,MN)GNP (vCP1452)
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV-1, AIDS Vaccines, CD8-Positive T-Lymphocytes, HIV Seronegativity, Avipoxvirus, Dose-Response Relationship, Immunologic, HIV Preventive Vaccine
Eligibility 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.
Sites / Locations
- Alabama Vaccine CRS
- San Francisco Vaccine and Prevention CRS
- UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
- Project Brave HIV Vaccine CRS
- Brigham and Women's Hosp. CRS
- Fenway Community Health Clinical Research Site (FCHCRS)
- Saint Louis Univ Health Sciences Ctr
- NY Blood Ctr./Union Square CRS
- Univ. of Rochester HVTN CRS
- Miriam Hospital's HVTU
- Vanderbilt Vaccine CRS
- Infectious Diseases Physicians, Inc.
- FHCRC/UW Vaccine CRS
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00027261
First Posted
November 29, 2001
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00027261
Brief Title
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
ALVAC(2)120(B,MN)GNP (vCP1452)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Goepfert
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
San Francisco Vaccine and Prevention CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
City
San Francisco
State/Province
California
Country
United States
Facility Name
Project Brave HIV Vaccine CRS
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Brigham and Women's Hosp. CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Fenway Community Health Clinical Research Site (FCHCRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Saint Louis Univ Health Sciences Ctr
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NY Blood Ctr./Union Square CRS
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ. of Rochester HVTN CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Miriam Hospital's HVTU
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vanderbilt Vaccine CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Infectious Diseases Physicians, Inc.
City
Annandale
State/Province
Virginia
Country
United States
Facility Name
FHCRC/UW Vaccine CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16136469
Citation
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.
Results Reference
result
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Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
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