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A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALVAC-HIV (vCP1452)
LIPO-5
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, ALVAC-HIV vCP1452, ALVAC Vaccine, HIV-1, Normal Values, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: HIV uninfected Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Access to participating site and available for follow-up during the study Exclusion Criteria: HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Current tuberculosis prophylaxis or therapy Hypersensitivity to neomycin or egg products Uveitis, chronic Lyme disease, active mycobacterial diseases, or sarcoidosis Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Active syphilis Unstable asthma Type 1 or Type 2 diabetes mellitus Thyroid disease requiring treatment in the past 12 months Serious angioedema within the past 3 years Uncontrolled hypertension Bleeding disorder Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period Seizure disorder requiring medication within the past 3 years Asplenia Mental illness that would interfere with compliance with the protocol Other conditions that, in the judgment of the investigator, would interfere with the study Pregnant or breast-feeding

Sites / Locations

  • Alabama Vaccine CRS
  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
  • Project Brave HIV Vaccine CRS
  • Brigham and Women's Hosp. CRS
  • Fenway Community Health Clinical Research Site (FCHCRS)
  • Saint Louis Univ. School of Medicine, HVTU
  • NY Blood Ctr./Bronx CRS
  • Univ. of Rochester HVTN CRS
  • Miriam Hospital's HVTU
  • Vanderbilt Vaccine CRS
  • FHCRC/UW Vaccine CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

E

Arm Description

Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.

Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.

Participants in Groups C will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Participants in Group D will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Participants in Group E will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Outcomes

Primary Outcome Measures

Immune response to vaccines
Clinical and laboratory adverse events

Secondary Outcome Measures

Full Information

First Posted
January 13, 2004
Last Updated
October 13, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
ANRS, Emerging Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT00076063
Brief Title
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
Official Title
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LIPO-5 Alone, ALVAC-HIV (vCP1452) Alone, and ALVAC Prime/LIPO-5 Boost 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
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
ANRS, Emerging Infectious Diseases

4. Oversight

5. Study Description

Brief Summary
This study will test the immune system response to and safety of two HIV vaccines alone and in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV. These vaccines are not produced from live HIV or from infected cells and do not contain the virus. It is not possible to become infected with HIV from these vaccines.
Detailed Description
Immune priming of cytotoxic T lymphocytes (CTLs) has been most successfully achieved with live attenuated virus or live virus vector vaccines. Recombinant canarypox vaccines have an excellent safety record and have induced HIV neutralizing antibodies and CTLs in early clinical trials. This study will evaluate the use of HIV lipopeptides (LIPO-5) alone and in combination with a canarypox-based HIV vaccine [ALVAC-HIV (vCP1452)] to further increase CTL activity. Participants in this study will be randomly assigned to one of five groups. Participants in Groups A and B will receive four injections over 6 months. Participants in Group A will receive four injections of either LIPO-5 or a placebo. Participants in Group B will receive four injections of either the ALVAC-HIV (vCP1452) or a placebo. Participants in Groups C, D, and E will receive six injections over 6 months. Participants in these groups will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E. Participants will have 11 study visits over 18 months; the total duration of the study will be 30 months. The length of visits will vary and may last up to 3 hours. Study visits will include a medical interview, brief physical exam, and blood and urine tests. Participants will be tested for HIV before entering the study and at least five times during the study. All vaccine and placebo injections will be given in the upper arm muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Seronegativity, ALVAC-HIV vCP1452, ALVAC Vaccine, HIV-1, Normal Values, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.
Arm Title
B
Arm Type
Experimental
Arm Description
Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.
Arm Title
C
Arm Type
Experimental
Arm Description
Participants in Groups C will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.
Arm Title
D
Arm Type
Experimental
Arm Description
Participants in Group D will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.
Arm Title
E
Arm Type
Experimental
Arm Description
Participants in Group E will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.
Intervention Type
Biological
Intervention Name(s)
ALVAC-HIV (vCP1452)
Intervention Description
experimental vaccine
Intervention Type
Biological
Intervention Name(s)
LIPO-5
Intervention Description
experimental vaccine
Primary Outcome Measure Information:
Title
Immune response to vaccines
Time Frame
Throughout study
Title
Clinical and laboratory adverse events
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: HIV uninfected Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Access to participating site and available for follow-up during the study Exclusion Criteria: HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Current tuberculosis prophylaxis or therapy Hypersensitivity to neomycin or egg products Uveitis, chronic Lyme disease, active mycobacterial diseases, or sarcoidosis Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. Autoimmune disease or immunodeficiency Active syphilis Unstable asthma Type 1 or Type 2 diabetes mellitus Thyroid disease requiring treatment in the past 12 months Serious angioedema within the past 3 years Uncontrolled hypertension Bleeding disorder Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period Seizure disorder requiring medication within the past 3 years Asplenia Mental illness that would interfere with compliance with the protocol Other conditions that, in the judgment of the investigator, would interfere with the study Pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Frey
Organizational Affiliation
St. Louis University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Larry Peiperl
Organizational Affiliation
San Francisco Dept. of Public Health
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Vaccine CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2041
Country
United States
Facility Name
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
City
Baltimore
State/Province
Maryland
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
02215
Country
United States
Facility Name
Saint Louis Univ. School of Medicine, HVTU
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
NY Blood Ctr./Bronx CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Univ. of Rochester HVTN CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
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
FHCRC/UW Vaccine CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10395842
Citation
Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis. 1999 Aug;180(2):290-8. doi: 10.1086/314895.
Results Reference
background
PubMed Identifier
10506650
Citation
Klinguer C, David D, Kouach M, Wieruszeski JM, Tartar A, Marzin D, Levy JP, Gras-Masse H. Characterization of a multi-lipopeptides mixture used as an HIV-1 vaccine candidate. Vaccine. 1999 Sep;18(3-4):259-67. doi: 10.1016/s0264-410x(99)00196-6.
Results Reference
background
PubMed Identifier
11426068
Citation
Pialoux G, Gahery-Segard H, Sermet S, Poncelet H, Fournier S, Gerard L, Tartar A, Gras-Masse H, Levy JP, Guillet JG; ANRS VAC 04 Study Team. Lipopeptides induce cell-mediated anti-HIV immune responses in seronegative volunteers. AIDS. 2001 Jul 6;15(10):1239-49. doi: 10.1097/00002030-200107060-00005.
Results Reference
background
PubMed Identifier
14512570
Citation
Gahery-Segard H, Pialoux G, Figueiredo S, Igea C, Surenaud M, Gaston J, Gras-Masse H, Levy JP, Guillet JG. Long-term specific immune responses induced in humans by a human immunodeficiency virus type 1 lipopeptide vaccine: characterization of CD8+-T-cell epitopes recognized. J Virol. 2003 Oct;77(20):11220-31. doi: 10.1128/jvi.77.20.11220-11231.2003.
Results Reference
background
PubMed Identifier
25253665
Citation
Frey SE, Peiperl L, McElrath MJ, Kalams S, Goepfert PA, Keefer MC, Baden LR, Lally MA, Mayer K, Blattner WA, Harro CD, Hammer SM, Gorse GJ, Hural J, Tomaras GD, Levy Y, Gilbert P, deCamp A, Russell ND, Elizaga M, Allen M, Corey L. Phase I/II randomized trial of safety and immunogenicity of LIPO-5 alone, ALVAC-HIV (vCP1452) alone, and ALVAC-HIV (vCP1452) prime/LIPO-5 boost in healthy, HIV-1-uninfected adult participants. Clin Vaccine Immunol. 2014 Nov;21(11):1589-99. doi: 10.1128/CVI.00450-14. Epub 2014 Sep 24.
Results Reference
derived

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A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines

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