A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
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
3 other identifiers
interventional
174
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Mar 2004
Typical duration for phase_1 hiv-infections
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2004
CompletedFirst Posted
Study publicly available on registry
January 14, 2004
CompletedStudy Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedOctober 14, 2021
October 1, 2021
January 13, 2004
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Immune response to vaccines
Throughout study
Clinical and laboratory adverse events
Throughout study
Study Arms (5)
A
EXPERIMENTALParticipants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.
B
EXPERIMENTALParticipants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.
C
EXPERIMENTALParticipants 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.
D
EXPERIMENTALParticipants 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.
E
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Alabama Vaccine CRS
Birmingham, Alabama, 35294-2041, United States
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
Brigham and Women's Hosp. CRS
Boston, Massachusetts, 02115, United States
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, 02215, United States
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, United States
Univ. of Rochester HVTN CRS
Rochester, New York, 14642-0001, United States
NY Blood Ctr./Bronx CRS
The Bronx, New York, 10456, United States
Miriam Hospital's HVTU
Providence, Rhode Island, 02906, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232, United States
FHCRC/UW Vaccine CRS
Seattle, Washington, 98104, United States
Related Publications (5)
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.
PMID: 10395842BACKGROUNDKlinguer 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.
PMID: 10506650BACKGROUNDPialoux 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.
PMID: 11426068BACKGROUNDGahery-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.
PMID: 14512570BACKGROUNDFrey 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.
PMID: 25253665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sharon Frey
St. Louis University
- STUDY CHAIR
Larry Peiperl
San Francisco Dept. of Public Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2004
First Posted
January 14, 2004
Study Start
March 1, 2004
Study Completion
March 1, 2007
Last Updated
October 14, 2021
Record last verified: 2021-10