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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Agence Nationale de Recherche sur le SIDA (ANRS), France
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00076063

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Biological: ALVAC-HIV (vCP1452) Biological: LIPO-5	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Immune response to vaccines [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Clinical and laboratory adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	174
Study Start Date:	January 2004
Study Completion Date:	March 2007
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.	Biological: LIPO-5 experimental vaccine
B: Experimental Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.	Biological: ALVAC-HIV (vCP1452) experimental vaccine
C: Experimental 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.	Biological: ALVAC-HIV (vCP1452) experimental vaccine Biological: LIPO-5 experimental vaccine
D: Experimental 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.	Biological: ALVAC-HIV (vCP1452) experimental vaccine Biological: LIPO-5 experimental vaccine
E: Experimental 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.	Biological: ALVAC-HIV (vCP1452) experimental vaccine Biological: LIPO-5 experimental vaccine

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076063

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2041
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205-1901
JHU-CIR/DC
Baltimore, Maryland, United States, 21205-1901
University of MD - Inst. of Human Virology (IHV)
Baltimore, Maryland, United States, 21201-1192
United States, Massachusetts
Harvard Medical School/Brigham & Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis University - New Hope Bldg
St. Louis, Missouri, United States, 63110-2500
United States, New York
University of Rochester
Rochester, New York, United States, 14642-0001
New York Blood Center - Union Square
New York, New York, United States, 10003
New York Blood Center - Bronx
Bronx, New York, United States, 10456
Columbia University
New York, New York, United States, 10032
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Washington
FHCRC/UW - Vaccine Trial Unit
Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Agence Nationale de Recherche sur le SIDA (ANRS), France

Investigators

Study Chair:	Sharon Frey	St. Louis University
Study Chair:	Larry Peiperl	San Francisco Dept. of Public Health

More Information

Additional Information:

Click here for more information on HIV preventive vaccines This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	HVTN 042, ANRS VAC019, DAIDS-ES ID 10119
Study First Received:	January 13, 2004
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00076063 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Seronegativity
ALVAC-HIV vCP1452
ALVAC Vaccine
HIV-1

HIV Seronegativity
Normal Values
HIV Preventive Vaccine

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010