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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
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

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

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

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
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


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:

Responsible Party:   DAIDS ( Rona Siskind )
Study ID Numbers:   HVTN 042, ANRS VAC019
First Received:   January 13, 2004
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00076063
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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 20, 2008




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