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

This study has been completed.
Sponsor:
Collaborator:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00076063
First received: January 13, 2004
Last updated: May 3, 2012
Last verified: May 2012

January 13, 2004
May 3, 2012
Not Provided
Not Provided
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00076063 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
HIV Infections
  • Biological: ALVAC-HIV (vCP1452)
    experimental vaccine
  • Biological: LIPO-5
    experimental vaccine
  • Experimental: A
    Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.
    Intervention: Biological: LIPO-5
  • Experimental: B
    Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.
    Intervention: Biological: ALVAC-HIV (vCP1452)
  • Experimental: C
    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.
    Interventions:
    • Biological: ALVAC-HIV (vCP1452)
    • Biological: LIPO-5
  • Experimental: D
    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.
    Interventions:
    • Biological: ALVAC-HIV (vCP1452)
    • Biological: LIPO-5
  • Experimental: 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.
    Interventions:
    • Biological: ALVAC-HIV (vCP1452)
    • Biological: LIPO-5

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
March 2007
Not Provided

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076063
HVTN 042, ANRS VAC019, 10119
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Chair: Sharon Frey St. Louis University
Study Chair: Larry Peiperl San Francisco Dept. of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP