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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 13, 2004

Last Updated Date

September 26, 2008

Start Date ^†

January 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00076063 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

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

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.

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

HIV Infections

Intervention ^†

Biological: ALVAC-HIV (vCP1452)
Biological: LIPO-5

Study Arms / Comparison Groups

Experimental: Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.
Experimental: Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.
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.
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.
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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

174

Completion Date

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00076063

Responsible Party

Rona Siskind, DAIDS

Secondary IDs ^††

ANRS VAC019

Study Sponsor ^†

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^††

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

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

December 2004

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.