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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076063
• Other study ID #: HVTN 042
• Secondary ID: ANRS VAC01910119
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2004
• Est. completion date: March 2007

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• ALVAC-HIV (vCP1452)
experimental vaccine
• LIPO-5
experimental vaccine

Locations

Country	Name	City	State
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	Alabama Vaccine CRS	Birmingham	Alabama
United States	Brigham and Women's Hosp. CRS	Boston	Massachusetts
United States	Fenway Community Health Clinical Research Site (FCHCRS)	Boston	Massachusetts
United States	NY Blood Ctr./Bronx CRS	Bronx	New York
United States	Vanderbilt Vaccine CRS	Nashville	Tennessee
United States	Miriam Hospital's HVTU	Providence	Rhode Island
United States	Univ. of Rochester HVTN CRS	Rochester	New York
United States	Saint Louis Univ. School of Medicine, HVTU	Saint Louis	Missouri
United States	FHCRC/UW Vaccine CRS	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Gahéry-Ségard H, Pialoux G, Figueiredo S, Igéa C, Surenaud M, Gaston J, Gras-Masse H, Lévy 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. — View Citation

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. — View Citation

Pialoux G, Gahéry-Ségard H, Sermet S, Poncelet H, Fournier S, Gérard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response to vaccines		Throughout study
Primary	Clinical and laboratory adverse events		Throughout study

External Links

•   Click here for more information on HIV preventive vaccines
•   Haga clic aquí para ver información sobre este ensayo clínico en español.