A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
Completed · Phase 1/Phase 2
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00076063
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 174
- Starts
- 2004-03-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Alabama Vaccine CRS — Birmingham, Alabama, 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
- Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
- Fenway Community Health Clinical Research Site (FCHCRS) — Boston, Massachusetts, United States
- Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
- Univ. of Rochester HVTN CRS — Rochester, New York, United States
- NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
- Miriam Hospital's HVTU — Providence, Rhode Island, United States
- Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
- FHCRC/UW Vaccine CRS — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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