Status:
COMPLETED
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
ANRS, Emerging Infectious Diseases
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
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 par...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00076063
Start Date
March 1 2004
End Date
March 1 2007
Last Update
October 14 2021
Active Locations (11)
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1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294-2041
2
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States
3
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
4
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States, 02115