Status:
COMPLETED
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative volunteers. ALVAC-HIV v...
Detailed Description
ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vect...
Eligibility Criteria
Inclusion Criteria
Volunteers must have:
- Normal history and physical exam.
- Negative ELISA and Western blot for HIV.
- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
- Occupational responsibilities that preclude compliance.
Exclusion Criteria
Co-existing Condition:
Volunteers with the following symptoms or conditions are excluded:
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
- Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- Allergy to egg products or neomycin.
Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease or use of immunosuppressive medications.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- Prior immunization against rabies.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
- History of cancer unless there has been surgical excision that is considered to have achieved cure.
- Occupational responsibilities that preclude compliance.
Prior Medication:
Excluded:
- Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
- Prior rabies immunization.
Prior Treatment:
Excluded:
- Blood products or immunoglobulin within 6 months prior to study entry.
Risk Behavior:
Excluded: Identifiable high-risk behavior for HIV infection, such as:
- injection drug use within past 12 months; higher- or intermediate-risk sexual behavior.
- Occupational exposure to birds. Low risk sexual behavior.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 1997
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00001055
End Date
November 1 1997
Last Update
November 4 2021
Active Locations (6)
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1
UAB AVEG
Birmingham, Alabama, United States, 35294
2
JHU AVEG
Baltimore, Maryland, United States
3
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63104
4
Univ. of Rochester AVEG
Rochester, New York, United States, 14642