Status:
TERMINATED
A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins (ISS P-002)
Lead Sponsor:
Barbara Ensoli, MD
Collaborating Sponsors:
Novartis Vaccines
Conditions:
HIV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This Phase I study was directed at evaluating the safety profile and the immunogenicity of the vaccination with recombinant HIV-1 Tat and V2-deleted Env (delta-V2 Env) proteins administered in associa...
Detailed Description
Since the inexorable spreading of HIV pandemic is unabated, the urgency of designing an effective, safe, inexpensive and easily administrable vaccine to protect people from HIV and/or AIDS is an absol...
Eligibility Criteria
Inclusion
- Age: 18 to 55 years;
- Negative blood pregnancy test for women of childbearing potential at screening evaluation (a urine dipstick test will be repeated just before each vaccination), and use of an acceptable mean of contraception by both men and women, since one month prior to immunization (only for women) and until at least 6 months after the last immunization;
- Blood pressure, heart rate and ECG within normal ranges or with mild alterations acknowledged as non clinically significant by the site clinician;
- Haematological and biochemical parameters within the clinical site normal ranges or with mild alterations acknowledged by the site clinician as non clinically significant;
- Normal urine dipstick with esterase and nitrite;
- Normal thyroid function;
- Negative for HIV infection and for anti-Tat antibodies;
- Good physical and mental health status;
- Availability for the planned study duration;
- Signed informed consent.
Exclusion
- Concomitant neoplastic diseases;
- History of malignant neoplastic diseases;
- History of encephalopathy, neuropathy or unstable CNS pathology, immunodeficiency, autoimmune disease, angina or cardiac arrhythmias, or any other clinically significant medical problems;
- History of anaphylaxis or serious adverse reactions to vaccines as well as serum IgE levels exceeding 1,000 U.I./mL;
- History of serious allergic reaction to any substance, requiring hospitalization or emergency medical care;
- Chest radiography showing evidence of active or acute cardiac or pulmonary disease;
- Any unstable cardiovascular disease;
- Active syphilis by TPHA and RPR tests \[NOTE: If the serology is documented to be a false positive or due to an adequately treated infection, the volunteer is eligible\];
- Active tuberculosis by cutaneous TB diagnostic test \[NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring specific therapy are eligible\];
- Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Persons with psychotic disorders, major affective disorders or suicidal ideation are specifically excluded;
- Current use of psychotropic drugs;
- Drug and/or alcohol abuse;
- Current or prior therapy with immunomodulators or immunosuppressive drugs and anticoagulant drugs within 30 days prior to study medication administration;
- Live attenuated vaccines within 60 days prior to study entry \[NOTE: Medically indicated sub-unit or killed vaccines (e.g, influenza, pneumococcal, hepatitis A and B) are not exclusionary, but should be given at least 4 weeks away from anti-HIV immunizations\];
- Use of investigational agents within 90 days prior to study entry;
- Participation in another experimental protocol within 6 months prior to pre-study screening;
- Prior receipt of HIV vaccine in a previous HIV vaccine trial;
- Receipt of blood products or immunoglobulin in the past 6 months;
- Pregnant or lactating women.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01441193
Start Date
September 1 2011
End Date
February 1 2014
Last Update
March 4 2016
Active Locations (3)
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1
Policlinico di Modena, Divisione di Malattie Infettive
Modena, Italy, 41100
2
Azienda Ospedaliera San Gerardo, Divisione di Malattie Infettive
Monza, Italy, 20052
3
IFO - S. Gallicano, Dermatologia Infettiva
Rome, Italy, 00153