Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine (ISS T-002)

This study has been completed.
Sponsor:
Information provided by:
Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:
NCT00751595
First received: September 11, 2008
Last updated: January 14, 2013
Last verified: January 2013

September 11, 2008
January 14, 2013
September 2008
June 2012   (final data collection date for primary outcome measure)
Humoral and cellular immune responses to Tat [ Time Frame: up to 144 weeks ] [ Designated as safety issue: No ]
It will be measured by the induction, magnitude and persistence of the humoral and cellular immune responses to Tat and by comparing the immunogenicity of a 3/5 immunizations of the different vaccine doses, 7.5 microg and 30 microg
It will be measured by the induction, magnitude and persistence of the humoral and cellular immune responses to Tat and by comparing the immunogenicity of a 3/5 immunizations of the different vaccine doses, 7.5 microg and 30 microg at week 24 and 48
Complete list of historical versions of study NCT00751595 on ClinicalTrials.gov Archive Site
The Secondary Endpoint will be focused on adverse events, including any significant change in hematological/biochemical laboratory parameters. [ Time Frame: up to 144 weeks ] [ Designated as safety issue: Yes ]
The Secondary Endpoint will be focused on adverse events, including any significant change in hematological/biochemical laboratory parameters. [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine (ISS T-002)
A Phase II Randomized, Open Label, Immunogenicity and Safety Trial of the Vaccine Based on the Recombinant Biologically Active HIV-1 Tat Protein in Anti-Tat Negative HIV-1 Infected HAART-treated Adult Subjects.

The study is a randomized, open label, phase II clinical trial directed at evaluating the immunogenicity (as a primary end-point) and the safety (as a secondary end-point), of the recombinant HIV-1 Tat vaccine in HIV-1 infected adult subjects, anti-Tat antibody negative, HAART-treated with chronic suppressed HIV-1 infection, CD4+ T cell counts > 400 cells/microliter, levels of plasma viremia < 50 copies/ml in the last 6 months prior to the screening and without a history of virologic rebound. The immunogenicity of 3 or 5 immunizations of the two different vaccine doses (7.5 and 30 micrograms) of the Tat vaccine will be evaluated.

This phase II clinical trial is directed at evaluating the immunogenicity and the safety of the HIV-1 Tat protein-based vaccine. Anti-Tat antibody negative, HIV-1 positive subjects treated successfully with HAART will be screened and recruited for a 48-weeks study, including a period of 16 or 8 weeks treatment phase and a period of 32 or 40 weeks follow-up phase, in arm A or Arm B, respectively. One hundred twenty-eight subjects will be randomized 1:1:1:1 to one in 2 arms (Arm A and Arm B) and each arm will be divided in the following groups:

Arm A - Group I: 5 immunizations with Tat (7.5 microg) at weeks 0, 4, 8, 12, 16; Arm A - Group II: 5 immunizations with Tat (30 microg) at weeks 0, 4, 8, 12, 16; Arm B - Group I: 3 immunizations with Tat (7.5 microg) at weeks 0, 4, 8; Arm B - Group II: 3 immunizations with Tat (30 microg) at weeks 0, 4, 8.

Four vaccination regimens will be tested by intradermal administration of the Tat vaccine at two different doses (7.5 microg or 30 microg) in 5 or 3 immunizations.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Biological: Tat protein
Biologically active recombinant Tat protein
  • Experimental: A
    Group I: Subjects receiving 5 intradermal immunization with Tat (7.5 microg); Group II: Subjects receiving 5 intradermal immunization with Tat (30 microg).
    Intervention: Biological: Tat protein
  • Experimental: B
    Group I: Subjects receiving 3 intradermal immunization with Tat (7.5 microg); Group II: Subjects receiving 3 intradermal immunization with Tat (30 microg)
    Intervention: Biological: Tat protein

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
December 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-55 years
  • Anti-Tat antibody negative subjects
  • HIV-1 infected subjects under successful HAART treatment with HIV plasma viremia < 50 copies/ml in the last 6 months prior to the screening
  • Subjects with any pre-HAART CD4 nadir;
  • CD4+ T cell counts ≥ 200 cells/μl at enrolment;
  • Availability for the planned study duration
  • Negative pregnancy test for women of childbearing potential (to be performed during the screening phase and just before the immunizations) and use of an acceptable mean of contraception (condom, hormonal or mechanical methods) for one month prior to immunization and for the all duration of the study
  • Signed informed consent

Exclusion Criteria:

  • Concomitant AIDS-related opportunistic disease;
  • Concomitant neoplastic diseases;
  • History of malignant neoplastic diseases [NOTE: Subjects with history of non malignant neoplastic diseases completely resolved according to the fulfillment of all the specific recovery criteria, in agreement with the current guidelines in medical oncology are eligible];
  • History of encephalopathy, neuropathy or unstable CNS pathology, immunodeficiency, autoimmune disease, angina or cardiac arrhythmias, or any other clinically significant medical problems;
  • Any evidence, as judged by the investigator, of unstable cardio-vascular disease (e.g. unstable hypertensive disease needing modification or introduction of an anti-hypertensive treatment);
  • Chest radiography showing evidence of active or acute cardiac or pulmonary disease within 6 months prior to study screening visit;
  • History of anaphylaxis or serious adverse reactions to vaccines as well as serum IgE levels exceeding 1000 U.I./ml;
  • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g. Steven-Johnson syndrome, bronchospasm, or hypotension);
  • Active tuberculosis documented PPD skin test within one year [NOTE: if the PPD skin test is positive, then a chest x-ray will be done and if no findings consistent with active pulmonary tuberculosis and no indications exist for prophylaxis or treatment, the subject is eligible for participation in this trial];
  • Medical or psychiatric condition which preclude subject compliance with the protocol. Specifically, persons with psychotic disorders, major affective disorders, suicidal ideation are to be excluded;
  • Current use of psychotropic drugs prescribed for major psychotic disorders;
  • Concomitant participation in any experimental study;
  • 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 of study inclusion [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 HIV immunizations];
  • Receipt of blood products or immunoglobulin in the past year;
  • Previous participation in an HIV-1 vaccine trial (subjects who despite their participation as placebo in a HIV-1 vaccine trial have never been effectively administered with a HIV-1 vaccine are eligible);
  • Drug and/or alcohol abuse;
  • Use in the last 6 months or concomitant use of anti CCR5 inhibitors and/or integrase inhibitors and/or fusion inhibitors;
  • Pregnant or lactating women
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00751595
ISS T-002
Yes
Barbara Ensoli, Istituto Superiore di Sanita
Istituto Superiore di Sanita
Not Provided
Study Director: Barbara Ensoli, MD, PhD National AIDS Center (CNAIDS), Istituto Superiore di Sanita', Rome, Italy
Istituto Superiore di Sanita
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP