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Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein (EVATAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
BIOSANTECH
ClinicalTrials.gov Identifier:
NCT01793818
First received: February 14, 2013
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells.

Condition Intervention Phase
AIDS
Biological: Tat Oyi
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein

Resource links provided by NLM:


Further study details as provided by BIOSANTECH:

Primary Outcome Measures:
  • Optimal vaccine dose (phase I/II) [ Time Frame: Two years ]
    No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of ART.


Secondary Outcome Measures:
  • Optimal Vaccine Dose (phase I/II) [ Time Frame: Two years ]
    An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades.


Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1 Phase I/II
Three injections with no active principle
Biological: Tat Oyi
Three injections in the arm
Active Comparator: Group 2 Phase I/II
Three injections of Tat Oyi vaccine containing 11 µg of active principle
Biological: Tat Oyi
Three injections in the arm
Active Comparator: Group 3 Phase I/II
Three injections Tat Oyi vaccine containing 33 µg of active principle
Biological: Tat Oyi
Three injections in the arm
Active Comparator: Group 4 Phase I/II
Three injections Tat Oyi vaccine containing 99 µg of active principle
Biological: Tat Oyi
Three injections in the arm

Detailed Description:

The protocol got a favorable judgment from an ethic committee (CPP SudMed 2) on November 9th, 2012 and was authorized by the French drug agency (ANSM) on January 24th, 2013. It will be proposed to HIV-1 infected volunteers to participate to a phase I/II clinical trial to test the Tat Oyi vaccine. Volunteers will have an undetectable viremia (lower than 40 copies/ml) and a level of CD4 cells higher than 350 /mm3 since at least one year under Anti Retroviral Treatment (ART). It will be a randomized double blinded clinical trial with a placebo.

Main Objective: No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of cART.

Secondary objective: An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades.

Main parameter of evaluation: Plasma viremia. Secondary parameter of evaluation: Detection with ELISA of antibodies able to recognize Tat variants representative of the five main HIV-1 clades.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 to 64 years old for the pre inclusion visit.
  • Documented HIV-1 Infection
  • Preferentially, group A patients from CDC classification but no group C patients.
  • HIV-1 patients treated with three antiretroviral drugs since 12 months not changed since three months and having an undetectable viremia since 12 months.
  • HIV-1 Chronic infection defined by a positive HIV-1 ELISA and HIV-1 proteins characterized in a full HIV-1 Western blot. Stable undetectable plasmatic HIV RNA (lower than 40 copies/ml) since 12 months. Lymphocyte CD4 cells higher than 350/mm3 with a NADIR higher than 200/mm3 since 12 months.
  • Free engagement, fully explained and wrote with the patient signature for the inclusion visit and before any test required for the clinical trial.
  • Patient affiliated to a social security system.
  • No vaccination against influenza or other pathogens since three months.
  • No chemotherapy or treatments with corticosteroid
  • HIV-1 patients being abstinent former drug users or drug users following substitution training.

Exclusion Criteria:

  • HIV-1 patient protected regarding French law (articles L1121-5, L1121-6, L1121-7, L1121-8 & L1122-2)
  • No HIV-1 infection
  • Patient infected with HIV-2
  • Patient in HIV-1 primo infection or recently in primo infection
  • Patient in symptomatic primo infection or CD4 cells lower than 200/mm3
  • Women sexually active with no efficient contraception
  • Pregnant women or brass feeding.
  • Patient with an opportunistic infection in the CDC group C.
  • Patient with a cancer and/or under chemotherapy or radiotherapy.
  • Patient with an evolutive psychiatric pathology
  • Patient being HBV and/or HCV positive
  • Patient being ELISA positive for HTLV-1
  • Patient being cirrhotic (Child and Pugh level A, B and C)
  • Patient under criminal investigation
  • Patients with abnormal blood formulation
  • Patient participating to another clinical research
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793818

Locations
France
Centre d'Investigation Clinique - Universitary Hospital Centre Conception
Marseille, France, 13385
Sponsors and Collaborators
BIOSANTECH
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Isabelle Ravaux, MD Assistance Publique Hopitaux De Marseille
  More Information

Publications:
Responsible Party: BIOSANTECH
ClinicalTrials.gov Identifier: NCT01793818     History of Changes
Other Study ID Numbers: EVATAT
Study First Received: February 14, 2013
Last Updated: February 9, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data base (HIV RNA, CD4, CD8, HIV DNA, Tat immune response) and statistical analysis

Keywords provided by BIOSANTECH:
Vaccine
HIV-1
Tat

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 27, 2017