Een fase I/II vaccinatie studie met patient eigen dendritische cellen geladen met TAT, REV en NEF mRNA in HIV geïnfecteerden tijdens stabiele HAART.
Completed
- Conditions
- HIV-1 infection, seroposoitive anti-retroviral treatment, cellular immunity, early proteins, Tat, Rev, Nef
- Registration Number
- NL-OMON25488
- Lead Sponsor
- Erasmus MC, Rotterdam, Vrije Universiteit Brussel, BrusselK.Thielemans, MD, PhD Director Laboratory of Molecular and Cellular Therapy Medical School Vrije Universiteit BrusselLaarbeeklaan 103 B-1090 BrusselsTel: + 32 (0)2 477 45 69Fax: + 32 (0)2 477 45 68e-mail: Kris.Thielemans@vub.ac.be
- Brief Summary
Allard S.D., Pletinckx K., Breckpot K., Heirman C., Michiels A., van Baalen C.A., Gruters R.A., Osterhaus A.D.M.E., Lacor P., Aerts J.L., Thielemans K. (2008) Functional T-cell responses generated by dendritic cells expressing the early HIV-1 proteins Tat, Rev and Nef. Vaccine 26, 3537-3541.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
1. HIV-1 seropositive;
2. >1 year on stable HAART;
Exclusion Criteria
1. Acute or serious illness <14 days before study entry;
2. HIV viral load >50 copies/ml in 3 months before entry;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine safety and toxicity of the subcutaneous and intradermal (SC/ID)<br>administration of autologous dendritic cells (DC) electroporated with mRNA encoding Tat,<br>Rev and Nef in HIV-1 infected patients who are virologically and immunologically<br>responding to HAART.
- Secondary Outcome Measures
Name Time Method 1. To assess the ability of mRNA electroporated autologous DC, administrated SC/ID, to<br>enhance HIV-specific T-cell responses against Tat, Rev and Nef in HIV-1 infected patients<br>under stable HAART;<br /><br>2. To assess the kinetics of the HIV viral load rebound after withdrawal of HAART in the<br>setting of an analytical treatment interruption (ATI), in HIV-1 infected patients to whom<br>autologous dendritic cells electroporated with mRNA encoding Tat, Rev or Nef have been<br>administered;<br /><br>3. To assess the duration of the period off HAART in the study patients;<br /><br>4. To determine whether genotypical variation occurs in the genes targeted by the vaccine and<br>whether this correlates with immune escape.