التفاصيل البيبلوغرافية
| العنوان: |
The candidate tuberculosis vaccine Mtb72F/AS02 in PPD positive adults: A randomized controlled phase I/II study. |
| المؤلفون: |
Spertini, François, Audran, Régine, Lurati, Floriana, Ofori-Anyinam, Opokua, Zysset, Frédéric, Vandepapelière, Pierre, Moris, Philippe, Demoitié, Marie-Ange, Mettens, Pascal, Vinals, Carlota, Vastiau, Ilse, Jongert, Erik, Cohen, Joe, Ballou, W. Ripley |
| المصدر: |
Tuberculosis (14729792); Mar2013, Vol. 93 Issue 2, p179-188, 10p |
| مصطلحات موضوعية: |
TUBERCULOSIS prevention, TUBERCULOSIS vaccines, CHEMOPREVENTION, T cells, DISEASE complications, RANDOMIZED controlled trials |
| مستخلص: |
Summary: Prevention of tuberculosis (TB) through vaccination would substantially reduce the global TB burden. Mtb72F/AS02 is a candidate TB vaccine shown to be immunogenic and well tolerated in PPD-negative adults. We evaluated the safety and immunogenicity of Mtb72F/AS02 in Mycobacterium-primed adults (BCG-vaccinated, or infected adults who had received post-exposure chemoprophylaxis or treatment for pulmonary TB disease). In this observer-blind controlled trial, 20 BCG-vaccinated adults and 18 adults previously infected with Mycobacterium tuberculosis (Mtb), were randomized 3:1 to receive three doses of Mtb72F/AS02 or AS02 at one-month intervals, and followed for 6 months post third vaccination. Mtb72F/AS02 was well tolerated in BCG-vaccinated adults, and tended to be more reactogenic in Mtb-infected adults. Adverse events were mainly self-limiting, resolving without sequelae. No serious adverse events were reported. The adverse events in Mtb72F/AS02 vaccinees were not clearly associated with vaccine-induced responses (as assessed by proinflammatory cytokines, total IgE and C-reactive protein levels). No Th2 T-cell responses, or vaccine-induced T-cell responses to Mtb antigens (CFP-10/PPD/ESAT-6) were detected by ICS. In both cohorts, Mtb72F/AS02 induced persistent polyfunctional Mtb72F-specific CD4+ T-cell responses and anti-Mtb72F humoral responses. IFN-γ was detectable in serum one day post each vaccination. Further evaluation of the candidate vaccine, Mtb72F/AS02, is warranted. Trial registration: ClinicalTrials.gov identifier: NCT00146744. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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