| Autor: |
Leroux-Roels, Isabel, Leroux-Roels, Geert, Ofori-Anyinam, Opokua, Moris, Philippe, De Kock, Els, Clement, Fre´de´ric, Dubois, Marie-Claude, Koutsoukos, Marguerite, Demoitie´, Marie-Ange, Cohen, Joe, Ballou, W. Ripley |
| Zdroj: |
Clinical and Vaccine Immunology (formerly CDLI); November 2010, Vol. 17 Issue: 11 p1763-1771, 9p |
| Abstrakt: |
ABSTRACTTuberculosis (TB) remains a major cause of illness and death worldwide, making a new TB vaccine an urgent public health priority. Purified protein derivative (PPD)-negative adults (n= 50) were equally randomized to receive 3 doses at 1-month intervals (at 0, 1, and 2 months) of one of the following vaccines: Mtb72F/AS02A(10 or 40 µg antigen), Mtb72F/saline (10 or 40 µg antigen), or AS02A. Mtb72F/AS02Arecipients received an additional dose 1 year after the first dose to evaluate if the elicited immune response could be boosted. Mtb72F/AS02Avaccines were locally reactogenic but clinically well tolerated, with transient adverse events (usually lasting between 1 and 4 days) that resolved without sequelae being observed. No vaccine-related serious adverse events were reported. Vaccination with Mtb72F/AS02Ainduced a strong Mtb72F-specific humoral response and a robust Mtb72F-specific CD4+T-cell response, both of which persisted at 9 months after primary immunization and for 1 year after the booster immunization. There was no significant difference between the magnitude of the CD4+T-cell response induced by the 10-µg and 40-µg Mtb72F/AS02Avaccines. The Mtb72F-specific CD4+T cells predominantly expressed CD40L; CD40L and interleukin-2 (IL-2); CD40L and tumor necrosis factor alpha (TNF-a); CD40L, IL-2, and TNF-a; and CD40L, IL-2, TNF-a, and gamma interferon (IFN-?). Serum IFN-?, but not TNF-a, was detected 1 day after doses 2 and 3 for the Mtb72F/AS02Avaccine but did not persist. Vaccine-induced CD8+T-cell responses were not detected, and no immune responses were elicited with AS02Aalone. In conclusion, Mtb72F/AS02Ais clinically well tolerated and is highly immunogenic in TB-nai¨ve adults. The 10- and 40-µg Mtb72F/AS02Avaccines show comparable safety and immunogenicity profiles. |
| Databáze: |
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