The candidate tuberculosis vaccine Mtb72F/AS02 in PPD positive adults: A randomized controlled phase I/II study.

Details

Serval ID
serval:BIB_2618668010F6
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
The candidate tuberculosis vaccine Mtb72F/AS02 in PPD positive adults: A randomized controlled phase I/II study.
Journal
Tuberculosis
Author(s)
Spertini F., Audran R., Lurati F., Ofori-Anyinam O., Zysset F., Vandepapelière P., Moris P., Demoitié M.A., Mettens P., Vinals C., Vastiau I., Jongert E., Cohen J., Ballou W.R.
ISSN
1873-281X (Electronic)
ISSN-L
1472-9792
Publication state
Published
Issued date
2013
Volume
93
Number
2
Pages
179-188
Language
english
Notes
Publication types: Journal ArticlePublication Status: ppublish. PDF type: Immunological aspects
Abstract
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.
Pubmed
Web of science
Create date
26/03/2013 16:44
Last modification date
20/08/2019 13:04
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