Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine when given as a booster to BCG in Gambian infants: An open-label randomized controlled trial - 03/12/14
, Olumuyiwa A. Owolabi a, 1 , Patrick K. Owiafe a , Philippe Moris b , Aderonke Odutola a , Anne Bollaerts b , Ezra Ogundare a , Erik Jongert b , Marie-Ange Demoitié b , Opokua Ofori-Anyinam b, 2 , Martin O. Ota a, c, 2 Summary |
We evaluated the candidate tuberculosis vaccine M72/AS01 in Bacille-Calmette-Guérin (BCG)-vaccinated infants after or concomitantly with Expanded-Programme-on-Immunization (EPI) vaccines.
Methods |
In a Phase-II study in The Gambia (NCT01098474), 2 cohorts of 150 BCG-vaccinated infants each were randomized 1:1:1. The ‘Outside-EPI’ cohort received one or two M72/AS01 doses, or meningitis vaccine, 1–2 months after primary EPI vaccination. The ‘Within-EPI’ cohort received one or two M72/AS01 doses concomitantly with the third or last two doses of their primary EPI-regimen, respectively, or EPI vaccines alone. Safety, M72-specific humoral (ELISA) and cell-mediated (whole-blood ICS) responses, and humoral responses to EPI vaccines were assessed.
Results |
M72/AS01 was acceptably tolerated with no vaccine-related serious adverse events reported. Seropositivity/seroprotection rates against EPI antigens in the Within-EPI cohort were comparable between groups, irrespective of M72/AS01 co-administration. Up to one year post M72/AS01 vaccination, M72-specific humoral and CD4+ T-cell responses were higher after 2 doses versus 1 dose in both cohorts (p < 0.0001), and comparable between cohorts after either 1 or 2 doses (p > 0.05).
Conclusion |
M72/AS01 given to infants after or concomitantly with EPI vaccines had an acceptable safety profile. Our results suggest no interference of immunogenicity profiles occurred following co-administration of M72/AS01 and EPI vaccines. Two M72/AS01 doses elicited higher immune responses than one dose.
Le texte complet de cet article est disponible en PDF.Keywords : Tuberculosis vaccine, Co-administration, M72, AS01, EPI
Plan
Vol 94 - N° 6
P. 564-578 - décembre 2014 Retour au numéro
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