Anemona, Alessandra

Basile, Venere

De Coster, Ilse

Di Cioccio, Vito

Hilbert, Anne Katrin

Kafeja, Froukje

Marchetti, Elisa

Martin, Laura B.

Micoli, Francesca

Podda, Audino

Qasim Kahn, Rana M.

Rondini, Simona

Saul, Allan

van Damme, Pierre

Abstract: Background Typhoid fever causes more than 21 million cases of disease and 200,000 deaths yearly worldwide, with more than 90% of the disease burden being reported from Asia. Epidemiological data show high disease incidence in young children and suggest that immunization programs should target children below two years of age: this is not possible with available vaccines. The Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM197) for infant vaccination concomitantly with EPI vaccines, either starting at 6 weeks with DTP or at 9 months with measles vaccine. We report the results from a Phase 1 and a Phase 2 dose ranging trial with Vi-CRM197 in European adults. Methodology Following randomized blinded comparison of single vaccination with either Vi-CRM197 or licensed polysaccharide vaccines (both containing 25\ub70 \ub5g of Vi antigen), a randomised observer blinded dose ranging trial was performed in the same center to compare three concentrations of Vi-CRM197 (1\ub725 \ub5g, 5\ub70 \ub5g and 12\ub75 \ub5g of Vi antigen) with the polysaccharide vaccine. Principal Findings All vaccines were well tolerated. Compared to the polysaccharide vaccine, Vi-CRM197 induced a higher incidence of mild to moderate short lasting local pain. All Vi-CRM197 formulations induced higher Vi antibody levels compared to licensed control, with clear dose response relationship. Conclusions Vi-CRM197 did not elicit safety concerns, was highly immunogenic and is therefore suitable for further clinical testing in endemic populations of South Asia

Institutional Repository Universiteit Antwerpen

Safety, immunogenicity and dose ranging of a new <tex>Vi-CRM_{197}$</tex> conjugate vaccine against typhoid fever : randomized clinical testing in healthy adults

Safety, immunogenicity and dose ranging of a new <tex>Vi-CRM_{197}$</tex> conjugate vaccine against typhoid fever : randomized clinical testing in healthy adults

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Institutional Repository Universiteit Antwerpen