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Safety, immunogenicity and dose ranging of a new Vi-CRM197 conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults

Anemona, Alessandra and Basile, Venere and Hilbert, Anne-Katrin and Rondini, Simona and Micoli, Francesca and Marchetti, Elisa and Di Cioccio, Vito and Saul, Allan and Martin, Laura and Podda, Audino and Khan, Rana M. Qasim and Van Damme, Pierre and Kafeja, Froukje and De Coster, Ilse (2011) Safety, immunogenicity and dose ranging of a new Vi-CRM197 conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS ONE, 6 (9). e2539. ISSN 1932-6203

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•0 µg of Vi antigen), a randomised observer blinded dose ranging trial was performed in the same center to compare three concentrations of Vi-CRM197 (1•25 µg, 5•0 µg and 12•5 µg of Vi antigen) with the polysaccharide vaccine. These studies are registered with ClinicalTrials.gov, number NCT01123941 and NCT01193907.
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.

Item Type: Article
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Keywords: enteric fever; clinical trial; typhoid conjugate vaccine
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Date Deposited: 13 Oct 2015 13:15
Last Modified: 13 Oct 2015 13:15
URI: https://oak.novartis.com/id/eprint/5295

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