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Title
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Safety, immunogenicity and dose ranging of a new conjugate vaccine against typhoid fever : randomized clinical testing in healthy adults
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Author
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Abstract
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| 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. 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. |
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Language
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English
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Source (journal)
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PLoS ONE
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Publication
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2011
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ISSN
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1932-6203
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DOI
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10.1371/JOURNAL.PONE.0025398
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Volume/pages
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6
(2011)
, p. 1-7
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ISI
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000295941300028
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Full text (Publisher's DOI)
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Full text (open access)
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