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Comparative Tolerability and Immunogenicity of TypherixTM or Typhim Vi™ in Healthy Adults

0,12-Month and 0, 24-Month Administration

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Abstract

Background: This study was carried out to compare the immunogenicity and tolerability of Typherix™, a recently developed typhoid Vi polysaccharide vaccine, with Typhim Vi™, the first available Vi polysaccharide vaccine, in healthy adults. Three different production lots of Typherix™ were also compared.

Methods: All subjects were randomised to receive an initial dose of Typhim Vi™, or one of three production lots of Typherix™, and subsequently randomised to receive a second dose of vaccine at 12 or 24 months. Adverse events were recorded by patients for 6 days after vaccination. Anti-Vi antibodies were measured in serum on days 0, 7, 14 and 28, at months 6, 12 and 24, and 1 month after the second dose (month 13 or 25).

Results: A total of 400 healthy subjects aged between 18 and 50 years received the first dose of vaccine. Significantly fewer patients in the three Typherix™ groups than in the Typhim Vi™ group reported adverse events (17 to 21% vs 44%, respectively). Seropositivity rates were 95.7 to 97.9% among subjects in the three Typherix™ groups at day 14, and 96.8% in the Typhim Vi™ group (no significant between-group differences). The only significant difference between the vaccines in seropositivity was observed at day 7 (71.8% for Typherix™ vs 86.4% for Typhim Vi™). Of subjects receiving the second dose of Typherix™ at 12 and 24 months, 77% and 61% were seropositive before revaccination, compared with 69% and 46% for Typhim Vi™ (no significant difference). There were no significant differences in seropositivity or adverse events between the two vaccines after administration of the second dose (12 or 24 months).

Conclusions: The initial dose of Typherix™ was associated with fewer adverse events than Typhim Vi™. On the basis of serum Vi titres, the two vaccines demonstrated equivalent immunogenicity, with 0, 12-month and 0, 24-month administration. There were no differences between the three different production lots of Typherix™.

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  1. Clinique Notre Dame de Grâce, Chaussée de Nivelles 212, 6041, Gosselies, Belgium

    Edouard Lebacq

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  1. Edouard Lebacq
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Correspondence to Edouard Lebacq.

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Lebacq, E. Comparative Tolerability and Immunogenicity of TypherixTM or Typhim Vi™ in Healthy Adults. BioDrugs 15 (Suppl 1), 5–12 (2001). https://doi.org/10.2165/00063030-200115001-00002

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