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Clinical Trial
. 1991 Oct 26;338(8774):1055-9.
doi: 10.1016/0140-6736(91)91910-m.

Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine

Affiliations
Clinical Trial

Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine

C H Simanjuntak et al. Lancet. .

Abstract

When tested under conditions of moderate transmission of typhoid fever, a liquid formulation of the oral typhoid fever vaccine Ty21a had a protective efficacy of 96% in Egypt, and an enteric coated capsule formulation had an efficacy of 67% in Chile. We compared the two formulations under conditions of intense transmission of typhoid fever in Indonesia in a randomised, double-blind trial. 20,543 subjects (age range 3-44 years) received either three doses of enteric coated capsules containing placebo or live Ty21a, or three doses of lyophilised placebo or live Ty21a reconstituted with phosphate buffer. During 30 months of follow-up, the rate of blood-culture-positive typhoid fever among controls was 810/100,000 per year. Rates of typhoid fever were 379/100,000 per year for subjects who received the liquid formulation of vaccine and 468/100,000 per year for subjects who received enteric coated capsules. The protective efficacies of the liquid and enteric coated formulations were 53% and 42%, respectively. Neither formulation protected against infection with Salmonella paratyphi A. No major side-effects were noted, but the overall incidence of side-effects was greater in the vaccine groups. Under conditions of intense transmission, Ty21a protected against typhoid fever; however, because Ty21a will not protect all individuals, there is a need for additional approaches to prevent the disease.

PIP: When tested under conditions of moderate transmission of typhoid fever, a liquid formulation of the oral typhoid fever vaccine, Ty21a, had a protective efficacy of 96% in Egypt, and an enteric coated capsule formulation had an efficacy of 67% in Chile. The authors compared the 2 formulations under conditions of intense transmission of typhoid fever in Indonesia in a randomized, double blind trial. 20,543 subjects (age range 3-44 years) received either 3 doses of enteric-coated capsules containing placebo or live Ty21a, or 3 doses of lyophilized placebo or live Ty21a reconstituted with phosphate buffer. During 30 months of followup, the rate of blood-culture-positive typhoid fever among controls was 810/100,000/year. Rates of typhoid fever were 379/100,000/year for subjects who received the liquid formulation of vaccine and 468/100,000/year for subjects who received enteric coated capsules. The protective efficacies of the liquid and enteric coated formulations were 53% and 42%, respectively. Neither formulation protected against infection with Salmonella paratyphi A. No major side effects were noted, but the overall incidence of side effects was greater in the vaccine groups. Under conditions of intense transmission, Ty21a protected against typhoid fever; however since it will not protect all individuals, there is a need for additional approaches in prevention of the disease.

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Comment in

  • Typhoid in Indonesia.
    Parson W. Parson W. Lancet. 1992 Feb 8;339(8789):363-4. doi: 10.1016/0140-6736(92)91681-w. Lancet. 1992. PMID: 1346434 No abstract available.

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