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More than 1.4 million doses of Ty21a have been administered in controlled clinical trials and more than 150 million doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) have been marketed world-wide. Active surveillance for adverse reactions of enteric-coated capsules was performed in a pilot study21 and in a subgroup of a large field trial14 involving a total of 483 individuals receiving 3 vaccine doses. The overall symptom rates from both studies when vaccinated with capsules were combined and shown to be: abdominal pain (6.4%), nausea (5.8%), headache (4.8%), fever (3.3%), diarrhea (2.9%), vomiting (1.5%) and skin rash (1.0%). Only the incidence of nausea occurred at a statistically higher frequency in the vaccinated group as compared to the placebo group14. Administration of vaccine doses more than 5-fold higher than the currently recommended dose caused only mild reactions in an open study involving 155 healthy adult males16.
Post-marketing surveillance has revealed that adverse reactions are infrequent and mild17. Adverse reactions reported to the manufacturer during 1991–1995, during which time over 60 million doses (capsules) were administered, included: diarrhea (N = 45), abdominal pain (N = 42), nausea (N = 35), fever (N = 34), headache (N = 26), skin rash (N = 26), vomiting (N = 18), or urticaria in the trunk and/or extremities (N = 13). One isolated, non-fatal anaphylactic shock considered to be an allergic reaction to the vaccine was reported.
To report SUSPECTED ADVERSE REACTIONS, contact Crucell Vaccines, Inc. at 1-800- 533-5899 http://www.crucell.com.us; or contact the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://www.fda.gov/vaers
Read the Vivotif Oral (typhoid vaccine) Side Effects Center for a complete guide to possible side effects
Several anti-malaria drugs, such as mefloquine, chloroquine and proguanil (not approved for use in US) possess anti-bacterial activity which may interfere with the immunogenicity of Vivotif17,18. To determine the effect of these anti-malaria drugs on the humoral IgG or IgA anti-S. typhi immune response, healthy adult subjects were given mefloquine (250 mg at weekly intervals; N = 30) chloroquine (500 mg at weekly intervals; N = 30) or proguanil (200 mg daily; N = 30) together with the S. typhi Ty21a vaccine strain19. Concomitant treatment with mefloquine or chloroquine did not result in a significant reduction in the serum anti-S. typhi immune response compared to subjects receiving vaccine strain only (N = 45). The simultaneous administration of proguanil did effect a significant decrease in the immune response rate. These findings indicate that mefloquine and chloroquine can be administered together with Vivotif. Proguanil should be administered only if 10 days or more have elapsed since the final dose of Vivotif was ingested. The concomitant administration of oral polio vaccine or yellow fever vaccine does not suppress the immune response elicited by the Ty21a vaccine strain19. There are no data regarding simultaneous administration of other parenteral vaccines or immunoglobulins with Vivotif.
14. Simanjuntak C.H., F.P. Paleologo, N.H. Punjabi, R. Darmowigoto, Soeprawoto, H. Totosudirjo, P. Haryanto, E. Suprijanto, N.D. Witham, S.L. Hoffman. Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine. Lancet 338: 1055–1059, 1991.
16. Gilman R.H., R.B. Hornick, W.E. Woodward, H.L. DuPont, M.J. Snyder, M.M. Levine, J.P. Libonati. Evaluation of a UDP-glucose-4-epimeraseless mutant of Salmonella typhi as a live oral vaccine. J. Infect. Dis. 136: 717–723, 1977.
17. Cryz S.J. Jr., Post-marketing experience with live oral Ty21a Vaccine. Lancet; 341: 49–50, 1993. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland.
18. Horowitz H., CA. Carbonaro, Inhibition of the Salmonella typhi oral vaccine strain Ty21a, by mefloquine and chloroquine. J. Infect. Dis. 166: 1462–1464, 1992.
19. Kollaritsch H., J.U. Que, C. Kunz, G. Wiedermann, C. Herzog, S.J. Cryz Jr. Safety and immunogenicity of live oral cholera and typhoid vaccines administered alone or in combination with anti-malarial drugs, oral polio vaccine or yellow fever vaccine. J. Infect. Dis. 175: 871–875, 1997.
21. Levine M.M., R.E. Black, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Gemanier. The efficacy of attenuated Salmonella typhi oral vaccine strain Ty21a evaluated in controlled field trials. In: Development of Vaccines and Drugs against Diarrhea. 11th Noble Conference, Stockholm, 1985, p. 90–101. J. Holmgren, A. Lindberg and R. Möllby (eds.). Studentlitteratur, Lund, Sweden, 1986.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/10/2014
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