Vaccine Information: Vivotif (Page 2 of 3)

CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits.

WARNINGS

Vivotif (Typhoid Vaccine Live Oral Ty21a) is not to be taken during an acute gastrointestinal illness. The vaccine should not be administered to individuals receiving sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response. Postpone taking the vaccine if persistent diarrhea or vomiting is occurring. Unless a complete immunization schedule is followed, an optimum immune response may not be achieved. Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms, i.e. travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water.

Drug Interactions

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 Vivotif (17,18). 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 strain (19). 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 strain (19). There are no data regarding simultaneous administration of other parenteral vaccines or immunoglobulins with Vivotif.

PRECAUTIONS

General

The health care provider should take all necessary precautions to ensure the safe and effective use of the vaccine. Patients should be questioned about previous reactions to this or similar products. The previous immunization history of the patient and current antibiotic usage should be obtained by the health care provider.

Information for Patients

It is essential that all 4 doses of vaccine be taken at the prescribed alternate day interval to obtain a maximal protective immune response. Vaccine potency is dependent upon storage under refrigeration [between 2 °C and 8 °C (35.6 °F – 46.4 °F)]. The vaccine should be stored under refrigeration at all times. It is essential to replace unused vaccine in the refrigerator between doses. The vaccine capsule should be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink. Care should be taken not to chew the vaccine capsule. The vaccine capsule should be swallowed as soon after placing in the mouth as possible.

Not all recipients of Vivotif (Typhoid Vaccine Live Oral Ty21a) will be fully protected against typhoid fever. Travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water. Several anti-malaria drugs, such as mefloquine, chloroquine and proguanil (not approved for use in US) possess antibacterial activity which may interfere with the immunogenicity of Vivotif. Clinical results (see WarningsDrug- Interactions) 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. Any serious adverse reactions related to the administration of the vaccine should be reported to your health care provider. You may also report an adverse reaction directly to the Vaccine Adverse Event Reporting System (1–800–822–7967) (20). Your health care provider should inform you of the benefits and risks of the vaccine, the importance of taking all 4 capsules in the correct schedule, and the importance of proper storage temperature of the capsules.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals with Vivotif have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility.

Pregnancy

Category C

Animal reproduction studies have not been conducted with Vivotif. It is not known whether Vivotif can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Vivotif should be given to a pregnant woman only if clearly needed.

Nursing Mothers

There is no data to warrant the use of this product in nursing mothers. It is not known if Vivotif is excreted in human milk.

Pediatric Use

The safety and efficacy of Vivotif has not been established in children under 6 years of age. This product is not indicated for use in children under 6 years of age.

ADVERSE REACTIONS

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 study (21) and in a subgroup of a large field trial (14) 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 group (14). 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 males (16).

Post-marketing surveillance has revealed that adverse reactions are infrequent and mild (17). 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 PaxVax, Inc. at 1-800-533-5899 http://www.paxvax.com; or contact the Vaccine Adverse Event Reporting System (VAERS) at 1-800- 822-7967 or http://www.fda.gov/vaers

DOSAGE AND ADMINISTRATION

One capsule is to be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink on alternate days, e.g., days 1, 3, 5 and 7. Immunization (ingestion of all 4 doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) should be completed at least 1 week prior to potential exposure to S. typhi.

The blister containing the vaccine capsules should be inspected to ensure that the foil seal and capsules are intact. The vaccine capsule should not be chewed and should be swallowed as soon after placing in the mouth as possible. A complete immunization schedule is the ingestion of 4 vaccine capsules as described above.

Re-immunization

The optimum booster schedule for Vivotif has not been determined. Efficacy has been shown to persist for at least 5 years. Further, there is no experience with Vivotif as a booster in persons previously immunized with parenteral typhoid vaccine. It is recommended that a re-immunization dose consisting of 4 vaccine capsules taken on alternate days be given every 5 years under conditions of repeated or continued exposure to typhoid fever (7).

HOW SUPPLIED

Product: 50090-2292

Storage

Vivotif (Typhoid Vaccine Live Oral Ty21a) is not stable when exposed to ambient temperatures. Vivotif should therefore be shipped and stored between 2 °C and 8 °C (35.6 °F–46.4 °F). Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at 2 °C–8 °C (35.6 °F–46.4 °F).

Manufactured by

PaxVax Berna GmbH, Oberriedstrasse 68, Thoerishaus, CH-3174 Switzerland
US-License No. 2015

Distributed by

PaxVax, Inc. 555 Twin Dolphin Dr., Ste. 360
Redwood City, CA 94065

RX only.jpgRX only.jpg

References

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2.
Germanier R., E. Fürer. Characteristics of the attenuated oral vaccine strain S. typhi Ty21a. Develop. Biol. Standard 53: 3–7, 1983.
3.
Miller S.I., E.L. Hohmann, D.A. Pegues. Salmonella (including Salmonella typhi). In: Principles and practice of infectious diseases. G.L. Mandell, J.E. Bennett, R. Dolin (ed.) fourth edition, Churchill Livingstone Inc. 2013–2033, 1995.
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Centers for Disease Control. Summary of notifiable diseases, United States 1995. MMWR 44 (Supplement), 1996.
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Ryan C.A., N.T. Hargrett-Bean, P.A. Blake. Salmonella typhi infections in the United States, 1975– 1984: Increasing role of foreign travel. Rev. Infect. Dis. 11: 1–8, 1989.
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Taylor D.N., R.A. Pollard, P.A. Blake. Typhoid in the United States and the Risk to the International Traveler. J. Infect. Dis. 148: 599–602, 1983.
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Recommendations of the Advisory Committee on Immunization Practices (ACIP): Typhoid Immunization. MMWR 43 (RR-14), 1994.
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Ames W.R., M. Robbins. Age and sex as factors in the development of the typhoid carrier state, and a model for estimating carrier prevalence. Am. J. Public Health 33: 221–230, 1943.
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Wahdan M.H., C. Sérié, Y. Cerisier, S. Sallam, R. Germanier. A controlled field trial of live Salmonella typhi strain Ty21a oral vaccine against typhoid: three-year results. J. Infect. Dis. 145: 292–296, 1982.
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Black R.E., M.M. Levine, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Germanier, Chilean Typhoid Committee. Efficacy of one or two doses of Ty21a Salmonella typhi vaccine in enteric-coated capsules in a controlled field trial. Vaccine 8: 81–84, 1990.
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Levine M.M., C. Ferreccio, R.E. Black, R. Germanier, Chilean Typhoid Committee. Large-Scale Field Trial of Ty21a Typhoid Vaccine Live Oral Ty21a in Enteric-Coated Capsule Formulation. Lancet 1: 1049– 1052, 1987.
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Levine M.M., C. Ferreccio, R.E. Black, C.O. Tacket, R. Germanier, Chilean Typhoid Committee. Progress in vaccines against typhoid fever. Rev. Infect. Dis. 11 (Supplement 3): S552–S567, 1989.
13.
Ferreccio C., M.M. Levine, H. Rodriguez, R. Contreras, Chilean Typhoid Committee. Comparative efficacy of two, three, or four doses of Ty21a live oral typhoid vaccine in enteric-coated capsules: a field trial in endemic area. J. Infect. Dis. 159: 766–769, 1989.
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.
15.
Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland.
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.
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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.
20.
Vaccine Adverse Event Reporting System – United States. MMWR 39: 730–733, 1990.
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.

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