Vivotif
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Questions & Answers
Side Effects & Adverse Reactions
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-InteractionsSeveral 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.
Drug-InteractionsSeveral 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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi ( 7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.
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. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.
History
There is currently no drug history available for this drug.
Other Information
Vivotif (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine for oral administration only. The vaccine contains the attenuated strain Salmonella typhi Ty21a ( 1, 2).
Vivotif is manufactured by the PaxVax Berna GmbH, Switzerland. The vaccine strain is grown in fermentors under controlled conditions in medium containing a digest of yeast extract, an acid digest of casein, dextrose and galactose. The bacteria are collected by centrifugation, mixed with a stabilizer containing sucrose, ascorbic acid and amino acids, and lyophilized. The lyophilized bacteria are mixed with lactose and magnesium stearate and filled into gelatin capsules which are coated with an organic solution to render them resistant to dissolution in stomach acid. The enteric-coated, salmon/white capsules are then packaged in 4-capsule blisters for distribution. The contents of each enteric-coated capsule are shown in Table 1.
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| Viable S. typhi Ty21a | 2.0–10.0x10 9 colony-forming units * |
| Non-viable S. typhi Ty21a | 5–50x10 9 bacterial cells |
| Sucrose | 3.3–34.2 mg |
| Ascorbic acid | 0.2–2.4 mg |
| Amino acid mixture | 0.3–3.0 mg |
| Lactose | up to 180-200 mg |
| Magnesium stearate | 3.6–4.0 mg |
Sources
Vivotif Manufacturers
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Paxvax Berna Gmbh
![Vivotif (Salmonella Typhi Ty21a) Capsule, Coated [Paxvax Berna Gmbh]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vivotif | Paxvax Berna Gmbh
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-immunizationThe 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).
Re-immunizationThe 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).
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