TYPHOID FEVER TRAVELER INFORMATION SHEET

Typhoid disease is a bacterial infection of the digestive tract caused by Salmonella typhi, transmitted via the fecal-oral route, and contracted by ingestion of contaminated food and water. Typhoid infects 16 to 33 million people yearly worldwide and kills at least 600,000, the majority of whom are in Asian nations. In the United States about 500 cases occur each year, with most acquired internationally. Typhoid fever is generally spread person to person, especially by food handlers who do not wash their hands adequately after bowel movements. Visitors who stray off the beaten path and eat meals prepared at foodstands or by street vendors are at highest risk. After an incubation period of one to three weeks, the onset and course of illness can range from very mild or unnoticed to quite severe, even fatal. Approximately 2-4% of acute cases results in the development of a chronic carrier state.

Although risk to travelers is generally low, typhoid fever immunization should be considered by all travelers to lesser developed countries, especially in countries with warm climates and with less developed sanitary facilities for sewage disposal and water treatment. Typhoid vaccine is available in both oral and injectable forms. Both vaccines are equally effective and offer 65 - 75% protection against the disease. Not all recipients of either vaccine will be fully protected against typhoid fever.

Vaccination does not decrease the importance of following proper food and drink precautions.

Oral Vaccine Instructions: It is essential that all four doses of Vivotif vaccine be taken on an alternate day interval to obtain maximum immunity. This vaccine is given in a 4-dose, every-other-day series on days 0,2,4 and 6. Each capsule consists of a single dose. Take each dose approximately one hour before a meal with cool or lukewarm water (below 98°F). Do not drink alcohol within one hour of taking a capsule. The vaccine should be stored under refrigeration at all times. It is essential to replace unused vaccine in the refrigerator between doses. The 4-dose series should be completed no later than 1 week before arrival at high-risk areas. The booster 4-dose series is recommended every 5 years under conditions of repeated or continuous exposure. Vivotif vaccine should not be taken during an acute gastrointestinal illness or an acute illness with fever. Vivotif vaccine should not be taken if you are receiving sulfonamides or antibiotics. Pregnant women should not receive this vaccine, nor should persons with altered immune status or those with a history of prior reaction to oral typhoid vaccine.

DO NOT DRINK ALCOHOL WITHIN (1 ) HOUR OF TAKING VIVOTIF BERNA®. Alcohol will break the enteric coated capsule and, therefore the capsule will dissolve in the stomach and not in the gut (intestinal tract). In addition, testing has confirmed that alcohol will kill the live bacteria in the vaccine. The capsule should NEVER BE OPENED and the contents administered in foods or liquids.

Side effects from Vivotif oral vaccine are not common however, if they occur, they may include

abdominal discomfort, nausea, vomiting, fever, headache, fever, diarrhea, vomiting and rash or hives. If you are unable to complete all four doses or you make an error completing the medication schedule, please call the Travel Clinic for advice.

ORAL TYPHOID VACCINE INSTRUCTION SUPPLEMENT

The following recommendations have NOT been approved by the FDA and are provided by Berna Products as a guide to assist physicians and patients on certain points based upon the most recently available data.

  1. Storage of vaccine outside of refrigeration: If the vaccine has been kept OUT of refrigeration at 80°F or below, not in a car and not exposed to direct sunlight FOR UP TO 48 HOURS, THEY MAY GO AHEAD AND USE IT. This is provided that the vaccine is used within a reasonably short period of time (eg., within 30 days.) If the lot is within 60 days prior to expiration, please refer to Berna Products Medical Inquiries at 1-800-533-5899. Recent data has confirmed that exposure to ambient temperatures (ie 72O-77°F) for short periods of time does not compromise vaccine potency. "To ensure long-term stability, such vaccines [live oral attenuated vaccines] must be stored at 5°C+/-3°C. However, exposure to ambient temperatures (77°C) for short periods of time (> 7 days) does not compromise vaccine potency." The potency of VIVOTIF BERNA® is not affected if it is accidentally frozen.
  2. Interruption in the Vaccine dosing schedule:

IN GENERAL: Only limited data is available on the effect of a slight change in schedule.

(The data from field trials reflect a 40% decrease in protection if vaccine was

given at a 21 day versus every other day schedule [with 3 dose schedule.])

IF 3 DOSES HAVE BEEN TAKEN PROPERLY: a delay of up to 72 hours (3 days) in

taking the 4th dose should not be expected to markedly affect efficacy.

IF 2 DOSES HAVE BEEN TAKEN PROPERLY: a delay of 24-48 hours in taking the

3rd dose should not be expected to markedly affect efficacy as long as the remaining doses are taken at the appropriate intervals.

  1. Completion of vaccine dosing schedule:

IN All CASES, All 4 DOSES OF VACCINE SHOULD BE TAKEN.

IF ONLY 3 DOSES ARE TAKEN, protection will be less than for 4 doses, although the absolute

degree of decrease protection cannot be stated with certainty.

IF ONLY 1 OR 2 DOSES HAVE BEEN TAKEN, the physician should consider restarting the

patient on a new 4-dose vaccine schedule since 1 or 2 doses of vaccine will provide only modest (15-

40%)protection. (This assumes that the vaccine has been well tolerated by the patient and was not the cause of the patient failing to complete the initial regimen.)

When a patient is restarted on the vaccine, the physician should instruct the patient to report any adverse event, as there is no clinical trial data on the safety of 5-6 doses administered in a short period of time. However, based upon prior experience including: administering larger doses of vaccine (up to 10 times more than is currently in each capsule) European re-immunization studies where only 1-2 years had elapsed since primary immunization. No adverse reactions were noted.

Drug Interactions

ANTIBIOTICS: AS A GENERAL RULE, NO ANTIBIOTICS SHOULD BE GIVEN 7 DAYS BEFORE THE

FIRST DOSE OR AFTER THE FOURTH DOSE OF VIVOTIF BERNA®.

ANTIMALARIALS:

Chloroquine: can be used concomitantly with Vivotif Berna®.

Doxycycline: see comments under Antibiotics.

Mefloquine(LARIAM®): can be used concomitantly with Vivotif Berna®.

IMMUNE GLOBULINS: concurrent administration of immune globulins and VIVOTIF BERNA® is

possible without affecting the immune response.

ORAL POLIO VACCINE: oral polio vaccine can be administered BEFORE, SIMULTANEOUSLY or

AFTER VIVOTIF BERNA®.

OTHER TRAVEl-RELATED VACCINES: there is no evidence that simultaneous administration of tetanus, diphtheria, rabies, measles, cholera, yellow fever or meningococcal vaccines interfere with the efficacy of VIVOTIF BERNA®.

For further information or other questions call Berna Products Medical Inquires at 1-(800)-533-5899.

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