Vivotif® (Typhoid Vaccine Live Oral Ty21a)


 

Typhoid fever vaccination probably comes to mind quickly when your patients are traveling to Asia, Africa, or Latin America. 1 But what about those taking a weekend getaway to Mexico or a cruise through the Caribbean? Typhoid fever doesn’t discriminate, and it may be closer to home than you think. If your patients will have continued or repeated exposure to Typhi, give them up to 5 years of protection with Vivotif, an oral vaccine for typhoid fever. 2,3

 

What Is Vivotif?

Vivotif is an oral vaccine for typhoid fever, a potentially severe and life-threatening infection caused by the bacterium Salmonella enterica serotype Typhi ( Typhi). 3,4

Taken orally, the vaccine is delivered to the mucosal surface of the gastrointestinal tract—the largest immunologic organ in the body. 5

Vivotif provides sustained efficacy for 5 years 2

  • It is recommended that re-immunization be given every 5 years under conditions of repeated or continued exposure to typhoid fever. 2 

  • Vivotif is not fully effective until 2 weeks after the first capsule is taken, or
    1 week after the full course of Vivotif (4 capsules) is completed. 6

Vivotif has an established safety profile

  • More than 150 million doses have been marketed worldwide. 2

  • Adverse reactions are infrequent and mild. 2

  • In clinical trials, the most common adverse reactions were abdominal pain (6.4%), nausea (5.8%), headache (4.8%), fever (3.3%), diarrhea (2.9%), vomiting (1.5%), and rash (1.0%). 2

Please see Important Safety Information below.

Vivotif mimics natural infection

  • The precise mechanism(s) that enables Vivotif to protect against typhoid fever is unknown. Delivery of the vaccine to the GI tract induces an immune response that resembles a natural Typhi infection. 2,5,7

    • Vivotif provides double protection through local and systemic immune responses.

Indications and Usage 2

  • 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:  

    • Travelers to areas in which there is a recognized risk of exposure to  S  Typhi

    • Persons with intimate exposure (eg, household contact) to an   Typhi carrier

    • Microbiology laboratorians who work frequently with   Typhi 

    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 Typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with Typhi.

 

Clinical Data

The efficacy of Vivotif was evaluated in a series of randomized, double-blind, controlled field trials performed in Santiago, Chile. 2 Results from clinical studies indicate that adults and children greater than 6 years of age may be protected against typhoid fever following the oral ingestion of 4 doses of Vivotif. 2

Trial 1

1- and 2-Dose Schedule 2

Objective

Compared the efficacy of Vivotif in 82,543
school-aged children

Vaccine Schedule

1 or 2 doses of vaccine were given 1 week apart

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Results

Dose Schedule Vaccine Efficacy (95% CI)
Single Dose 29% (4%-47%)
Two Doses 59% (41%-71%)

Trial 2

3-Dose Schedule 2

Objective

Evaluated the efficacy of Vivotif in
109,594 school-aged children

Vaccine Schedule

3 doses of Vivotif were administered either on alternate days (short immunization schedule) or
21 days apart (long immunization schedule)

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Results

Vaccine efficacy was evaluated 3, 4, and 5 years postvaccination

Administration of Vivotif Alternate days 21 days apart
Vaccine Efficacy (95% CI)
36 months 67% (47%-79%) 49% (24%-66%)
48 months 69% (55%-80%) Not determined
60 months Undiminished level of protection

Trial 3

2-, 3-, and 4-Dose Schedule 2

Objective & Vaccine Schedule

Evaluated the relative efficacy of 2, 3, and 4 doses of Vivotif administered on alternate days in school-aged children

Results

  • After comparing disease incidence within the
    3 groups, relative vaccine efficacy was highest among 4-dose group
  • The incidence of typhoid fever per 105 study subjects was 160.5 (95% CI, 130-191) for the 3-dose regimen versus 95.8 (95% CI, 71-121) for the 4-dose regimen (P < 0.004)
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Dosing regimen Incidence per 105 subjects (95% CI)
3-dose 160.5 (130-191)
4-dose 95.8 (71-121)

Seroconversion Rates 2

  • The precise mechanism(s) by which Vivotif provides protection against typhoid fever is unknown. However, it is known that immunization of adult subjects can elicit an antibody response against S  Typhi.

    • Studies comparing levels of anti- S  Typhi antibodies between adults living in endemic areas (Chile) and nonendemic areas (United States and Switzerland) show comparable seroconversion rates between these groups.
  • Challenge studies in North American volunteers have shown that the Ty21a strain is capable of providing significant protection to an experimental challenge of S  Typhi.
  • Because of the very low incidence of typhoid fever in US citizens, efficacy studies are not currently feasible in this population; however, the above observations support the expectation that 4 doses of Vivotif will provide protection to recipients from non–typhoid-endemic areas such as the United States.

Safety Data

  • Postmarketing surveillance has revealed that adverse reactions are infrequent and mild. 2

Adverse reactions observed in clinical trials (N = 483) 2

Adverse reactions %
Abdominal pain 6.4
Nausea a 5.8
Headache 4.8
Fever 3.3
Diarrhea 2.9
Vomiting 1.5
Rash 1.0

aNausea was the only adverse reaction that occurred at a statistically higher frequency in the vaccinated group compared with the placebo group.

  • Only mild reactions occurred when a 5-fold higher than recommended dose was administered to 155 healthy adult males in an open study. 2

  • Adverse reactions were monitored in postmarketing surveillance from 1991 to 1995 during which more than 60 million doses were administered. 2

Adverse reactions reported in postmarketing surveillance of more than 60 million administered doses (1991-1995) 2

Adverse reaction N
Diarrhea 45
Abdominal pain 42
Nausea 35
Fever 34
Headache 26
Rash 26
Vomiting 18
Urticaria in the trunk or extremities 13

One instance of isolated, nonfatal anaphylactic shock considered to be an allergic reaction to Vivotif was also reported. 2

Please see additional Important Safety Information below.

 

Dosing and Administration

The dosage and administration instructions for Vivotif should be carefully explained to patients.

  • Take the capsules on alternate days (eg, days 1, 3, 5, and 7) 2

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  • Capsules should be swallowed as soon after placing in the mouth as possible. 2
  • A complete immunization schedule is the ingestion of 4 vaccine capsules. 2 Immunization should be completed at least 1 week prior to potential exposure to Typhi. 2,8

  • The blister containing the vaccine capsules should be inspected to ensure that the foil seal and capsules are intact. 2

  • Administering the oral polio or yellow fever vaccines at the same time as Vivotif does not suppress the immune response triggered by Vivotif. 2 Please refer to the MMWR  for additional information on concomitant use.

For medical inquiries about administering Vivotif, please contact Medical Information at (888) 483-9053.

Presentation and Storage

Vivotif is supplied in a single foil blister containing
4 doses of vaccine in a single package. 2

  • Vivotif is not stable when exposed to ambient temperatures.

  • Vivotif should be shipped and stored between
    2°C and 8°C (35.6°F and 46.4°F).

  • Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at the proper temperature.

PAXVAX

Vivotif must be refrigerated between 35.6°F and 46.4°F
(the typical temperature of a refrigerator) to maintain optimal efficacy. 35.6 oF-46.4 oF

Be sure to remind your patients about
the importance of properly storing Vivotif.

For medical inquiries regarding temperature deviations by patients, please contact Medical Information at (888) 483-9053.


 
 

Resources

  • PaxVAx Resources
    Vivotif Product Replacement Program

    PaxVax will supply replacement doses of Vivotif for patients who qualify. View details or request a replacement product here.

  • PaxVAx Resources
    Vivotif Educational Video

    Learn about Vivotif® and considerations for your patients from presenter James McCarty, MD, Clinical Professor of Pediatrics in the Division of Infectious Diseases at Stanford University School of Medicine.

  • PaxVAx Resources
    Patient Text Reminders

    Help your patients stay on course with Vivotif® by encouraging them to sign up for free text message reminders.

  • PaxVAx Resources
    Helpful Links

    See a collection of websites that provide useful information about health and safety while traveling.

  • PaxVAx Resources
    Related Materials

    Here you will find an assortment of helpful resources for patients that are available for download.

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Please see full Prescribing Information.

References