TYPHIM Vi

Typhim Vi Generic Name & Formulations

Legal Class

General Description

Typhoid vaccine cell; surface purified Vi polysaccharide 25micrograms per 0.5mL; soln; for IM inj; contains phenol.

How Supplied

Syringe (0.5mL)—1
Multidose vial (20 doses)—1

Storage

Store at 2° to 8°C (35° to 46°F); do not freeze.

Manufacturer

Sanofi Pasteur, Inc.

Mechanism of Action

An increase in serum anti-capsular antibodies is thought to be the basis of protection provided by Typhim Vi vaccine. However, a specific correlation of post-vaccination antibody levels with subsequent protection is not available, and the level of Vi antibody that will provide protection has not been determined.

Typhim Vi Indications

Indications

Immunization against typhoid fever.

Typhim Vi Dosage and Administration

Prior to Treatment Evaluations

Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States.

Selective immunization against typhoid fever is recommended under the following circumstances:

Travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water.
Persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier.
Workers in microbiology laboratories who frequently work with S typhi.

Adult

Give at least 2 weeks before expected exposure; may repeat every 2 years. Adults: 0.5mL IM once in deltoid.

Children

≥2yrs: 0.5mL in deltoid or vastus lateralis.

Administration

For intramuscular use only.

Adults: Administer in the deltoid.
Children: Administer in the deltoid or the anterolateral thigh.

Immunization with Typhim Vi vaccine should occur at least 2 weeks prior to expected exposure to S typhi.

Typhim Vi Contraindications

Contraindications

Not for use in chronic carriers or patients with active infection.

Typhim Vi Boxed Warnings

Not Applicable

Typhim Vi Warnings/Precautions

Warnings/Precautions

Have epinephrine (1:1000) inj available. Immunocompromised states: immune response may be suboptimal. Previous typhoid vaccination. Acute infection, active febrile illness: may consider delaying vaccination unless withholding entails a greater risk. Syncope possible following vaccination. Exposure to contaminated food and water should be avoided. Pregnancy. Nursing mothers.

Pregnancy Considerations

Only administer to pregnant women if clearly needed; no data available on fetal harm or reproduction capacity.

Nursing Mother Considerations

No data available on use in nursing mothers; use caution. It is not known whether Typhim Vi vaccine is excreted in human milk.

Pediatric Considerations

Safety and effectiveness have not been established in children under 2 years of age.

Typhim Vi Pharmacokinetics

See Literature

Typhim Vi Interactions

Interactions

Concomitant corticosteroids, alkylating drugs, antimetabolites, radiation: may get suboptimal immune response. Do not mix with any vaccine in the same syringe.

Typhim Vi Adverse Reactions

Adverse Reactions

Local reactions, malaise, headache, GI upset, myalgia, fever.

Typhim Vi Clinical Trials

Clinical Trials

A randomized double-blind controlled trial with Typhim Vi vaccine (liquid formulation) was conducted in 5 villages west of Kathmandu, Nepal.

3454 received Typhim Vi; 3454 in the control group received 23-valent pneumococcal polysaccharide vaccine.
Study included 6439 individuals 5 to 44 years old, 165 children 2 to 4 years old and 304 adults over 44 years old.
Overall protective efficacy of Typhim Vi vaccine was 74% (95% CI, 49-87) for blood culture confirmed cases of typhoid fever during 20 months of post-vaccination follow-up.

The protective efficacy of the Typhoid Vi Polysaccharide Vaccine, lyophilized formulation, was evaluated in a randomized double-blind controlled trial conducted in South Africa.

5692 children received Vi capsular polysaccharide vaccine; 5692 in the control group received meningococcal polysaccharide (Groups A+C) vaccine.
The protective efficacy for the Vi capsular polysaccharide (lyophilized formulation) group for blood culture confirmed cases of typhoid fever was 55% (95% CI, 30-70) overall during 3 years of post-vaccination follow-up, and was 61%, 52% and 50%, respectively, for years 1, 2, and 3.

Efficacy studies were not feasible in a US population because of the low incidence of typhoid fever. Immunogenicity and safety trials were conducted in an adult US population. A single dose of Typhim Vi vaccine induced a 4-fold or greater increase in antibody levels in 88% and 96% of this adult population for 2 studies, respectively, following vaccination.

Concurrently Administered Vaccines

Double-blind, randomized, controlled clinical trial.
945 participants aged 18 through 55 years.
Study participants received Typhim Vi and Menactra vaccines concomitantly (n=469), or Typhim Vi vaccine followed 1 month later by Menactra vaccine (n=476).
Sera were obtained approximately 28 days after each respective vaccination.
Antibody response to Typhim Vi vaccine and to Menactra vaccine components were similar between groups.

Typhim Vi Note