Vivotif®

Product Information

• Name: Vivotif®
• Type: Typhoid Vaccine Live Oral Attenuated (Ty21a)
• Form: Enteric-coated capsules for oral administration
• Manufacturer: PaxVax Berna GmbH
• Distributor: Crucell Vaccines Canada, a division of Janssen Inc.

Indications and Clinical Use

• Indication: Immunization against typhoid fever caused by Salmonella typhi.
• Use Cases:
  • Adults and children 5 years and older.
  • Travelers to endemic areas.
  • Individuals with household or intimate exposure to typhoid carriers.
  • Laboratory workers handling S. typhi cultures.
• Protection Duration: Up to 7 years.

Dosage and Administration

• Recommended Dose:
  • Adults and Children (5 years and older): Four capsules taken on alternate days (Days 1, 3, 5, 7).
  • Complete immunization at least one week prior to exposure.
• Administration:
  • Swallow capsules with cool or lukewarm water, one hour before or two hours after meals.
  • Do not chew capsules.
• Booster Doses: Recommended every 7 years for those at continuous risk.

Contraindications

• Hypersensitivity to any component of the vaccine.
• Immunocompromised individuals.
• Acute febrile or gastrointestinal illnesses.

Warnings and Precautions

• General: Postpone vaccination during acute febrile or gastrointestinal illness.
• Special Populations:
• Pregnant Women: Use only if clearly needed.
• Nursing Women: Unknown if excreted in human milk.
• Pediatrics: Not recommended for children under 5 years of age.
• Geriatrics: No data available.

Adverse Reactions

• Common: Abdominal pain, nausea, diarrhea, vomiting, fever, headache, rash.
• Rare: Allergic reactions, anaphylactic reactions, asthenia, malaise, shivering, dizziness, joint and muscle pain.
• Post-Market Surveillance: Confirmed that adverse reactions are rare, with 3.6 adverse reactions per 100,000 immunizations.

Drug Interactions

• Antibiotics and Sulfonamides: May inhibit vaccine organisms; avoid concomitant use.
• Alcohol: Avoid consumption one hour before and two hours after taking the vaccine.
• Anti-Malaria Drugs: Chloroquine, mefloquine, atovaquone/proguanil, and pyrimethamine/sulfadoxine can be taken with Vivotif®. Other anti-malaria drugs should not be started within three days of the last dose of Vivotif®.

Storage and Stability

• Store at 2°C to 8°C. Protect from light and moisture. Capsules should not be frozen and should be stored in the refrigerator between doses.

Clinical Trials and Efficacy

• Field Trials:
  • Indonesia: 42% efficacy for capsules.
  • Chile: Efficacy varied; higher protection with sachet formulation compared to capsules.
  • Egypt: 95% decrease in typhoid incidence with three-dose regimen.
• Multiple studies demonstrated protection ranging from 25% to 67% depending on the dosage schedule.
• Protection: Demonstrated in both endemic and non-endemic areas, with evidence of effective immune response in vaccinated individuals.