Typhim Vi® Vaccine Clinical Trials, Dosage, Indication, News
Typhim VI® (Typhoid Vi Polysaccharide Vaccine) is a sterile solution prepared from the purified polysaccharide capsule of Salmonella typhi (Ty 2 strain). The purified polysaccharide capsule is diluted in an isotonic buffer solution that contains phenol as a preservative, sodium chloride, disodium phosphate dihydrate, monosodium phosphate dihydrate, and water for injection. Typhim VI protects against the risk of infection related to Salmonella typh i. Still, it does not confer vis-à-vis protection of Salmonella Paratyphi A or B or non-typhoid salmonella.
First licensed in 1988 in France, the Typhim Vi® vaccine, manufactured at Sanofi Pasteur's facility in Marcy L'Etoile, France, has established a longstanding safety and seroprotection track record. The U.S. Food and Drug Administration (FDA) updated information (STN#: 103936) was posted in March 2020, Package Insert (TYPHOID VI POLYSACCHARIDE VACCINE TYPHIM VI®).
On February 1, 2024, BMC published a study—A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity—that concluded the Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years old.
Sanofi Pasteur is the vaccine division of the French multinational pharmaceutical company Sanofi.
Typhim VI Vaccine Indication
People who are actively ill with typhoid fever and people who are carriers of the bacteria that cause typhoid fever can both spread the bacteria to other people. When someone eats or drinks contaminated food or drink, the bacteria can multiply and spread into the bloodstream, causing typhoid fever. Typhim VI is indicated for use to protect against Typhoid Fever in adults and children over two years of age. Travelers going to endemic areas, migrants, health personnel, and soldiers should consider being vaccinated. A single injection provides protection; however, if the risk of exposure is maintained and depending on the exposure level, revaccination should be performed every 2 to 3 years. Immunity appears between 1 to 3 weeks after the injection. The term of protection is approximately three years.
Typhim VI Dosage and Side Effects
Typhim VI is administered as an intramuscular injection. The vaccine is overall 74% in adults and 55% in children. The safety profile has been reassessed based on clinical studies (15,000 people) and population surveillance. The most common side effects reported in children and adolescents (aged 2 to 17 years) are injection site reactions (pain: 53%; swelling or induration: 16%; redness: 14%), muscle pain (15%), and headaches (13%). In adults, pain at the injection site (76%), muscle pain (47%), and fatigue (25%).
Typhim VI News 2011 - 2022
June 21, 2022—The Lancet published a study that found Independent acquisition of plasmids and homoplastic mutations conferring antimicrobial resistance have occurred repeatedly in multiple lineages of S Typhi, predominantly arising in South Asia before spreading to other regions.
May 12, 2021 - The U.S. CDC confirmed the outbreak of extensively drug-resistant typhoid fever in Pakistan is ongoing
February 12, 2021 - U.S. CDC reports extensive drug-resistant salmonella typhi infections among U.S. residents without international travel.
September 30, 2020 - Travel Alert: Extensive drug-resistant typhoid fever in Pakistan. The CDC recommends that all travelers (even short-term travelers) to South Asia, including Pakistan, be vaccinated against typhoid fever before travel.
June 23, 2011 - the WHO granted Sanofi Pasteur's Typhim Vi® prequalification. WHO prequalification is a crucial step that allows for the procurement of vaccines by UNICEF and other United Nations (UN) agencies like the Pan American Health Organization (PAHO) Revolving Fund. It is also a prerequisite for GAVI Alliance New and Underused Vaccines Support for vaccine distribution. It ensures and improves developing countries' access to vaccines that meet unified quality, safety, and efficacy standards.
Typhim VI Clinical Trials
NCT02645032: Phase 1 Trial of the Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Last Update Posted on April 28, 2020.
NCT03460405: Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants.