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A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine.
Vaccine. 2015 Nov 27; 33(48):6697-702.V

Abstract

BACKGROUND

Although typhoid fever is rare in Japan, imported cases have been reported occasionally in travelers returning from endemic areas. To achieve licensing of a typhoid Vi polysaccharide vaccine (Typhim Vi(®)) and make it widely available in Japan, this study was conducted at the request of the Japanese Ministry of Health Labor and Welfare to assess the immunogenicity and safety of this vaccine when given as a single dose (the recommended schedule of administration) in a Japanese population.

METHODS

In this multi-center, open-label, non-comparative, intervention study performed in Japan, 200 healthy volunteers (188 adults [≥ 18 years of age], 7 adolescents [12-17 years of age] and 5 children [2-11 years of age]) were administered Typhim Vi(®). Immunogenicity was assessed 28 days after vaccinations using an ELISA method of anti-Vi antibody detection. A 4-fold increase in anti-Vi titer was considered as the threshold for seroconversion for anti-Vi antibodies. Safety was assessed up to 28 days following vaccination.

RESULTS

Overall, 92.0% (95% confidence interval [CI]: 87.3-95.4%) of participants achieved seroconversion 28 days after a single dose of typhoid Vi polysaccharide vaccine. GMTs of Vi antibody titers increased from 6.6 (95% CI: 5.8-7.4) prior to vaccination to 157.3 (95% CI: 135.1-183.2) on Day 28 after vaccination. The geometric mean of individual anti-Vi antibody titer ratios (Day 28/Day 0) was 23.9 (95% CI: 20.3-28.3). There were no immediate adverse events and no adverse events led to the discontinuation of participants from the study. Across all age groups, pain and myalgia were the most frequently reported injection site and systemic reactions, respectively. Most of these reactions were mild in intensity and resolved within 7 days.

CONCLUSIONS

A single dose of typhoid Vi polysaccharide vaccine, Typhim Vi(®), demonstrated good safety and immunogenicity profile in a Japanese population.

Authors+Show Affiliations

Meitetsu Hospital, Sako, Nishi-ku, Nagoya-Shi, Aichi, Japan. Electronic address: mmiyazu@meitetsu-hpt.jp.Meitetsu Hospital, Sako, Nishi-ku, Nagoya-Shi, Aichi, Japan. Electronic address: hkikuchi@meitetsu-hpt.jp.Tokyo Medical University Hospital, Nishi-Shinjuku, Shinjuku-Ku, Tokyo, Japan. Electronic address: a-hamada@tokyo-med.ac.jp.Tokyo Medical University Hospital, Nishi-Shinjuku, Shinjuku-Ku, Tokyo, Japan. Electronic address: fuku789@tokyo-med.ac.jp.Kawasaki Medical School, Matsushima 577, Kurashiki-Shi, Okayama, Japan. Electronic address: kouchi@med.kawasaki-m.ac.jp.Sanofi Pasteur, Marcy l'Etoile, France. Electronic address: valerie.boschcastells@sanofipasteur.com.Sanofi K.K., Tokyo, Japan. Electronic address: hanako.mihara@sanofi.com.Sanofi Pasteur, Marcy l'Etoile, France. Electronic address: marieclaudebonnet38@gmail.com.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

26518404

Citation

Miyazu, Mitsunobu, et al. "A Japanese Study to Assess Immunogenicity and Safety of a Typhoid Vi Polysaccharide Vaccine." Vaccine, vol. 33, no. 48, 2015, pp. 6697-702.
Miyazu M, Kikuchi H, Hamada A, et al. A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine. Vaccine. 2015;33(48):6697-702.
Miyazu, M., Kikuchi, H., Hamada, A., Fukushima, S., Ouchi, K., Bosch Castells, V., Mihara, H., & Bonnet, M. C. (2015). A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine. Vaccine, 33(48), 6697-702. https://doi.org/10.1016/j.vaccine.2015.10.086
Miyazu M, et al. A Japanese Study to Assess Immunogenicity and Safety of a Typhoid Vi Polysaccharide Vaccine. Vaccine. 2015 Nov 27;33(48):6697-702. PubMed PMID: 26518404.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine. AU - Miyazu,Mitsunobu, AU - Kikuchi,Hitoshi, AU - Hamada,Atsuo, AU - Fukushima,Shinji, AU - Ouchi,Kazunobu, AU - Bosch Castells,Valerie, AU - Mihara,Hanako, AU - Bonnet,Marie-Claude, Y1 - 2015/10/28/ PY - 2015/06/25/received PY - 2015/09/28/revised PY - 2015/10/17/accepted PY - 2015/11/1/entrez PY - 2015/11/1/pubmed PY - 2016/10/7/medline KW - Immunogenicity KW - Japan KW - Safety KW - Typhoid KW - Vaccine SP - 6697 EP - 702 JF - Vaccine JO - Vaccine VL - 33 IS - 48 N2 - BACKGROUND: Although typhoid fever is rare in Japan, imported cases have been reported occasionally in travelers returning from endemic areas. To achieve licensing of a typhoid Vi polysaccharide vaccine (Typhim Vi(®)) and make it widely available in Japan, this study was conducted at the request of the Japanese Ministry of Health Labor and Welfare to assess the immunogenicity and safety of this vaccine when given as a single dose (the recommended schedule of administration) in a Japanese population. METHODS: In this multi-center, open-label, non-comparative, intervention study performed in Japan, 200 healthy volunteers (188 adults [≥ 18 years of age], 7 adolescents [12-17 years of age] and 5 children [2-11 years of age]) were administered Typhim Vi(®). Immunogenicity was assessed 28 days after vaccinations using an ELISA method of anti-Vi antibody detection. A 4-fold increase in anti-Vi titer was considered as the threshold for seroconversion for anti-Vi antibodies. Safety was assessed up to 28 days following vaccination. RESULTS: Overall, 92.0% (95% confidence interval [CI]: 87.3-95.4%) of participants achieved seroconversion 28 days after a single dose of typhoid Vi polysaccharide vaccine. GMTs of Vi antibody titers increased from 6.6 (95% CI: 5.8-7.4) prior to vaccination to 157.3 (95% CI: 135.1-183.2) on Day 28 after vaccination. The geometric mean of individual anti-Vi antibody titer ratios (Day 28/Day 0) was 23.9 (95% CI: 20.3-28.3). There were no immediate adverse events and no adverse events led to the discontinuation of participants from the study. Across all age groups, pain and myalgia were the most frequently reported injection site and systemic reactions, respectively. Most of these reactions were mild in intensity and resolved within 7 days. CONCLUSIONS: A single dose of typhoid Vi polysaccharide vaccine, Typhim Vi(®), demonstrated good safety and immunogenicity profile in a Japanese population. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/26518404/A_Japanese_study_to_assess_immunogenicity_and_safety_of_a_typhoid_Vi_polysaccharide_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)01529-7 DB - PRIME DP - Unbound Medicine ER -