肺炎球菌多糖体23価ワクチン (ニューモバックス) の安全性と抗原性に関する臨床報告

福見 秀雄; 木村 三生夫; 加藤 俊一; 村中 清一郎; 林 秀樹; 川名 林治; 島田 馨; 稲松 孝思; 浦山 京子; 大友 英一; 柏木 征三郎; 松本 慶蔵; 野口 行雄; 田口 幹雄; 東郷 靖

doi:10.11150/kansenshogakuzasshi1970.58.495

Clinical Report on Safety and Antigenicity of 23-valent Pneumococcal Polysaccharide Vaccine

Hideo FUKUMI, Mikio KIMURA, Shunichi KATO, Seiichiro MURANAKA, Hideki HAYASHI, Rinji KAWANA, Kaoru SIMADA, Takashi INAMATSU, Kyoko URAYAMA, Eiichi OTOMO, Seizaburo KASHIWAGI, Keizo MATSUMOTO, Yukio NOGUCHI, Mikio TAGUCHI, Yasushi TOGO

Author information

Hideo FUKUMI
Nagasaki University
Mikio KIMURA
Department of Pediatrics, Tokai University, School of Medicine
Shunichi KATO
Department of Pediatrics, Tokai University, School of Medicine
Seiichiro MURANAKA
Department of Pediatrics, Tokai University, School of Medicine
Hideki HAYASHI
Department of Pediatrics, Tokai University, School of Medicine
Rinji KAWANA
Department of Bacteriology, Iwate Medical University, School of Medicine
Kaoru SIMADA
Department of Internal Medicine, Tokyo Metropolitan Geriatric Hospital
Takashi INAMATSU
Department of Internal Medicine, Tokyo Metropolitan Geriatric Hospital
Kyoko URAYAMA
Department of Internal Medicine, Tokyo Metropolitan Geriatric Hospital
Eiichi OTOMO
Department of Internal Medicine, The Yokufukai Geriatric Hospital
Seizaburo KASHIWAGI
The First Department of Internal Medicine, Kyushu University, School of Medicine
Keizo MATSUMOTO
Department of Internal Medicine, Nagasaki University, Institute for Tropical Medicine
Yukio NOGUCHI
Department of Internal Medicine, Nagasaki University, Institute for Tropical Medicine
Mikio TAGUCHI
Department of Internal Medicine, Nagasaki University, Institute for Tropical Medicine
Yasushi TOGO
Department of Research and Development, Nippon Merck Banyu Co. Ltd.

Keywords: 23-valent pneumococcal polysaccharide vaccine, 22-valent, 14-valent, Safety & Antigenicity study, Titer

JOURNAL FREE ACCESS

1984 Volume 58 Issue 6 Pages 495-511

DOI https://doi.org/10.11150/kansenshogakuzasshi1970.58.495

Details

Abstract

Safety and antigenicity studies were conducted in 173 and 163 subjects with the 22-valent and 23-valent pneumococcal polysaccharide vaccines, respectively. Systemic and local reactions after vaccination were monitored and antibody titers (23-valent vaccine) were determined.
The local reactions after the 22-valent and 23-valent vaccines were: pain was reported most frequently, that is in 60.7% of the 22-valent group and in 40.7% of the 23-valent group; this was followed by erythema, swelling, induration and local heat in 17.9 to 23.7%, and 4.3 to 12.3% of the 22-valent and 23-valent groups, respectively.
Fever over 37.5° C was noted in 4.1% and 1.9% with the 22-valent and 23-valent vaccines, respectively.
The incidence of systemic reactions, such as chills, headache, fatigue, malaise and myalgia/arthralgia, was reported in 1.7 to 18.5% and in 4.9 to 14.7% with the 22-valent and 23-valent vaccines, respectively.
The severity of both systemic and local reactions was usually mild and the symptoms disappeared in a few days.
Antibody titers were determined by a radioimmunoassay method in 30 subjects selected at random among the 23-valent vaccinees. The geometric mean antibody titers after vaccination were 2.3 to 6.8 fold greater than before vaccination. A 2-fold or greater increase in titer was found in 73 to 100% of the 30 subjects for each of the 23 types. These antibody responses were considered to be quite good.

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