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Historical Review of BCG Vaccine in Japan

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Historical Review of BCG Vaccine in Japan Jpn. J. Infect. Dis., 60, 331-336, 2007 Invited Review Historical Review of BCG Vaccine in Japan Saburo Yamamoto1,2* and Toshiko Yamamoto1 1Department of Microbial and Molecular Pathogenesis, Texas A & M University Health Science Center, College of Medicine, Texas, USA, and 2Ex Laboratory of Tuberculosis Control, Department of Bacterial Pathogenesis and Infection Control, National Institute of Infectious Diseases, Tokyo 208-0011, Japan (Received June 29, 2007) CONTENTS: 1. Introduction 4. Quality control 2. BCG vaccine in Japan 5. Vaccine efficacy 2-1. Freeze-dried vaccine 6. Adverse reactions 2-2. Percutaneous administration 7. Genetic characterization of BCG strains 3. Vaccine production 8. Aspects of BCG vaccines SUMMARY: Bacillus Calmette and Guérin (BCG) was introduced to Japan in 1924 by Kiyoshi Shiga and has been propagated for research purposes ever since propagation is accomplished using a glycerin-bile-potato mixture in the same manner used by Calmette and Guérin. To prepare a stable and safe freeze-dried BCG vaccine, several joint research projects were organized in 1949. At the National Institute of Infectious Diseases (formerly the National Institute of Health), the 172nd passage of BCG from the first culture was freeze-dried in 1961 and was used as the origin of the Japanese BCG strain, Tokyo-172. The Tokyo-172 was registered as an International Reference Strain in 1965 by the World Health Organization. In 1967, a multiple puncture method for BCG vaccination using a plastic cylinder implanted with nine fine needles at one end was introduced to Japan; there- after, percutaneous administration replaced intradermal injection. The efficacy and adverse reactions of BCG vaccines as well as recent knowledge on the genetic characterization of BCG is also discussed. lion children throughout the world have been vaccinated. 1. Introduction Tuberculosis (TB) is a pandemic disease that represents a 2. BCG vaccine in Japan major public health and economic problem throughout the world. Mycobacterium tuberculosis, the causative agent of 2-1. Freeze-dried vaccine TB, is estimated to have infected nearly one-third of the The BCG strain, which was donated by Calmette himself, world’s population, with an annual incidence of approximately was brought to Japan by Kiyoshi Shiga (1890-1957), one of eight million and two million tuberculosis from deaths each the discoverers of the dysentery bacillus, in November 1924. year. The strain was been maintained and utilized for research by Robert Koch (1843 -1910) first discovered M. tuberculosis Professor Imamura at Osaka University, while Professor Sato in 1882; his discovery prompted numerous lines of research was charged with the maintenance of the strain at the Insti- to create prophylactic and therapeutic vaccines against tuber- tute of Infectious Diseases at University of Tokyo. The strain culosis. In 1908, Albert Calmette (1863-1933) and Camille was removed from University of Tokyo to the Research In- Guérin (1872-1961) at the Pasteur Institute in Lille, France, stitute for Tuberculosis (RIT) of the Japan Anti-tuberculosis started working with a virulent strain of Mycobacterium bovis Association in 1940, where Ken Yanagisawa was charged that had been isolated by Edmond Nocard (1850-1903) from with the monthly propagation of the strain using a glycerin- a cow with tuberculous mastitis. Calmette and Guérin sub- bile-potato medium. In 1947, the strain was transported from cultured the organism every 3 weeks on potato slices cooked RIT to the National Institute of Infectious Diseases (NIID) in beef bile, supplemented with glycerol. In 1921, after 230 (formerly known as the National Institute of Health [NIH]) successive passages over the course of 13 years, they found and was maintained in the same manner as that used by that the resulting culture was stable to reversion to virulence Calmette and Guérin. The BCG strain has been utilized for but retained limited invasiveness in experimental animals. the production of vaccine and for research ever since. The first human vaccination using this attenuated strain, Tuberculosis became endemic in Japan after World War named the bacillus of Calmette and Guérin (BCG), was II as a result of social confusion and the critical status of applied to a newborn whose grandmother had pulmonary national sanitation programs. Consequently, the mortality rate tuberculosis in Paris in 1921. The BCG vaccine was adopted of tuberculosis increased to more than 250 per 100,000 popula- by the Health Committee of the League of Nations in 1928, tion, peaking among individuals aged 25 to 29 years. Accord- and the mass vaccination of children was begun and was ingly, a BCG vaccination program was considered an urgent adopted by many countries, after newer and safer production priority, and a safe, stable and reliably potent vaccine--such processes were implemented. Since then, more than one bil- as a freeze-dried form--was needed. Research on a freeze- dried BCG vaccine had begun in Japan in 1943, and the mass *Corresponding author: Mailing address: 4-1-18 Nakacho, Koganei- production of dried BCG vaccine was initiated in 1947. BCG shi, Tokyo 184-0012, Japan. E-mail: [email protected] vaccination using the freeze-dried vaccine became compul- 331 sory under the Immunization Law in 1948 for all tuberculin- leaving tiny flat and sometimes depigmented slight scars. negative individuals aged 25 years or under. Subsequently, Lymph node involvement almost did not occur. A total of BCG vaccination emerged as a national policy for the control 114 newborn babies in a maternity hospital were vaccinated of tuberculosis; since 1949, the usage of all freeze-dried BCG using the multiple puncture method and were followed for vaccine has required official approval by the NIH in Tokyo. 1 year; an 89.5% tuberculin-positive rate and a reaction In 1961, the 172nd passage of BCG from the first culture diameter of 14.0 mm was obtained 1 year after vaccination was freeze-dried and selected as the origin of the Japanese in this cohort, with only one case of lymph node swelling. BCG strain, Tokyo-172. This lot has been kept at the NIID. The swollen lymph node was about the size of a soybean and Tokyo-172 was registered as an International Reference Strain was observed 3 months after vaccination; however, the swol- in 1965 by the World Health Organization (WHO). Thereafter, len lymph node was no longer palpable after 6 months. The commercial laboratories began producing and distributing the formation of keloid was not reported as a troublesome side BCG vaccine nationwide and also internationally, after in- reaction in this series, and the scars had disappeared in 40% house and national assessments. Today, only the Japan BCG of the vaccinated infants 1 year after vaccination. These Laboratory produces BCG vaccine in Japan. In 1951, BCG results suggested that newborn babies could be easily and vaccination was enforced by the Tuberculosis Prevention Law effectively vaccinated using a needle-implanted cylinder and so that all persons under the age of 30 years and employees percutaneous dried BCG vaccine made from the Japanese of all of ages were required to be vaccinated intradermally BCG strain (the multiple puncture method) without trouble- if they exhibited a negative to tuberculin reaction. In 1974, some side reactions. the Tuberculosis Prevention Law was revised so that all in- fants and children under the age of 4 years were primarily 3. Vaccine production vaccinated and all 1st grade students of elementary school or junior high school were revaccinated if they exhibited a nega- The tuberculosis mortality rate, which had been the leading tive tuberculin reaction. The Tuberculosis Prevention Law cause of death in Japan for several years, decreased steadily was further revised in 2003 so that only infants under the age after the war from over 200 per 100,000 population in 1951 of 6 months are primarily vaccinated, and no tuberculin tests to half that rate and falling as low as 1.8 per 100,000 popula- have been conducted since then. The Tuberculosis Preven- tion in 2004, to become the 25th leading cause of death in tion Law was integrated into Infectious Diseases Prevention Japan. The reduction in the mortality rate was most dramatic Law in 2007. among younger age groups. 2-2. Percutaneous administration Freeze-dried BCG vaccine is one of the most beneficial In Japan, although intradermal BCG vaccination success- achievements of medical science in Japan. The purpose of fully achieved high tuberculin conversion rates, complaints BCG vaccination is to provide resistance to tuberculous of side reactions--mainly local lesions like ulcers, abscesses infection in the form of cellular immunity; this has been shown and ugly scars--mounted up to such an extent that an improved to be induced most effectively using living BCG, but not dead vaccination method was urgently requested. After more than bacilli, in humans. Therefore, each dose of BCG vaccine 10 years of cooperative studies examining percutaneous BCG should contain as many viable organisms and as few dead vaccination, a multiple puncture method using a plastic cyl- bacilli as possible to ensure a high potency. To perform the inder implanted with nine fine needles at one end was finally necessary basic and applied studies on freeze-dried BCG chosen in 1967. Thereafter, the multiple puncture vaccina- vaccine and its administration, several joint research projects tion method completely replaced intradermal injections in have been successively organized since 1949 to concentrate Japan. Local lesions noticeably decreased, both in intensity on the production, control and vaccination method for the and duration, compared with those produced by intradermal dried vaccine. vaccination. These research teams performed a joint study on the corre- To produce the vaccine, an ampoule containing 80 mg, 40 lation between viable numbers of dried BCG vaccine prepara- mg or 12 mg of dried BCG is reconstituted with 1.0 mL, 0.5 tions and the tuberculin conversion rate following intradermal mL or 0.15 mL of physiological saline, respectively.
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