Study on efficacy and improvement of diphtheria and tetanus toxoids and pertussis (DPT) vaccine

白喉、破伤风类毒素和百日咳（DPT）疫苗的功效和改进研究

• 批准号: 11670765
• 负责人: KUSUHARA Koichi
• 金额: $ 0.9万
• 依托单位: Kyushu University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 1999
• 资助国家: 日本
• 起止时间: 1999 至 2001
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-11670765/
• 关键词: DPT vaccine; adult; safety; efficacy; adverse reactions; immunization; pertussis; epidemiology

Purified component (acellular) Bordetella pertussis (aP) vaccines were first developed in Japan. Their emergency introduction to the nation 20 years ago made prospective double blind efficacy trial difficult. In order to obtain reliable domestic data on their efficacy, we conducted a case control study using WHO's case definition of pertussis in the City of Kitakyushu where the two-component Kaketsuken aP vaccine combined with diphtheria and tetanus toxoids (DTaP) has been exclusively used since 1991.Among 116 cases registered during the investigation period, 16 fulfilled the definition. Based on the data of the confirmed cases and their age-matched controls, the efficacy of Kaketsuken aP vaccine was estimated to be 87.4 % and comparative to the data of Japanese aP vaccines obtained in European countries. The risk of pertussis in children who had received less than two doses of DTaP vaccine was 7.39 times higher than that of children who had two or more doses.DTaP vaccine was injected to a total of 186 adolescents and adults to evaluate its safety for these age groups, Forty-four persons were 10-19 years of age (Group A) and 142 persons were 20 years of age or older (Group B). Each one case in both groups showed swelling of more than 5 cm in diameter around the injection site. One case in Group A and 3 cases in group B had swelling of 1-5 cm in diameter. Systemic adverse reactions were not observed.

纯化组分（无细胞）百日咳博德特氏菌（aP）疫苗首先在日本开发。他们在20年前被紧急引入全国，这使得前瞻性双盲疗效试验变得困难。为了获得关于其有效性的可靠国内数据，我们在自1991年以来专门使用白喉和破伤风类毒素（DTaP）联合的双组分Kaketsuken aP疫苗的北九州市，使用WHO百日咳病例定义进行了病例对照研究。在调查期间登记的116例病例中，16例符合定义。根据确诊病例及其年龄匹配对照的数据，Kaketsuken aP疫苗的有效性估计为87.4%，与欧洲国家获得的日本aP疫苗的数据相当。接种过两剂次以下百白破疫苗的儿童患百日咳的风险是接种过两剂次及以上百白破疫苗的儿童的7.39倍。为评价百白破疫苗对这些年龄组的安全性，共对186名青少年和成人进行了注射，其中10-19岁（A组）44人，20岁及以上（B组）142人。两组各有一例注射部位周围肿胀直径超过5 cm。A组和B组分别有1例和3例出现直径1-5 cm的肿胀。未观察到全身不良反应。

项目成果

Sasaki Y, Nomura A, Kusuhara K et al.: "Genetic basis of patients with bacille Calmette-Guerin osteomyelitis in Japan: identification of dominant partial interferon-gamma receptor 1 deficiency as a redominant type"J Infect Dis. 185(5). 706-709 (2002)

Sasaki Y、Nomura A、Kusuhara K 等人：“日本卡介苗骨髓炎患者的遗传基础：将显性部分干扰素 γ 受体 1 缺陷鉴定为显性类型”J Infect Dis。

Sasaki Y, Nomura A, Kusuhara K et al.: "Genetic basis of patients with bacille Calmette-Guerin osteomyelitis in Japan : identification of dominant partial interferon-gamma receptor 1 deficiency as a predominant type"J Infect Dis. 185(5). 706-709 (2002)

Sasaki Y、Nomura A、Kusuhara K 等人：“日本卡介苗骨髓炎患者的遗传基础：将显性部分干扰素-γ 受体 1 缺陷鉴定为主要类型”J Infect Dis。

Nakao F, Ihara K, Ahmed S, Sasaki Y, Kusuhara K et al.: "Lack of association between CD28/CTLA-4 gene polymorphisms and atopic asthma in the Japanese population"Exp Clin Immunogenet. 17(4). 179-84 (2000)

Nakao F、Ihara K、Ahmed S、Sasaki Y、Kusuhara K 等人：“日本人群中 CD28/CTLA-4 基因多态性与特应性哮喘之间缺乏关联”Exp Clin Nutrition。

Kusuhara K, Sakaki Y, Nakao F et al.: "Analysis of measles virus binding sites of the CD46 gene in patients with subacute sclerosing panencephalitis"J Infect Dis. 181(4). 1447-9 (2000)

Kusuhara K、Sakaki Y、Nakao F 等：“亚急性硬化性全脑炎患者 CD46 基因的麻疹病毒结合位点分析”J Infect Dis。