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国产麻疹-腮腺炎-风疹联合疫苗的免疫原性和反应原性

Immunogenicity and reactogenicity of indigenously produced MMR vaccine.

作者信息

Bhargava I, Chhaparwal B C, Phadke M A, Irani S F, Chhaparwal D, Dhorje S, Maheshwari C P

机构信息

Serum Institute of India Research Foundation Pune.

出版信息

Indian Pediatr. 1995 Sep;32(9):983-8.

PMID:8935261
Abstract

OBJECTIVES

To study immunogenicity and reactogenicity of indigenously produced MMR vaccine and to assess the booster effect of MMR immunization on measles seroconversion.

DESIGN

A longitudinal follow up.

SETTING

Hospital based and home follow up, as required.

SUBJECTS

89 children already immunized for measles, between 15 to 24 months of age for immunogenic evaluation and 866 subjects for the reactogenic component.

METHODS

Prevaccination and postvaccination samples collected one and four weeks after vaccination were studied by ELISA for IgG and IgM antibodies against the three diseases. A clinical follow up of immunized children was done at 3 days, 7 days, 6 weeks and 6 months after immunization.

RESULTS

IgG positivity 4 weeks after immunization rose from 75% to 100% for measles, from 12% to 92% for mumps, and from 13% to 99% for rubella. Only mild side effects including pain and swelling in 37 (4.3%) cases, mild fever in 51 (5.9%) cases, cough in 40 (4.6%) cases and a transient rash in 7 (0.8%) cases were observed.

CONCLUSIONS

The indigenously manufactured MMR vaccine has an excellent immunogenicity and low reactogenicity with a booster effect for measles seroconversion in children already immunized for this disease.

摘要

目的

研究国产麻疹-腮腺炎-风疹(MMR)疫苗的免疫原性和反应原性,并评估MMR免疫对麻疹血清转化的加强作用。

设计

纵向随访。

地点

根据需要在医院及家庭进行随访。

研究对象

89名已接种麻疹疫苗的儿童,年龄在15至24个月之间,用于免疫原性评估;866名受试者用于反应原性研究。

方法

通过酶联免疫吸附测定(ELISA)法检测接种疫苗前及接种疫苗后1周和4周采集的样本中针对三种疾病的IgG和IgM抗体。对免疫儿童在免疫后3天、7天、6周和6个月进行临床随访。

结果

免疫后4周,麻疹IgG阳性率从75%升至100%,腮腺炎从12%升至92%,风疹从13%升至99%。仅观察到37例(4.3%)出现包括疼痛和肿胀在内的轻微副作用,51例(5.9%)出现轻度发热,40例(4.6%)出现咳嗽,7例(0.8%)出现一过性皮疹。

结论

国产MMR疫苗具有良好的免疫原性和低反应原性,对已接种该疾病疫苗的儿童的麻疹血清转化有加强作用。

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