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目的观察国产A+C脑膜炎多糖疫苗(A+C疫苗)的接种反应和免疫原性。方法以A+C疫苗为观察苗、伤寒Vi多糖疫苗(Vi疫苗)为对照苗,采样用整群随机对照的临床试验方法,确定观察人群和对照人群。在已接种的两组人群中,采取整群分层抽样的方法抽取接种反应观察对象,并进行连续3天随访以观察接种反应。采集部分A+C疫苗接种对象免前、免后血标本,检测血清抗体IgG4倍增长情况。结果共随访接种反应观察对象1239人,其中接种流脑A+C疫苗的771人、接种伤寒Vi疫苗的468人。A+C疫苗接种后第1天局部反应发生率为15.06%,第2天的为0.13%,第3天的为0;接种后第1天全身反应的发生率为1.16%,第2天为0.39%和第3天为0.13%。除接种后第1天A+C疫苗的局部反应发生率要明显高于Vi疫苗的外,接种后2天、3天的局部反应和第1、2、3天全身反应的发生率,A+C疫苗和Vi疫苗无显著性差异。共采集A+C疫苗接种对象免前、免后血标本各100份,抗C群脑膜炎球菌抗体4倍增长率达到94%,抗A群脑膜炎球菌抗体仅达到62%。结论A+C疫苗和伤寒Vi多糖疫苗一样,接种反应轻微,安全性好;抗C群脑膜炎球菌抗体免疫应答良好。接种前人群血清抗A群脑膜炎球菌抗体平均浓度比抗C群的高2.6倍,抗A群脑膜炎球菌抗体4倍增长率低可能与本底抗A群脑膜炎球菌抗体水平高有关。
Objective To observe the vaccination and immunogenicity of domestic A + C meningitis polysaccharide vaccine (A + C vaccine). Methods The A + C vaccine and the Vi vaccine were used as control vaccine, and randomized clinical trials were conducted to determine the observed population and the control population. Inoculated two groups of people, stratified sampling cluster sampling method to extract the vaccination observation object, and for 3 consecutive days to observe the inoculation reaction. Collect part of A + C vaccination subjects before and after the free blood samples to detect serum IgG4 times the growth. Results A total of 1239 participants were observed in the vaccination reaction, of which 771 were vaccinated with meningococcal A + C vaccine and 468 were vaccinated with typhoid Vi vaccine. The incidence of local reactions was 15.06% on day 1 after vaccination with A + C, 0.13% on day 2 and 0 on day 3. The incidence of systemic reactions on day 1 after inoculation was 1.16%, on day 2 0.39% on the 3rd day and 0.13% on the 3rd day. The incidence of local response to A + C vaccine was significantly higher than that of the Vi vaccine on day 1 after inoculation. The local reactions at 2 and 3 days after inoculation and the incidence of systemic reactions at days 1, 2 and 3, A + There was no significant difference between C vaccine and Vi vaccine. A total of 100 samples of A + C vaccines were collected before and after immunization. The four-fold increase rate of anti-C meningococcal antibody was 94%, anti-meningococcal group A antibodies only reached 62%. Conclusions A + C vaccination is the same as typhoid Vi polysaccharide vaccine with mild inoculation and good safety. Anti-C meningococcal antibody has a good immune response. The average serum concentration of anti-group A meningococcal antibody in pre-vaccination populations was 2.6-fold higher than that of anti-C group and the low 4-fold increase in anti-group A meningococcal antibody was probably related to the high level of anti-group A meningococcal antibody.