6至7岁儿童的加强免疫反应，随机分为四组，通过气雾剂或注射方式接种两种麻疹、腮腺炎和风疹（MMR）疫苗。
Booster immune response in children 6-7 years of age, randomly assigned to four groups with two MMR vaccines applied by aerosol or by injection.
作者信息
Díaz-Ortega José-Luis, Bennett John V, Castañeda-Desales Deyanira, Quintanilla Doris-Ma Arellano, Martínez David, de Castro Jorge Fernández
机构信息
Instituto Nacional de Salud Pública, Cuernavaca, México.
Retired from Centers for Disease Control and Prevention, Atlanta, GA, USA.
出版信息
Vaccine. 2014 Jun 17;32(29):3680-6. doi: 10.1016/j.vaccine.2014.04.031. Epub 2014 May 14.
IMPORTANCE
Aerosol immunization may be a useful tool to reach and sustain the elimination of measles, rubella, and congenital rubella syndrome. We compared booster seroresponses to aerosolized or injected MMR vaccines containing different strains of measles (Attenuvax or Edmonston-Zagreb) and mumps (Jeryl-Lynn or Leningrad-Zagreb).
OBJECTIVE
To assess the safety and immunogenicity of two MMR: Vaccines administered by aerosol.
METHODS
A randomized and controlled clinical trial was conducted to evaluate the safety and booster responses to the MMR SII (Serum Institute of India) and MMR II (Merck Sharp & Dhome) vaccines, both of which were administered by aerosol (ae) or injection (inj) to Mexican children aged 6-7 years in elementary schools. The seroresponses were evaluated by PRN (measles) and ELISA (rubella and mumps). Adverse events were followed-up for 28 days after the immunization.
RESULTS
Two hundred and fifty-three of 260 children completed the one-month follow-up. All participants reached protective seropositivity for measles and rubella after immunization, and 98.3 to 100% reached protective seropositivity for mumps (p=0.552). The proportions of the seroresponses (a 2-fold rise from the baseline antibody titers) to measles were 38.3% for MMR SII (ae), 31.3% for MMR II (ae), 37.5% for MMR SII (inj), and 44.6% for MMR II (inj) (p=0.483). The seroresponses for rubella were 26.7% for MMR SII (ae), 31.3% for MMR II (ae), 46.9% for MMR SII (inj), and 40.0% for MMR II (inj) (p=0.086). The seroresponse to mumps were 31.7% for MMR SII (ae), 25.0% for MMR II (ae), 48.4% for MMR SII (inj), and 53.9% for MMR II (inj) (p=0.002). The difference in the seroresponse of a 4-fold rise from the baseline antibody titers was not statistically significant. Only mild adverse events were noted.
CONCLUSION
Aerosolized vaccines were as safe and as immunogenic as injected vaccines.
PROTOCOL REGISTRATION
CMN 2010-005 (National Regulatory Authority).
重要性
气溶胶免疫接种可能是实现并维持消除麻疹、风疹和先天性风疹综合征的有用工具。我们比较了含有不同麻疹毒株（Attenuvax或埃德蒙斯顿-萨格勒布株）和腮腺炎毒株（杰里尔-林恩株或列宁格勒-萨格勒布株）的气溶胶化或注射用MMR疫苗的加强免疫血清反应。
目的
评估两种通过气溶胶接种的MMR疫苗的安全性和免疫原性。
方法
开展了一项随机对照临床试验，以评估墨西哥6至7岁小学儿童对印度血清研究所生产的MMR疫苗（MMR SII）和默克公司生产的MMR疫苗（MMR II）的安全性和加强免疫反应，两种疫苗均通过气溶胶（ae）或注射（inj）方式接种。通过PRN法（麻疹）和ELISA法（风疹和腮腺炎）评估血清反应。免疫接种后对不良事件进行28天的随访。
结果
260名儿童中有253名完成了为期1个月的随访。所有参与者免疫接种后麻疹和风疹均达到保护性血清阳性，腮腺炎达到保护性血清阳性的比例为98.3%至100%（p = 0.552）。MMR SII（ae）对麻疹的血清反应比例（抗体滴度较基线升高两倍）为38.3%，MMR II（ae）为31.3%，MMR SII（inj）为37.5%，MMR II（inj）为44.6%（p = 0.483）。MMR SII（ae）对风疹的血清反应为26.7%，MMR II（ae）为31.3%，MMR SII（inj）为46.9%，MMR II（inj）为40.0%（p = 0.086）。MMR SII（ae）对腮腺炎的血清反应为31.7%，MMR II（ae）为25.0%，MMR SII（inj）为48.4%，MMR II（inj）为53.9%（p = 0.002）。抗体滴度较基线升高四倍的血清反应差异无统计学意义。仅观察到轻度不良事件。
结论
气溶胶化疫苗与注射用疫苗一样安全且具有免疫原性。
方案注册
CMN 2010 - 005（国家监管机构）
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