Díaz Ortega José Luis, Castaneda Deyanira, Arellano Quintanilla Doris Ma, Martínez David, Trumbo Silas P, Fernández de Castro Jorge
Instituto Nacional de Salud Pública, Mexico.
Instituto Nacional de Salud Pública, Mexico.
Vaccine. 2017 May 25;35(23):3116-3122. doi: 10.1016/j.vaccine.2017.04.027. Epub 2017 Apr 28.
In a previous study on booster vaccination, we reported that two aerosolized MMR vaccines were as safe and immunogenic as injectable vaccines containing the same antigens. We now present results of antibody persistence one year after immunization.
To assess the antibody persistence for measles, mumps, and rubella one year following booster immunization.
We performed clinical and serological follow-up of participants in a previous study of Mexican children aged 6-7years, in which participants were randomized to four groups receiving, by aerosolized or by injection, the MMR SII vaccine (Serum Institute of India), or the MMR II (Merck Sharp & Dhome). We evaluated the antibody persistence by PRN test for measles and by ELISA for rubella and mumps. The occurrence of clinical events was evaluated via periodic visits of a nurse team to children's schools and homes.
Of the 260 initial participants, 241 completed one-year follow-up. There were only statistically significant differences in baseline seropositivity for mumps. One year after immunization, seropositivity in all groups was 100% for measles and rubella. The seropositivity rank for mumps was from 90.3% for the injected vaccine MMR II to 96.6% for vaccine MMR SII applied by aerosol; these differences were not statistically significant. With exception of the aerosolized vaccine MMR SII for the geometric mean titer (GMT) for measles, all study groups presented declination of GMT for the three viruses. The difference between the aerosolized vaccines MMR SII and MMR RII was statistically significant for mumps antibodies. Only mild clinical events were identified.
Under conditions of no endemic transmission for measles and rubella, and of low circulation of mumps virus, school-aged children remained seropositive to the three viruses one year following booster immunization. The study was registered under CMN 2010-005 number at COFEPRIS (National Regulatory Authority).
在之前一项关于加强免疫接种的研究中,我们报告称,两种雾化麻疹、腮腺炎和风疹(MMR)疫苗与含有相同抗原的注射用疫苗一样安全且具有免疫原性。我们现在展示免疫一年后的抗体持久性结果。
评估加强免疫一年后麻疹、腮腺炎和风疹的抗体持久性。
我们对之前一项针对6 - 7岁墨西哥儿童的研究中的参与者进行了临床和血清学随访,在该研究中,参与者被随机分为四组,通过雾化或注射方式接种MMR SII疫苗(印度血清研究所)或MMR II(默克雪兰诺)。我们通过针对麻疹的PRN试验以及针对风疹和腮腺炎的ELISA来评估抗体持久性。临床事件的发生通过护士团队定期走访儿童学校和家庭来评估。
260名初始参与者中,241人完成了一年的随访。仅腮腺炎的基线血清阳性率存在统计学显著差异。免疫一年后,所有组中麻疹和风疹的血清阳性率均为100%。腮腺炎的血清阳性率从注射用疫苗MMR II的90.3%到雾化接种的疫苗MMR SII的96.6%;这些差异无统计学意义。除了雾化疫苗MMR SII的麻疹几何平均滴度(GMT)外,所有研究组的三种病毒的GMT均下降。雾化疫苗MMR SII和MMR RII之间的腮腺炎抗体差异具有统计学意义。仅发现了轻微的临床事件。
在麻疹和风疹无地方性传播以及腮腺炎病毒低传播的情况下,学龄儿童在加强免疫一年后对这三种病毒仍保持血清阳性。该研究在墨西哥联邦预防卫生风险委员会(国家监管机构)以CMN 2010 - 005编号注册。