两剂次四价麻疹-腮腺炎-风疹-水痘疫苗在健康儿童中的免疫原性和安全性
Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children.
作者信息
Knuf Markus, Habermehl Pirmin, Zepp Fred, Mannhardt Wilma, Kuttnig Martin, Muttonen Pekka, Prieler Albrecht, Maurer Hartwig, Bisanz Helmtrud, Tornieporth Nadia, Descamps Dominique, Willems Paul
机构信息
Childrens Hospital, Johannes Gutenberg-University Hospital, Mainz, Germany.
出版信息
Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58.
BACKGROUND
Combination vaccines against common childhood diseases are widely used, provide an improved coverage, are more convenient and are more cost-effective than multiple injections. We conducted a study to evaluate the safety and immunogenicity of a combined measles-mumps-rubella-varicella (MMRV) candidate vaccine in comparison with the separate administration of licensed measles-mumps-rubella (MMR; Priorix) and varicella (V; Varilrix) vaccines.
METHODS
Healthy children 12-18 months of age received 2 doses of MMRV vaccine (3 lots) 6-8 weeks apart (MMRV group) or 1 dose of MMR vaccine administered concomitantly with 1 dose of varicella vaccine, followed by a second dose of MMR at 6-8 weeks later (MMR+V group). Local symptoms (redness, pain and swelling) were recorded for 4 days after vaccination, and fever (any, axillary temperature > or =37.5 degrees C or rectal temperature > or =38.0 degrees C; grade 3, axillary temperature >39.0 degrees C or rectal temperature >39.5 degrees C) was monitored daily for 15 days. Other adverse events were monitored for 6 weeks.
RESULTS
A total of 494 children were vaccinated (371 in the MMRV group and 123 in the MMR+V group. Two doses of MMRV vaccine were at least as immunogenic as 2 doses of MMR and 1 dose of varicella vaccine. After the second dose, all children had seroconverted to measles, rubella and varicella in both vaccine groups, and 98% versus 99% had seroconverted to mumps in the MMRV versus the MMR+V group, respectively. The MMRV vaccine did not induce an increased local or general reactogenicity compared with the separate administration, although a higher incidence of low grade fever was seen after the first dose in the MMRV group (67.7% after MMRV versus 48.8% after MMR+V; P < 0.05), this was not observed for grade 3 fever (11.6% after MMRV versus 10.6% after MMR+V; P = 0.87). After the second dose, no differences in incidence of fever were found in either MMRV or MMR+V groups.
CONCLUSION
Administration of 2 doses of the combined MMRV vaccine was as immunogenic and well-tolerated as separate injections of MMR and varicella vaccine.
背景
针对常见儿童疾病的联合疫苗被广泛使用，与多次注射相比，其接种覆盖率更高、更方便且更具成本效益。我们开展了一项研究，以评估麻疹 - 腮腺炎 - 风疹 - 水痘（MMRV）候选联合疫苗与单独接种已获许可的麻疹 - 腮腺炎 - 风疹（MMR；Priorix）疫苗和水痘（V；Varilrix）疫苗相比的安全性和免疫原性。
方法
12至18月龄的健康儿童，间隔6 - 8周接种2剂MMRV疫苗（3个批次）（MMRV组），或1剂MMR疫苗与1剂水痘疫苗同时接种，6 - 8周后再接种第2剂MMR（MMR + V组）。接种疫苗后4天记录局部症状（发红、疼痛和肿胀），连续15天每日监测发热情况（任何情况，腋温≥37.5℃或直肠温度≥38.0℃；3级，腋温＞39.0℃或直肠温度＞39.5℃）。其他不良事件监测6周。
结果
共有494名儿童接种疫苗（MMRV组371名，MMR + V组123名）。2剂MMRV疫苗的免疫原性至少与2剂MMR疫苗和1剂水痘疫苗相同。接种第2剂后，两个疫苗组的所有儿童对麻疹、风疹和水痘均产生了血清转化，MMRV组和MMR + V组中腮腺炎血清转化率分别为98%和99%。与单独接种相比，MMRV疫苗并未诱导更高的局部或全身反应原性，尽管MMRV组在接种第1剂后低热发生率较高（MMRV组为67.7%，MMR + V组为48.8%；P < 0.05），但3级发热情况未观察到差异（MMRV组为11.6%，MMR + V组为10.6%；P = 0.87）。接种第2剂后，MMRV组和MMR + V组发热发生率均无差异。
结论
接种2剂联合MMRV疫苗的免疫原性和耐受性与单独接种MMR疫苗和水痘疫苗相同。
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