Sabchareon A, Chantavanich P, Pasuralertsakul S, Pojjaroen-Anant C, Prarinyanupharb V, Attanath P, Singhasivanon V, Buppodom W, Lang J
Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Pediatr Infect Dis J. 1998 Nov;17(11):1001-7. doi: 10.1097/00006454-199811000-00007.
The use of intradermal (i.d.) injections of purified Vero cell rabies vaccine (PVRV) for preexposure prophylaxis has not been well-established. We studied the safety and immunogenicity of i.d. and intramuscular (i.m.) PVRV injections for primary and booster preexposure immunizations.
One of two rabies preexposure PVRV regimens comprising three doses of either 0.1 ml i.d. or 0.5 ml i.m. administered during 28 days was assigned at random to 190 school children. One booster dose was given 1 year later either i.d. or i.m., according to their initial randomization group. Serologic results were available from 155 (82%) children at 1 year after primary immunization and 118 (62%) children at 2 years after booster.
Although children vaccinated i.d. had significantly lower rabies-neutralizing antibody titers after primary immunization as well as after booster than children vaccinated i.m. (P< 0.001 for all time points), there were no significant differences in the percentages of children with adequate titers (> or =0.15 IU/ml) between the i.d. and i.m. groups after both primary and booster immunizations. Mild local reactions were more frequent after i.d. vaccination. Mild or moderate systemic reactions were infrequent and similar after i.d. and i.m. vaccinations. Fever and headache were reported by < or =6%. The reactions after booster were not different from those of post-primary immunization.
Purified Vero cell rabies vaccine appears to be safe and immunogenic for primary and booster preexposure immunizations. An i.d. PVRV preexposure regimen should be useful especially for rabies-endemic countries with low per capita income.
皮内注射纯化的Vero细胞狂犬病疫苗(PVRV)用于暴露前预防的效果尚未得到充分证实。我们研究了皮内注射和肌内注射PVRV进行初次和加强暴露前免疫的安全性和免疫原性。
将190名学童随机分为两组,分别接受两种狂犬病暴露前PVRV免疫方案中的一种,即在28天内分3次注射,每次皮内注射0.1 ml或肌内注射0.5 ml。1年后,根据其初始随机分组,给予一次皮内或肌内加强剂量。初次免疫后1年有155名(82%)儿童、加强免疫后2年有118名(62%)儿童的血清学结果可用。
尽管皮内接种疫苗的儿童在初次免疫和加强免疫后的狂犬病中和抗体滴度均显著低于肌内接种疫苗的儿童(所有时间点P<0.001),但在初次免疫和加强免疫后,皮内注射组和肌内注射组中抗体滴度足够(≥0.15 IU/ml)的儿童百分比无显著差异。皮内接种疫苗后轻度局部反应更常见。轻度或中度全身反应不常见,皮内注射和肌内注射后的反应相似。报告发热和头痛的儿童≤6%。加强免疫后的反应与初次免疫后无差异。
纯化的Vero细胞狂犬病疫苗似乎对初次和加强暴露前免疫是安全且具有免疫原性的。皮内注射PVRV暴露前免疫方案尤其适用于人均收入较低的狂犬病流行国家。