Kulkarni Prasad S, Sapru Amita, Bavdekar Ashish, Naik S S, Patwardhan Moreshwar, Barde Prajakt, Pandit Anand N
Serum Institute of India Ltd. 212/2, Hadapsar, Pune, India.
Hum Vaccin. 2011 Sep;7(9):941-4. doi: 10.4161/hv.7.9.15994. Epub 2011 Sep 1.
Because of the high mother-to-infant transmissibility of hepatitis B (HB) infection, neonatal vaccination is necessary, but the further doses of HB vaccines can be combined with conventional diphtheria-tetanus-whole cell pertussis (DTPw) vaccines. We compared immunogenicity and reactogenicity of two tetravalent vaccines in Indian children, who after neonatal HB immunization, were vaccinated thrice with one of these vaccines.
In this open-label randomized study, 287 infants received a dose of an Indian- (Q-Vac (TM )) or European-made (Tritanrix-HB (TM )) tetravalent vaccine at age 6, 10, and 14 weeks. The ELISA antibodies were measured prior to the first and one month after the third dose. Immunogenicity was determined by measuring the seroprotection/seropositivity rates and geometric mean titres (GMT), whereas vaccine reactogenicity was elucidated with diary cards for 7 days following each dose. The potential unsolicited events were queried throughout the whole 3-month study period.
Out of the 250 subjects who completed the study, 123 received the Indian and 127 the European vaccine. After 3 doses, the seroprotection/seropositivity rates were 99 % and 100% for diphtheria, 98% and 95% for tetanus, 89% and 94% for pertussis, and 100% and 100% for hepatitis B, respectively. GMT of tetanus antibodies was significantly higher with the Indian vaccine. Low-grade reactogenicity was rather similar in the two vaccine groups, the most common events being local pain, redness, swelling, fever, irritability, unusual crying, drowsiness, and non-specific gastrointestinal symptoms.
Since both immunogenicity and reactogenicity of the two vaccines were almost identical, the Indian vaccine poses a good alternative to the costlier competitor vaccines.
由于乙肝（HB）感染的母婴传播率很高，新生儿接种疫苗很有必要，但后续的乙肝疫苗剂量可与传统的白喉-破伤风-全细胞百日咳（DTPw）疫苗联合使用。我们比较了两种四价疫苗在印度儿童中的免疫原性和反应原性，这些儿童在新生儿期接种乙肝疫苗后，又用其中一种疫苗进行了三次接种。
在这项开放标签随机研究中，287名婴儿在6、10和14周龄时分别接种一剂印度生产的（Q-Vac (TM)）或欧洲生产的（Tritanrix-HB (TM)）四价疫苗。在第一次接种前和第三次接种后一个月测量ELISA抗体。通过测量血清保护/血清阳性率和几何平均滴度（GMT）来确定免疫原性，而疫苗反应原性则通过每次接种后7天的日记卡来阐明。在整个3个月的研究期间询问潜在的非预期事件。
在完成研究的250名受试者中，123人接种了印度疫苗，127人接种了欧洲疫苗。接种3剂后，白喉的血清保护/血清阳性率分别为99%和100%，破伤风为98%和95%，百日咳为89%和94%，乙肝为100%和100%。印度疫苗的破伤风抗体GMT显著更高。两个疫苗组的低级别反应原性相当相似，最常见的事件是局部疼痛、发红、肿胀、发热、易怒、异常哭闹、嗜睡和非特异性胃肠道症状。
由于两种疫苗的免疫原性和反应原性几乎相同，印度疫苗是更昂贵的竞争疫苗的一个很好的替代品。
