Lin H, Perrin P
National Institute for the Control of Pharmaceutical and Biololgical Products, Beijing 100050.
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 1999 Jun 30;13(2):133-5.
To study whether the rabies vaccine for human use should contain aluminum adjuvant.
Testing vaccine antibodies and efficacy (ED50), comparing the effect between aluminum adjuvant contained and non-aluminum adjuvant contained vaccines in a new animal model which accords with the rabies field practice.
At fourth and seventh day after immunization, the neutralizing antibody titres of the rabies vaccine containing aluminium adjuvant were much lower than that of the vaccine not containing aluminum adjuvant. In the NIH efficacy test the ED50 of the vaccine containing aluminum adjuvant was 93-132 ng while the ED50 of the vaccine not containing aluminum adjuvant was 221 ng, but the NIH test does not accord with the rabies field practice. In that new animal model, aluminum adjuvant to rabies vaccine had not any promoting effect for preventing and treating rabies.
Aluminum adjuvant to rabies vaccine has no advantages, this paper suggests that the vaccines containing and not-containing aluminium adjuvant had better compare in human bodies. If the results are the same as our experiments, the aluminum adjuvant should be eliminated from rabies vaccine for human use.
研究人用狂犬病疫苗是否应含有铝佐剂。
检测疫苗抗体和效力(ED50),在符合狂犬病实际情况的新动物模型中比较含铝佐剂疫苗和不含铝佐剂疫苗的效果。
免疫后第4天和第7天,含铝佐剂的狂犬病疫苗中和抗体滴度远低于不含铝佐剂的疫苗。在NIH效力试验中,含铝佐剂疫苗的ED50为93 - 132纳克,而不含铝佐剂疫苗的ED50为221纳克,但NIH试验不符合狂犬病实际情况。在该新动物模型中,铝佐剂对狂犬病疫苗预防和治疗狂犬病无任何促进作用。
狂犬病疫苗的铝佐剂无优势,本文建议含铝佐剂和不含铝佐剂的疫苗最好在人体中进行比较。如果结果与我们的实验相同,人用狂犬病疫苗应去除铝佐剂。