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发表于 2022-8-5 22:45:23
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本帖最后由 黄帮主 于 2022-8-31 22:42 编辑
SA14-14-2疫苗株
疫苗的减毒毒性在很多动物模型中得到验证， 对于一个减毒活疫苗来讲，一个安全性指标就是是否出现毒性返祖。该疫苗在26000儿童中进行临床实验，接种后一个月，对照组和实验组住院和患病率没有区别，没有发生疫苗后的神经性疾病。one safety concern is the
possibility of reversion to a virulent form. Vaccine safety was assessed in a post-licensure,
randomized, placebo-controlled trial in 26 000 children (Liu et al., 1997). One month
after vaccination, the two groups (vaccinated and placebo control) had similar rates
of hospitalization and illness. There were no cases of post-vaccination anaphylaxis or
neurological disease. Numerous other smaller studies have demonstrated a very good
safety record for SA14-14-2 vaccine (Xin et al., 1988; Sohn et al., 1999).
The SA14-14-2 vaccine did not immediately gain regulatory approval outside
China because of concerns about the PHK substrate, which is not an accepted cell
type for vaccine production (i.e. primary hamster kidney cell culture derived from
baby hamsters), uncertainty about the quality-control tests for adventitious agents,
and other issues related to manufacturing practices. The WHO developed guidelines
to facilitate the international acceptance of the vaccine (WHO, 2002). Work is still
in progress to follow-up on GACVS recommendations made in 2005. As a result
of a comprehensive review on the safety of the vaccine conducted by GACVS in
2005, some specific recommendations were made requesting more detailed study
of: the safety profile in special risk groups including immunocompromised people
and pregnant women; whether viral shedding occurs in vaccinees and the potential
implications of such shedding; further analysis of sequential or co-administration of
JE and measles vaccines; the interchangeability of inactivated and live JE vaccines;
the safety of vaccine administration to infants aged under one year, and the implications
for the efficacy and safety of the vaccine in infants with maternal antibodies against
JE virus. Also, population-based safety data from the use of the vaccine in countries with
a functioning adverse events following immunization (AEFI) system were considered
desirable (WHO, 2005). In the meantime acceptable results of vaccine co-administration
with measles vaccine and immunogenicity in children below one year of age have been
published (Gatchalian, 2008). Publication of the results of other studies (viraemia and
interchangeability of vaccines) is awaited.
On balance, no specific safety signal is associated with this vaccine, and GACVS
noted that reported data suggest an excellent safety and efficacy profile of the SA14-
14-2 vaccine. While not WHO-prequalified, this vaccine is now licensed and used in
many countries, 这个疫苗目前在以下国家注册和使用，包括中国，印度，朝鲜，尼泊尔，斯里兰卡，泰国等等。
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发表于 2020-10-10 15:27:21
