Talwar Research Foundation, E-8 Neb valley, Neb Sarai, New Delhi-110 068, India.
J Reprod Immunol. 2011 Sep;91(1-2):24-30. doi: 10.1016/j.jri.2011.06.099. Epub 2011 Aug 31.
The objective of this work was to identify a human use-permissible adjuvant to enhance significantly the antibody response to a recombinant anti-hCG vaccine. Previous Phase II efficacy trials in sexually active women have demonstrated the prevention of pregnancy at hCG bioneutralization titers of 50ng/ml or more. Mycobacterium indicus pranii (MIP), a non-pathogenic Mycobacterium employed as an autoclaved suspension in aqueous buffer, significantly increased antibody titers in the FVB strain of mice. Three other genetic strains of mice: SJL, C3H, and C57Bl/6 responded with antibody titers several-fold higher than 50 ng/ml, which is the protective threshold in women, although there were differences in the peak titers attained. In addition, the duration of the antibody response was lengthened. The vaccine hCGβ-LTB, given together with MIP, induces both a Th1 and Th2 response, which is reflected in the production of not only IgG1, but also a high proportion of IgG2a and IgG2b antibodies.
本研究旨在寻找一种人用可接受的佐剂，以显著增强对重组抗 hCG 疫苗的抗体应答。先前在性活跃女性中进行的 II 期疗效试验表明，在 hCG 中和滴度达到 50ng/ml 或更高时，可以预防妊娠。印度分枝杆菌（MIP）是一种非致病性分枝杆菌，作为经高压灭菌的悬浮液在水性缓冲液中使用，可显著增加 FVB 品系小鼠的抗体滴度。其他三种遗传品系的小鼠：SJL、C3H 和 C57Bl/6 的抗体滴度比女性的保护阈值 50ng/ml 高出数倍，尽管达到的峰值滴度有所不同。此外，抗体应答的持续时间延长。与 MIP 一起给予 hCGβ-LTB 疫苗可诱导 Th1 和 Th2 反应，这反映在不仅产生 IgG1，而且还产生高比例的 IgG2a 和 IgG2b 抗体。
