Abstract：
UNASSIGNED: Human Chorionic Gonadotropin (hCG) plays a crucial role in embryo implantation and in maintenance of pregnancy. An immuno-contraceptive approach involves the use of a recombinant hCGβ-LTB vaccine formulated with adjuvant Mycobacterium indicus pranii (MIP), to prevent pregnancy without disturbing ovulation, hormonal profiles, and menstrual cycles in women. The present work in mice was designed to address issues encountered in clinical trials conducted with hCGβ-LTB vaccine, with focus on two primary concerns. Firstly, it aimed to determine the optimal vaccine dosage required to induce a high level of anti-hCG antibodies. Secondly, it aimed to assess the safety profile of the vaccine, specifically injection site reactions in the form of nodules, observed in some of the subjects.
UNASSIGNED: Studies undertaken indicate that a 2 µg dose of the protein version of the vaccine, administered in mice through the intramuscular route, can induce high anti-hCG titres. Furthermore, administering a booster dose enhances the antibody response. Our findings suggest that the concentration and frequency of administration of the adjuvant MIP can also be reduced without compromising vaccine efficacy.
UNASSIGNED: The issue of nodule formation at the injection site can be mitigated either by administering the vaccine along with MIP intramuscularly or injecting hCG vaccine and MIP at separate intradermal sites. Thus, protein vaccine administered at a 2µg dose via the intramuscular route addresses both efficacy and safety concerns.
The Phase I/II clinical trials initiated with the recombinant hCG vaccine in women revealed inadequate antibody titres in all subjects, alongside the development of nodules at the injection sites in some participants. Studies were undertaken in mice to propose potential strategies for mitigating injection site reactions and enhancing the antibody response. It was concluded that the optimum dose of the protein version of the vaccine to get high antibody titres, is 2 µg administered intramuscularly while upholding safety standards.
UNASSIGNED: Studies undertaken indicate that a 2 µg dose of the protein version of the vaccine, administered in mice through the intramuscular route, can induce high anti-hCG titres. Furthermore, administering a booster dose enhances the antibody response. Our findings suggest that the concentration and frequency of administration of the adjuvant MIP can also be reduced without compromising vaccine efficacy.
UNASSIGNED: The issue of nodule formation at the injection site can be mitigated either by administering the vaccine along with MIP intramuscularly or injecting hCG vaccine and MIP at separate intradermal sites. Thus, protein vaccine administered at a 2µg dose via the intramuscular route addresses both efficacy and safety concerns.
The Phase I/II clinical trials initiated with the recombinant hCG vaccine in women revealed inadequate antibody titres in all subjects, alongside the development of nodules at the injection sites in some participants. Studies were undertaken in mice to propose potential strategies for mitigating injection site reactions and enhancing the antibody response. It was concluded that the optimum dose of the protein version of the vaccine to get high antibody titres, is 2 µg administered intramuscularly while upholding safety standards.
摘要：
目的：人绒毛膜促性腺激素（hCG）在胚胎着床和维持妊娠中起着至关重要的作用。免疫避孕方法包括使用用佐剂indicuspranii分枝杆菌（MIP）配制的重组hCGβ-LTB疫苗，为了防止怀孕而不干扰排卵，荷尔蒙档案，和女性的月经周期。目前在小鼠中的工作旨在解决使用hCGβ-LTB疫苗进行的临床试验中遇到的问题，重点关注两个主要问题。首先,其目的是确定诱导高水平抗hCG抗体所需的最佳疫苗剂量.其次,它旨在评估疫苗的安全性，特别是结节形式的注射部位反应，在一些主题中观察到。
方法和结果：研究表明，2µg剂量的蛋白质版本的疫苗，通过肌内途径在小鼠中给药，可诱导高抗hCG滴度。此外，施用加强剂量增强抗体应答。我们的发现表明，佐剂MIP的浓度和给药频率也可以降低，而不会损害疫苗的效力。
结论：注射部位结节形成的问题可以通过肌内注射疫苗和MIP或在不同的皮内部位注射hCG疫苗和MIP来缓解。因此，通过肌内途径以2µg剂量给药的蛋白质疫苗解决了功效和安全性问题.
在女性中使用重组hCG疫苗启动的I/II期临床试验显示，所有受试者的抗体滴度不足，一些参与者在注射部位出现结节。在小鼠中进行研究以提出减轻注射部位反应和增强抗体反应的潜在策略。结论是获得高抗体滴度的蛋白质版本疫苗的最佳剂量，在坚持安全标准的同时，肌内给药2µg。
方法和结果：研究表明，2µg剂量的蛋白质版本的疫苗，通过肌内途径在小鼠中给药，可诱导高抗hCG滴度。此外，施用加强剂量增强抗体应答。我们的发现表明，佐剂MIP的浓度和给药频率也可以降低，而不会损害疫苗的效力。
结论：注射部位结节形成的问题可以通过肌内注射疫苗和MIP或在不同的皮内部位注射hCG疫苗和MIP来缓解。因此，通过肌内途径以2µg剂量给药的蛋白质疫苗解决了功效和安全性问题.
在女性中使用重组hCG疫苗启动的I/II期临床试验显示，所有受试者的抗体滴度不足，一些参与者在注射部位出现结节。在小鼠中进行研究以提出减轻注射部位反应和增强抗体反应的潜在策略。结论是获得高抗体滴度的蛋白质版本疫苗的最佳剂量，在坚持安全标准的同时，肌内给药2µg。
