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.
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。