A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
A phase 1 random, double blind, positive and placebo control trail was conducted in 120
healthy women in the arm A: 18-26 years old and Arm B: 27-45 years old. The 40 subjects to be
inoculated with low, middle, and high dose vaccinefirst in sequence if there was no safety
issue. In each dose group SCT1000 : placebo: positive =3:1:1.Two arms can be recruited at the
same time. If the DSMB assessment shows that the adverse events of a certain dose group meet
the criteria of suspension / termination, the dose group will be suspended / terminated, and
the vaccination of this dose group or higher dose group will not be carried out, and the
study of other dose groups will continue. If this happens at a low dose, the study will be
suspended / terminated.