A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2022
This exploratory trial will have two parts. Part A is a dose escalation part and Part B is an expanded safety and dose evaluation part. Part A will focus on the safety evaluations, but vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and also enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses than could be assessed in Part A.
Epistemonikos ID: 123a5f129718af8a5f5314e4d6151380231f40f6
First added on: Oct 02, 2023