Herpes Vaccine Candidate Launches First-Time-in-Human Study
GlaxoSmithKline (GSK) launched a limited phase 1 clinical trial for a herpes simplex virus type 2 (HSV-2) candidate known as HSV vaccine (GSK4108771A). This USA-based study will include sixty participants and was last updated on March 18, 2021.
This first-time-in-human study intends to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental HSV-2 vaccine when administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40 years.
The Inclusion Criteria for this study include, but is not limited to the following:
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
- Written informed consent obtained from the participant prior to the performance of any study-specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- Participants documented to be positive for HIV will not be eligible for study participation.
- Seronegative for HSV-2 as determined by Western blot.
There are several Exclusion Criteria for this phase 1 study, including a pregnant or lactating woman, and woman planning to become pregnant, or planning to discontinue contraceptive precautions.
The study's Estimated Study Completion Date is August 9, 2022.
GSK's vaccines business has a portfolio of more than 20 vaccines to help protect people from a range of diseases throughout their lives.
Clinical researchers have been developing herpes vaccine candidates and evaluating them in clinical trials to test therapeutic (intended to reduce viral shedding in people who are already infected with HSV) and preventive (designed to prevent infection) vaccine candidates. An updated listing of herpes vaccine candidates is published on this PrecisionVaccinations webpage.