A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Again… (NCT07330440) | Clinical Trial Compass
By InvitationPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
China144 participantsStarted 2025-10-13
Plain-language summary
A Preliminary Evaluation of the Safety and Immunogenicity Post-Vaccination with Different Doses of an mRNA Vaccine against Herpes Simplex Virus Type 2 (HSV-2) in Populations with Different Serostatus
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Is a healthy male or female aged 18 to 55 years (inclusive) at the time of screening.
* Has provided written informed consent prior to performing any study-specific procedure.
* Is available and willing to comply with all study procedures for the entire duration of the study.
* For participants of childbearing potential: agrees to practice highly effective contraception for the required period and has no plans for reproduction or gamete donation.
* Provides consent for HSV-1/HSV-2 serology testing at screening.
Exclusion Criteria:
* Axillary temperature \>37.0°C during screening and/or on the day of vaccination.
* History of clinically diagnosed genital herpes within 6 months prior to the first vaccination.
* Acute infectious disease or acute exacerbation of a chronic condition within 3 days prior to screening/vaccination.
* Positive blood pregnancy test at screening or currently breastfeeding (for female participants).
* History of severe allergic reactions requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction, allergic purpura), severe adverse reactions to previous vaccinations, or known hypersensitivity to any component of the investigational vaccine (e.g., lipid nanoparticles).
* Known or suspected malignancy, autoimmune disease, immunodeficiency, organ transplantation, or immunosuppression (e.g., HIV infection, systemic lupus erythematosus \[SLE\], rheumatoid arthritis).
* Use of immunosuppressants or immunomodulators (e.…