> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-study-to-evaluate-the-safety-tolerability-and-edff5705-7bd7-49a2-92a7-e17b5e602a0b > Record changed: 2026-10-29 # 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 NCT07330440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) Lead sponsor Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) Start date 2025-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Official title** A Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) in Healthy Participants Aged 18-55 Years, Stratified by Serostatus Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **First posted** 2026-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Registry last updated** 2026-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Primary completion date** 2027-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Start date** 2025-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Lead sponsor** Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Identifiers **Registry ID** NCT07330440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **ClinicalTrials.gov ID** NCT07330440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Outcomes ### Primary outcomes 1. Safety Endpoints Timeframe: Up to 30 days after each dose Incidence of Adverse Events within 30 Days After Each Vaccination ### Secondary outcomes 1. Safety Endpoints Timeframe: from Day 0 up to 540 days The incidence of all Serious Adverse Events (SAEs)、Adverse Events of Special Interest (AESIs) from Day 0 until 12 months after the final vaccination 2. Safety Endpoints Timeframe: up to 14 days Incidence of clinically significant abnormal electrocardiogram (ECG) findings after each vaccination. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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.g., systemic corticosteroids for >14 consecutive days) or cytotoxic therapy within 6 months prior to the first vaccination, or planned use during the study. - Congenital anomalies or developmental disorders affecting organ function. - History of cardiovascular diseases (e.g., myocardial ischemia, myocardial infarction, myocarditis, pericarditis, idiopathic cardiomyopathy, arrhythmias), or any condition increasing the risk of myocarditis/pericarditis; QTcF >450 ms for males or >470 ms for females; or uncontrolled hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg despite medication). - For HSV-1/HSV-2 seronegative participants: clinically significant abnormalities in hematology, blood biochemistry, coagulation, or urinalysis parameters at screening. - For HSV-1/HSV-2 seropositive participants: hematology, blood biochemistry, coagulation, or urinalysis parameters ≥ Grade 1 per the study-specific toxicity grading scale and deemed clinically significant by the investigator. - Contraindications to intramuscular injection (e.g., thrombocytopenia, coagulation disorders). - Medical conditions requiring intervention affecting the endocrine, hematologic, hepatic, renal, respiratory, metabolic, or skeletal systems. - History of convulsions (excluding febrile seizures in childhood), epilepsy, encephalopathy, psychiatric disorders, or other neurological conditions; or family history of psychiatric disorders. - Positive markers for HBV, HCV, HIV, or syphilis infection. - Administration of blood products or immunoglobulins within 3 months prior to the first vaccination or planned use during the study. - Treatment with anti-herpetic drugs (e.g., acyclovir, valacyclovir, famciclovir, ganciclovir) for genital herpes within 6 months prior to the first vaccination. - Receipt of live-attenuated vaccines within 14 days, or subunit/inactivated vaccines within 7 days prior to vaccination. - Participation in another clinical trial (drug, device, or vaccine) within 3 months prior to the first vaccination or concurrent enrollment in any interventional study. - Any other condition deemed by the investigator to compromise participant safety or interfere with study objectives. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Sites - Beijing Jishuitan HospitalBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07330440) ## Related records ### Drugs (2) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) ### Lead sponsors (1) - [Changchun BCHT Biotechnology Co.](https://trialight.com/data/company/changchun-bcht-biotechnology-co-2f38a069-5e9a-44f3-93e1-84ac3c4da340.md) ### Conditions (1) - [Genital herpes](https://trialight.com/data/condition/genital-herpes-07f6bf40-9937-5924-bf15-bb89bedc2b84.md) Primary condition ### Targets (3) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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