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
Phase
Phase 1
Recruitment status
Enrolling by invitation
Participants
Lead sponsor
Changchun BCHT Biotechnology Co.
Start date
2025-10-13
Number of sites
- 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
- 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
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Enrolling by invitation
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-06-01
- First posted
- 2026-01-09
- Registry last updated
- 2026-01-09
- Primary completion date
- 2027-03-04
- Start date
- 2025-10-13
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07330440
- ClinicalTrials.gov ID
- NCT07330440
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Outcome assessors
Sources for study design
Safety Endpoints
Timeframe: Up to 30 days after each dose
Incidence of Adverse Events within 30 Days After Each Vaccination
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
Safety Endpoints
Timeframe: up to 14 days
Incidence of clinically significant abnormal electrocardiogram (ECG) findings after each vaccination.
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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
- Beijing Jishuitan HospitalBeijing, China
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Genital herpes Primary condition