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 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: B2101-F20240206-1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

• Safety Endpoints

  Incidence of Adverse Events within 30 Days After Each Vaccination

  Up to 30 days after each dose

Secondary Outcomes (2)

• Safety Endpoints

  from Day 0 up to 540 days

• Safety Endpoints

  up to 14 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Biological: Placebo Group

Low-Dose

EXPERIMENTAL

HSV-2 mRNA Vaccine

Biological: Low-Dose Cohort

Mid-Dose

EXPERIMENTAL

HSV-2 mRNA Vaccine

Biological: Mid-Dose Cohort

High-Dose

EXPERIMENTAL

HSV-2 mRNA Vaccine

Biological: High-Dose Cohort

Interventions

Low-Dose Cohort BIOLOGICAL

Each human dose is 0.25 mL

Low-Dose

Mid-Dose Cohort BIOLOGICAL

Each human dose is 0.5 mL

Mid-Dose

Placebo Group BIOLOGICAL

Each human dose: 0.25 mL, 0.5 mL, or 1.0 mL

Placebo

High-Dose Cohort BIOLOGICAL

Each human dose is 1.0 mL

High-Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 9, 2026
• Study Start: October 13, 2025
• Primary Completion (Estimated): March 4, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)