Genital HerpesPhase 1NCT07330440
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
A Phase 1 study testing Low-Dose Cohort, Mid-Dose Cohort and High-Dose Cohort in people with Genital Herpes, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Genital Herpes
- What is being tested?
- Low-Dose Cohort, Mid-Dose Cohort and High-Dose Cohort
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Low-Dose Cohort, Mid-Dose Cohort, High-Dose Cohort, Placebo Group
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose CohortBiological
Each human dose is 0.25 mL
Mid-Dose CohortBiological
Each human dose is 0.5 mL
High-Dose CohortBiological
Each human dose is 1.0 mL
Placebo GroupBiological
Each human dose: 0.25 mL, 0.5 mL, or 1.0 mL
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo Group |
| Low-Dose | Experimental | HSV-2 mRNA Vaccine Receives: Biological: Low-Dose Cohort |
| Mid-Dose | Experimental | HSV-2 mRNA Vaccine Receives: Biological: Mid-Dose Cohort |
| High-Dose | Experimental | HSV-2 mRNA Vaccine Receives: Biological: High-Dose Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints
Incidence of Adverse Events within 30 Days After Each Vaccination
Measured: Up to 30 days after each dose
Secondary outcomes (2)
Safety Endpoints
The incidence of all Serious Adverse Events (SAEs)、Adverse Events of Special Interest (AESIs) from Day 0 until 12 months after the final vaccination
Measured: from Day 0 up to 540 days
Safety Endpoints
Incidence of clinically significant abnormal electrocardiogram (ECG) findings after each vaccination.
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start13 Oct 2025
- Primary completion4 Mar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330440
- Sponsor's protocol ID
- B2101-F20240206-1
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07330440
- Acronym / sponsor ID
- B2101-F20240206-1
- Conditions
- Genital Herpes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo Group |
| Low-Dose | Experimental | Biological: Low-Dose CohortHSV-2 mRNA Vaccine |
| Mid-Dose | Experimental | Biological: Mid-Dose CohortHSV-2 mRNA Vaccine |
| High-Dose | Experimental | Biological: High-Dose CohortHSV-2 mRNA Vaccine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose CohortEach human dose is 0.25 mL | Biological | Low-Dose |
| Mid-Dose CohortEach human dose is 0.5 mL | Biological | Mid-Dose |
| High-Dose CohortEach human dose is 1.0 mL | Biological | High-Dose |
| Placebo GroupEach human dose: 0.25 mL, 0.5 mL, or 1.0 mL | Biological | Placebo |
Primary outcome
Safety Endpoints
Time frame: Up to 30 days after each dose
Incidence of Adverse Events within 30 Days After Each Vaccination
2 secondary outcomes
Safety Endpoints
Time frame: from Day 0 up to 540 days
Safety Endpoints
Time frame: up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Related trials for Genital Herpes
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Genital Herpes Simplex Type 2
Not yet recruitingPhase 2
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-Dose Cohort, Mid-Dose Cohort and High-Dose Cohort in people with Genital Herpes, run by Changchun BCHT Biotechnology Co. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints (time frame: Up to 30 days after each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.