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Low-dose experimental vaccine

Phase 1

Herpes Zoster | Monoclonal antibody | Infectious Disease |Sinovac Biotech, Ltd|Last Updated: Feb 10, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as experimental vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment519

FDA Designations

No designations recorded

Clinical trial landscape

Low-dose experimental vaccine · 1 trial · 2 indications

Phase 1 1
NCT07400003Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA VaccineHerpes Zoster
RECRUITING519 Analytics
PHASE1RECRUITING
Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine
Herpes ZosterUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of adverse reactions within 30 days
0~30 days after each dose vaccination

The incidence of adverse reactions within 0\~30 days after each dose vaccination.

Seroconversion rate of gE antibody
Day 30 after two doses

The seroconversion rate of gE antibody on Day 30 after two doses vaccination.

Geometric mean concentration (GMC) of gE antibody
Day 30 after two doses

The GMC of gE antibody on Day 30 after two doses vaccination.

Secondary Endpoints

Adverse reactions within 0~14 days
0~14 days after each dose vaccination
Incidence of serious adverse events (SAEs)
From the first dose to 12 months after the second dose
Incidence of adverse events of special interest(AESI)
From the first dose to 12 months after the second dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Low-dose groupEXPERIMENTALParticipants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (low dosage), with 30 days or 60 days apart
High-dose groupEXPERIMENTALParticipants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (high dosage), with 30 days or 60 days apart
Comparator AACTIVE_COMPARATORParticipants will receive a single dose of saline on day 0 and a single dose of herpes zoster vaccine, live on day 60
Comparator BACTIVE_COMPARATORParticipants will receive two doses of recombinant zoster vaccine (CHO cell), with 60 days apart
Comparator CPLACEBO_COMPARATORParticipants will receive two doses of saline, with 60 days apart

Interventions

NameTypeDescription
Low-dose experimental vaccineBIOLOGICALLyophilized herpes zoster virus mRNA vaccine
High-dose experimental vaccineBIOLOGICALLyophilized herpes zoster virus mRNA vaccine
Active-controlled vaccine ABIOLOGICALherpes zoster attenuated live vaccine, lyophilized
Active-controlled vaccine BBIOLOGICALShingrix®
Placebo groupOTHERSaline
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Phase I: Age ≥ 40 years; Phase II: Age ≥ 50 years; * Participants are able to understand and voluntarily sign the informed consent form; * Able to provide legal identification; * Participants of childbearing potential and their sexual partners agree to voluntarily adopt effect...

Countries:China
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Frequently asked questions about Low-dose experimental vaccine

What is the Experimental vaccine used for?

The Experimental vaccine is an investigational vaccine being developed for the prevention of Epidemic Meningitis, specifically meningococcal disease caused by groups A, C, Y, and W135. It is also being studied for use in Poliomyelitis and Herpes Zoster, though its primary clinical trials focus on meningococcal conjugate vaccination in children.

Who makes the Experimental vaccine?

The Experimental vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVA. The company is conducting Phase 3 clinical trials for this vaccine candidate in China.

What phase is the Experimental vaccine in?

The Experimental vaccine is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. All four of its registered clinical trials are Phase 3 studies, with three actively recruiting participants and one active but not recruiting.

What clinical trials is the Experimental vaccine in?

The Experimental vaccine is being evaluated in four Phase 3 clinical trials in China, all studying its use against Epidemic Meningitis. These trials are NCT07505810 (children aged 3-5 months), NCT07505823 (children aged 6-11 months), NCT07505836 (children aged 12-23 months), and NCT07505888 (children aged 2-6 years).

Is the Experimental vaccine the same as the Low-dose experimental vaccine?

Yes, the Experimental vaccine is also known as the Low-dose experimental vaccine. This alternative name may be used in some contexts to refer to the same vaccine candidate being developed by Sinovac Biotech for meningococcal disease prevention.

How does the Experimental vaccine work?

The Experimental vaccine is a meningococcal conjugate vaccine designed to protect against Neisseria meningitidis serogroups A, C, Y, and W135. By presenting these bacterial antigens to the immune system, it stimulates the production of protective antibodies that can prevent meningococcal infection and the associated epidemic meningitis.