Evaluating a new vaccine to prevent shingles in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the protective efficacy and safety of a recombinant herpes zoster vaccine (LZ901) in healthy adults aged 40 years and older. It is a phase Ⅲ, randomized, double-blind, placebo-controlled study involving approximately 26,000 participants who will receive either the vaccine or a placebo in two doses. The study aims to assess the vaccine's effectiveness against shingles and its immunogenicity over time. Participants will undergo screening tests and have multiple follow-up visits to monitor their health and response to the vaccine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females able to provide legal identity certificate, aged ≥ 40 years inclusive at the time of signing the ICF;
* Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF;
* Female subjects are not pregnant or lactating. Female subjects with childbearing potential should take reliable contraceptive measures, and have no pregnancy and fertility plan within 7 months;
* Axillary temperature ≤ 37.0℃ on the day of enrollment;
* Able to attend all scheduled follow-up visits and able to comply with protocol requirements;

Exclusion Criteria:

* Subjects who have had herpes zoster within the previous 5 years;
* Previous vaccination against varicella or shingles (including use of a registered product or participation in a clinical trial of varicella or shingles vaccine);
* Hypersensitivity to any of the components of the test vaccine: or prior hypersensitivity to any recombinant vaccine of CHO cell origin \[e.g., recombinant hepatitis B vaccine (CHO cell)\], polysorbate, etc.; or prior history of severe allergy\* to any of the vaccinations;

  \*Severe allergies: anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction), severe urticaria.
* Developed immunodeficiency diseases (congenital or acquired immunodeficiency diseases, human immunodeficiency virus infection) or received immunosuppressive/cytotoxic treatments (cancer chemotherapy, organ transplantation, or treatment planned during a clinical trial in the 6 months prior to vaccination);
* Receiving immunosuppressive therapy (e.g., long-term systemic glucocorticoid application for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day of prednisone or prednisone-equivalent dose) within 3 months prior to vaccination or within 1 month after the planned full course of immunization；
* Received an inactivated or recombinant vaccine or mRNA vaccine within 14 days or any live attenuated vaccine within 28 days prior to vaccination;
* Subjects who are suffering from an acute illness or are in the acute exacerbation phase of a chronic disease within 3 days prior to vaccination;
* History of asplenia or functional asplenia, and asplenia or splenectomy due to any condition;
* Treatment with blood products or globulins within 3 months prior to enrollment, or planned use of such products within 2 months of vaccination;
* Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical studies before the end of this clinical study;
* Significant underlying medical conditions that, in the opinion of the investigator, may prevent completion of the trial (e.g., life-threatening disease that may limit survival to less than 4 years) or any other condition

Where it's running

• Jiangsu Province Center for Disease Control and Prevention (China)
  Zhenjiang, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Fengcai Zhu, MM — Jiangsu Province Center for Disease Control and Prevention (China)
• Study coordinator: Fengcai Zhu, MM
• Email: jscdczfc@126.com
• Phone: 13951994867

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Recombinant Zoster Vaccine with ZFA01 Adjuvant in Adults 40+

  A two-part study tests a recombinant herpes zoster vaccine in healthy adults aged 40 and older to see if it boosts immune responses and is safe.

  Recruiting at 2 sites Phase 1/2 Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Guangxi, Nanning and 1 other locations · NCT07920172

• How long the live shingles vaccine protects you

  This will see if the live attenuated shingles vaccine keeps adults from the original Phase III trial protected against herpes zoster for up to six years after vaccination.

  Recruiting Jiangsu Province Centers for Disease Control and Prevention · Nanjing, Jiangsu · NCT07585370

• Recombinant zoster (Shingrix) to see if it lowers new dementia diagnoses in people 76 and older in Finland.

  This trial will test whether the Shingrix shingles vaccine lowers the chance of a new dementia diagnosis in people aged 76 or older who live in Finland.

  Recruiting at 8 sites Phase 4 GlaxoSmithKline · Espoo and 7 other locations · NCT07502560

• Erector spinae plane block versus transcutaneous radiofrequency for postherpetic neuralgia

  This project will see if erector spinae plane block or transcutaneous radiofrequency works better to reduce pain in adults with postherpetic neuralgia.

  Recruiting Diskapi Teaching and Research Hospital · Ankara · NCT07400640

• Lyophilized shingles mRNA vaccine safety and immune response

  This trial will test a lyophilized mRNA vaccine to see if it is safe and produces immune responses in adults aged 40 years and older.

  Recruiting Phase 1/2 Sinovac Biotech Co., Ltd · Xinjiang · NCT07400003

• Loxoprofen patch for relieving shingles pain

  This will test if adding a loxoprofen sodium patch to standard care reduces pain in adults with shingles.

  Recruiting Beijing Tiantan Hospital · Beijing · NCT07378059

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.