Evaluating a new vaccine to prevent shingles in adults

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety, and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Subjects Aged 40 Years and Older

This study is testing a new vaccine to see if it can prevent shingles in healthy adults aged 40 and older.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 4 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Beijing Luzhu Biotechnology Co., Ltd. (other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Zhenjiang, Jiangsu)
• Trial ID: NCT06088745 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 40 years and older who have not had shingles in the past five years.

Not a fit: Patients who have previously been vaccinated against varicella or shingles or have had shingles within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of shingles in adults, improving their quality of life.

How similar studies have performed: Other studies on herpes zoster vaccines have shown promising results, indicating that this approach is supported by previous research.

Eligibility criteria

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 this trial is running

Zhenjiang, Jiangsu

• 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

Conditions: Vaccine-Preventable Diseases, Herpes Zoster