Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older

NCT06447779 | Active Not Recruiting Phase 3

• 1 other identifier: MKKCT-100-003
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the sutdy is to evaluate efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Incidence of confirmed Herpes Zoster(HZ) Cases per person years in subjects aged 40 years and older

  A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the Endpoint Adjudication Committee (EAC), consisting of physicians with HZ expertise.

  30 days after the last vaccination

Secondary Outcomes (14)

• Incidence of confirmed Herpes Zoster(HZ) Cases per person years in different age group.

  30 days after the last vaccination

• Incidence of any and severe Postherpetic Neuralgia (PHN) cases per person years in subjects aged 40 years and older, 40-49years , 50-59 years , 60-69 years and ≥70 years , with confirmed HZ.

  30 days after the last vaccination

• Geometric Mean Concentration(GMC) of anti-gE antibody and anti-VZV antibody in immunogenicity subset

  At 1, 12, 24 and 36 months after the last vaccination

• Seropositivity rate of anti-gE antibody and anti-VZV antibody in immunogenicity subset

  At 1, 12, 24 and 36 months after the last vaccination

• Seroresponse rate of anti-gE antibody and anti-VZV antibody in immunogenicity subset

  30 days after the last vaccination

Study Arms (2)

Vaccine Group

EXPERIMENTAL

Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule

Biological: Recombinant Zoster Vaccine (CHO Cell)

Placebo Group

PLACEBO COMPARATOR

Subjects will receive NaCl solution placebo according to a 0, 2-month schedule

Biological: NaCl solution Placebo

Interventions

Recombinant Zoster Vaccine (CHO Cell) BIOLOGICAL

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection

Vaccine Group

NaCl solution Placebo BIOLOGICAL

0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

Placebo Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or famale permanent resident aged 40 years and older at enrollment, with valid identity;
• Subjects voluntarily agree to participate in the study and signed an informed consent;
• Be able to understand clinical trials, participate in all scheduled visits and comply with the protocol requirements(e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
• Women of childbearing potential plan to aviod pregnancy and are willing to use effcetive contraception(e.g. oral contraceptive pills, injectable progestogen, percutaneous contraceptive patches, implants of levonorgestrel, intrauterine device, female and male sterilization or abstinence) within 12 months after the last vaccination, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable.

You may not qualify if:

• Axillary temperature\>37.0℃;
• Current or history of herpes zoster;
• Previous vaccination against varicella or herpes zoster (either registered product or participation in a previous vaccine study);
• Pregnant (urine pregnancy test was positive) or lactating female;
• Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
• Receipt of immunoglobulin or intravenous immunoglobulin during 3 months before vaccination to 1 month post the last vaccination;
• Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
• Receipt of antipyretic, analgesic and allergy drugs within 3 days before vaccination, except enteric-coated aspirin for cardiovascular diseases prevention;
• A known allergy to any components of the study vaccine, or history of severe allergy (e.g. Anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, severe urticaria) to any previous vaccination;
• Allergy to aminoglycoside antibiotics;
• History of convulsions, epilepsy, encephalopathy (e.g. congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning), mental illness and family history, and other serious neurological diseases;
• Asplenia or functional asplenia, or splenectomy caused by any condition;
• Primary or secondary impairment of immune function, diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases;
• Receipt of immunosuppressive therapy (e.g. long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose) during 6 months before vaccination to 1 minth post the last vaccination, but inhaled, nasal spray, intra-articular, eyedrops, ointment and other topical steroids are acceptable;
• Receipt of long-acting immune-modifying drugs (e.g. Infliximab) within 6 months before vaccination or during the study period;

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead

Study Sites (4)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

Location

Henan Center for Diseases Control and Prevention

Zhengzhou, Henan, 450016, China

Location

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, 430070, China

Location

Yunnan Center For Disease Control and Prevention

Kunming, Yunnan, 650022, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Wang Yanxia

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 7, 2024
• Study Start: July 13, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)