Phase III Clinical Trial of Lot-to-lot Consistency of Recombinant Herpes Zoster Vaccine (CHO Cell).

NCT06654700 | Not Yet Recruiting Phase 3

• 1 other identifier: MKKCT-100-004
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• The geometric mean concentration (GMC) of anti-gE antibodies one month after full vaccination.

  Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter.

  At Month 0 and Month 3.

Secondary Outcomes (6)

• The seroconversion rate of anti-gE antibodies one month after full vaccination.

  At Month 3.

• The incidence, severity, and vaccine-related association of solicited local adverse events (AEs) within 7 days after each dose of vaccination.

  During the 7 days (Days 0-6) after each vaccine dose.

• The incidence, severity, and relevance to vaccination of solicited general adverse events (AEs) within 7 days after each dose of vaccination.

  During the 7 days (Days 0-6) after each vaccine dose.

• The incidence, severity, and relevance to vaccination of unsolicited adverse events (AEs) within 30 days after each vaccine dose.

  During 30 days (Days 0-29) after each vaccination.

• The incidence of serious adverse events (SAEs) from the first dose of vaccination to one month after the final dose.

  From first vaccination up to 30 days post last vaccination (Month 0-Month 3).

Study Arms (3)

Herpes Zoster vaccine（Commercial-scale batch 1 group）

EXPERIMENTAL

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

Biological: Recombinant Zoster Vaccine (CHO Cell)

Herpes Zoster vaccine（Commercial-scale batch 2 groups）

EXPERIMENTAL

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

Biological: Recombinant Zoster Vaccine (CHO Cell)

Herpes Zoster vaccine（Commercial-scale batch 3 groups）

EXPERIMENTAL

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

Biological: Recombinant Zoster Vaccine (CHO Cell)

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

Herpes Zoster vaccine（Commercial-scale batch 1 group）; Herpes Zoster vaccine（Commercial-scale batch 2 groups）; Herpes Zoster vaccine（Commercial-scale batch 3 groups）

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 female 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 avoid pregnancy and are willing to use effective 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°C on the day of vaccination or acute illness;
• 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, or planned receipt 1 month post the last vaccination;
• Acute diseases(such as acute upper respiratory tract infection with fever, cough, sore throat) 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, congenital brain dysplasia, mental illness or family history, or history of brain nerve tissue damage due to other severe neurological disorders(e.g. brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, chemical drug poisoning);
• 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(such as long-term use of systemic glucocorticoid ≥14 days, ≥20mg/day prednisone or equivalent dose) or long-acting immune-modifying drugs(e.g. Infliximab) during the period starting 6 months before vaccination or planned administration 1 month after the last vaccination, but topical steroids(e.g. ointment, eye drops, inhalants, nasal sprays) that do not exceed the dosage recommended in the instructions or have any systemic signs are acceptable;
• Patients with severe chronic diseases, including but not limited to severe cardiovascular diseases (pulmonary heart disease, pulmonary edema), severe liver and kidney diseases, and diabetes mellitus with complications;

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead

Study Sites (1)

Henan Center for Diseases Control and Prevention

Zhengzhou, Henan, 450016, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanxia Wang, Master

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Wang, Master

CONTACT

+86 13613816598; wangyanxia99@163.com

Study Design

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

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: December 9, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)