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

Launched by MAXVAX BIOTECHNOLOGY LIMITED LIABILITY COMPANY · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the consistency of a herpes zoster vaccine made from recombinant proteins, which means it’s looking at whether different batches of the vaccine work the same way. The trial will involve adults aged 40 and older who will receive two doses of the vaccine spaced two months apart. The goal is to ensure that the vaccine is safe and effective for preventing herpes zoster, commonly known as shingles.

To participate, individuals must be at least 40 years old and agree to take part in the study by signing a consent form. They should also be able to attend scheduled visits and follow the study guidelines. However, there are several criteria that might exclude someone from participating, such as having a recent illness, a history of herpes zoster, or certain medical conditions. Participants can expect to receive the vaccine and will need to complete follow-up visits to monitor their health. It's also important for women of childbearing age to avoid pregnancy during the study. This trial is not yet recruiting participants but aims to ensure the vaccine is reliable for public use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A male or female permanent resident aged 40 years and older at enrollment, with valid identity;
• • 2. Subjects voluntarily agree to participate in the study and signed an informed consent;
• • 3. 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);
• • 4. 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.
• Exclusion Criteria:
• • 1. Axillary temperature \> 37.0°C on the day of vaccination or acute illness;
• • 2. Current or history of herpes zoster;
• • 3. Previous vaccination against varicella or herpes zoster (either registered product or participation in a previous vaccine study);
• • 4. Pregnant (urine pregnancy test was positive) or lactating female;
• • 5. Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
• • 6. Receipt of immunoglobulin or intravenous immunoglobulin during 3 months before vaccination, or planned receipt 1 month post the last vaccination;
• • 7. 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;
• • 8. Receipt of antipyretic, analgesic and allergy drugs within 3 days before vaccination, except enteric-coated aspirin for cardiovascular diseases prevention;
• • 9. 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;
• • 10. Allergy to aminoglycoside antibiotics;
• • 11. 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);
• • 12. Asplenia or functional asplenia, or splenectomy caused by any condition;
• • 13. 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;
• • 14. 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;
• • 15. 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;
• • 16. History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
• • 17. Abnormal and uncontrolled blood pressure during physical examination before vaccination (for subjects aged 40-59: systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg; for subjects aged ≥60, systolic pressure ≥ 150 mmHg and/or diastolic pressure ≥ 100 mmHg);
• • 18. History of drug abuse (narcotic drugs, psychotropic drugs);
• • 19. Patients with previous or current malignant tumors (except papillary thyroid cancer);
• • 20. Receipt of investigational or unapproved products (drugs or vaccines) within 6 months before vaccination; or planned participation in another clinical study during the study period;
• • 21. Any condition that, in the opinion the investigator, makes subjects ineligible for the study.