Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above

Launched by MAXVAX BIOTECHNOLOGY LIMITED LIABILITY COMPANY · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new herpes zoster vaccine, which is designed to help prevent shingles, a painful skin rash caused by the same virus that causes chickenpox. The study aims to determine how safe the vaccine is and how well it works in healthy adults aged 18 years and older. Participants will receive two doses of the vaccine, spaced two months apart, and the trial will closely monitor their health and any side effects.

To be eligible for this study, participants must be permanent residents who are at least 18 years old and willing to join the trial by signing a consent form. However, certain individuals cannot participate, such as those who have had shingles recently, are pregnant or breastfeeding, or have certain medical conditions that affect their immune system. If someone decides to join this trial, they can expect to attend scheduled visits for vaccinations and follow-ups to help researchers understand the vaccine's effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Permanent residents aged 18 years and above;
• • 2. Subjects voluntarily agree to participate in the study and signed an informed consent;
• • 3. Be able to participate in all scheduled visits and comply with the protocol requirements.
• Exclusion Criteria:
• • 1. Axillary temperature\>37.0℃;
• • 2. History of herpes zoster within 5 years before vaccination;
• • 3. Prior vaccination with chickenpox vaccine or herpes zoster vaccine;
• • 4. Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination;
• • 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 within 3 months before vaccination;
• • 7. Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
• • 8. A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination;
• • 9. History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history;
• • 10. Asplenia or functional asplenia, or splenectomy caused by any condition;
• • 11. Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
• • 12. Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable;
• • 13. Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication;
• • 14. History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
• • 15. Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg);
• • 16. Abnormal and clinically significant laboratory test results as determined by the investigator before vaccination;
• • 17. Current or history of alcohol and/or drug abuse;
• • 18. Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.