A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine

Официальное название

A Randomized, Double-blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults

Обзор

The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.

Вмешательства

• Биопрепарат Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose
  Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;
• Биопрепарат Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose
  Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;
• Биопрепарат Placebo control: Saline
  The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;
• Биопрепарат Shingrix®
  Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart
• Биопрепарат Ganwei®
  Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60；

Первичные конечные точки

• phase 1: Incidence and intensity of solicited adverse events (AEs) [Срок оценки: within 14 days after each vaccination]
• phase 1: Incidence and intensity of unsolicited AEs [Срок оценки: within 30 days after each vaccination]
• phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody [Срок оценки: at 30 days after full vaccination]

Вторичные конечные точки (11)

• phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody [Срок оценки: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination]
• phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS) [Срок оценки: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination]
• phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs) [Срок оценки: during the study (from the first vaccination to 12 months after full vaccination)]
• phase 1: Incidence and intensity of abnormal laboratory tests indicators [Срок оценки: 3 days after each vaccination]
• phase 2: GMI of antigen-specific antibody [Срок оценки: at 30 days after full vaccination]
• phase 2: GMC, GMI, and seroconversion rate of antigen-specific antibody [Срок оценки: before the second vaccination, and at 6 months, 12 months and 24 months after full vaccination]
• phase 2: GMT/GMC, GMI, and seroconversion rate of VZV-specific antibody [Срок оценки: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination]
• phase 2: Frequencies and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by ICS [Срок оценки: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination]
• phase 2: Incidence and intensity of solicited AEs [Срок оценки: within 14 days after each vaccination]
• phase 2: Incidence and intensity of unsolicited AEs [Срок оценки: within 30 days after each vaccination]
• phase 2: Incidence of SAEs and AESIs [Срок оценки: from the first vaccination to 12 months after full vaccination]

Критерии участия

Критерии включения

• Male or female subjects ≥ 40 years of age;
• The subject can and fully understand the trial procedures and voluntarily sign the ICF;
• The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;
• The subject can comply with the requirements of the protocol;
• The axillary temperature of the subject is < 37.0℃ on the day of enrollment;
• Fertile men and women with childbearing potential voluntarily agree to take effective contraceptive measures from the first vaccination to at least 90 days after the last dose of study vaccines.

Критерии исключения

• History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;
• Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);
• Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
• History or family history of convulsions, epilepsy, and psychiatric disorders;
• Suffering from serious chronic diseases or in the active stage of chronic diseases, which are evaluated by the investigator to affect the trial observation, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, hypertension that cannot be controlled after drug treatment (subjects 40-59 years of age have systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, and subjects ≥60 years of age have systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), diabetes with severe complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart disease, respiratory diseases, liver and kidney diseases, and thyroid diseases;
• Primary or secondary immunosuppressive condition, or diagnosed with primary or acquired immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.
• History of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection and venous blood collection;
• Fever (axillary temperature ≥37.3℃) within 3 days before enrollment or systemic antibiotic or antiviral treatment within 7 days;
• Use of antipyretic analgesics or other drugs with antipyretic and analgesic effects, such as acetaminophen and ibuprofen, within 72 h before vaccination.
• Abnormal laboratory test (blood routine, blood biochemistry, urine routine) results that are outside the reference range and clinically significant (only apply to Phase I);
• Those who are pregnant (positive urine pregnancy test) or breast-feeding, or those who plan to become pregnant during the study period;
• Long-term or high-dose corticosteroid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other corticosteroids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination. Short-term or topical use (such as ointments, eye drops, inhalants, intra-articular medications or nasal sprays) of glucocorticoids is permitted;
• Vaccination with non-attenuated vaccines within 14 days before the first dose of study vaccines, or with live-attenuated vaccines within 28 days before the first dose of study vaccines;
• Participation in other clinical trials (drug or vaccine) within 30 days preceding the first dose of study vaccines or planning to participate in other clinical trials before this clinical study is completed;
• Asplenia or functional asplenia;
• Those who are known to have been diagnosed or currently have an infectious disease, including hepatitis B, hepatitis C, syphilis or AIDS;
• Those who have any acute illness or acute onset of chronic illness within 72 hours before the first dose of vaccination;
• Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period;
• Subjects deemed by the investigator to have other conditions that render them ineligible to participate in this study, which include but are not limited to those who are incapable of participating in follow-up visits based on the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Dazhu CDC — Dazhou

Идентификаторы

NCT: NCT06801509 · SCTV04C-X201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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