A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 835
- 试验地点
- 24
- 主要终点
- Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
研究概览
简要总结
The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.
详细描述
The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to PCV20 in adults aged 50 to 64 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 18 to 49 years (inclusive) for the Phase 1 group, or 50 to 64 years (inclusive) for the Phase 2 group at the time of enrollment into the study.
- •Able and willing to complete the informed consent process.
- •Available for clinical follow-up through the last study visit at 6 months after the study vaccination.
- •In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the investigator.
- •Screening laboratory values must be within the central laboratory normal limits prior to study enrollment. Minor abnormalities are considered acceptable if not clinically significant.
- •Willing to have blood samples collected, stored indefinitely, and used for research purposes.
- •Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.
- •Negative pregnancy test (urine and serum) for women of childbearing potential.
排除标准
- •Previous pneumococcal disease (either confirmed or by self-reporting).
- •Previous receipt of a licensed or investigational pneumococcal vaccine.
- •Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- •Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Day
- •Physical examination indicating any clinically significant medical condition.
- •Body Temperature > 38.0°C (> 100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
- •Seropositive to HIV, HCV, or HBsAg.
- •History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- •Female who is breast-feeding or planning to become pregnant during study participation.
- •Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- •Any other chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
- •Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
- •Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
- •Received systemic corticosteroids for ≥ 14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
- •Receiving immunosuppressive therapy.
- •History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
结局指标
主要结局
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
时间窗: 6 months after vaccination
Percentage of participants with SAEs and NOCIs
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
时间窗: 7 days after vaccination
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
时间窗: 7 days after vaccination
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group
Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group
时间窗: 1 month after vaccination
Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.
次要结局
- VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)(1 month after vaccination)
- Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values(1 month after vaccination)
- VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)(1 month after vaccination)