A Phase 2, Randomized, Observer-Blind, Dose-Finding, Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults 65 Years and Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 18
- 主要终点
- Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
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 65 years of age and older.
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 65 years of age and older.
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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 65 or older.
- •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. Preexisting medical conditions must be stable as defined by no change in treatment at least 6 weeks prior to study participation.
- •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.
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).
- •Previous or existing diagnosis of HIV, Hepatitis B or Hepatitis C.
- •History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- •Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular 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.
研究组 & 干预措施
VAX-24 Low Dose
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
干预措施: 24-Valent Pneumococcal Conjugate Vaccine (Biological)
VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
干预措施: 24-Valent Pneumococcal Conjugate Vaccine (Biological)
VAX-24 Mixed Dose
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
干预措施: 24-Valent Pneumococcal Conjugate Vaccine (Biological)
PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
干预措施: Pneumococcal 20-valent Conjugate Vaccine (Biological)
结局指标
主要结局
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
时间窗: 6 months after vaccination
Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)
Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination
时间窗: 1 month after vaccination
Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
时间窗: 7 days after vaccination
Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
时间窗: 7 days after vaccination
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination
次要结局
- 24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)(1 month after vaccination)
- VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)(1 month after vaccination)