A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Healthy Adults Aged 50 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,015
- 试验地点
- 24
- 主要终点
- Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) in Each Age Group
研究概览
简要总结
The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years 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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 50 to 64 years (inclusive) for Stage 1, or 50 years and older (inclusive) for Stage 2 at the time of randomization 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.
- •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.
- •Women of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception
- •Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an electronic diary.
排除标准
- •Previous pneumococcal disease (either confirmed or self-reported).
- •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 Month
- •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.
- •Female who is pregnant, breastfeeding, or planning to become pregnant during study participation.
- •Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically 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 (except for inhaled, topical, intra-articular) 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
Group 1
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
干预措施: 31 valent pneumococcal conjugate vaccine (Biological)
Group 2
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
干预措施: 31 valent pneumococcal conjugate vaccine (Biological)
Group 3
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
干预措施: 31 valent pneumococcal conjugate vaccine (Biological)
Group 4
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
干预措施: 20 valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) 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 Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group 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 Subjects Reporting Unsolicited Adverse Event 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 1 month after vaccination.
Percentage of Subjects Reporting Serious Adverse Event
时间窗: 6 months after vaccination
Percentage of participants with SAEs.
Percentage of Subjects Reporting New Onset of Chronic Illness
时间窗: 6 months after vaccination
Percentage of participants with NOCIs
Percentage of Subjects Reporting Medically Attended Adverse Event
时间窗: 6 months after vaccination
Percentage of participants with MAAEs.
次要结局
- Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values(1 month after vaccination)
- Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)(1 month after vaccination)
- 31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer(1 month after vaccination)
- 31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration(1 month after vaccination)