A Phase 1, Multicenter, Randomized, Active-Controlled, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Inventprise's 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults (18 Through 40 Years)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Adult Safety: solicited local and systemic adverse events
研究概览
简要总结
A first-in-human, Phase 1 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
详细描述
A first-in-human, multicenter, randomized, active-controlled, observer-blind Phase 1 study of IVT PCV-25 designed to evaluate the safety, tolerability, and immunogenicity of the vaccine. Adult subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 20™.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults who are 18 through 40 years old on the day of randomization (Day 1).
- •Subject, or subject's LAR, must provide voluntary written informed consent for the subject to participate in the study.
- •Subject or subject's LAR must be able to comprehend and comply with study requirements and procedures and must be willing and able to return for all scheduled follow-up visits.
- •There will be an allowance though not a requirement for COVID-19 vaccination in all participants in compliance with Canadian national recommendations.
- •Adult female subjects who are not surgically sterile must have a negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination.
排除标准
- •Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
- •Adults who have previously been vaccinated against S. pneumoniae.
- •History of microbiologically confirmed invasive disease caused by S. pneumoniae.
- •History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- •Known or suspected allergy to PEG.
- •History of angioedema.
- •Any abnormal vital sign deemed clinically relevant by the PI.
- •Acute illness (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
- •Use of antibiotics (oral or parenteral) within 5 days of randomization.
- •History of administration of any non-study vaccine (e.g. influenza; COVID-19 vaccine) within 14 days of first administration of study vaccine or planned vaccination prior to 14 days post-vaccination blood draw.
- •Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine in the case of adults), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.
- •Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine, or anticipation of such administration during the study period.
- •History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia).
- •Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
- •Subject is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the CRO, the PI.
- •Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by the PI and PATH Medical Officer when a toxicity score and the normal range overlap significantly. A subject may repeat each laboratory assessment once during the screening period, with the most recent laboratory value being used for evaluation of exclusion criteria.
- •A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab).
- •History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
- •Recent history (within the past year) or signs of alcohol or substance abuse.
- •History of major psychiatric disorder.
- •Female adult subjects who are pregnant or breastfeeding
研究组 & 干预措施
Adult Cohort Group 2
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
干预措施: PCV 20 (Biological)
结局指标
主要结局
Adult Safety: solicited local and systemic adverse events
时间窗: 7 days post-vaccination (Day 8)
Number and severity of solicited local and systemic adverse events (AEs)
Adult Safety: unsolicited adverse events
时间窗: 28 days post-vaccination (Day 29)
Number, severity, and relatedness of all unsolicited AEs
Adult Safety: newly diagnosed chronic medical conditions
时间窗: through 6 months post last vaccination (Day 169)
Number of newly diagnosed chronic medical conditions
Adult Safety: clinically significant hematological and biochemical measurements
时间窗: 7 days post-vaccination (Day 8)
Number, severity, and relatedness of clinically significant hematological and biochemical measurements
Adult Safety: related serious adverse events
时间窗: through 6 months post last vaccination (Day 169)
Number, severity, and relatedness of serious adverse events (SAEs)
次要结局
- Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)(28 days post-vaccination (Day 29))
- Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs)(28 days post-vaccination (Day 29))
- Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)(28 days post-vaccination (Day 29))
- Adult Immunogenicity: GMFR OPA GMTs(28 days post-vaccination (Day 29))