A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Unsolicited AEs
研究概览
简要总结
Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
详细描述
A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).
- •Participant must provide voluntary written informed consent to participate in the study.
- •Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.
- •Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.
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 (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.
- •Any abnormal vital sign deemed clinically relevant by the PI.
- •Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)
- •History of any non-study vaccine administration within 14 days of study vaccine administration.
- •No planned vaccines until after Day 29 (Visit 3).
- •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), 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.
- •Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.
- •Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.
- •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 participants who are pregnant or breastfeeding.
- •Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.
研究组 & 干预措施
Group D
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)
Group A
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
干预措施: IVT PCV-25 Formulation A (Biological)
Group B
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
干预措施: IVT PCV-25 Formulation B (Biological)
Group C
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
干预措施: IVT PCV-25 Formulation C (Biological)
结局指标
主要结局
Unsolicited AEs
时间窗: 28 days post-vaccination (Day 29)
Number and severity of unsolicited AEs within 28 days after vaccination by group
Solicited Local Adverse Events (AEs)
时间窗: 7 days post-vaccination (Day 8)
Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group
Solicited Systemic AEs
时间窗: 7 days post-vaccination (Day 8)
Number and severity of solicited systemic AEs within 7 days after vaccination by group
Severe Adverse Events (SAEs)
时间窗: 6 months post-vaccination (Day 169)
Number of SAEs within 6 months after vaccination by group
次要结局
- Geometric Mean Concentration (GMC) of IgG by Timepoint and Group(Baseline (Day 1) and 28 days post-vaccination (Day 29))
- Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group(28 days post-vaccination (Day 29))
- Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29(28 days post-vaccination (Day 29))
- OPA Geometric Mean Concentration Titer (GMT)(Baseline (Day 1) and 28 days post-vaccination (Day 29))
- Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group(From Baseline (Day 1) to 28 days post-vaccination (Day 29))