A Phase 1 Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 449
- 试验地点
- 5
- 主要终点
- The primary immunogenicity endpoint in stage 1 is antigen-specific antibody levels using an Ig binding assay (Ig titers) 28 days after vaccination at visit 1 in the 50- to 85-year age stratum at each vaccine group (3 SA3Ag dose levels and placebo).
研究概览
简要总结
This study is a first-in-human (Phase 1) study using three dose levels of an investigational vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to assess how safe and well tolerated SA3Ag is, but will also describe the immune response over 12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within the nose and throat.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 to 24 years or 50 to 85 years who are available for the entire duration of the study, able to be contacted by phone, and able to complete all study procedures, including completion of an electronic diary (e-diary).
- •Men and women who are able to have children, must use a reliable method of birth control for the duration of the study.
排除标准
- •Any major illness that would substantially increase the risk associated with participation in the study, or interfere with the evaluation of the study objectives - this is determined by the local physician.
- •Donation of 250 mL or more of blood within the last 3 months.
- •Condition associated with prolonged bleeding time, including subjects taking anticoagulant medication or antiplatelet therapy.
- •Any contraindication to vaccination or vaccine components.
- •Immunocompromised persons and subjects who receive treatment with immunosuppressive therapy.
- •Previous administration of S. aureus vaccination.
- •Receipt of blood products or immunoglobulins within 12 months prior to study
- •Participation in another trial (not including observational trials) within the last 30 days.
- •Study site personnel or immediate family members (first-degree relatives).
- •Women who are pregnant (as determined by urine pregnancy test) or breast-feeding.
- •Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
- •For subjects aged 65 years or older, a Mini-Mental State Examination (MMSE) score of <=21.
研究组 & 干预措施
1
SA3Ag in both stage 1 and stage 2
干预措施: Colonization swab samples (Procedure)
1
SA3Ag in both stage 1 and stage 2
干预措施: SA3Ag vaccine (Biological)
1
SA3Ag in both stage 1 and stage 2
干预措施: Blood draw (Procedure)
2
SA3Ag in stage 1 followed by placebo in stage 2.
干预措施: SA3Ag followed by Placebo (Biological)
2
SA3Ag in stage 1 followed by placebo in stage 2.
干预措施: Blood draw (Procedure)
2
SA3Ag in stage 1 followed by placebo in stage 2.
干预措施: Colonization swab samples (Procedure)
3
Placebo in both stage 1 and stage 2
干预措施: Placebo (Biological)
3
Placebo in both stage 1 and stage 2
干预措施: Blood draw (Procedure)
3
Placebo in both stage 1 and stage 2
干预措施: Colonization swab samples (Procedure)
4
SA3Ag in stage 1 and no vaccine in stage 2.
干预措施: SA3Ag with no booster in stage 2 (Biological)
4
SA3Ag in stage 1 and no vaccine in stage 2.
干预措施: Blood draw (Procedure)
4
SA3Ag in stage 1 and no vaccine in stage 2.
干预措施: Colonization swab samples (Procedure)
5
Placebo in stage 1 and no vaccine in stage 2.
干预措施: Placebo with no booster in stage 2 (Procedure)
5
Placebo in stage 1 and no vaccine in stage 2.
干预措施: Blood draw (Procedure)
5
Placebo in stage 1 and no vaccine in stage 2.
干预措施: Colonization swab samples (Procedure)
结局指标
主要结局
The primary immunogenicity endpoint in stage 1 is antigen-specific antibody levels using an Ig binding assay (Ig titers) 28 days after vaccination at visit 1 in the 50- to 85-year age stratum at each vaccine group (3 SA3Ag dose levels and placebo).
时间窗: 1 month
The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.
时间窗: 1 month
次要结局
- The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.(12 months)
- OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).(1 month)
- The secondary immunogenicity endpoints are Ig titers for each antigen (CP5, CP8, and rClfAm) 28 days after vaccination in the 18- to 24-year age stratum at each dose level cohort.(1 month)
- Ig titers for each antigen 28 days after the booster dose.(7 months)