A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,609
- 试验地点
- 42
- 主要终点
- Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- •Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe Coronavirus disease 2019 (COVID-19), except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs
- •All female participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
- •Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
- •Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
排除标准
- •Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
- •Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- •Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations
- •Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
- •Participant previously received a coronavirus vaccine
研究组 & 干预措施
Group 1: Ad26.COV2.S Dose Level 1
Participants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57.
干预措施: Ad26.COV2.S (Biological)
Group 2: Ad26.COV2.S Dose Level 2
Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study.
干预措施: Ad26.COV2.S (Biological)
Group 3: Ad26.COV2.S Dose Level 3
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57.
干预措施: Ad26.COV2.S (Biological)
Group 4: Ad26.COV2.S Dose Level 4
Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study.
干预措施: Ad26.COV2.S (Biological)
Group 5: Ad26.COV2.S Dose Level 5
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57.
干预措施: Ad26.COV2.S (Biological)
Group 6: Ad26.COV2.S Dose Level 6
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57.
干预措施: Ad26.COV2.S (Biological)
结局指标
主要结局
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
时间窗: 14 days after second vaccination (at Day 71)
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
时间窗: 28 days after first vaccination (at Day 29)
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
次要结局
- Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination(28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85]))
- Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA(Day 29, Day 57, Day 71, Week 32, and Week 60)
- Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA(Day 29, Day 57, Day 71, Week 32, and Week 60)
- Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination(7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64]))
- Number of Participants With Serious Adverse Events (SAEs)(From Day 1 (post-vaccination) up to end of the study (up to 60 weeks))
- Number of Participants With Adverse Events of Special Interest (AESIs)(From Day 1 (post-vaccination) up to end of the study (up to 60 weeks))
- Number of Participants With AEs Leading to Study Discontinuation(Up to 60 weeks)
- Number of Participants With Medically-Attended Adverse Events (MAAEs)(6 months after second vaccination (up to 32 weeks))
- Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination(7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64]))