A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 8
- 主要终点
- Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
研究概览
简要总结
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
- •A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
- •Agree to not donate blood from the time of vaccination until 3 months after vaccination
- •Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
- •Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study
排除标准
- •Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
- •Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
- •History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
- •Has hepatitis B or C infection, including history of treated hepatitis C infection
- •Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
研究组 & 干预措施
Cohort 1 Group 1: RSV Vaccine
Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 1 Group 2: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 1 Group 3: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 1 Group 4: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 1 Group 5: Placebo
Participants will receive IM injection of placebo on Day 1.
干预措施: Placebo (Other)
Cohort 2 Group 6: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 2 Group 7: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 2 Group 8: Placebo
Participants will receive IM injection of placebo on Day 1.
干预措施: Placebo (Other)
Cohort 3 Group 9: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 3 Group 10: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
干预措施: RSV Vaccine (Biological)
Cohort 3 Group 11: Placebo
Participants will receive IM injection of placebo on Day 1.
干预措施: Placebo (Other)
结局指标
主要结局
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
时间窗: Until 7 days after Vaccination on Day 1 (Day 8)
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
时间窗: Until 28 days after Vaccination on Day 1 (Day 29)
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
时间窗: 14 days after vaccination on Day 1 (Day 15)
Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
时间窗: Until 7 days after Vaccination on Day 1 (Day 8)
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius).
次要结局
- Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1(At 14 days and 3 and 6 months after vaccination on Day 1)
- Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1(At 14 days and 3 and 6 months after vaccination on Day 1)
- Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1(Until 7 days after vaccination on Day 1 (Day 8))
- Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1(Until 7 days after vaccination on Day 1 (Day 8))
- Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1(At 3 and 6 months after vaccination on Day 1)
- Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1(At 14 days and 3 and 6 months after vaccination on Day 1)
- Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides(At 14 days and 3 and 6 months after vaccination on Day 1)
- Cohort 1: Number of Participants With Serious Adverse Events (SAEs)(Baseline (Day1) up to 6 months)
- Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1(Until 28 days after vaccination on Day 1 (Day 29))
- Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1(At 14 days and 3 and 6 months after vaccination on Day 1)
- Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)(Baseline (Day1 ) up to 6 months)