NCT07220109进行中（未招募）3 期
A Phase 3, Randomized, Controlled, Observer Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 15
- 主要终点
- RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs)
研究概览
简要总结
The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.
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)
盲法说明
Observer blind study: participants the site and sponsor personnel involved in the clinical evaluation of the participants are blinded while the treatment is administered by unblinded study personnel who will not participate in data collection evaluation or review of any study endpoint.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
- •A male or female participant 18-59 YOA at the time of the study intervention administration.
- •Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable* by the investigator:
- •A stable condition is defined as a disease not requiring significant change (based on the investigator's opinion) in therapy or worsening during the 3 months before enrollment.
- •Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long-term medication: oChronic obstructive pulmonary disease (COPD)
- •Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade 2-4 oAsthma
- •Patient on Maintenance and Reliever Therapy (MART) OR with at least one rescue treatment per week (excluding exercise asthma) oCystic fibrosis oOther chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis oChronic heart failure:
- •A minimum of class II symptoms according to New York Heart Association classification of heart failure oPre-existing CAD (CAD not otherwise specified)
- •Physician diagnosis of CAD based on electrocardiogram, exercise stress test, nuclear stress test, cardiac computed tomography scan or cardiac angiogram (more than the presence of hypercholesterolemia) oCardiac arrhythmia
- •Patient diagnosed with a cardiac arrythmia that require medical support either pharmacologically or with a medical device -Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
- •Other diseases at increased risk for RSV disease oChronic kidney disease
- •G2-G3 disease (Glomerular Filtration Rate between 30 and 90 mL/min/1.73 m2) oChronic moderate to severe liver disease
- •Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
- •Female participants of childbearing potential may be enrolled in the study, if the participant:
- •has practiced adequate contraception from 1 month prior to study intervention administration, and
- •has a negative pregnancy test on the day of study prior to intervention administration, and
- •has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.
排除标准
- •Medical conditions
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention
- •Unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.
- •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Contact, Month 6).
- •Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.
- •Previous vaccination with any RSV vaccine, including investigational RSV vaccines.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the EOS.
- •Up to 3 months prior to the study intervention administration:
- •oFor corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed oAdministration of immunoglobulins and/or any blood products or plasma derivatives -Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy, monoclonal antibodies, antitumoral medication.
- •Prior/Concurrent clinical study experience
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).
- •Other exclusion criteria
- •History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- •Bedridden participants.
- •Planned move during the study conduct that prohibits participation until study end.
- •Participation of any study personnel or their immediate dependents, family, or household members.
- •Pregnant or lactating female participant.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.
研究组 & 干预措施
RSV AIR group
Experimental
Participants at increased risk (AIR) of RSV disease will receive a single dose of investigational RSVPreF3 OA investigational vaccine on Visit 1 (Day 1).
干预措施: RSVPreF3 OA vaccine (Biological)
Placebo AIR group
Placebo Comparator
Participants AIR of RSV disease will receive a single dose of Placebo on Visit 1 (Day 1).
干预措施: Placebo (Biological)
结局指标
主要结局
RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs)
时间窗: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
The serum neutralizing titers are expressed in Estimated Dilution (ED60). The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
RSV-A neutralizing titers expressed as group Seroresponse rate (SRR)
时间窗: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
The SRR is defined as the proportion of participants having a 4-fold increase in neutralizing titers. The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
RSV-B neutralizing titers expressed as group GMTs
时间窗: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
The serum neutralizing titers are expressed in ED60. The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
RSV-B neutralizing titers expressed as group SRR
时间窗: At Day 31 (i.e., 1 month after RSVPreF3 OA investigational vaccine administration)
The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
次要结局
- RSV-A and RSV-B neutralizing titers expressed as group GMTs(At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration))
- RSV-A and RSV-B neutralizing titers expressed as group SRR(At Day 31 and at Month 6 (i.e., 1 month and 6 months after RSVPreF3 OA investigational vaccine administration))
- Duration of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD episodes, assessed for all the groups of the current study(Day 1 to Month 6 of the current study)
- Number of participants with RT-PCR-confirmed RSV A and/or B-associated acute respiratory illness (ARI) and lower respiratory tract disease (LRTD), assessed for all groups of the current study(Day 1 to Month 6 of the current study)
- Number of participants reporting symptoms/signs of RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD, assessed for all the groups of the current study(Day 1 to Month 6 of the current study)
- Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by severity, assessed for all the groups of the current study(Day 1 to Month 6 of the current study)
- Number of participants with RT-PCR-confirmed RSV A and/or B-associated ARI and LRTD by frailty status, assessed for all the groups of the current study(Day 1 to Month 6 of the current study)
- Number of participants with each solicited administration site event assessed for all the groups of the current study(Day 1 to Day 7 of the current study)
- Number of participants with each solicited systemic event assessed for all the groups of the current study(Day 1 to Day 7 of the current study)
- Number of participants with unsolicited adverse events (AEs) assessed for all the groups of the current study(Day 1 to Day 30 of the current study)
- Number of participants with serious adverse events (SAEs) assessed for all the groups of the current study(Day 1 up to study end (Month 6) of the current study)
- Number of participants with potential immune-mediated disease (pIMDs) assessed for all the groups of the current study(Day 1 up to study end (Month 6) of the current study)
研究者
研究点 (15)
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