2025-524374-42-00招募中2 期
Immunogenicity and safety of two respiratory syncytial virus vaccine strategies in lung and allogeneic haematopoietic stem cell transplant recipients: A phase 2 trial RSVaxID
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 16
- 主要终点
- Proportion of participants in each group who achieve a seroresponse one month after completion of vaccination (V2). A seroresponse is defined as either (1) seroconversion or (2) a ≥4-fold rise in RSVpreF-binding serum IgG concentration from baseline, as measured by enzyme immunoassay (EIA).
研究概览
简要总结
To evaluate the RSVpreF-binding antibody response to each of the two RSV vaccine strategies one month after completing vaccination, in two distinct subcohorts which will be separately analyzed: LTR and HSCTR
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Prior lung transplantation (including combined transplants) performed ≥3 months before the first vaccine administration (LTR) OR prior allogeneic haematopoietic stem cell transplantation performed within ≥3 months to 5 years before the first vaccine administration (HSCTR)
- •active follow-up at one of the study centres
- •age ≥18 years at inclusion
- •providing written, informed consent
排除标准
- •Previous vaccination with any licensed or investigational RSV vaccine
- •any person non affiliated to National French social security system or equivalent
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
- •Active malignant disease at inclusion (with the exclusion of non-melanoma skin cancer)
- •Receipt of immunoglobulins and/or any plasma derivatives during the period starting 90 days before the first study vaccine administration, or planned administration during the study period
- •Acute cellular graft rejection episode treated by corticosteroid boli within one month before first vaccine administration (LTR)
- •ongoing plasmapheresis for acute humoral graft rejection (LTR)
- •ongoing, acute graft-versus-host disease of grade II/III/IV (HSCTR)
- •Chronic graft-versus-host disease which is not stable for at least one month prior to first vaccine administration (HSCTR)
- •anti-CD20 and/or anti-CD52 therapy within the last 6 months
- •administration of anti-thymocyte globulin within the last 3 months;
- •any vaccine administration within two weeks before inclusion or planned receipt within two weeks following each experimental vaccine administration
- •known bleeding disorder which, in the opinion of the investigator, contraindicates intramuscular injection
- •any female participant who is pregnant, lactating or planning to become pregnant during the study period. Female participants of childbearing potential may be enrolled if they have a negative pregnancy test on the day of each vaccine administration and must agree to continue adequate contraception during 12 weeks; (Contraception is considered effective when it consists of one of the following: use of a male condom during all sexual activity and/or efficient oral hormonal contraception (better considered combined contraception) and/or an intrauterine device and/or hormone-releasing intrauterine system and/or history of bilateral tubal ligation and/or history of vasectomy, provided the male partner is the trial participant's only sexual partner and/or sexual abstinence)
- •expected unavailability for the planned study visits
- •concurrent participation in another active clinical study at the time of inclusion which includes the application of investigational products (medication, vaccine) or an interventional research using an invasive medical device during the study period
- •acute, severe febrile illness at the time of inclusion
- •any person deprived of liberty by a judicial or administrative decision
- •any person under legal protection measures
结局指标
主要结局
Proportion of participants in each group who achieve a seroresponse one month after completion of vaccination (V2). A seroresponse is defined as either (1) seroconversion or (2) a ≥4-fold rise in RSVpreF-binding serum IgG concentration from baseline, as measured by enzyme immunoassay (EIA).
Proportion of participants in each group who achieve a seroresponse one month after completion of vaccination (V2). A seroresponse is defined as either (1) seroconversion or (2) a ≥4-fold rise in RSVpreF-binding serum IgG concentration from baseline, as measured by enzyme immunoassay (EIA).
次要结局
- RSV-A and RSV-B serum 50% neutralizing geometric mean titres (GMT) and corresponding neutralizing titre geometric mean fold rises (GMFR), measured by an RSV neutralization assay [time frame: baseline (visit 1), one month after completing vaccination (V2)].
- Geometric mean concentrations (GMC) and corresponding geometric mean fold rises (GMFR) of RSVpreF-binding serum IgG, measured by standard EIA; proportion of participants in each group achieving a ≥2-fold rise in RSVpreF-binding serum IgG between baseline and visit 2, as measured by standard EIA; Log (serum dilution) for 50% signal inhibition in D25- and palivizumab-competitive EIA [time frame: baseline, pre-dose-2 (only arm B, visit 1b), v2 and one-year after first vaccine dose (v3)
- Descriptive: frequency, type and severity of local and systemic solicited adverse events within 7 days following each vaccine administration; frequency, type and severity of unsolicited adverse events within 30 days following each vaccine administration; severe adverse events and adverse events of special interest until the end of study
- Geometric mean titres (GMT) and corresponding geometric mean fold rises (GMFR) of RSVpreF-binding oral fluid IgA, measured by EIA in oral fluid [time frame: baseline, visit 2]
- Analysis of determinants of humoral immunogenicity: [Time frame: baseline, V1b, V2, V3] age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR)
- Descriptive: frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed, medically attended RSV infection episodes
- Full-length genome sequencing and sequence analysis of any clinical RSV isolate
- Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA in vaccinated participants with medically attended RSV infection [Time frame: at the time of medically attended RSV infection]
- Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA in participants with medically attended RSV infection and matched participants without medically attended RSV infection episodes [Time frame: baseline, visit 2]
研究者
CONRAD Anne
Scientific
Hospices Civils De Lyon
研究点 (16)
Loading locations...
相似试验
招募中
3 期
A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.Respiratory Syncytial Virus (RSV)NCT07543380Pfizer130
尚未招募
4 期
RSV Vaccination to Reduce Recurrent AECOPDRSVCOPDNCT07508644Chinese University of Hong Kong320
尚未招募
4 期
THRIVE - Trial of Passive Humoral RSV Immunity for Value and EffectivenessNCT07578298Menzies School of Health Research1,000
招募中
2 期
呼吸道合胞病毒 mRNA 疫苗Ⅱ期临床试验用于预防由呼吸道合胞病毒（Respiratory syncytial virus，RSV）感染引起的相关疾病CTR20252307合肥阿法纳生物科技有限公司
进行中（未招募）
1 期
呼吸道合胞病毒 mRNA 疫苗 I 期临床试验用于预防由呼吸道合胞病毒（Respiratory syncytial virus，RSV）感染引起的相关疾病CTR20243675合肥阿法纳生物科技有限公司