NCT04748471Unknown2 期
A Phase II Trial Assessing Immunogenicity and Safety of SARS-CoV-2 Vaccine mRNA-1273 in Volunteers Aged of 65 Years or More Compared to Participants 18-45 Years Old
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 主要终点
- Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera
研究概览
简要总结
This study aims to evaluate the immunogenicity of Moderna mRNA-1273 vaccine in volunteers aged 65 years or more compared to volunteers aged 18-45 years, over 24 months duration. It will provide necessary data on the early immunological response to the vaccine and its evolution in quantitative and qualitative terms. This study will allow establishing how aging influences the response to the vaccine and help to adapt the vaccinal plan. For instance it will suggest the necessity of a vaccination booster.
详细描述
Phase II, comparative, non-randomized trial assessing the immunogenicity and safety of vaccine candidate Moderna-1273 against SARS-CoV-2. A total of 180 volunteers will be included and vaccinated (2 doses, at day 1 and day 29), divided in 3 groups (60 volunteers 18 - 45 years old, 60 volunteers 65 - 74 years old, 60 volunteers at least 75 years old). Vaccinated volunteers of the three arms will be immune-monitored during 24 months via a battery of in vitro and ex vivo tests to comprehensively assess the course of humoral, cellular and mucosal immunity over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 65 years old, at least 75 years old or 18 to 45 years old, depending on the group of inclusion.
- •Healthy adults, or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
- •Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent.
- •Able to comply with study procedures based on Investigator judgement.
- •Affiliated to a social security system, (except state medical aid)
- •Exclusion criteria:
- •Subject is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit.
- •(Ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms)
- •History of documented COVID-19 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV-2+) prior to first vaccine administration
- •Subjects with positive serology to SARS-CoV-2 at the enrolment visit
- •Subjects who already received another anti-SARS-CoV-2-vaccine
- •Subjects who received BCG given within the last year.
- •An immediate family member or household member of study staff.
- •Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg/day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
- •Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
- •Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection.
- •History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rush, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2-vaccine.
- •History of severe allergic event
- •Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visits or planned before the study completion.
- •Known HIV, active HCV or HBV infection
- •Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
- •Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
- •The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
- •Any condition which in the opinion of the investigator may interfere with the aim of the study
- •Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit.
- •Woman in childbearing without efficacious contraception (in the opinion of the investigator) for 31 days after treatment (2nd vaccine injection)
- •People under legal protection measure (tutorship, curatorship or safeguard measures)
排除标准
- 未提供
结局指标
主要结局
Titers of anti-SARS-CoV-2 Spike IgG Immunoglobulin in sera
时间窗: Day 57 (28 days after second injection of mRNA-1273)
Anti-SARS-CoV-2 Spike specific IgG Immunity acquisition
次要结局
- Anti SARS-CoV -2 IgG, IgA and IgM (total and subclasses IgG1-4) as measured by ELISA.(From Day 1 to Month 24)
- Anti-SARS-CoV-2 neutralizing antibody (in vitro neutralisation assay.(From Day 1 to Month 24)
- Anti-SARS-CoV-2 -specific neutralizing antibody (Pseudo neutralisation assay using lentiviral phenotypes carrying specific SARS-Cov-2 proteins.(From Day 1 to Month 24)
- Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of antigen specific T-Cells via Mass cytometry, B cell repertoire and memory(From Day 1 to Month 24)
- Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays.(From Day 1 to Month 24)
- Functionality of mucosal sIgA and sIgM by Antibody Dependent Cellular Cytotoxicity (ADCC) assay specific for SARS-CoV-2 mucosal IgA and IgM(From Day 1 to Month 24)
- Local and systemic reactogenicity(From Day 1 to Month 24)
- Determination of autoimmunity markers such as antibodies Anti-nuclear (unit measure: titers)(From Day 1 to Month 24)
- Determination of autoimmunity markers such as antibodies Anti-ACL, Anti-β2-GP1, Rheumatoid factor (unit measure: U/L)(From Day 1 to Month 24)
- Determination of autoimmunity markers such as antibodies Anti-GM1, Anti-MAG ( unit measure: pos/ne)(From Day 1 to Month 24)
研究者
相似试验
已完成
2 期
A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) VariantsSARS-CoV-2NCT04927065ModernaTX, Inc.5,161
已完成
3 期
A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult ParticipantsSARS-CoV-2NCT04860297ModernaTX, Inc.234
进行中（未招募）
1 期
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 MonthsRespiratory Syncytial VirusHuman MetapneumovirusNCT05743881ModernaTX, Inc.186
终止
1 期
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of AgeHerpes ZosterNCT05701800ModernaTX, Inc.659
已完成
2 期
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial VirusRespiratory Syncytial VirusNCT06097299ModernaTX, Inc.349