CONCOMITANT ADMINISTRATION OF LICENSED VACCINES AGAINST COVID-19 AND FLU WITH OR WITHOUT MF59 ADJUVANT: A MULTI-CENTRE, RANDOMIZED, SINGLE-BLIND CLINICAL TRIAL TO ASSESS IMMUNOGENICITY IN ADULTS AGED 65 AND OVER
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- A. Serum neutralizing antibody response (pseudotype, and whole virus neutralizing antibodies (VNAb)) to SARS-CoV-2 variants of concern (VOCs) at days 0, 10, and 28
研究概览
简要总结
The primary objective of this trial is to assess the humoral immune response elicited by a licensed COVID-19 vaccine when co-administered with a licensed MF59 adjuvanted seasonal FLU vaccine in adults aged 65 years and over, relative to the licensed COVID-19 vaccine co-administered with an unadjuvanted seasonal FLU vaccine or the COVID-19 vaccine alone.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Willingness to provide written informed consent.
- •Men or women aged 65 years or older at the time of consent.
- •Ability to comply with the trial protocol requirements
排除标准
- •Presence of any chronic disease, or history of significant disease, that might interfere with the conduct or completion of the trial. Certain conditions may be accepted if they have been stable for at least 3 months preceding the start of the trial (visit 1), such as hypertension, at discretion of the Investigator.
- •Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator.
- •Use of B-cell depleting therapy (i.e. Rituximab) within 12 months prior to vaccination, or within 90 days following vaccination
- •Reported Human Immunodeficiency Virus (HIV) infection with a CD4 lymphocyte count of < 100 cells per mm3 in the year prior to vaccination
- •Administration of immunosuppressant or immuno-modifying drugs for more than 3 months prior of trial start, or intended future use of any other immunosuppressant medication, judged by the Investigator to result in a severely reduced response to the vaccine. Asthma inhalers are exempt from this requirement.
- •Use of systemic corticosteroids ≥20 mg of prednisone per day, or equivalent within 28 days prior to vaccination, or planned treatment within 90 days following vaccination
- •Confirmed or suspected (at the discretion of the Investigator) immuno-suppressive or immuno-deficient condition.
- •Receipt of a blood transfusion, blood products, or immunoglobulins within the 3-month period preceding start of the trial (Visit 1), or planned infusion within 90 days after the end of the trial.
- •Presence of acute disease and/or fever (≥38°C measured by the oral route) at the time of vaccine administration.
- •Vaccinated with any SARS-CoV-2 vaccine, or history of documented COVID-19, within four months prior to trial vaccination
- •Vaccination with a FLU vaccine within a 6-month period preceding the start of the trial (Visit 1)
- •Vaccination other than COVID-19 or FLU within 6 months prior to trial or expected during the trial period – with the exception of the routine vaccination campaign against Pneumococcus, or vaccines administered in the context of this trial
- •Presence of any other significant findings that, in the opinion of the Investigator, would increase the risk of experiencing adverse outcomes from participating in the trial.
- •Use of any investigational drug within 90 days prior to trial entry.
结局指标
主要结局
A. Serum neutralizing antibody response (pseudotype, and whole virus neutralizing antibodies (VNAb)) to SARS-CoV-2 variants of concern (VOCs) at days 0, 10, and 28
A. Serum neutralizing antibody response (pseudotype, and whole virus neutralizing antibodies (VNAb)) to SARS-CoV-2 variants of concern (VOCs) at days 0, 10, and 28
B. Change in Geometric mean titres (GMT) of serum anti SARS-CoV-2 spike glycoprotein specific binding antibody – kinetics and magnitude at days 10, and 28, relative to those measured on Day 0
B. Change in Geometric mean titres (GMT) of serum anti SARS-CoV-2 spike glycoprotein specific binding antibody – kinetics and magnitude at days 10, and 28, relative to those measured on Day 0
C. Longevity of humoral responses as measured by serum neutralizing antibody response (pseudotype, and whole VNAb) and binding antibody response to SARS-CoV-2 VOCs at day 90.
C. Longevity of humoral responses as measured by serum neutralizing antibody response (pseudotype, and whole VNAb) and binding antibody response to SARS-CoV-2 VOCs at day 90.
次要结局
- A. Characterization of cellular immunity (antigen specific cytotoxic T cells (CTL), T helper cells (Th) responses and T cell memory): ELISpot and/or intracellular cytokine staining (Flow cytometry) to SARS-CoV-2 at days 0 and 28
- B. Longevity of cellular immune responses to SARS-CoV-2 as measured by cellular immunity assays (described under a) on day 90
- Safety and reactogenicity A. The frequency and severity of solicited local (injection site) and systemic adverse events (AEs) reported within 7 days of vaccination
- Safety and reactogenicity B. All unsolicited AEs reported within 28 days of vaccination;
- Safety and reactogenicity C. All serious adverse events (SAEs) reported from day 0 until day 90 or end of trial.
研究者
Nick van den Bulk
Scientific
Cr2o B.V.