Fourth Dose of Pfizer mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Detection of neutralizing antibodies
研究概览
简要总结
This study is a multi-centre, blinded, randomized controlled trial. LTCF residents ≥ 65 years who have received three doses of mRNA vaccine will be randomized to vaccination with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine or to vaccination with a control (Prevnar-13 vaccine).
详细描述
The primary objective of this study is to test whether vaccinating LTCF residents ≥65 years with a fourth dose of Pfizer-BioNtech mRNA- COVID-19 vaccine as compared to control (PCV13) leads to an increase in detectable neutralizing antibodies. Participants will be randomized to receive either the Pfizer COVID-19 vaccine or the Pnemoccocal Prevnar-13 vaccine at baseline after bloodwork is drawn. Another blood sample will be taken 28 days later. After completion of the study, participants in the control group (pneumococcal Prevnar-13 vaccine) will be given a fourth dose of mRNA COVID-19 vaccine and will have their blood drawn 28 days post-vaccination.
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, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, laboratory staff, safety monitoring committee and research assistants will be blinded. To maintain blinding of the participants, those allocated to the control will receive .5ml Prevnar-13 vaccine to mimic mRNA vaccine. Study vaccine will be administered by unblinded nurses.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LTCF residents ≥ 65 years who have received three doses of mRNA vaccine.
排除标准
- •Immunocompromised individuals due to known or suspected immunodeficiency or due to receipt of immunosuppressive medication (e.g., steroids, biologics).
- •Having had a severe adverse reaction (e.g., anaphylactic allergy) to mRNA or pneumococcal vaccine.
- •Having received pneumococcal polysaccharide vaccine within 12 months.
- •LTCF residents who have an interval less than 3 months from their third mRNA COVID vaccine dose.
研究组 & 干预措施
Pfizer-BioNtech mRNA- COVID-19
Eligible participants will be vaccinated with the Pfizer-BioNtech mRNA- COVID-19. A 0.3ml dose of the vaccine will be administered intramuscularly.
干预措施: mRNA- COVID-19 (Drug)
Pneumococcal Prevnar-13
Eligible participants will be vaccinated with Pfizer Prevar-13 (pneumococcal vaccine) in a blinded manner such that the vaccination with Pfizer-BioNtech mRNA- COVID-19 will be mimicked. That is, a 0.5ml dose of the vaccine will be administered intramuscularly. After completion of the study participants in the control arm will be given a fourth dose of Pfizer-BioNtech mRNA- COVID-19.
干预措施: Prevnar13 (Drug)
结局指标
主要结局
Detection of neutralizing antibodies
时间窗: 28 days
The primary outcome of this study will be detectable neutralizing antibody to the Omicron strain of SARS-CoV-2.
次要结局
- Anti-RBD antibody titre(28 Days)
- IgA spike antibodies titre(28 Days)
- ADCC Response(28 Days)
- Total IgG spike response(28 Days)
- Total IgM spike response(28 Days)
研究者
Mark Loeb
M.D., MSc, Professor, Pathology and Molecular Medicine, and Clinical Epidemiology and Biostatistics
McMaster University