ACTRN12622000411741已完成2 期
COVID-19 vaccine boost to enhance immunity in healthy adults aged 18-65 (The Booster Study)
niversity of Melbourne0 个研究点目标入组 52 人开始时间: 2022年3月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Aged 18-65 years
- •Healthy with no significant immunosuppressive illnesses. These include but are not limited to:
- •- cancer or treatment of cancer or organ transplantation
- •- treatment of auto-immune or inflammatory conditions such as inflammatory arthritis or inflammatory bowel disease
- •- use of corticosteroid, TNF inhibitor, interleukins, interferons, cyclosporine or other immunosuppressive medications
- •- significant renal or liver disease
- •Two or 3 prior doses of a COVID-19 vaccine, the last dose at least 4 months prior to recruitment
- •No previous significant adverse events to 2-3 prior doses of COVID-19 vaccine, according to the criteria below. Severe grading indicates the event prevented daily activity, temperature >40.0°C or >10.0 cm in diameter for redness and swelling at the site of injection
- •- severe systemic events (fatigue, headache, fever, muscle or joint pain)
- •- severe local events (pain at injection site, redness and swelling
- •- any event requiring emergency department visit or hospitalisation
- •No prior anaphylaxis to any cause, including to prior CIVID-19 vaccines
- •No prior cardiac inflammatory condition (myocarditis, pericarditis), including to prior COVID-19 vaccines
- •Willing and available to have regular blood and saliva samples taken per the schedule of events
- •Willing to be randomly assigned to receive a booster dose of Moderna Bivalent Omicron vaccine either upon enrolment or 3 months later
- •Willing to provide a signed and dated informed consent form.
排除标准
- •Prior COVID-19 infection
- •Pregnant or breastfeeding women and women planning to become pregnant
- •Unwilling to use reliable contraception around the timing of the vaccine (one month before and one month after)
- •Receiving medication that might reduce immune responses. These include but are not limited to:
- •- systemic corticosteroids
- •- interleukins
- •- interferons
- •- cyclosporine
- •- systemic chemotherapy
研究者
相似试验
尚未招募
不适用
Immunogenicity and safety COVID-19 vaccine in healthy adults: a single institute based cohort studyCOVID-19JPRN-UMIN000043589Saga University60
Unknown
不适用
The booster vaccination of the COVID-19 vaccine and its effect for preventing death in COVID-19 infected patients hospitalized in Si Sa Ket HospitalBooster dose of covid-19 vaccine can prevent death in hospitalized with covid-19 casesefficacycovid-19 vaccinebooster immunizationTCTR20230622004/A1,855
进行中（未招募）
1 期
COVID-19 vaccine induced immune response in patients with primary antibody deficiencyCOVID-19EUCTR2021-004891-33-FITurku University Hospital50
已完成
Unknown
Efficacy and safety evaluation of PPCE for immune enhancement in healthy adults.KCT0008678MnF Korea30
进行中（未招募）
1 期
Vaccination for immune recovery following sepsisMedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestationsSepsisEUCTR2017-002236-17-GBGuy's and St Thomas' NHS Foundation Trust214