COVID-19 Booster Vaccination in Persons With Multiple Sclerosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percent who test positive for COVID-19 spike protein antibodies following booster
研究概览
简要总结
The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination. This group includes a significant number of persons with multiple sclerosis (PWMS), many of whom are on therapies that chronically suppress their immune function. It is unclear what advice clinicians should provide regarding COVID-19 precautions to patients who fail to develop detectable COVID-19 spike protein antibodies using standard commercially-available tests after a standard series of vaccination, or whether they should test for antibody responses to COVID-19 vaccines in the absence of guidelines. A key research question is whether, in the absence of stopping or reducing potentially immune-altering therapies, there is a way to increase the likelihood of a neutralizing antibody response to COVID-19 vaccination in PWMS who are taking immune suppressive medications.
详细描述
The goal of this study is to test whether adding booster doses of COVID-19 vaccine to PWMS can improve the immune response to COVID-19.
Specific Aims:
- To compare pre and post anti-COVID-19 immunity after a booster vaccination in PWMS who initially test negative for neutralizing antibodies to COVID-19 after initial vaccination;
- To determine how disease modifying treatments, baseline antibody panels and lymphocyte subsets associate with the efficacy of booster vaccines;
- To compare immune responses between homologous vs. heterologous booster vaccination.
Research Implications:
It is hoped that the results of this study will help guide clinical recommendations on the use of booster vaccination and whether to endorse heterologous versus homologous boosters. It is also hoped that this study will add to the growing body of data on COVID-19 immunity after vaccination in PWMS on various disease modifying treatments (DMTs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label study. No masking.
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
- •Diagnosis of clinically definite multiple sclerosis (CDMS) by the 2017 McDonald Criteria 38;
- •Age greater than or equal to 18 years;
- •Ability to travel to Griffin Hospital for phlebotomy and booster vaccination;
- •Completion of an initial COVID-19 vaccine series at least 4 weeks prior to booster randomization (i.e., two doses of either BNT162b2 or mRNA-1273, or one dose of Ad26.COV2.S);
- •Prior negative test for COVID-19 spike protein antibodies using a commercial assay;
- •Willing to undergo a booster vaccination with either BNT162b2, mRNA-1273 or Ad26.COV2.S.
排除标准
- •Inability to give consent;
- •Non-fluency in English;
- •Inability to adhere to the protocol;
- •Anticipated life expectancy of less than six months;
- •Lack of a primary care physician or treating neurologist;
- •Taking an immunosuppressive medication or chemotherapy for any other conditions aside fromMS;
- •Presence of another autoimmune condition requiring treatment;
- •Active treatment for cancer;
- •History of heavy alcohol use within the past year, as defined by the following criteria:
- •Men: 5 or more alcoholic beverages per session or per day, or 15 or more per week;
- •Women: 4 or more alcoholic beverages per session or per day, or 8 or more per week;
- •History of illicit drug abuse, e.g., cocaine, heroin, PCP, and/or narcotics within the past year;
- •Any condition that would jeopardize the safety or rights of the subject, make it unlikely for the subject to complete the study, or confound the study results.
- •Anaphylactic or other severe reaction to a previously administered COVID-19 vaccine;
- •MS relapse or worsening symptoms after initial COVID-19 vaccination.
- •Positive urine pregnancy test at screening [women only]. Test is waived in women who are post-menopausal or incapable of conception.
结局指标
主要结局
Percent who test positive for COVID-19 spike protein antibodies following booster
时间窗: 4-6 weeks
Percentage of subjects who test positive for COVID-19 spike protein antibodies following a booster vaccination.
次要结局
- Comparison of COVID-19 spike protein antibodies based on booster received(4-6 weeks)
- Comparison of COVID-19 spike protein antibodies based on disease-modifying treatment(4-6 weeks)
- Correlation of COVID-19 spike protein antibodies with B and T cell levels and immunoglobulins(4-6 weeks)