COVID-19 Booster Vaccination in Persons With Multiple Sclerosis
Stopped early · Early Phase 1
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05081271
- Run by
- Griffin Hospital
- People needed
- 10
- Starts
- 2021-10-15
- Expected to finish
- 2022-05-30
- Last updated by the study team
- 2022-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Griffin Hospital — Derby, Connecticut, United States
Full record on ClinicalTrials.gov
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