COVID-19 Booster Vaccination in Persons With Multiple Sclerosis
COVID-19 Booster Vaccination in Persons With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Most potential participants had already received their booster vaccinations outside of the study
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Homologous booster
- Heterologous booster
What it measured
Main measures
Percent who test positive for COVID-19 spike protein antibodies following booster
4-6 weeks
Other measures (3)
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
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
1. Diagnosis of clinically definite multiple sclerosis (CDMS) by the 2017 McDonald Criteria 38; 2. Age greater than or equal to 18 years; 3. Ability to travel to Griffin Hospital for phlebotomy and booster vaccination; 4. 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); 5. Prior negative test for COVID-19 spike protein antibodies using a commercial assay; 6. Willing to undergo a booster vaccination with either BNT162b2, mRNA-1273 or Ad26.COV2.S.
Exclusion criteria
1. Inability to give consent; 2. Non-fluency in English; 3. Inability to adhere to the protocol; 4. Anticipated life expectancy of less than six months; 5. Lack of a primary care physician or treating neurologist; 6. Taking an immunosuppressive medication or chemotherapy for any other conditions aside fromMS; 7. Presence of another autoimmune condition requiring treatment; 8. Active treatment for cancer; 9. History of heavy alcohol use within the past year, as defined by the following criteria: 1. Men: 5 or more alcoholic beverages per session or per day, or 15 or more per week; 2. Women: 4 or more alcoholic beverages per session or per day, or 8 or more per week; 10. History of illicit drug abuse, e.g., cocaine, heroin, PCP, and/or narcotics within the past year; 11. 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. 12. Anaphylactic or other severe reaction to a previously administered COVID-19 vaccine; 13. MS relapse or worsening symptoms after initial COVID-19 vaccination. 14. Positive urine pregnancy test at screening [women only]. Test is waived in women who are post-menopausal or incapable of conception.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, Garonzik-Wang JM. Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients. JAMA. 2021 Jun 1;325(21):2204-2206. doi: 10.1001/jama.2021.7489.Background
Kennedy NA, Lin S, Goodhand JR, Chanchlani N, Hamilton B, Bewshea C, Nice R, Chee D, Cummings JF, Fraser A, Irving PM, Kamperidis N, Kok KB, Lamb CA, Macdonald J, Mehta S, Pollok RC, Raine T, Smith PJ, Verma AM, Jochum S, McDonald TJ, Sebastian S, Lees CW, Powell N, Ahmad T; Contributors to the CLARITY IBD study. Infliximab is associated with attenuated immunogenicity to BNT162b2 and ChAdOx1 nCoV-Background
Wu GF, Alvarez E. The immunopathophysiology of multiple sclerosis. Neurol Clin. 2011 May;29(2):257-78. doi: 10.1016/j.ncl.2010.12.009.Background
Popescu BF, Pirko I, Lucchinetti CF. Pathology of multiple sclerosis: where do we stand? Continuum (Minneap Minn). 2013 Aug;19(4 Multiple Sclerosis):901-21. doi: 10.1212/01.CON.0000433291.23091.65.Background
Weissert R. The immune pathogenesis of multiple sclerosis. J Neuroimmune Pharmacol. 2013 Sep;8(4):857-66. doi: 10.1007/s11481-013-9467-3. Epub 2013 May 10.Background
Doshi A, Chataway J. Multiple sclerosis, a treatable disease. Clin Med (Lond). 2016 Dec;16(Suppl 6):s53-s59. doi: 10.7861/clinmedicine.16-6-s53.Background
Zheng C, Kar I, Chen CK, Sau C, Woodson S, Serra A, Abboud H. Multiple Sclerosis Disease-Modifying Therapy and the COVID-19 Pandemic: Implications on the Risk of Infection and Future Vaccination. CNS Drugs. 2020 Sep;34(9):879-896. doi: 10.1007/s40263-020-00756-y.Background
Ciotti JR, Valtcheva MV, Cross AH. Effects of MS disease-modifying therapies on responses to vaccinations: A review. Mult Scler Relat Disord. 2020 Oct;45:102439. doi: 10.1016/j.msard.2020.102439. Epub 2020 Aug 1.Background
Brownlee WJ, Altmann DR, Prados F, Miszkiel KA, Eshaghi A, Gandini Wheeler-Kingshott CAM, Barkhof F, Ciccarelli O. Early imaging predictors of long-term outcomes in relapse-onset multiple sclerosis. Brain. 2019 Aug 1;142(8):2276-2287. doi: 10.1093/brain/awz156.Background
Altmann DM, Douek DC, Boyton RJ. What policy makers need to know about COVID-19 protective immunity. Lancet. 2020 May 16;395(10236):1527-1529. doi: 10.1016/S0140-6736(20)30985-5. Epub 2020 Apr 27. No abstract available.
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History
Started
Oct 2021
Main results due
May 2022
Finished
May 2022