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| Title:
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COVID-19 Booster Vaccination in Persons with Multiple Sclerosis |
| Status:
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Current |
| Topic:
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Multiple Sclerosis;COVID-19 Vaccine |
| Funding Source:
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The Connecticut Department of Public Health’s Biomedical Research Trust Fund |
| Funding Period:
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2021-2022 |
| Study Design:
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Prospective, randomized study |
| Purpose:
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Certain medications prescribed to persons with multiple sclerosis (MS) may suppress their immune systems and reduce the effectiveness of vaccines. This study will test whether adding a booster dose of one of three currently available COVID-19 vaccines to persons with MS on immune-suppressive medications can improve their immune response to COVID-19. Two of the vaccines (Pfizer and Moderna) are mRNA vaccines, while the third (Johnson & Johnson) is a DNA vaccine.
This study is designed to:
- determine immune response by testing for the spike protein antibodies to COVID-19 after receiving a booster of either an mRNA or a DNA vaccine;
- test whether receiving the same vs. different type of vaccine for a booster – relative to the type of vaccine received initially - is more likely to produce an immune response;
- test whether certain MS medications are more or less likely to affect response to a booster vaccine;
- test whether the levels of lymphocytes (T or B cells) and total antibodies affect the likelihood of a response to a booster vaccine.
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| Further Study Details:
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Study participants will be randomized to receive a booster dose of either a homologous vaccine or a heterologous vaccine. This means the Johnson & Johnson vaccine if they originally received the Pfizer or Moderna vaccine, or vice versa.
At the first visit, participants will provide information on their medication history and course of their MS, undergo a neurological evaluation, have a blood sample taken, and receive a booster vaccination. At the second visit 4 to 6 weeks later, they will respond to questions regarding their booster vaccine experience and state of their MS, and will have a blood sample taken.
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| Eligibility:
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We plan to enroll up to 60 adults with MS. They must meet the following criteria:
- have completed an initial course of one of the three vaccines (Pfizer, Moderna, or Johnson & Johnson);
- have tested negative for CovID-19 spike protein antibodies after vaccination;
- are willing to receive one of the three available vaccines as a one-shot booster;
- women of child-bearing potential must not be pregnant.
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| Evaluation:
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Outcome measures include: • percentage of participants who test positive for COVID-19 spike protein antibodies following a booster vaccination; • comparison of percentage of participants who test positive for COVID-19 specific spike protein antibodies between those who receive homologous vs. heterologous boosters. from baseline; • comparison of percentage of participants who test positive for COVID-19 spike protein antibodies based on disease modifying treatment; • correlation of COVID-19 spike antibody presence and levels based on B and T cell subsets and overall immune globulin levels. |