Focus | Research-related issues | Considerations |
---|---|---|
Measurement of humoral and cellular immunity | Measurement of antibody levels at various time-points. How do various agents impair vaccine response? |
Measure antibodies 2–4 weeks after completion of the vaccination, measure cellular response (if feasible) at the same time-point. In positive patients, measure antibodies during routine clinical follow-up (first assessment after 3 months or during routine controls?) Attributes of different immunosuppressive measures: rituximab, cyclophosphamide, azathioprine, mycophenolate mofetil, high-doses of steroids. |
Efficacy outcome | Assessment of efficacy of different vaccine platforms to prevent mild/moderate COVID-19 and especially severe/life-threatening SARS-CoV-2 infections. | Is a cellular immune response sufficient to prevent severe disease (especially in rituximab-treated patients)? Consider booster doses early after vaccination. |
Vaccination after SARS-CoV-2 infection | What is the risk of re-infection of patients following COVID-19? When is the ideal timepoint to vaccinate patients? |
Define the vaccine response in patients with pre-existing antibodies; is one dose of the respective vaccine sufficient to mount an adequate immune response or do patients need a second dose. |
Use of different vaccines (if unresponsive) | What strategy should we use in patients who fail to mount an adequate immune response? | Administration of additional doses of the same or different vaccines (“heterologous vaccination strategy”) or different routes of administration (e.g. a respiratory booster dose, if approved) may be considered. |
Safety | Systematic assessment of systemic/local reactions. Impact of COVID-19 vaccines on relapse risk/risk to develop de novo disease. |