Rye Brook, N.Y., July 15, 2021—The Leukemia & Lymphoma Society® (LLS) began recruitment this week for a new study evaluating T-cell immune response to COVID-19 vaccine among people with a current or past diagnosis of blood cancer. This invitation-only follow-up study will include a sub-set of participants from a larger LLS study examining COVID-19 spike antibody response to vaccination. Both studies are being conducted as part of the LLS National Patient Registry, a project of the Michael J. Garil Patient Data Collective.
Together, these studies will provide important information about two ways people with blood cancers respond to vaccines. The first is by producing antibodies, which is done by the immune system’s B cells. The second is through a response from the immune system’s T-cells, which create the “killer cells” that are the first line of defense against infections like COVID-19. The studies include patients with all types of blood cancers who are on active treatment, post-treatment, or in a “watch and wait” period.
People with and without a measurable antibody response in the larger study are being asked to join the T-cell study. Invitees also represent a diverse cross-section of patients to help LLS learn more about whether age, race, and ethnicity affect immune response to COVID-19 vaccination. Unlike in the antibody study, participants in the T-cell study will not receive individual results. Current T-cell tests are valuable for researchers examining population-based trends but are not approved for individual clinical decision making.
These trials are needed because the COVID-19 vaccine clinical trials leading to authorization for their use in the U.S. essentially excluded people with current or past cancer diagnoses. This has left blood cancer patients, who are at greatly increased risk of serious outcomes and death from COVID-19, without important information about how well the vaccines will protect them. LLS urges blood cancer patients to get vaccinated, unless they have a vaccine contraindication per their healthcare provider, which is rare, but they should also continue following prevention protocols, including masking, social distancing, frequent handwashing, and avoiding crowds and poorly ventilated indoor spaces, even after they have been vaccinated.
Analysis of the data generated on antibody immune response is expected to be available later in 2021. Timing for the T-cell study results will be determined following completion of the study recruitment and collection of the blood samples needed to measure T-cell response. LLS recently published preliminary safety findings from the antibody study.
In addition to collecting blood samples before and after vaccination to test antibody response, the study collected data on vaccine adverse events. Preliminary findings from 3,574 blood cancer patients and survivors show that their self-reported vaccine side effects closely mirror the side effects among healthy volunteers who took part in the vaccine clinical trials (the most common reactions were a sore arm, tiredness, and headache). This should help reassure individuals yet to be vaccinated about vaccine safety and tolerability.