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The LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies after receiving a complete COVID-19 vaccination, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry.
The results of the Leukemia and Lymphoma Society (LLS) COVID-19 Registry indicate that about twenty-five percent (25%) of people with blood cancer and on immunosuppressants participating in the LLS COVID-19 Registry, who received a complete COVID-19 vaccination, did not develop antibodies.
The Food and Drug Administration has authorized third doses (boosters) of the Pfizer and Moderna Covid-19 vaccines for people with weakened immune systems, in a bid to bolster their protection against infection as the highly contagious Delta variant circulates. The agency will amend the emergency-use authorizations for the two vaccines to allow immunocompromised people to get an additional dose.
Therefore the LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies as noted above, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry. Using the same design as the initial COVID-19 Registry (Protocol LLSC19-001), this amended LLS COVID-19 Registry will determine if people who have decided to receive a booster vaccination, who did not develop antibodies after receiving a complete COVID-19 vaccination will develop antibodies after a single dose booster of either the Pfizer or Moderna COVID-19 vaccination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amended LLS COVID-19 Registry | Biological | Do people with blood cancer who did not develop antibodies after a complete COVID-19 vaccination, develop antoibodies after a COVID-19 booster? |
| Measure | Description | Time Frame |
|---|---|---|
| A SARS antibody test will be paired with surveys to measure the response people with blood cancer, who did not develop antibodes after a complete COVID-19 vaccination, have to the COVID-19 booster. | Observational Study | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lymphoma and Leukemia Society | Rye Brook | New York | 10573 | United States |
ONLY De-identified data will be made available to researchers approved by The Lymphoma and Leukemia Society.
data will become available after it is de-identified and entered into a secure database. This data will be collected and made available over 10 years.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |