A study assessing how people with immune system deficiencies or dysregulations respond to Covid-19 vaccination has begun enrolling participants at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The single-site study is led by researchers from the National Institute of Allergy and Infectious Diseases (NIAID) and aims to enrol 500 people, 400 with primary or secondary immune system disorders and 100 without such conditions.
“Through large Phase III trials, several experimental Covid-19 vaccines were shown to be safe and effective and three are now authorised by the US Food and Drug Administration for emergency use in the United States,” said NIAID Director Anthony Fauci. “People with immune disorders are typically excluded from trials of experimental vaccines, and this was the case in the Covid-19 vaccine trials. This new study will characterise the features and adequacy of immune responses to Covid-19 vaccination in people with a range of immune deficiencies and dysregulation syndromes and will provide valuable information about benefits and potential risks in these individuals.”
“Currently, there are few published studies on the incidence and clinical presentation of Covid-19 disease in people who have immune deficiencies, especially those who have inborn conditions involving deficits or dysregulations in antibody or cell-based immune responses to infections,” said study principal investigator Emily Ricotta of the NIAID Laboratory of Clinical Immunology and Microbiology. “Our study aims to fill this knowledge gap.”
Potential volunteers may be identified and invited to join the new study through existing NIH study protocol pools of healthy volunteers or via existing protocols involving persons with immune system disorders. Healthcare providers also may refer their patients with immune deficiencies or dysregulation conditions for enrolment. Initially, the study will enrol participants 16 years of age and older, unless Covid-19 vaccines are authorised for use in younger people in the future, in which case the enrolment age criterion could expand to include them.
Study participants can receive any authorised Covid-19 vaccine in their local communities. Depending on which manufacturer’s vaccine a participant receives, additional blood samples will be collected between 14 and 28 days after the first dose.
Participants also will have the option to be screened for SARS-CoV-2 infections following vaccination using at-home saliva collection kits that they will return to the NIH biweekly for six months.
“The information we gather on how well Covid-19 vaccines protect these specific populations and about any adverse events experienced by those with immune dysregulation or other disorders will aid decision-making about vaccination,” said Steven Holland, Director of the NIAID Division of Intramural Research, and the study’s medically responsible principal investigator.