Background:Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effectiveagainst preventing severe disease. But the protective effects of these vaccines appear towane over time. Researchers want to learn why.Objective:To learn more about how the immune system responds to vaccines against infections likeSARS-CoV-2.Eligibility:Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or abooster shot against SARS-COV-2 or another emerging infection.Design:Participants will be screened with a medical history and blood and urine tests.Participants will have up to 8 study visits in 1 year. Each visit should last less than 2hours. At each visit, participants will give blood samples. Some blood samples will beused for genetic testing. They will also give updates on their health.After the first study visit, participants will receive either a first vaccination or abooster shot. They must get the vaccine in their community or workplace. They will notget the vaccine at NIH.This study currently focuses on SARS-CoV-2, but it will expand to other infectiousdiseases as they emerge and become the target of new vaccines....
Study Description: This protocol will enroll up to 200 adults per year who are scheduled
to be vaccinated against severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) or
other emerging pathogens.Participants will provide blood samples prior to and serially
aftervaccination. The blood will be used to perform research studies of the immune
response to primary (new) and secondary (booster) vaccines.
Objectives:
Primary Objective: Characterize longitudinal serologic and cellular responses to
vaccination to SARS-CoV-2 and other emerging
infections.
Secondary Objectives:
1. Evaluate baseline correlates of immune response to vaccination.
2. Correlate cellular and serologic responses after vaccination.
3. For vaccines that require two or more doses; characterize the immunologic responses
following both the primary (new) and the secondary (booster) dose(s).
4. Evaluate the longevity of immune responses to primary (new) and secondary (booster)
vaccination.
Endpoints: Primary Endpoint: Establish immunologically well characterized cohorts of
primary (new) and secondary (booster) vaccinated individuals.
Secondary Endpoints: Establish factors associated with longevity of serologic and
cellular responses to primary (new) and secondary
(booster) vaccination.
- INCLUSION CRITERIA:
General Inclusion Criteria for All Groups:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Stated willingness to comply with all study procedures and availability for the
duration of the study
2. Age 18 years or older
3. Hemoglobin >= 9.0 grams per deciliter (g/dL) or >= 11.2 for women who are pregnant.
4. Willingness to give consent for the storage of blood samples for research
5. Ability of subject to understand and the willingness to sign a written informed
consent document
Inclusion Criteria for Primary (New) Vaccination Group:
1. No history of having received a dose of the vaccine for the infectious disease being
studied. Subjects who have enrolled under another Laboratory of Immunoregulation
(LIR) protocol and had samples drawn prior to vaccination will also be eligible for
enrollment.
Inclusion Criteria for Secondary (Booster) Vaccination Group:
1. Willingness to return for baseline research blood collection prior to booster
vaccination.
EXCLUSION CRITERIA:
1. Current abuse of alcohol or other drugs that, in the judgement of the Principal
Investigator (PI) could interfere with patient compliance.
2. Any medical or mental health condition that, in the judgement of the PI, would make
the volunteer unable to participate in the study.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Investigator: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Contact: 800-411-1222
prpl@cc.nih.gov
Catherine A Seamon, R.N.
(301) 402-3481
cseamon@cc.nih.gov
Susan Moir, Ph.D.
(301) 402-4559
sm221a@nih.gov
Susan Moir, Ph.D., Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)