Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
Background:
Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why.
Objective:
To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2.
Eligibility:
Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster 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 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health.
After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH.
This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines.
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Eligibility criteria
This trial accepts healthy volunteersQualifiers
Stated willingness to comply with all study procedures and availability for the duration of the study
Age 18 years or older
Hemoglobin >= 9.0 grams per deciliter (g/dL) or >= 11.2 for women who are pregnant.
Willingness to give consent for the storage of blood samples for research
Disqualifiers
Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
Trial population
Individuals greater than 18 years of age who are scheduled to receive a initial or booster vaccination to an emerging infectious disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,200 Participants
are grouped into 1 trial groupGroup A: Individuals Receiving Vaccine
Trial outcomes
Primary outcomes
1
Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.
Establish immunologically well characterized cohorts of primary and secondary vaccinated individuals.
Time frame
throughoutSponsors and contacts
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Source ClinicalTrials.gov