Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Oct 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how our immune system responds to vaccines, particularly those that protect against COVID-19 and other infectious diseases. Researchers want to understand why the protection from these vaccines seems to decrease over time. The trial is looking for healthy adults aged 18 and older who are either getting a new vaccine or a booster shot for COVID-19 or other emerging infections.

If you decide to participate, you'll go through a screening process that includes a medical history review and some blood and urine tests. Over the course of a year, you'll have up to eight visits, each lasting less than two hours. During these visits, you'll provide blood samples, which may be used for genetic testing, and share updates about your health. After your first visit, you’ll receive your vaccine at a location in your community, not at the research facility. It’s important to note that while the focus is currently on COVID-19, the study may expand to include other infectious diseases in the future.

Gender

ALL

Eligibility criteria

• * 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.