RECRUITING

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

Conditions

COVID-19 Vaccination Healthy Volunteer Pandemic Pathogens Immune Response Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

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

Quick Facts

Study Start:2021-10-13

Study Completion:2050-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05078905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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. 1. Willingness to return for baseline research blood collection prior to booster vaccination.	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.

Inclusion Criteria

Exclusion 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
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.
1. Willingness to return for baseline research blood collection prior to booster vaccination.

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.

Contacts and Locations

Study Contact

Catherine A Seamon, R.N.

CONTACT

(301) 402-3481

cseamon@cc.nih.gov

Susan Moir, Ph.D.

CONTACT

(301) 402-4559

sm221a@nih.gov

Principal Investigator

Susan Moir, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Susan Moir, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-13

Study Completion Date2050-01-01

Study Record Updates

Study Start Date2021-10-13

Study Completion Date2050-01-01

Terms related to this study

Keywords Provided by Researchers

Vaccination
Pandemic
COVID-19
Pathogens
Immune Response
Natural History

Additional Relevant MeSH Terms

COVID-19
Vaccination
Healthy Volunteer