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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Immune Response;
Natural History

Recruitment Keyword(s)



Healthy Volunteer

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases


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.


To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2.


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.


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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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.


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.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Susan Moir, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6A02
10 Center Drive
Bethesda, Maryland 20892
(301) 402-4559

Catherine A. Seamon, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 8C404
10 Center Drive
Bethesda, Maryland 20892
(301) 402-3481

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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