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

NCT05078905 | Recruiting

• 2 other identifiers: 10000688000688-I
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

COVID-19; Vaccination; Healthy Volunteer

Keywords

Vaccination; Pandemic; COVID-19; Pathogens; Immune Response; Natural History

Outcome Measures

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.

  throughout

Study Arms (1)

Individuals Receiving Vaccine

Individuals receiving a vaccination for an emerging infection, like SARS-CoV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals greater than 18 years of age who are scheduled to receive a initial or booster vaccination to an emerging infectious disease.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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
• Ability of subject to understand and the willingness to sign a written informed consent document
• \. 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.
• \. Willingness to return for baseline research blood collection prior to booster vaccination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Susan L Moir, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine A Seamon, R.N.

CONTACT

(301) 402-3481; cseamon@cc.nih.gov

Susan L Moir, Ph.D.

CONTACT

(301) 402-4559; sm221a@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 15, 2021
• Study Start: October 13, 2021
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2050
• Last Updated: January 22, 2026

Record last verified: 2026-01-20

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first. Genomic data will be shared following the guidelines of the Genomic Data Sharing Policy, when applicable.
• Access Criteria: Identified data in BTRIS (automatic for activities in the Clinical Center and will be available for use following the BTRIS Policy for Data Sharing and Use). De-identified or identified data with approved outside collaborators under appropriate agreements. De-identified genomic data may be shared in an NIH-funded or approved public repositories, including the Database of Genotypes and Phenotypes (dbGAP) and the use of the data within will be governed by their policies.

Locations

US (1)