Active, Not Recruiting

NCT Number: NCT05078905

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

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.

...

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Healthy Volunteer Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccination Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

Study Description: This protocol will enroll up to 200 adults per year who are scheduled to be vaccinated against severe acute respiratory syndromecorona virus 2 (SARS-CoV-2) or other emerging pathogens. Participants will provide blood samples prior to and serially aftervaccination. The blood will be used to perform research studies of the immune response to primary (new) and secondary (booster) vaccines.

Objectives:

Primary Objective: Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.

Secondary Objectives:

Evaluate baseline correlates of immune response to vaccination.
Correlate cellular and serologic responses after vaccination.
For vaccines that require two or more doses; characterize the immunologic responses following both the primary (new) and the secondary (booster) dose(s).
Evaluate the longevity of immune responses to primary (new) and secondary (booster) vaccination.

Endpoints: Primary Endpoint: Establish immunologically well characterized cohorts of primary (new) and secondary (booster) vaccinated individuals.

Secondary Endpoints: Establish factors associated with longevity of serologic and cellular responses to primary (new) and secondary (booster) vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

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

Inclusion criteria

for Primary (New) Vaccination Group:

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:

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.

Time frame: throughout

Establish immunologically well characterized cohorts of primary and secondary vaccinated individuals.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2050
Study completion: 2050
First posted: Oct 15, 2021
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting