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

Recruiting

• Conditions: COVID-19; Healthy Volunteer; Vaccination

• Registration Number: NCT05078905
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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Detailed Description

Study Description: This protocol will enroll up to 200 adults per year who are scheduled to be vaccinated against severe acute respiratory syndromecoronavirus 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:

1. Evaluate baseline correlates of immune response to vaccination.

2. Correlate cellular and serologic responses after vaccination.

3. For vaccines that require two or more doses; characterize the immunologic responses following both the primary (new) and the secondary (booster) dose(s).

4. 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.

Study Timeline

• Study Start: 2021-10-13
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-15
• Status Verified: 2024-10-01
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Primary Completion: 2050-01-01
• Study Completion: 2050-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.	throughout	Establish immunologically well characterized cohorts of primary and secondary vaccinated individuals.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States