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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078905
• Other study ID #: 10000688
• Secondary ID: 000688-I
• Status: Recruiting
• Start date: October 13, 2021
• Est. completion date: January 1, 2050

Study information

• Verified date: September 15, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Catherine A Seamon, R.N.
• Phone: (301) 402-3481
• Email: cseamon[@]cc.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. ...

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 1, 2050
• Est. primary completion date: January 1, 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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:

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.

EXCLUSION CRITERIA:

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Communicable Diseases, Emerging
• COVID-19
• Healthy Volunteer
• Infections
• Vaccination

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page