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

Longitudinal Observations of 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.

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Study Overview

• Status: Recruiting
• Conditions: COVID-19; Healthy Volunteer; Vaccination

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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Catherine A Seamon, R.N.; Phone Number: (301) 402-3481; Email: cseamon@cc.nih.gov
• Study Contact Backup: Name: Susan Moir, Ph.D.; Phone Number: (301) 402-4559; Email: sm221a@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Individuals Receiving Vaccine; Individuals receiving a vaccination for an emerging infection, like SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Susan Moir, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2050

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 15, 2023

More Information

Terms related to this study

• Keywords: Natural History; COVID-19; Vaccination; Immune Response; Pandemic; Pathogens
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Communicable Diseases, Emerging
• Other Study ID Numbers: 10000688; 000688-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .Identified data in BTRIS (automatic for activities in the Clinical Center).@@@@@@De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. De-identified data may be shared in an NIH-funded or approved public repositories, including the Database of Genotypes and Phenotypes (dbGAP) or in NCBI Virus Portal for viral sequencing.
• IPD Sharing 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.
• IPD Sharing 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.@@@@@@01
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No