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

• ClinicalTrials.gov Identifier: NCT05078905
• Recruitment Status: Recruiting
• First Posted: October 15, 2021
• Last Update Posted: July 11, 2022
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description

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.

...

Condition or disease
COVID-19; Vaccination; Healthy Volunteer

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 Design

• Study Type: Observational
• Estimated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
• Actual Study Start Date: October 13, 2021
• Estimated Primary Completion Date: January 1, 2050
• Estimated Study Completion Date: January 1, 2050

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

• 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.

Contacts and Locations

Contacts

Contact: Catherine A Seamon, R.N.; (301) 402-3481; cseamon@cc.nih.gov

Contact: Susan Moir, Ph.D.; (301) 402-4559; sm221a@nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center; Recruiting

Bethesda, Maryland, United States, 20892

Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT05078905
• Other Study ID Numbers: 10000688; 000688-I
• First Posted: October 15, 2021
• Last Update Posted: July 11, 2022
• Last Verified: July 5, 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: 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.@@@@@@01

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

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

Additional relevant MeSH terms:

COVID-19; Communicable Diseases; Infections; Communicable Diseases, Emerging; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes