Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

NCT06776367 | Active Not Recruiting

• 2 other identifiers: BP-24-00175A50123D00005.
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 16

Brief Summary

This trial is designed to assess immunological biomarkers measured from blood samples that can be used to reliably predict how well vaccines work against symptomatic COVID-19 as well as to evaluate the feasibility of remote, self-collected specimens when conducting a correlates analysis. For a lot of research studies, people need to go to the study doctor's office regularly. For this study, we want to see if it is okay that people do the study doctor visits virtually, fill out questionnaires electronically, and collect their own samples remotely. Participants will enroll in the study after receiving a COVID-19 vaccine in their community, and saliva and blood specimens will be collected at pre-defined time-points over a 12-month period. Additionally, participants will report weekly whether they experience symptoms of COVID-19, and if so, will be prompted to collect a nasal swab for testing. Most participants will complete all activities remotely and via electronic communications, but a small number will complete activities in person at the doctor's office to provide a comparison group. Samples from the study will be analyzed to determine whether the biomarkers can be measured, and data from the study will be used to evaluate the feasibility of doing the specimen and data collection without the participant going to the doctor's office in person.

Conditions

COVID-19

Keywords

COVID-19; Pandemic Preparedness; COVID-19 vaccine; immune correlates; self-collected; feasibility

Outcome Measures

Primary Outcomes (1)

• Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population using self-collected specimens (Group B only)

  Serum S protein-specific binding antibody (bAb) concentrations (peak and exposure-proximal assessments) * Serum SARS-CoV-2 specific neutralizing antibody (nAb) titers (peak and exposure-proximal assessments) * COVID-19: Virologically confirmed SARS-CoV-2 infection (by qualitative reverse transcriptase polymer chain reaction \[PCR\]), along with one or more of the following: fever, chills, cough, headache, fatigue, diarrhea, new loss of taste or smell, sore throat, congestion, runny nose, nausea or vomiting, shortness of breath or difficulty breathing, or muscle or body ache

  From Enrollment through Day 366

Secondary Outcomes (4)

• Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population (across Groups A and B)

  From Enrollment through Day 366

• Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine against severe disease in a heterogeneous US population (Group B only)

  From Enrollment through Day 366

• Assess the feasibility of gathering valid remote self-collected specimens (across Groups A and B)

  From Enrollment through Day 366

• Assess safety of an FDA authorized/approved COVID-19 vaccine (across Groups A and B)

  From Enrollment through Day 181

Study Arms (2)

Group A

In-clinic study visits and clinic-collected specimens

Other: Traditional clinical trial participation with clinician-collected specimens

Group B

Fully remote evaluation and self-collected specimens

Other: Remote study participation and self-collection of specimens

Interventions

Remote study participation and self-collection of specimens OTHER

Participants in Group B will complete all study procedures remotely and will not physically visit any clinical research site. This will include telehealth (videoconference) visits with study personnel, self-collection of specimens, shipping of specimens using pre-labeled packaging, and completion of electronic diaries for data collection.

Group B

Traditional clinical trial participation with clinician-collected specimens OTHER

Participants in Group A will attend study visits in person at a clinical research site and will have the majority of specimens collected by a clinician at the clinic. Group A participants will have some electronic diary usage.

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population: approximately 4,000 individuals in the US with the following considerations: * Target 25% of participants ≥65 years of age * Appropriate representation of participants at high risk for severe COVID-19 * Appropriate representation of racially and ethnically diverse populations

You may qualify if:

• Are willing and able to provide voluntary electronic informed consent (eConsent) to participate in the study and written authorization (via electronic signature) for use and disclosure of protected health information
• Are able to understand and comply with planned study procedures, including specimen collection devices, use of eCOA application on a tablet or smartphone, and the wearable biometric device.
• Are ≥18 years old at time of informed consent
• Are available for all study data collection timepoints
• Completed primary approved/authorized COVID-19 vaccination series, defined as previous receipt of one of the following options:
• Doses of original monovalent mRNA or bivalent mRNA vaccine or a combination of the two,
• Doses of original monovalent Novavax COVID-19 Vaccine, alone or in combination with any mRNA vaccine doses; or
• Doses of Janssen COVID-19 Vaccine, alone or in combination with any mRNA or Original monovalent Novavax vaccine doses.
• Receipt of an FDA licensed/authorized COVID-19 vaccine within the previous 14 days or on the day of enrollment

You may not qualify if:

• Receipt or planned receipt of any of the following vaccines, on the same day or within 28 days prior to or after receipt of the FDA licensed/authorized COVID-19 vaccine:
• Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
• Receipt of COVID-19 vaccine within 120 days prior to current vaccine
• Any disease or medical condition that, in the opinion of the Investigator or appropriate sub-investigator, is a contraindication to study participation
• Currently participating or plans to participate in another clinical trial that is interventional and/or involving an investigational product.
• Are assessed by the Investigator as unsuitable for participation in this study for any reason.

Sponsors & Collaborators

• Biomedical Advanced Research and Development Authority: lead
• Fred Hutchinson Cancer Center: collaborator
• Allucent: collaborator

Study Sites (16)

Accel Research Site Networks - Birmingham CRU / Elite

Vestavia Hills, Alabama, 35216, United States

Location

Desert Clinical Research

Mesa, Arizona, 85213, United States

Location

Apex Research Group

Fair Oaks, California, 95628, United States

Location

Wake Research Encino

Los Angeles, California, 91316, United States

Location

Wake Research San Diego

San Diego, California, 92111, United States

Location

Research Institute of South Florida

Miami, Florida, 33173, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Wake Research Atlanta

Atlanta, Georgia, 30328, United States

Location

Johnson County Clinical Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

Research Integrity / WCG

Owensboro, Kentucky, 42303, United States

Location

Alcanza / hyperCORE

Boston, Massachusetts, 02131, United States

Location

Be Well Clinical Studies / Elite

Lincoln, Nebraska, 68516, United States

Location

SUNY / Upstate Medical University Global Health Institute

Syracuse, New York, 13057, United States

Location

Kroger The Little Clinic (Remote Site)

Blue Ash, Ohio, 45242, United States

Location

Lynn Health Science Institute East / Elite

Oklahoma City, Oklahoma, 73112, United States

Location

Wake Research Dallas

Dallas, Texas, 75246, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Peripheral Blood Mononuclear Cells (PBMC), saliva, nasal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: December 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (16)