Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

Description

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 timepoints 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

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Study Overview

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Study Details

Study overview

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 timepoints 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.

Longitudinal Assessment of Potential Immunologic Correlates of Risk and Protection Following COVID-19 Vaccination Comparing Remote and Site-based Specimen Collection (feasibility, Validity, and Proof of Concept)

Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

Condition
COVID-19
Intervention / Treatment

-

Contacts and Locations

Fair Oaks

Apex Research Group, Fair Oaks, California, United States, 95628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * Pregnant individuals (only exclusionary for the peripheral blood mononuclear cells \[PBMCs\] blood draws portion of the study)
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Biomedical Advanced Research and Development Authority,

Study Record Dates

2026-07