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Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

CompletedN/A

Sponsor: Biomedical Advanced Research and Development Authority

Conditions: COVID-19

Interventions: Remote study participation and self-collection of specimens, Traditional clinical trial participation with clinician-collected specimens

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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.

Locations (16)

Vestavia Hills, Alabama, United States
Mesa, Arizona, United States
Fair Oaks, California, United States
Los Angeles, California, United States
San Diego, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Lenexa, Kansas, United States
Owensboro, Kentucky, United States
Boston, Massachusetts, United States
Lincoln, Nebraska, United States
Syracuse, New York, United States
Blue Ash, Ohio, United States
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States