Clinical trial NCT06776367: Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: COVID-19
Pandemic Preparedness
COVID-19 vaccine
immune correlates
self-collected
feasibility
Lead sponsor: Biomedical Advanced Research and Development Authority
Sponsor class: FED
Collaborators: name: Fred Hutchinson Cancer Center
name: Allucent (NL) BV
First posted: 2025-01-15
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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 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.

Detailed description: This is a non-interventional, minimal-risk, observational study to determine correlates of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population. Most participants will be remotely consented, screened, enrolled, and randomized outside of a physical clinical research site. Participants will be screened for study participation from Days -14 to -1 either remotely or at a clinical research site. After screening, eligible participants will be enrolled and will be randomized to one of two groups. Participants randomized to Group A (n\~200) will be evaluated at a traditional clinical research site to include site visits for venous blood and saliva specimens to be collected by appropriately trained site personnel within 7 days of enrollment and again at approximately Months 1, 3, 6 and 12. Participants randomized to Group B (n\~3800) will undergo fully remote evaluation to include self-collection of capillary blood and saliva specimens occurring within 7 days of enrollment, after receipt of the self-collection sample kits/wearable device. Self-collection will be aided by the electronic Clinical Outcome Assessment (eCOA) platform and/or virtual telehealth visits with the site staff and will occur within 7 days of enrollment and approximately at Months 1, 3, 6, and 12 to mirror group A visits.

Though not part of the study, participants will be required to obtain a currently FDA-approved or -authorized COVID-19 vaccine as part of the inclusion criteria. Participants will be followed for 12 months from receipt of vaccination. Both groups will be surveilled with weekly queries for COVID-19 like symptoms for the duration of the study using an eCOA application on the participant's tablet or smartphone. Should Group A participants identify the presence of COVID-19 like symptoms they will be prompted to schedule an acute visit with their respective site where site staff will collect a nasal swab for PCR to confirm COVID-19 disease. Should Group B participants identify the presence of COVID-19 like symptoms they will be prompted to schedule an acute telehealth visit with their respective site and then self-collect a nasal swab for PCR to confirm COVID-19.

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.

Primary outcomes:
measure: 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)
timeFrame: From Enrollment through Day 366
Secondary outcomes:
measure: Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population (across Groups A and B)
timeFrame: From Enrollment through Day 366
measure: 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)
timeFrame: From Enrollment through Day 366
measure: Assess the feasibility of gathering valid remote self-collected specimens (across Groups A and B)
timeFrame: From Enrollment through Day 366
measure: Assess safety of an FDA authorized/approved COVID-19 vaccine (across Groups A and B)
timeFrame: From Enrollment through Day 181
Other outcomes:
Locations:
city: Fair Oaks
country: United States
facility: Apex Research Group
state: California
Study officials:
References: