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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biomedical Advanced Research and Development Authority
- Enrollment
- 4000
- Locations
- 16
- Primary Endpoint
- 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)
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
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.
Investigators
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.
Outcomes
Primary Outcomes
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)
Time Frame: From Enrollment through Day 366
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
Secondary Outcomes
- Assess safety of an FDA authorized/approved COVID-19 vaccine (across Groups A and B)(From Enrollment through Day 181)
- 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)