This trial is designed to assess immunological biomarkers measured from blood samplesthat can be used to reliably predict how well vaccines work against symptomatic COVID-19as well as to evaluate the feasibility of remote, self-collected specimens whenconducting a correlates analysis. For a lot of research studies, people need to go to thestudy doctor's office regularly. For this study, we want to see if it is okay that peopledo the study doctor visits virtually, fill out questionnaires electronically, and collecttheir own samples remotely.Participants will enroll in the study after receiving a COVID-19 vaccine in theircommunity, and saliva and blood specimens will be collected at pre-defined timepointsover a 12-month period. Additionally, participants will report weekly whether theyexperience symptoms of COVID-19, and if so, will be prompted to collect a nasal swab fortesting. Most participants will complete all activities remotely and via electroniccommunications, but a small number will complete activities in person at the doctor'soffice to provide a comparison group.Samples from the study will be analyzed to determine whether the biomarkers can bemeasured, and data from the study will be used to evaluate the feasibility of doing thespecimen and data collection without the participant going to the doctor's office inperson.
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.
Other: Remote study participation and self-collection of specimens
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.
Other: Traditional clinical trial participation with clinician-collected specimens
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.
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.
Apex Research Group
Fair Oaks, California, United States
Investigator: Dr. Marsaru Oshita Principal Investigator
Contact: (279) 346-5181
info@apexresearchgroup.net
Jessica Andriesen, PhD
206-667-5000
jandries@fredhutch.org
Alan Nguyen
206-667-5000
hvtn.covpn.sdmc@hvtn.org
Not Provided