Assessing immune responses to COVID-19 vaccines through remote participation
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)
This study is testing how well COVID-19 vaccines work by collecting blood and saliva samples from vaccinated people at home over a year to see if they can predict who might get sick.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biomedical Advanced Research and Development Authority Federal |
| Locations | 1 site (Fair Oaks, California) |
| Trial ID | NCT06776367 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate immunological biomarkers from blood samples to predict the effectiveness of COVID-19 vaccines against symptomatic cases. Participants will be enrolled after receiving a COVID-19 vaccine and will provide saliva and blood samples remotely over a 12-month period. The study will assess the feasibility of self-collected specimens and virtual consultations, allowing participants to engage without frequent in-person visits. Weekly symptom reporting and nasal swab testing will also be conducted to monitor COVID-19 symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have completed an FDA-approved COVID-19 vaccination series.
Not a fit: Patients who have not received a COVID-19 vaccine or are unable to comply with remote participation requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of vaccine efficacy and improve pandemic preparedness.
How similar studies have performed: Other studies have successfully utilized remote participation and self-collection methods, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fair Oaks, California
- Apex Research Group — Fair Oaks, California, United States (Recruiting)
Study contacts
- Study coordinator: Jessica Andriesen, PhD
- Email: jandries@fredhutch.org
- Phone: 206-667-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.