At-Home COVID-19 vaccine study could change how trials are done
NCT ID NCT06776367
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study looks at whether people can reliably collect their own blood and saliva samples at home to measure how well COVID-19 vaccines work. About 4,000 adults who recently got a COVID-19 vaccine will either do everything remotely or visit a clinic. Researchers will compare the results to see if at-home collection is a good alternative to in-person visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could make future vaccine studies easier and more convenient by allowing people to participate from home.
- What could go wrong
- This is an observational study, not testing a new treatment. It focuses on feasibility, so it may not directly improve vaccines or health outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,753 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Aug 2026
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Accel Research Site Networks - Birmingham CRU / Elite
Vestavia Hills, Alabama, 35216, United States
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Alcanza / hyperCORE
Boston, Massachusetts, 02131, United States
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Apex Research Group
Fair Oaks, California, 95628, United States
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Be Well Clinical Studies / Elite
Lincoln, Nebraska, 68516, United States
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Desert Clinical Research
Mesa, Arizona, 85213, United States
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Emory University
Atlanta, Georgia, 30322, United States
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Johnson County Clinical Trials (JCCT)
Lenexa, Kansas, 66219, United States
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Kroger The Little Clinic (Remote Site)
Blue Ash, Ohio, 45242, United States
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Lynn Health Science Institute East / Elite
Oklahoma City, Oklahoma, 73112, United States
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Research Institute of South Florida
Miami, Florida, 33173, United States
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Research Integrity / WCG
Owensboro, Kentucky, 42303, United States
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SUNY / Upstate Medical University Global Health Institute
Syracuse, New York, 13057, United States
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Wake Research Atlanta
Atlanta, Georgia, 30328, United States
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Wake Research Dallas
Dallas, Texas, 75246, United States
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Wake Research Encino
Los Angeles, California, 91316, United States
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Wake Research San Diego
San Diego, California, 92111, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Home antibody tests put to the test: can you read your own COVID-19 result?
- Can lung ultrasound reveal COVID-19's signature in the lungs?
- When the immune system Can't fight back: tracking three respiratory viruses
- The household maze: how does COVID-19 move between family members?
- Can an oral drug stop COVID-19 from turning deadly?
- Can COVID-19 rapid tests slip into HIV and TB clinics without disrupting care?