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At-Home COVID-19 vaccine study could change how trials are done

NCT ID NCT06776367

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

1,753 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Accel Research Site Networks - Birmingham CRU / Elite

    Vestavia Hills, Alabama, 35216, United States

  • Alcanza / hyperCORE

    Boston, Massachusetts, 02131, United States

  • Apex Research Group

    Fair Oaks, California, 95628, United States

  • Be Well Clinical Studies / Elite

    Lincoln, Nebraska, 68516, United States

  • Desert Clinical Research

    Mesa, Arizona, 85213, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Johnson County Clinical Trials (JCCT)

    Lenexa, Kansas, 66219, United States

  • Kroger The Little Clinic (Remote Site)

    Blue Ash, Ohio, 45242, United States

  • Lynn Health Science Institute East / Elite

    Oklahoma City, Oklahoma, 73112, United States

  • Research Institute of South Florida

    Miami, Florida, 33173, United States

  • Research Integrity / WCG

    Owensboro, Kentucky, 42303, United States

  • SUNY / Upstate Medical University Global Health Institute

    Syracuse, New York, 13057, United States

  • Wake Research Atlanta

    Atlanta, Georgia, 30328, United States

  • Wake Research Dallas

    Dallas, Texas, 75246, United States

  • Wake Research Encino

    Los Angeles, California, 91316, United States

  • 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.