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New COVID booster shows promise in trial

NCT ID NCT06181292

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new booster vaccine called PHH-1V81, designed to target recent COVID-19 variants. About 900 adults who had already received mRNA vaccines got either the new booster or an existing one. Researchers checked for side effects and measured immune responses to see if the new booster is safe and works as well as current options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PHH-1V81 (adapted protein booster vaccine against SARS-CoV-2)
What this could lead to
If successful, this could provide a safe and effective booster option that protects against newer COVID-19 variants.
What could go wrong
This is a mid-stage trial with 913 participants, so results may not apply to everyone. The vaccine may not work as well as existing boosters or could cause side effects.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

913 people

The number who actually took part.

Started

Nov 2023

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * Adults aged 18 or older at Day 0 * Are willing and able to sign the informed consent and can comply with all study visits and procedures * Participant must have received a primary scheme of an EU-approved mRNA vaccine (2 doses) and at least one booster dose with an EU-approved mRNA vaccine. Last booster dose must have been administered at least 6 months before Day 0. * Having a negative Rapid Antigen Test for COVID-19 at Day 0 prior to vaccination. * Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with pre-existing chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment. * Uses an accepted method of contraception Exclusion Criteria: * Participant with an acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator * Participant with a medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Participant with history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention * Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination * Participant with a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection * Have receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months * Participation in other studies involving study intervention if last dose is within 28 days prior to screening and/or it is planned to receive during study participation * Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening * Received any COVID-19 vaccines other than EU-approved mRNA vaccines * Received any Omicron XBB adapted vaccine before Day 0 * COVID-19 infection diagnosed in the previous 6 months before Day 0. History of COVID-19 infections is allowed * History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.

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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

  • CAP Centelles

    Centelles, Barcelona, 08540, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital HM Delfos

    Barcelona, Barcelona, 08023, Spain

  • Hospital HM Puerta del Sur

    Móstoles, Madrid, 28938, Spain

  • Hospital HM Sanchinarro

    Madrid, Madrid, 28050, Spain

  • Hospital Josep Trueta

    Girona, Girona, 17001, Spain

  • Hospital Quironsalud Madrid

    Madrid, Madrid, 28223, Spain

  • Hospital Regional de Málaga

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario de Cruces

    Barakaldo, Vizcaya, 48903, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.