New COVID booster shows promise in trial
NCT ID NCT06181292
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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913 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Jun 2024
- Lead sponsor
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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
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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: * 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
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CAP Centelles
Centelles, Barcelona, 08540, Spain
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Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
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Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
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Hospital HM Delfos
Barcelona, Barcelona, 08023, Spain
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Hospital HM Puerta del Sur
Móstoles, Madrid, 28938, Spain
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Hospital HM Sanchinarro
Madrid, Madrid, 28050, Spain
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Hospital Josep Trueta
Girona, Girona, 17001, Spain
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Hospital Quironsalud Madrid
Madrid, Madrid, 28223, Spain
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Hospital Regional de Málaga
Málaga, Málaga, 29010, Spain
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Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903, Spain
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