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New booster aims to shield the vulnerable from COVID-19

NCT ID NCT05303402

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Updated 1 time

Summary

This study tested an extra dose of the HIPRA COVID-19 vaccine in 241 adults with conditions like HIV, kidney disease, or autoimmune disorders that weaken the immune system. The goal was to see if the booster raises antibody levels against virus variants and remains safe. Researchers measured immune responses before and 14 days after the shot, with follow-ups up to a year.

What this could mean

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

Active substance
HIPRA COVID-19 vaccine (PHH-1V)
What this could lead to
If successful, this could provide a safe and effective booster option for people with weakened immune systems, helping them stay protected against COVID-19 variants.
What could go wrong
This is a mid-stage trial with only 241 participants and no comparison group, so results may not apply to everyone. The vaccine may not work as well in all immunosuppressed individuals.

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

241 people

The number who actually took part.

Started

May 2022

Finished

Dec 2023

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Male, female or transgender, ≥ 18 years old at Day 0. * Provide inform consent form * Participant who has: * 3 doses of mRNA vaccines * 2 doses of mRNA vaccines and previous COVID-19 infection * 2 doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty * Participant who has: * HIV infection with CD4 Tcells counts \<400 * Primary antibody deficiency disorders * Kidney disease on dialysis * Kidney transplant at least \>1 year * Auto Immune Disease (AID) in treatment with rituximab * For a female of childbearing potential, to have a negative pregnancy test at Day 0 * Use of any of these contraception: * Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom. * Male: Vasectomized participant, sexual abstinence, condom. Exclusion Criteria: * History of anaphylaxis to any prior vaccine * Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines. * Pregnant or breast-feeding at Day 0. * A confirmed COVID-19 diagnose \<90 days prior to vaccination day 0. * A clinically significant acute illness or fever at screening or 48h before day 0. * Participant had a surgery requiring hospitalisation and has not received the hospital discharge. * Participant has an ongoing severe and non-stable psychiatric condition * Participant has a problematic or risky use of substances including alcohol * Participant has a bleeding disorder that contraindicates intramuscular injection * Participant suffering from post-acute COVID-19 syndrome / long COVID * Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days * Participant is already participating in another research involving drug, biologics or device * Participant has donated ≥450 ml of blood products within 12 weeks before screening * Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.

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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

  • Ankara University Medical Faculty Hospitals

    Ankara, Ankara, 06620, Turkey (Türkiye)

  • Hacettepe University Medical Faculty Hospitals

    Ankara, Ankara, 06230, Turkey (Türkiye)

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Josep Trueta

    Girona, Girona, 17001, Spain

  • Koc University Hospital

    Istanbul, Istanbul, 34010, Turkey (Türkiye)

More trials for these conditions

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