New booster aims to shield the vulnerable from COVID-19
NCT ID NCT05303402
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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241 people
The number who actually took part.
- Started
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May 2022
- Finished
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Dec 2023
- 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
-
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 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: * 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
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Ankara University Medical Faculty Hospitals
Ankara, Ankara, 06620, Turkey (Türkiye)
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Hacettepe University Medical Faculty Hospitals
Ankara, Ankara, 06230, Turkey (Türkiye)
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Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
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Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
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Hospital Josep Trueta
Girona, Girona, 17001, Spain
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Koc University Hospital
Istanbul, Istanbul, 34010, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill stop COVID-19 before it starts?
- Four weeks vs twelve weeks: can a shorter TB prevention course work?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Can a phone app keep young people with HIV engaged in care?
- Massive Real-World database aims to map how chronic diseases interact