SARS CoV 2 InfectionPhase 2/3NCT05303402
A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.
A Phase 2/3 study testing PHH-1V in people with SARS CoV 2 Infection, run by Hipra Scientific, S.L.U at 6 sites in 2 countries.
Trial summary
A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- PHH-1V
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 12 May 2022to 1 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain3 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital Josep Trueta
Girona, Girona, 17001
Turkey (Türkiye)3 sites
Hacettepe University Medical Faculty Hospitals
Ankara, Ankara, 06230
Ankara University Medical Faculty Hospitals
Ankara, Ankara, 06620
Koc University Hospital
Istanbul, Istanbul, 34010
About this study
Official title: A Phase IIb/III, Open Label, Single Arm, Multi-centre, Trial to Assess the Immunogenicity and Safety of an Additional Dose Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults With Pre-existing Immunosuppressive Conditions Vaccinated Against COVID-19
A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19
- Conditions
- SARS CoV 2 Infection
- Being tested
- PHH-1V
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHH-1VBiological
COVID-19 Vaccine HIPRA, 40 mcg/dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose | Experimental | Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose. Receives: Biological: PHH-1V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
Changes in neutralising antibodies measured by pseudovirus (or live virus for the HIV cohort*) neutralization against Omicron, Beta and Delta any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Day 14 after administration of HIPRA's vaccine (PHH-1V).
Measured: Day 0 and Day 14
Secondary outcomes (3)
Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365
- To determine and compare the changes of the immunogenicity measured by pseudovirus (or live virus for the HIV cohort) neutralization against Omicron, Beta and Delta and any other relevant Variants of Concern (VOC) in the epidemiologic moment at Days, 91, 182 and 365, after administration of HIPRA's vaccine (PHH-1V).
Measured: Day 91, Day 182 and Day 365
Total antibodies
To evaluate the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2 quantification, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91, 182 and 365 after administration of HIPRA's vaccine (PHH-1V).
Measured: Day 0, Day 14, Day 91, Day 182, Day 365
Safety and tolerability of the booster vaccine
To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions
Measured: Day 0, Day 14, Day 91, Day 182, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start12 May 2022
- Primary completion29 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hipra Scientific, S.L.U
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc., Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Asphalion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303402
- Sponsor's protocol ID
- HIPRA-HH-4
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb/III, Open Label, Single Arm, Multi-centre, Trial to Assess the Immunogenicity and Safety of an Additional Dose Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults With Pre-existing Immunosuppressive Conditions Vaccinated Against COVID-19
- ClinicalTrials.gov ID
- NCT05303402
- Acronym / sponsor ID
- HIPRA-HH-4
- Conditions
- SARS CoV 2 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Hipra Scientific, S.L.UIndustry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc., Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Asphalion
- Study start
- 12 May 2022 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose | Experimental | Biological: PHH-1VIntramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHH-1VCOVID-19 Vaccine HIPRA, 40 mcg/dose | Biological | Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose |
Primary outcome
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
Time frame: Day 0 and Day 14
Changes in neutralising antibodies measured by pseudovirus (or live virus for the HIV cohort*) neutralization against Omicron, Beta and Delta any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Day 14 after administration of HIPRA's vaccine (PHH-1V).
3 secondary outcomes
Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365
Time frame: Day 91, Day 182 and Day 365
Total antibodies
Time frame: Day 0, Day 14, Day 91, Day 182, Day 365
Safety and tolerability of the booster vaccine
Time frame: Day 0, Day 14, Day 91, Day 182, Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PHH-1V in people with SARS CoV 2 Infection, run by Hipra Scientific, S.L.U at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14 (time frame: Day 0 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.