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COVID-19Phase 3NCT05246137

A Phase III Trial to Assess the Safety and Immunogenicity of a HIPRA's Candidate Booster Vaccination Against COVID-19.

A Phase 3 study testing COVID-19 Vaccine 40 ug/dose in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Hipra Scientific, S.L.U at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
What is being tested?
COVID-19 Vaccine 40 ug/dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,646 participants
Where
18 sitesin 2 countries
Study dates
3 Feb 2022to 3 Mar 2023
Phase
Phase 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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Male or female, ≥ 16 years old at Day 0.
  • Willing to provide consent indicating that she or he understands the purpose and potential risks and is willing and able to participate in the study and comply with all the study requirements and procedures.
  • Have a recognized primary vaccination scheme recognized by the authorities with Comirnaty, Spikevax, Vaxevria or Janssen at least 91 days and preferably a maximum of 240 days before Day 0.
  • If having an underlying illnesses must be stable and well-controlled according to the investigator judgment.
  • Participant is willing to avoid receiving live attenuated vaccines (licensed) within 4 weeks before screening or after receiving any study vaccine, or other not live vaccines (licensed) within 14 days before and after receiving any study vaccine.
  • Participant agrees not to donate blood, blood products and bone marrow at least 3 months before and after vaccination.
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  • Female participant of childbearing potential must have a negative pregnancy test on the on Day 0 prior to vaccination.
  • Female participant of childbearing potential must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (hormonal contraception: oral, injectable or transdermal patch, intrauterine device, vasectomized partner, sexual abstinence or condom).
  • Male participants must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (vasectomized participants, condom, sexual abstinence).
  • Male participants must refrain from donating sperm for at least 28 days after day 0.

Who cannot join

  • History of anaphylaxis to any prior vaccine.
  • Previous severe SARS-CoV-2 infections that required >24 hous of hospitalisation.
  • Participant received or plans to receive live attenuated vaccines within 4 weeks before and after day 0; or other not live vaccines within 14 days before and after day 0.
  • Pregnancy or breast-feeding at screening or Day 0 or willingness/intention to become pregnant during the study.
  • Having a clinically significant acute illness or fever (temperature ≥38º C (100.4ºF)) at screening or within 48 hours prior to Day 0.
  • Participant had a surgery requiring hospitalization before vaccination and he/she has not received the hospital discharge at day 0; or has a surgery requiring hospitalization planned within 12 weeks after study vaccine administration.
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  • Having any active malignancy even if under treatment except for non-melanoma skin cancer, uterine cervical carcinoma, anal carcinoma, localized prostate cancer.
  • Having ongoing severe and non-stable psychiatric condition likely to affect participation in the study.
  • Having problematic or risk use of substances including alcohol that can compromise the study follow-up.
  • Having a bleeding disorder or has any condition that in the opinion of the investigator contraindicates intramuscular injections.
  • Having abnormal function of the immune system, except stable clinical conditions like controlled HIV.
  • Having clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder judged by the investigator within 3 months before screening.
  • Chronic or recurrent administration of systemic immunosuppressant medication.
  • Having received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study.
  • Having received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days before day 0.
  • Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study.
  • Participant has donated ≥ 450ml of blood products within 12 weeks before screening.
  • Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

Spain17 sites

  • Hospital Germans Trias I Pujol

    Badalona, Barcelona, 08916

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital HM Delfos

    Barcelona, 08023

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Hospital Vall Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 17170

  • Hospital Universitari Dr. Josep Trueta

    Girona, 17007

  • Hospital Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital HM Sanchinarro

    Madrid, 28050

  • Hospital Quironsalud Madrid

    Madrid, 28223

  • Hospital HM Montepríncipe

    Madrid, 28660

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Principe de Asturias

    Meco, Madrid, 28805

  • Hospital de Mollet

    Mollet del Vallès, Barcelona, 08100

  • Hospital HM Puerta del Sur

    Móstoles, Madrid, 28938

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Italy1 site

  • Hospital de Niguarda

    Milan, 20162

Other trials in Italy

About this study

Official title: A Phase III, Open Label, Single Arm, Multi-centre, Trial to Assess the Safety and Immunogenicity of a Booster Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Vaccinated Against COVID-19.

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.

Read the detailed description

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adults vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine at least 91 days before day 0. All the participants will receive a booster dose of the HIPRA's COVID-19 Vaccine and will be followed for 26 weeks or 52 weeks if they participate in the safety cohort, or the immunogenicity cohort, respectively.

Being tested
COVID-19 Vaccine 40 ug/dose
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 Vaccine 40 ug/doseBiological

    Intramuscular injection of 0,5 ml with 40 ug of recombinant PHH-1V

Study groups in NCT05246137
Study groupRoleWhat they receive
Experimental: COVID-19 Vaccine HIPRA 40 ug/doseExperimentalCOVID-19 Vaccine HIPRA, where subjects will receive one intramuscular injection of COVID-19 vaccine developed by HIPRA
Receives: Biological: COVID-19 Vaccine 40 ug/dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

    Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.

    Measured: Day 7

  2. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)

    Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination

    Measured: Day 28

  3. Incidence of Serious Adverse Events (Safety and tolerability) (SAE)

    Number and percentage of serious adverse events (SAEs) through the end of the study.

    Measured: Day 365

  4. Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).

    Number and percentage of adverse event of special interest (AESI) through the end of the study.

    Measured: Day 365

  5. Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs)

    Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study.

    Measured: Day 365

  6. Incidence of Adverse Events in laboratory parameters (Safety and tolerability)

    Grade 3 and 4 changes from baseline in safety laboratory parameters at Days 14, 91 and 182 after vaccination.

    through the end of the study.

    Measured: Day 365

Secondary outcomes (5)

  1. Changes in the immunogenicity measured by pseudovirus neutralisation

    Neutralisation titre against Wuhan and Omicron strains, and any other relevant VOC in the epidemiologic moment, measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titre (GMT) for descriptive statistics analysis at Baseline and at Days 14, 91, 182 and 365.

    Measured: Day 365

  2. Changes in the immunogenicity measured by pseudovirus neutralisation

    The geometric mean fold rise (GMFR) in neutralising antibody titre from baseline to Day 14.

    Measured: Day 14

  3. Changes in the immunogenicity measured by means of total antibody against RBD

    Binding antibodies titre measured for each individual sample and GMT for descriptive statistics analysis at Baseline and Days 14, 91, 182 and 365.

    Measured: Day 365

  4. Changes in the immunogenicity measured by means of total antibody against RBD.

    The geometric mean fold rise (GMFR) in binding antibody titre from baseline to Day 14.

    Measured: Day 14

  5. Changes in the immunogenicity measured by means of total antibody against RBD

    The percentage of subjects that after the booster dose have a ≥4-fold change in binding antibodies titre from Baseline to Day 14.

    Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start3 Feb 2022
  3. Primary completion3 Mar 2022
  4. Study completion3 Mar 2023

Resources

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 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05246137
Sponsor's protocol ID
HIPRA-HH-5
Status last verified
Mar 2023
First submitted
8 Feb 2022
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moros A, Prenafeta A, Barreiro A, Perozo E, Fernandez A, Canete M, Gonzalez L, Garriga C, Pradenas E, Marfil S, Blanco J, Cebollada Rica P, Sistere-Oro M, Meyerhans A, Prat Cabanas T, March R, Ferrer L. Immunogenicity and safety in pigs of PHH-1V, a SARS-CoV-2 RBD fusion heterodimer vaccine candidate. Vaccine. 2023 Aug 7;41(35):5072-5078. doi: 10.1016/j.vaccine.2023.07.008. Epub 2023 Jul 16.

    PubMed 37460353

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing COVID-19 Vaccine 40 ug/dose in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Hipra Scientific, S.L.U at 18 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 10 inclusion and 18 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain, Italy. 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 phase mean?

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?

Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (time frame: Day 7). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05246137, which also lists 1 linked publication.

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 15 Mar 2023.

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