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

March 14, 2023 updated by: Hipra Scientific, S.L.U

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2646

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20162
        • Hospital de Niguarda
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall Hebron
      • Barcelona, Spain, 08023
        • Hospital Quironsalud Barcelona
      • Barcelona, Spain, 08023
        • Hospital HM Delfos
      • Barcelona, Spain, 17170
        • Hospital Clínic de Barcelona
      • Girona, Spain, 17007
        • Hospital Universitari Dr. Josep Trueta
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28660
        • Hospital HM Montepríncipe
      • Madrid, Spain, 28050
        • Hospital HM Sanchinarro
      • Madrid, Spain, 28223
        • Hospital Quirónsalud Madrid
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Mollet Del Vallès, Barcelona, Spain, 08100
        • Hospital de Mollet
    • Madrid
      • Meco, Madrid, Spain, 28805
        • Hospital Principe de Asturias
      • Móstoles, Madrid, Spain, 28938
        • Hospital HM Puerta del Sur
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: COVID-19 Vaccine HIPRA 40 ug/dose
COVID-19 Vaccine HIPRA, where subjects will receive one intramuscular injection of COVID-19 vaccine developed by HIPRA
Biological: COVID-19 Vaccine 40 ug/dose
Intramuscular injection of 0,5 ml with 40 ug of recombinant PHH-1V

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Time Frame: Day 7
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Day 7
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)
Time Frame: Day 28
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination
Day 28
Incidence of Serious Adverse Events (Safety and tolerability) (SAE)
Time Frame: Day 365
Number and percentage of serious adverse events (SAEs) through the end of the study.
Day 365
Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).
Time Frame: Day 365
Number and percentage of adverse event of special interest (AESI) through the end of the study.
Day 365
Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs)
Time Frame: Day 365
Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study.
Day 365
Incidence of Adverse Events in laboratory parameters (Safety and tolerability)
Time Frame: Day 365

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.
Day 365

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the immunogenicity measured by pseudovirus neutralisation
Time Frame: Day 365
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.
Day 365
Changes in the immunogenicity measured by pseudovirus neutralisation
Time Frame: Day 14
The geometric mean fold rise (GMFR) in neutralising antibody titre from baseline to Day 14.
Day 14
Changes in the immunogenicity measured by means of total antibody against RBD
Time Frame: Day 365
Binding antibodies titre measured for each individual sample and GMT for descriptive statistics analysis at Baseline and Days 14, 91, 182 and 365.
Day 365
Changes in the immunogenicity measured by means of total antibody against RBD.
Time Frame: Day 14
The geometric mean fold rise (GMFR) in binding antibody titre from baseline to Day 14.
Day 14
Changes in the immunogenicity measured by means of total antibody against RBD
Time Frame: Day 14
The percentage of subjects that after the booster dose have a ≥4-fold change in binding antibodies titre from Baseline to Day 14.
Day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess number of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster.
Time Frame: Day 365
Number and percentage of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster according to COVID-19 infection criteria throughout the study duration.
Day 365
To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V. SARS-CoV-2 infections ≥14 days after PHH-1V booster.
Time Frame: Day 365
Number and percentage of COVID-19 severe infections ≥14 days after PHH-1V booster and through the end of the study.
Day 365
To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V and hospital admissions SARS-CoV-2 infections ≥14 days after PHH-1V booster.
Time Frame: Day 365
Number and percentage of hospital admissions associated with COVID-19 ≥14 days after PHH-1V booster and through the end of the study.
Day 365
To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V in ICU. SARS-CoV-2 infections ≥14 days after PHH-1V booster.
Time Frame: Day 365
Number and percentage of intensive care unit (ICU) admissions associated with COVID-19 ≥14 days after PHH-1V booster and through the end of the study.
Day 365
To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V receiving noninvasive ventilation. SARS-CoV-2 infections ≥14 days after PHH-1V booster.
Time Frame: Day 365
Number and percentage of noninvasive ventilation administration associated with COVID-19 ≥14 days after PHH-1V booster and through the end of the study.
Day 365
To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V causing death.
Time Frame: Day 365
Number and percentage of deaths associated with COVID-19 ≥14 days after PHH-1V booster and through the end of the study.
Day 365
To evaluate T-cell mediated responses against the SARS-CoV-2 S glycoprotein at Baseline and Day 14 in subjects who have received two doses of Vaxzevria vaccine and PHH-1V as a booster..
Time Frame: Day 14
T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole peripheral blood mononuclear cell (PBMC) stimulation by enzyme-linked immune absorbent spot (ELISpot) at Baseline and at Day 14. This analysis will be performed in 30 subjects.
Day 14
To assess Th-1/Th-2 T-cell mediated responses against S protein at Baseline and Day 14 in subjects who have received two doses of Vaxzevria vaccine and PHH-1V as a booster.
Time Frame: Day 14
CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at Baseline and at Day 14. This analysis will be performed in 30 subjects.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hipra Scientific, S.L.U

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIPRA-HH-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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