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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05246137
Recruitment Status : Completed
First Posted : February 18, 2022
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Hipra Scientific, S.L.U

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Acute Respiratory Disease Biological: COVID-19 Vaccine 40 ug/dose Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2646 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : February 3, 2022
Actual Primary Completion Date : March 3, 2022
Actual Study Completion Date : March 3, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246137


Locations
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Sponsors and Collaborators
Hipra Scientific, S.L.U
More Information
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Responsible Party: Hipra Scientific, S.L.U
ClinicalTrials.gov Identifier: NCT05246137    
Other Study ID Numbers: HIPRA-HH-5
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Diseases
Respiration Disorders
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases