Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine

NCT06181292
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Phase
Phase 2/Phase 3
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Recruitment status
Completed
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Participants
913
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Lead sponsor
Hipra Scientific, S.L.U
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Start date
2023-11-15
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Number of sites
10
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Summary
This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain (RBD) fusion homodimer of XBB.1.16 adapted candidate against SARS-CoV-2 developed by HIPRA (PHH-1V81).
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Short title
Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine
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Official title
Phase IIb/III, Double-Blind, Randomised, Active-Controlled, Multi-Center, Non-Inferiority Clinical Trial, to Assess the Safety and Immunogenicity of a Booster Vaccination With an Adapted Recombinant Protein RBD Fusion Homodimer Candidate Against SARS-CoV-2, in Adults Vaccinated Against COVID-19
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2024-06-17
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First posted
2023-12-26
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Registry last updated
2026-03-12
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Primary completion date
2024-06-17
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Start date
2023-11-15
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Actual participants
913
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Participants
913
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
2:1
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Number of sites
10
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Registry sponsor category
Industry
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Lead sponsor
Hipra Scientific, S.L.U
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06181292
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ClinicalTrials.gov ID
NCT06181292
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Number, percentage and characteristics of solicited local and systemic AEs, unsolicited AEs, SAEs, AESIs and MAAEs

    Timeframe: 0, 7, 14, 91 and 182 days post-vaccination

    To assess the safety and tolerability of a PHH-1V81 booster in adults who previously received primary vaccination and at least one booster dose of an EU-approved mRNA vaccine

  2. Neutralising antibody titers of PHH-1V81 booster at Day 0 and 14

    Timeframe: 0 and 14 days post-vaccination

    To determine and compare the changes in immunogenicity measured by pseudovirus neutralisation assay (PBNA) against Omicron XBB.1.16 variant at Baseline and Day 14 in the PHH-1V81 vaccine arm versus the Comirnaty arm.

  1. Neutralising antibody titers of PHH-1V81 booster at Day 91 and 182

    Timeframe: 91 and 182 days post-vaccination

    To determine and compare the changes in immunogenicity measured by PBNA against Wuhan, Omicron BA.1 and Omicron XBB.1.5 at Baseline and at Days 14, 91 and 182, and Omicron XBB.1.16 at Days 91 and 182, after vaccination in the PHH-1V81 vaccine arm vs. the Comirnaty arm.

  2. Total binding antibody titers of PHH-1V81 booster at Days 0, 14, 91 and 182

    Timeframe: 0, 14, 91 and 182 days post-vaccination

    To evaluate and compare the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91 and 182 in the PHH-1V81 vaccine arm vs the Comirnaty arm.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • Adults aged 18 or older at Day 0
  • Are willing and able to sign the informed consent and can comply with all study visits and procedures
  • Participant must have received a primary scheme of an EU-approved mRNA vaccine (2 doses) and at least one booster dose with an EU-approved mRNA vaccine. Last booster dose must have been administered at least 6 months before Day 0.
  • Having a negative Rapid Antigen Test for COVID-19 at Day 0 prior to vaccination.
  • Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with pre-existing chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment.
  • Uses an accepted method of contraception

  • Participant with an acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator
  • Participant with a medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participant with history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention
  • Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination
  • Participant with a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
  • Have receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months
  • Participation in other studies involving study intervention if last dose is within 28 days prior to screening and/or it is planned to receive during study participation
  • Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening
  • Received any COVID-19 vaccines other than EU-approved mRNA vaccines
  • Received any Omicron XBB adapted vaccine before Day 0
  • COVID-19 infection diagnosed in the previous 6 months before Day 0. History of COVID-19 infections is allowed
  • History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Sources for eligibility
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  • Hospital Germans Trias i PujolBadalona, Spain
  • Hospital HM DelfosBarcelona, Spain
  • CAP CentellesCentelles, Spain
  • Hospital Josep TruetaGirona, Spain
  • Hospital HM SanchinarroMadrid, Spain
  • Hospital Quironsalud MadridMadrid, Spain
  • Hospital HM Puerta del SurMóstoles, Spain
  • Hospital Regional de MálagaMálaga, Spain
  • Hospital Clínico Universitario de ValenciaValencia, Spain
  • Hospital Universitario de CrucesBarakaldo, Spain
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)