This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre,non-inferiority clinical trial that aims to determine safety, tolerability andimmunogenicity of a booster vaccination with a recombinant protein receptor bindingdomain (RBD) fusion homodimer of XBB.1.16 adapted candidate against SARS-CoV-2 developedby HIPRA (PHH-1V81).
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).
Approximately 612 participants who have received a primary scheme with an EU-approved
mRNA vaccine (two doses) and at least one booster dose of an EU-approved mRNA vaccine
against COVID-19, will be randomly assigned to the following two treatment arms in a
PHH-1V81 : Comirnaty (Omicron XBB.1.5) 2:1 ratio:
- PHH-1V81 vaccine arm: Approximately 408 adults will receive a booster dose of
PHH-1V81 (HIPRA adapted vaccine).
- Comirnaty vaccine arm: Approximately 204 adults will receive a booster dose of
Comirnaty Omicron XBB.1.5.
Participants will be stratified before randomisation by age group (approximately 10% of
adults ≥60 years old), and by number of doses previously received.
All participants will receive a booster dose of PHH-1V81 or Comirnaty Omicron XBB.1.5 at
Day 0 and will be followed for 6 months. All subjects will be closely observed for 15
minutes after vaccination on site.
Biological: PHH-1V81
booster of PHH-1V81
Biological: Comirnaty Omicron XBB1.5
booster of Comirnaty Omicron XBB1.5
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital HM Delfos
Barcelona, Barcelona, Spain
CAP Centelles
Centelles, Barcelona, Spain
Hospital Josep Trueta
Girona, Girona, Spain
Hospital HM Sanchinarro
Madrid, Madrid, Spain
Hospital Quironsalud Madrid
Madrid, Madrid, Spain
Hospital HM Puerta del Sur
Móstoles, Madrid, Spain
Hospital Regional de Málaga
Málaga, Málaga, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain
Teresa Prat, Study Director
Hipra Scientific, S.L.U