Clinical trial NCT06181292: Safety and Immunogenicity of a Booster Vaccination with an Adapted Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: SARS-CoV2 Infection
Lead sponsor: Hipra Scientific, S.L.U
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 913
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Neutralising antibody titers of PHH-1V81 booster at Day 0 and 14
timeFrame: 0 and 14 days post-vaccination
Secondary outcomes:
measure: Neutralising antibody titers of PHH-1V81 booster at Day 91 and 182
timeFrame: 91 and 182 days post-vaccination
measure: Total binding antibody titers of PHH-1V81 booster at Days 0, 14, 91 and 182
timeFrame: 0, 14, 91 and 182 days post-vaccination
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Centelles
country: Spain
facility: CAP Centelles
state: Barcelona
city: Móstoles
country: Spain
facility: Hospital HM Puerta del Sur
state: Madrid
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital HM Delfos
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Madrid
country: Spain
facility: Hospital HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Quironsalud Madrid
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Hipra Scientific, S.L.U
name: Teresa Prat
role: STUDY_DIRECTOR
References: