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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06181292
Other study ID # HIPRA-HH-14
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 15, 2023
Est. completion date June 1, 2024

Study information

Verified date May 2024
Source Hipra Scientific, S.L.U
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 612
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PHH-1V81
booster of PHH-1V81
Comirnaty Omicron XBB1.5
booster of Comirnaty Omicron XBB1.5

Locations

Country Name City State
Spain Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital de Cruces Barakaldo Vizcaya
Spain Hospital HM Delfos Barcelona
Spain CAP Centelles Centelles Barcelona
Spain Hospital Josep Trueta Girona
Spain Hospital HM Sanchinarro Madrid
Spain Hospital Quironsalud Madrid Madrid
Spain Hospital Regional de Málaga Málaga
Spain Hospital HM Puerta del Sur Móstoles Madrid
Spain Hospital Clínico Universitario de Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
Hipra Scientific, S.L.U

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number, percentage and characteristics of solicited local and systemic AEs, unsolicited AEs, SAEs, AESIs and MAAEs 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 0, 7, 14, 91 and 182 days post-vaccination
Primary Neutralising antibody titers of PHH-1V81 booster at Day 0 and 14 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. 0 and 14 days post-vaccination
Secondary Neutralising antibody titers of PHH-1V81 booster at Day 91 and 182 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. 91 and 182 days post-vaccination
Secondary Total binding antibody titers of PHH-1V81 booster at Days 0, 14, 91 and 182 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. 0, 14, 91 and 182 days post-vaccination
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