Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine

NCT06181292 | Completed Phase 2

• 1 other identifier: HIPRA-HH-14
• Study Type: interventional
• Target: 913
• Locations: 1 country
• Sites: 10

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).

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

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

  91 and 182 days post-vaccination

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

  0, 14, 91 and 182 days post-vaccination

Study Arms (2)

PHH-1V81

EXPERIMENTAL

One dose of 40ug of PHH-1V81, administered intramuscularly

Biological: PHH-1V81

Comirnaty Omicron XBB1.5

ACTIVE COMPARATOR

One dose of 30ug of Comirnaty Omicron XBB1.5, administered intramuscularly

Biological: Comirnaty Omicron XBB1.5

Interventions

PHH-1V81 BIOLOGICAL

booster of PHH-1V81

PHH-1V81

Comirnaty Omicron XBB1.5 BIOLOGICAL

booster of Comirnaty Omicron XBB1.5

Comirnaty Omicron XBB1.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hipra Scientific, S.L.U: lead

Study Sites (10)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital HM Delfos

Barcelona, Barcelona, 08023, Spain

Location

CAP Centelles

Centelles, Barcelona, 08540, Spain

Location

Hospital Josep Trueta

Girona, Girona, 17001, Spain

Location

Hospital HM Sanchinarro

Madrid, Madrid, 28050, Spain

Location

Hospital Quironsalud Madrid

Madrid, Madrid, 28223, Spain

Location

Hospital HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Hospital Regional de Málaga

Málaga, Málaga, 29010, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Teresa Prat

  Hipra Scientific, S.L.U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 26, 2023
• Study Start: November 15, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

ES (10)