A 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 (PHH-1V81) against SARS-CoV-2, in adults vaccinated against COVID-19.
- Conditions
- COVID-19 diseaseMedDRA version: 23.0Level: LLTClassification code: 10084270Term: SARS-CoV-2 acute respiratory disease Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-508458-25-00
- Lead Sponsor
- Hipra Scientific S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 612
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., Participants biologically able to have children may be enrolled in the study if the participant fulfils all the following criteria: • Has a negative urine pregnancy test at Day 0, only for those participants who are biologically able to become pregnant. • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the study treatment, only for those participants who are biologically able to become pregnant. • Has agreed to continue adequate contraception or abstinence through 3 months following the booster dose. - Participants with female reproductive system: i. Hormonal contraception (progestogen-only or combined: oral, injectable or transdermal (patch)) ii. Intrauterine device. iii. Vasectomized partner (the vasectomized partner should be the sole partner for that participant). iv. Condom. - Participants with male reproductive system: i. Vasectomized participants. ii. Agree to use a condom in partners biologically able to become pregnant.
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., 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., Other 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. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results., 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., Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method