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
概览
- 阶段
- 2 期
- 干预措施
- PHH-1V81
- 疾病 / 适应症
- SARS-CoV2 Infection
- 发起方
- Hipra Scientific, S.L.U
- 入组人数
- 913
- 试验地点
- 10
- 主要终点
- Number, percentage and characteristics of solicited local and systemic AEs, unsolicited AEs, SAEs, AESIs and MAAEs
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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).
详细描述
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.
研究者
入排标准
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
PHH-1V81
One dose of 40ug of PHH-1V81, administered intramuscularly
干预措施: PHH-1V81
Comirnaty Omicron XBB1.5
One dose of 30ug of Comirnaty Omicron XBB1.5, administered intramuscularly
干预措施: Comirnaty Omicron XBB1.5
结局指标
主要结局
Number, percentage and characteristics of solicited local and systemic AEs, unsolicited AEs, SAEs, AESIs and MAAEs
时间窗: 0, 7, 14, 91 and 182 days post-vaccination
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
Neutralising antibody titers of PHH-1V81 booster at Day 0 and 14
时间窗: 0 and 14 days post-vaccination
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.
次要结局
- Total binding antibody titers of PHH-1V81 booster at Days 0, 14, 91 and 182(0, 14, 91 and 182 days post-vaccination)
- Neutralising antibody titers of PHH-1V81 booster at Day 91 and 182(91 and 182 days post-vaccination)