NCT05303402已完成2 期
A Phase IIb/III, Open Label, Single Arm, Multi-centre, Trial to Assess the Immunogenicity and Safety of an Additional Dose Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults With Pre-existing Immunosuppressive Conditions Vaccinated Against COVID-19
Hipra Scientific, S.L.U6 个研究点 分布在 2 个国家目标入组 241 人开始时间: 2022年5月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 6
- 主要终点
- Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
研究概览
简要总结
A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, female or transgender, ≥ 18 years old at Day
- •Provide inform consent form
- •Participant who has:
- •3 doses of mRNA vaccines
- •2 doses of mRNA vaccines and previous COVID-19 infection
- •2 doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty
- •Participant who has:
- •HIV infection with CD4 Tcells counts <400
- •Primary antibody deficiency disorders
- •Kidney disease on dialysis
- •Kidney transplant at least >1 year
- •Auto Immune Disease (AID) in treatment with rituximab
- •For a female of childbearing potential, to have a negative pregnancy test at Day 0
- •Use of any of these contraception:
- •Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom.
- •Male: Vasectomized participant, sexual abstinence, condom.
排除标准
- •History of anaphylaxis to any prior vaccine
- •Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines.
- •Pregnant or breast-feeding at Day
- •A confirmed COVID-19 diagnose <90 days prior to vaccination day
- •A clinically significant acute illness or fever at screening or 48h before day
- •Participant had a surgery requiring hospitalisation and has not received the hospital discharge.
- •Participant has an ongoing severe and non-stable psychiatric condition
- •Participant has a problematic or risky use of substances including alcohol
- •Participant has a bleeding disorder that contraindicates intramuscular injection
- •Participant suffering from post-acute COVID-19 syndrome / long COVID
- •Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days
- •Participant is already participating in another research involving drug, biologics or device
- •Participant has donated ≥450 ml of blood products within 12 weeks before screening
- •Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.
研究组 & 干预措施
Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose
Experimental
Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.
干预措施: PHH-1V (Biological)
结局指标
主要结局
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
时间窗: Day 0 and Day 14
Changes in neutralising antibodies measured by pseudovirus (or live virus for the HIV cohort\*) neutralization against Omicron, Beta and Delta any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Day 14 after administration of HIPRA's vaccine (PHH-1V).
次要结局
- Safety and tolerability of the booster vaccine(Day 0, Day 14, Day 91, Day 182, Day 365)
- Total antibodies(Day 0, Day 14, Day 91, Day 182, Day 365)
- Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365(Day 91, Day 182 and Day 365)
研究者
研究点 (6)
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