EUCTR2021-005226-26-ES
进行中（未招募）
1 期
A Phase IIb, double-blind, randomized, active controlled, multi-centre, non-inferiority trial followed by a Phase III, single arm, open label trial, to assess immunogenicity and safety of a booster vaccination with a recombinant protein RBD fusion dimer candidate (PHH-1V) against SARS-CoV-2, in adults fully vaccinated against COVID-19 followed with an extension period to study a fourth dose administration of PHH-1V.
HIPRA SCIENTIFIC0 个研究点目标入组 802 人2021年11月2日
适应症SARS-CoV-2MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
相关药物Comirnaty
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- SARS-CoV-2
- 发起方
- HIPRA SCIENTIFIC
- 入组人数
- 802
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Male or female, by birth, \= 18 years old at Screening.
- •\- Willing and able to comply with scheduled visits, laboratory tests, complete diaries, and other study procedures.
- •\- Body Mass Index (BMI) between 18 to 40 kg/m2\.
- •\- Has received a complete COVID\-19 vaccination programme (two administrations, prime and boosting) at least 182 days and with a maximum of 365 days before Screening with Comirnaty vaccine.
- •\- Has a negative COVID\-19 polymerase chain reaction (PCR) test at Screening.
- •\- Willing to avoid all other vaccines within 4 weeks before and after vaccination in this study (Day 0\). Seasonal influenza vaccination is allowed if it is received at least 14 days before or after Day 0\.
- •\- Willing to refrain from blood donation during the study.
- •\- Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0 (before vaccination).
- •\- Women of childbearing potential must be willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the vaccination (Day 0\). Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen\-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone\-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
- •\- Males who are not sterilised, must be willing to avoid impregnating female partners from Screening until 8 weeks after vaccination (Day 0\).
排除标准
- •\- Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
- •\- Positive pregnancy test at Screening or Day 0\.
- •\- Any medical disease (acute, subacute, intermittent, or chronic) or condition that in the opinion of the Investigator compromises the subject's safety, preclude vaccination or compromises interpretation of the results.
- •\- Ongoing serious psychiatric condition likely to affect participation in the study (e.g., ongoing severe depression, recent suicidal ideation, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- •\- History of respiratory disease requiring daily medications currently or any treatment of respiratory disease exacerbation in the last 6 months.
- •\- History of significant cardiovascular disease or history of myocarditis or pericarditis as an adult. Controlled hypertension will be permitted at the discretion of the Investigator.
- •\- History of neurological or neurodevelopmental conditions
- •\- Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
- •\- Any confirmed or suspected autoimmune, immunosuppressive or immunodeficiency disease/condition (iatrogenic or congenital), including human immunodeficiency virus (HIV) infection, asplenia, or recurrent severe infections.
- •\- Acute illness within 72 hours before Day 0
结局指标
主要结局
未指定
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