EUCTR2022-000785-18-ES进行中（未招募）1 期
A Phase III, open label, single arm, multi-center, 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 immunosupressive conditions vaccinated against COVID-19.
HIPRA SCIENTIFIC0 个研究点目标入组 400 人开始时间: 2022年3月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male, female or transgender, = 18 years old at Day 0.
- •2. Participant must provide consent indicating that she or he understands the purpose and potential risks and is willing and able to participate in the study and comply with all the study requirements and procedures (scheduled visits, laboratory tests, complete diaries, etc).
- •3. Participant who has one of the following SARS-CoV-2 vaccination schemes :
- •Three doses of mRNA vaccines (Comirnaty and/or Spikevax) with or without past history of positive test for COVID-19, provided that last vaccination and diagnose of COVID-19 is at least 91 days before day 0, and if hospitalization was required, participant was discharged from hospital at least 30 days before day 0.
- •Two doses of mRNA vaccines (Comirnaty and/or Spikevax) and previous history of positive test for COVID-19, provided that last vaccination and diagnose of COVID-19 is at least 91 days before day 0, and if hospitalization was required, participant was discharged from hospital at least 30 days before day 0.
- •For sites in Turkey were vaccination with Coronavac was started, the following vaccinations schemes will be allowed:
- •A combination of 2 doses of Coronavac and 1 Comirnaty, or 1 Coronavac and 2 Comirnaty without past history of a positive test for COVID-19, provided that last vaccination is at least 91 days before day 0
- •4. Participant who has any of the following underlying immunosuppressive conditions*:
- •Confirmed HIV infection with CD4 T cell counts <400 within last 6 months prior to Day0 regardless of pVL determination and ARV;
- •Primary Antibody Deficiency Disorder on immunoglobulin replacement therapy for at least 6 months prior to Day0 (maintenance dose);
- •Kidney disease on dialysis program for at least 6 months prior to Day0;
- •Kidney transplant at least >1 year and with last anti-CD20/anti-CD3 biological treatment given at least >1 year prior to Day0 and on maintenance triple immunosuppressive therapy based on tacrolimus, glucocorticoids and mycophenolate or everolimus/sirolimus;
- •Auto-immune disease (AID**) on treatment with rituximab (RTX) during at least 14 days within the last 6 months prior to Day0
- •*approximately 60 participants per condition will be included and approximately 50% of individuals in each condition will have past history of COVID-19
- •** AID includes: vasculitis, myositis, SLE/Sjögren, rheumatoid arthritis and multiple sclerosis.
- •5. Contraceptive use should be consistent with local regulation for participants in clinical trials.
- •a. Female participants of childbearing potential [defined as any female who has experienced menarche and until becoming postmenopausal (defined as having = 12 months amenorrhea prior to screening without an alternative cause) unless is surgically sterile]:
- •Have a negative pregnancy test on the day of vaccination.
- •Use of any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination, except hormonal contraception. Acceptable contraceptive methods are:
- •oHormonal contraception (progestogen-only or combined): oral, injectable or transdermal (patch) started at least 28 days before day 0 and until 8 weeks after vaccination
- •oIntrauterine device.
- •oVasectomized partner (the vasectomized partner should be the sole partner for that participant).
- •oSexual abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle.
- •b. Male participants:
- •Vasectomized participants.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •6. History of anaphylaxis to any prior vaccine.
- •7. Participant received or plans to receive:
- •Live attenuated vaccines (licensed) within 4 weeks before or after receiving any study vaccine.
- •Other not live vaccines (licensed) within 14 days before and after receiving any study vaccine
- •Viral-vectored COVID-19 vaccines, such as Vaxzevria (AstraZenca) or Ad26.CoV2.S from Janssen
- •8. Pregnancy or breast-feeding at screening or Day 0 (vaccination time-point) or willingness/intention to become pregnant during the entire length of the study for female participants. For male participants, willingness/intention that your parent becomes pregnant during the entire length of the study.
- •Medical conditions
- •9. A confirmed COVID-19 diagnose (by RT-PCR or RAT, asymptomatic or symptomatic) <90 days prior to Day0
- •10. Participant has a clinically significant acute illness (this does not include minor self-limited illness such as mild diarrhea) or fever (temperature =38º C (100.4oF) at screening or within 48 hours prior to the planned vaccination (Day 0).
- •11. Participant had a surgery requiring hospitalization (defined as inpatient stay for > 24 hours) before vaccination and he/she has not received the hospital discharge at day 0; or has a surgery requiring hospitalization planned within 12 weeks after study vaccine administration. Minor surgical procedures not requiring hospitalization are accepted.
- •12.Participant has ongoing severe and non-stable psychiatric condition likely to affect participation in the study (e.g., ongoing and non-stable severe depression, recent suicidal ideation, severe eating disorder, psychosis)
- •13. Participant has a problematic or risk use of substances including alcohol (except tobacco) that can compromise the study follow-up. Problematic or risk use of psychoactive substances is understood as the one that causes evident damage, whether it is dependence or any other physical, psychological, or social problem or that carries a high risk of suffering these damages. The negative consequences that consumption causes to third parties could be included.
- •14. Participant has a bleeding disorder (e.g., factor deficiency, platelet disorder), blood dyscrasia, or continuous use of anticoagulants or has any condition that in the opinion of the investigator contraindicates intramuscular injections or frequent phlebotomy. The use of = 325mg of aspirin or = 75mg of clopidogrel per day as prophylaxis is permitted but not combined.
- •15. Participant suffering from post-acute COVID-19 syndrome / long-covid
- •Prior/Concomitant Therapy and Clinical Study Experience.
- •16. Participant received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days preceding the planned administration of study vaccine (180 days in case of Evusheld)
- •17. Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study.
- •18. Participant has donated = 450ml of blood products within 12 weeks before screening.
- •19. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
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