EUCTR2021-002171-19-AT进行中（未招募）1 期
Heterologous vaccination with a Vaxzervia (ChAdOx1-S) prime and a Comirnaty (BNT162b2) boost
Medizinische Universität Innsbruck, Institut für Virologie0 个研究点目标入组 3,000 人开始时间: 2021年4月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
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.Subject provides written informed consent
- •2.Participant is = 18 and = 65 years of age on the day of signing the ICF
- •3.Individuals that are eligible for vaccination according to the Austrian vaccination plan.
- •4.Participants that have been vaccinated with either ChAdOx1-S prime within the last 12 weeks or BNT162b2 prime within the last 3 – 6 weeks
- •5.Subject understands and agrees to comply with study procedures
- •6.Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
- •7.Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- •-has a negative urine pregnancy test at screening
- •-has agreed to practice adequate contraception from providing consent until 3 months after administration of study vaccine
- •-is not currently breastfeeding
- •Adequate female contraception is defined as consistent and correct use of an approved contraceptive method, for example:
- •Barrier method (condoms, diaphragm, cervical cap) used in conjunction with spermicide
- •Prescription hormonal contraceptive taken administered via oral (pill), transdermal (patch), subdermal or IM route
- •Intrauterine device
- •Sterilization of a female participant`s monogamous male partner prior to study inclusion
- •Cave: periodical abstinence (eg calendar, ovulation, symptothermal,...) and withdrawal are not acceptable methods of contraception.
- •8.Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as: surgically sterile (history of bilateral dubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (amenorrhea for ? 12 consecutive months prior to Screening without an alternative medical cause).
- •9.Participants agrees to not donate bone marrow, blood and blood products from the study vaccine administration until 3 months after receiving the study vaccine
- •Amendment protocol 2021-08-18: 3rd vaccination
- •1. Subjects that have received the second dose of vaccination within this study.
- •2. No neutralizing antibodies on day 90 post second dose (only for participants that will receive the third dose between day 110 and 180). All other participants will be offered a third dose between
- •day 200 and 260 after the second dose, independent of their antibody titers.
- •3. Subject provides written informed consent
- •4. Subject understands and agrees to comply with study procedures
- •5. Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
- •6. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- •- has a negative urine pregnancy test at screening
- •- has agreed to practise adequate contraception from providing consent until 3 months after administration of study vaccine
- •- is not currently breastfeeding
- •8. Participants agrees to not donate bone marrow, blood and blood products from the study vaccine administration until 3 months after receiving the study vaccine
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1.Participant has already received full vaccination against SARS-CoV-2
- •2.Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19
- •3.Participant has received/plans to receive a non-study vaccine within 14 days prior to or after any dose of IP
- •4.Participant has a contraindication to IM injections and blood draws (eg, bleeding disorders)
- •5.Participants has a known or suspected allergy or history of anaphylaxis, urticaria or other significant adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the IB)
- •6.Subjects with previous positive PCR-test result for SARS-CoV-2 or positive anti-SARS-CoV-2 N protein antibody test
- •7.History of leukemia, lymphoma, or underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant.
- •8.Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment.
- •9.Has participated in an interventional clinical study within 30 days prior to study inclusion
- •Amendment protocol 2021-08-18: 3rd vaccination
- •1. Participant already received a third dose of vaccination.
- •2. Subjects with positive PCR-test result for SARS-CoV-2 after study enrolment or a positive anti-SARS-CoV-2 N antibody test on day 180.
研究者
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