Status:
UNKNOWN
Heterologous SARS-CoV-2 Vaccination With ChAdOx-1 and BNT162b2
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Medical University of Graz
Medical University of Vienna
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will analyze the safety and efficacy of the heterologous vaccination with Vaxzevria followed by Comirnaty. As a control individuals will be vaccinated with Comirnaty or Vaxzevria twice. Eac...
Detailed Description
The immune escape variants are spreading worldwide. Local transmission of the B.1.351 is observed in several European regions while P1 cases are mostly still travel associated. In Austria, there is lo...
Eligibility Criteria
Inclusion
- Subject provides written informed consent
- Participant is ≥ 18 and ≤ 65 years of age on the day of signing the ICF
- Individuals that are eligible for vaccination according to the Austrian vaccination plan.
- Participants that have been vaccinated with either ChAdOx1-S prime within the last 12 weeks or BNT162b2 prime within the last 3 - 6 weeks
- Subject understands and agrees to comply with study procedures
- Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
- 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.
- 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).
- Participants agrees to not donate bone marrow, blood and blood products from the study vaccine administration until 3 months after receiving the study vaccine
Exclusion
- 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
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04907331
Start Date
May 10 2021
End Date
December 30 2021
Last Update
September 10 2021
Active Locations (1)
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1
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020