Immunization for SARS-CoV-2 MedDRA version: 20.0 Level: LLT Classification code 10021433 Term: Immunization System Organ Class: 100000004865
Conditions
Sponsors
Medizinische Universität Innsbruck, Institut für Virologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: 1. To determine whether the immune response to vaccine SARS-CoV-2 spike protein is at least as effective for the heterologous prime-boost regime Vaxzevria followed by Comirnaty as in the approved homologous Vaxzevria and Comirnaty regimen. 2. To determine immune responses in non-responders after a third immunization 3. To determine immune responses all participants after a third immunization;Secondary Objective: 1. Potentially show clinical efficacy against infection, especially with B.1.351, B.1.1.7+E484K and other immune escape variants 2. To analyze in detail safety and tolerability after the second vaccination especially in the heterologous arm. (clinical, lab) 3. To evaluate the clinical course and outcome of COVID-19 diseases after vaccination with ChAdOx1-S prime & boost vs. ChAdOx1-S prime and BNT162b2 boost vs BNT162b2 prime & boost 4. To analyze safety and tolerability after the 3rd dose vaccination (clinical, lab) ;Primary end point(s): 1a Level of neutralizing antibodies against wild-type and immune escape variants in the 3 study groups at 10, 30, 90 and 180 days post boost. 1b Level of neutralizing antibodies against wild-type and immune escape variants at 10, 30, 90 and 180 days post 3rd immunization. ;Timepoint(s) of evaluation of this end point: Day 10, Day 30, Day 90, Day 180 Amendment protocol 2021-08-18: 3rd vaccination Day 10, Day 30, Day 90, Day 180 after 3rd vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Level of T cell responses against SARS-CoV-2 spike protein peptides pools per subgroup at 30 days. 2. Occurrence of breakthrough infection with wild type, B.1.351 and other immune escape variants of SARS-CoV-2 3. Occurrence of adverse events, serious adverse events and adverse events of special interest 4. The clinical course (hospitalization, ICU admission) and outcome of COVID-19 diseases (recovery, long-Covid mortality). 5. Occurrence of adverse events, serious adverse events and adverse events of special interest after 3rd immunization 6. Level of T cell responses against SARS-CoV-2 spike protein peptides pools in non-responders after 3rd immunization 7. Occurrence of breakthrough infection with wild type, B.1.351 and other immune escape variants of SARS-CoV-2 after 3rd immunization ;Timepoint(s) of evaluation of this end point: Day 1 - day 10 and weekly antigen-tests until day 180 after Boost shot Amendment protocol 2021-08-18: 3rd vaccination Day 1 - day 10 and weekly antigen-tests until day 180 after 3rd vaccination | — |
Countries
Austria
Contacts
Public ContactSponsor representative and PI
Medizinische Universität Innsbruck
Outcome results
None listed