Heterologous vaccination with a Vaxzervia (ChAdOx1-S) prime and a Comirnaty (BNT162b2) boost

Phase 1

• Conditions: Immunization for SARS-CoV-2; MedDRA version: 20.0Level: LLTClassification code 10021433Term: ImmunizationSystem Organ Class: 100000004865; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2021-002171-19-AT
• Lead Sponsor: Medizinische Universität Innsbruck, Institut für Virologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-27
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3000

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified