COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN73765130

Prof Saul Faust

s.faust@soton.ac.uk

2021-05-13

Recruiting

nonRCT

Non-randomized

Adaptive

Blind label

single-center

Prevention

Current participant inclusion criteria as of 10/01/2022: 1. Willing and able to give written informed consent for participation in the trial. 2. Aged 30 years or above and in good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity. 3. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 5. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial 6. Willing to allow investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures. 7. Agreement to refrain from blood donation during the study 8. Received priming dose of COVID-19 vaccination between December 2020 and January 2021 (inclusive) and booster dose no less than 84 days prior to day 0. Due to the NHS deployment timelines, some sites may need to invite people who have been prime-boosted with their second dose of AstraZeneca with a minimum of 70 days from their second dose. Sites need Sponsor approval for this prior to enrolment of people with a 70-83 day gap since their second dose in any study arm For the External Vaccine Trial Participants sub-study, the inclusion criteria are: 1. Willing and able to give written informed consent for participation in the trial 2. Male or female aged 30 years or above 3. In the Investigator’s opinion, is able and willing to comply with all trial requirements 4. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial 5. Willing to allow investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures 6. Primary immunization course (2 doses) of NVXCoV2373 COVID-19 vaccine 7. Plans to receive 1 or 2 doses of licensed vaccine (1 dose will be received as part of this trial, the second dose will not be provided by the trial but the participant may receive a second dose via the NHS if they wish to). Previous participant inclusion criteria: 1. Willing and able to give written informed consent for participation in the trial. 2. Aged 30 years or above and in good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity. 3. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 5. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial 6. Willing to allow investigators to discuss the volunteer’

Current participant exclusion criteria as of 10/01/2022: 1. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination (one week for licensed seasonal influenza vaccine or pneumococcal vaccine) 2. Prior or planned receipt of any other investigational or licensed vaccine or product likely to impact on the interpretation of the trial data (e.g. adenovirus vectored vaccines, any coronavirus vaccines) 3. Pregnant at enrolment or planning to become pregnant during the first 3 months of the trial period 4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines 5. Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days) 6. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed ingredients of the Pfizer vaccine) 7. Any history of anaphylaxis 8. Current diagnosis of or treatment for cancer, except basal cell carcinoma of the skin and cervical carcinoma in situ 9. Bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 10. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran, and edoxaban) 11. History of cerebral venous sinus thrombosis, antiphospholipid syndrome, or heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2) 12. Suspected or known current alcohol or drug dependency 13. Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data 14. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed) 15. History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion. 16. Significant renal or hepatic impairment 17. Scheduled elective surgery during the trial 18. Life expectancy of <6 months 19. Have participated in another research trial involving an investigational product in the past 12 weeks. This does not exclude participants in trials of AZD1222 (ChAdOx1 nCOV-19) who were originally recipients of placebo and who received AZD1222 (ChAdOx1 nCOV-19) or BNT162b2 as part of the “national schedule” with AZD1222 (ChAdOx1 nCOV-19) or BNT162b2 dose 1 from mid-Dec 2020 through end February 2021 and then AZD1222 (ChAdOx1 nCOV-19) or BNT162b2

11

University Hospital Southampton NHS Foundation Trust

30

100

United Kingdom

Healthy volunteers

N/A

2886

1. Immunology measured using serum Anti Spike protein IgG levels at 28 days 2. Safety/Reactogenicity measured using the following from participant records: 2.1. Incidence and details of solicited adverse events between 0 and 7 days 2.2. Incidence and details of unsolicited adverse events between 0 and 28 days 2.3. Incidence and details of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) throughout the study

Phase 2

[{"arm_notes": "5x1010vp (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2.5 \u00b5g SARS-CoV-2 rS + 25 \u00b5g Matrix-M1 adjuvant (0.25ml);1;IM; Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g (0.3ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "33 AU + 0.5mg Aluminium hydroxide +1mg CPG (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 1375, "treatment_name": "Vla2001", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "16.5 AU + 0.25mg Aluminium hydroxide +0.5mg CPG (0.25ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 1375, "treatment_name": "Vla2001", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.1mg (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "12 \u00b5g (in 0.6ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 364, "treatment_name": "Cvncov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "15 \u00b5g (0.3ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5x10\u00b9\u2070 vp/ml (in 0.5 ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.5ml;1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 780, "treatment_name": "Menacwy vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]