COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12622000597796.aspx

Sepehr Shakib

Sepehr.shakib@cmax.com.au

2022-04-21

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Subjects can be included in the study if they have received three doses of a COVID-19 vaccine. The first two COVID-19 vaccines can be any combination of Comirnaty® (Pfizer-BioNTech), Spikevax (Moderna Inc), and Vaxzevria (AstraZeneca) but participants must have received a third dose of either Comirnaty® (Pfizer-BioNTech) or Spikevax (Moderna Inc) (not Vaxzevria (AstraZeneca). The third dose must have be administered at least four months prior to the commencement of the study (Day 0). Addition inclusion criteria are: 1. Participants must be healthy with no clinically significant underlying chronic conditions/illness 2. Aged 18–50 years (inclusive) at Day 0 (pre-dose), 3. With a body mass index (BMI) within the range 18.0–32.0 kg/m² (inclusive), 4. Satisfactory medical assessment: no clinically significant or relevant abnormalities (in the opinion of the Investigator) in medical history, physical examination, vital signs (blood pressure, tympanic temperature, heart rate, respiratory rate, ECG) and laboratory evaluation (haematology or biochemistry),

1. Subject has tested positive for COVID-19 (PCR or RAT confirmed) since receiving their last COVID-19 vaccination or considers themselves highly likely to have had symptomatic COVID-19 disease in the four months prior to Day 0 of the study period. 2. Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) on upper arm region (where IP would be applied) that could be expected to obscure the observation of application-site reactions, 3. Subject with known chronic spontaneous urticaria / dermographism, 4. Known anaphylactic hypersensitivity or clinically significant allergy to a previous vaccination or to any of the vaccine components (recombinant human serum albumin, sodium chloride, sodium phosphate, potassium chloride), 5. Known anaphylactic hypersensitivity or clinically significant allergy as determined by the investigator 6. Recent vaccination (within 14 days prior to enrolment) with any vaccine, or a plan to be vaccinated during the study period with a COVID-19 vaccine or with an investigational COVID-19 vaccine (other than the study vaccine), 7. Known predisposition to keloid-scar formation, 8. History of granulomatous diseases (especially sarcoidosis and granuloma annulare), 9. History of convulsions, seizures (including childhood febrile), or epilepsy, 10. History of clinically significant haematological, gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, that, at the discretion of the Investigator, precludes the volunteer from the study, 11. An acute febrile illness at the time of enrolment, 12. A clinically significant history of cancer defined as lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to screening 13. An active medical condition or recent illness (within 3 months) that is considered clinically significant by the PI and is under evaluation or treatment, 14. A history of major surgery within the past 3 months or planned major surgery during the course of the study that is considered clinically significant, for example within the past year, 15. History of illness and/or infection with Hepatitis B, or Hepatitis C or HIV, or, during screening, a positive test for Hepatitis B surface antigen, Hepatitis C or antibodies against HIV.

3

Vaxxas Pty Ltd

18

50

Australia

Healthy volunteers

N/A

44

The primary outcome is a composite of Safety and tolerability of VXS-1223 (either 30 mcg or 90 mcg coated); compared with VXS-1223U. Assessed by:• Number of subjects with SAEs deemed possibly; probably or definitely related to treatment administration from application to Day 90 (EoS) as reported by PI.• Number of subjects with AEs deemed possibly; probably or definitely related to treatment administration from application to Day 28 as reported by PI or self reported.• Changes in clinical laboratory samples (biochemistry; haematology) at screening and Day 0 (pre-treatment) through Day 7; Day 28 and Day 56 as determined by PI.• Local skin response (including erythema and swelling) assessed by photo imaging; standardized scoring; measured at 1 hour; 2 hours following application on Day 0; and at Days 3; 7; 28; 56 and 90 as reported by PI[SAEs will be measured if reported from application to Day 90 post doseAEs will be measured from application to Day 28 post dose by self reporting at clinic visits or noted on the diary card.Clinical Laboratory findings will be assessed pre-dose then throughout the study to Day 90 post doseLocal skin response will be determined on Day 0 at pre-dose; 1 hr 2hr then at Days 3; 7; 28; 56 and 90 post dose]

Phase 1

[{"arm_notes": "3 patches of VXS-1223 30mg ", "treatment_id": 2455, "treatment_name": "Vxs-1223", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 patch of VXS-1223 30mg and 2 patches of uncoated (placebo) ", "treatment_id": 2455, "treatment_name": "Vxs-1223", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]