Phase I clinical study to evaluate the safety and tolerability of SARS-CoV-2 spike protein (HexaPro) delivered intradermally by a high-density microarray patch (HD-MAP), in healthy adults aged 18 to 50 years.

Vaxxas Pty Ltd0 sites44 target enrollmentApril 21, 2022

ConditionsSARS-CoV-2 infection Infection - Other infectious diseases Respiratory - Other respiratory disorders / diseases

Overview

Phase: 未知
Intervention: Not specified
Conditions: SARS-CoV-2 infection
Sponsor: Vaxxas Pty Ltd
Enrollment: 44
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 21, 2022

End Date

May 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Vaxxas Pty Ltd

Eligibility Criteria

Inclusion Criteria

•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);

Exclusion Criteria

•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;