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.

Not Applicable

Completed

• Conditions: SARS-CoV-2 infection; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622000597796
• Lead Sponsor: Vaxxas Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-21
• Study Completion: 2023-05-30
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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;
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified