| Eligibility |
Inclusion Criteria:
1. Signed informed consent prior to any study-related procedure;
2. Subjects must have received a complete primary vaccination schedule and a third and/or
fourth booster dose with registered and commercial vaccine(s) against SARS-CoV-2, of
which the last dose was given at least 3 months prior to study vaccination (maximum of
1,000 IU of anti-S IgG);
3. Healthy males and females, 18-55 years of age, inclusive at screening;
4. Body mass index (BMI) = 18.0 and < 30.0 kg/m2;
5. Good health, based upon the results of medical history, physical examination, vital
signs, laboratory profiles of both blood and urine, and according to the clinical
judgement of the investigator;
6. Female participants of childbearing potential must be willing to comply with effective
contraception up to 90 days after the study vaccine administration;
7. Willing to comply with the study procedures.
Exclusion Criteria:
- 1. Known immune deficiency; 2. Chronic airway disease; 3. Has experienced an acute
illness, as determined by the investigator, or fever (>38.5°C) within 72 hours prior
to study vaccine administration; in such case, the subject may be screened again after
normalization of the temperature and/or healing of the illness; 4. Active hay fever or
other active allergies involving the lower airways (bronchial and pulmonary); 5.
Laboratory-confirmed PCR positive result for SARS-CoV-2 in nose/throat swab during
screening; 6. Previous participation in a study to evaluate a non-registered COVID-19
vaccine within 3 months prior to study vaccination; 7. Received any other commercial
vaccine within the 28 days prior to enrolment in the study, or immunization planned
within 3 months after enrolment in the study (influenza vaccines are allowed up to one
week before and one week after study vaccination; Exclusion criteria CONFIDENTIAL
Cohort 2: 15 µg Protein (N=10), IN Cohort 4: 5 µg Protein, 25 µg CpG (N=10), IN Cohort
6: 15 µg Protein, 25 µg CpG (N=10), IN Cohort 8: 15 µg Protein, 125 µg CpG (N=10), IN
ACM-001-01 Version 2.0 09 May 2022 Page 10 of 74 DocuSign Envelope ID:
C34D91C3-4686-427D-BB78-CF7178216E74 CONFIDENTIAL 8. Any confirmed severe allergic
reactions (urticaria, angioedema or anaphylaxis); 9. Evidence of any other active or
chronic disease (hematologic, renal, hepatic, cardiovascular, neurologic, endocrinal,
gastrointestinal, oncologic, pulmonary, immunologic or psychiatric disorders) or
condition that could interfere with, or for which the treatment of might interfere
with the conduct of the study, or that would pose an unacceptable risk to the subject
in the opinion of the investigator (following a detailed medical history, physical
examination, vital signs (systolic and diastolic blood pressure, and body
temperature). Minor deviations from the normal range may be accepted, if judged
without clinical relevance by the Investigator; 10.
Clinicallysignificantabnormalities,asjudgedbytheInvestigator,in laboratory test
results (including blood chemistry, hematology and urinalysis). In the case of
uncertain or questionable results, tests performed during screening may be repeated
before randomization to confirm eligibility or judged to be clinically irrelevant for
healthy subjects; 11. Positive hepatitis B surface antigen, hepatitis C antibody, or
human immunodeficiency virus antibody at screening; 12. Asplenia; 13.
Useofanychronictreatmentwithsystemiccorticosteroids(episodic treatments with topical
and intranasal corticosteroids are allowed) and immunosuppressive drugs; 14. Use of
paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to
vaccination; 15. Receivedbloodproducts(transfusionsorimmunoglobulins)within3 months
prior to screening, or planned administration of blood products or immunoglobulins
during the study; 16. History of substance use disorder (alcohol, illegal substances),
current alcohol use disorder (according to Australian guidelines:
https://www.health.gov.au/news/australian-alcohol-guidelines- revised) or drug abuse;
17. Participation in an investigational drug or device study within 3 months prior to
first study vaccine administration or more than 4 times a year; 18.
Lossordonationofbloodover500mLwithin3months(males)or4 months (females) prior to
screening or intention to donate blood or blood products during the study; 19. History
of bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder
requiring special precautions), significant bleeding or bruising following IM
injections or venous punctures, or currently receiving anticoagulants; 20. Has body
art (e.g., tattoos), skin lesions or abnormalities that could interfere with the
observation of injection site reactions; ACM-001-01 Version 2.0 09 May 2022 Page 11 of
74
DocuSign Envelope ID: C34D91C3-4686-427D-BB78-CF7178216E74 Endpoints 21. Close contact with
laboratory-confirmed COVID-19 cases within 10 days prior to vaccination, high risk of
exposure or has an occupation with a high risk of exposure to SARS-CoV-2 (emergency
response); 22. Pregnancy confirmed by a positive pregnancy test, lactation or intention to
become pregnant during the study; 23. Any cancer diagnosed and/or treated within the past 5
years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 24. Veins
not suitable for repeated blood sampling; 25. Serious reaction, such as anaphylactic
reaction, following primary COVID-19 vaccination; 26. Any known factor, condition, or
disease that might interfere with treatment compliance, study conduct or interpretation of
the results; 27. Sponsor employees or Investigator site personnel directly affiliated with
this study, and their immediate families. Immediate family is defined as a spouse, parent,
child or sibling, whether biological or legally adopted, including children of newly
composed families.
|
