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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05385991




Registration number
NCT05385991
Ethics application status
Date submitted
17/05/2022
Date registered
23/05/2022
Date last updated
24/10/2023

Titles & IDs
Public title
Booster Dose Study to Assess the Safety and Immunogenicity of ACM-001 Administered Intramuscularly or Intranasally.
Scientific title
An Open Label, Randomized, Dose and Route of Administration Comparison Phase 1 Study to Evaluate the Safety and Immunogenicity of the ACM-SARS-CoV-2-beta With ACM-CpG Vaccine Candidate (ACM-001), Administered Intramuscularly or Intranasally as a Booster Dose in Healthy Adults Aged 18 to 55 Years, Who Were Previously Vaccinated Against SARS-CoV-2.
Secondary ID [1] 0 0
ACM-001-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)

Experimental: SARS-CoV-2 beta S vaccine arm 1 - SARS-CoV-2 beta S vaccine Antigen dose 1, no adjuvant, IM

Experimental: SARS-CoV-2 beta S vaccine arm 2 - SARS-CoV-2 beta S vaccine Antigen dose 1, no adjuvant, IN

Experimental: SARS-CoV-2 beta S vaccine arm 3 - SARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IM

Experimental: SARS-CoV-2 beta S vaccine arm 4 - SARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IN

Experimental: SARS-CoV-2 beta S vaccine arm 5 - SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 1, IM

Experimental: SARS-CoV-2 beta S vaccine arm 6 - SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 1, IN

Experimental: SARS-CoV-2 beta S vaccine arm 7 - SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 2, IM

Experimental: SARS-CoV-2 beta S vaccine arm 8 - SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 2, IN


Other interventions: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001): Artificial Cell Membranes (ACM) containing recombinant SARS-CoV-2, beta- variant strain, spike protein and ACMs containing CpG adjuvant
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverses events
Timepoint [1] 0 0
through study completion, an average of 6 months
Secondary outcome [1] 0 0
Immune responses
Timepoint [1] 0 0
through study completion, an average of 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2023
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Paratus Research Central Coast - Kanwal
Recruitment hospital [2] 0 0
Paratus Research Sydney - Sydney
Recruitment hospital [3] 0 0
Paratus research Brisbane - Brisbane
Recruitment hospital [4] 0 0
Paratus research Canberra - Canberra
Recruitment hospital [5] 0 0
Emeritus Research Melbourne - Melbourne
Recruitment hospital [6] 0 0
Emeritus Research Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
4010 - Brisbane
Recruitment postcode(s) [4] 0 0
ACT 2617 - Canberra
Recruitment postcode(s) [5] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ACM Biolabs
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An open label, randomized, dose comparison, sequential cohorts study design in healthy
volunteers (young adults) is a frequently used design in vaccine Phase 1 studies.

ACM-001 is developed as a booster vaccine against SARS-CoV-2 after a full primary vaccination
with or without 1-2 booster doses (2 or 3 or 4 doses) schedule with any registered and
commercial SARS-CoV-2 vaccines.

The plan is to start with a low dosage of antigen alone, followed by a combination of antigen
and adjuvant and then to progress to higher dosages to define the safety profile of the
candidate vaccine as primary endpoint, and its immunogenicity as secondary endpoint.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05385991
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries