A Phase 1 interventional study of ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001) in SARS-CoV-2 Infection, sponsored by ACM Biolabs. Completed at 6 sites in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by ACM Biolabs · Phase 1, Interventional, and Prevention
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with ACM Biolabs as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
SARS-CoV-2 beta S vaccine Antigen dose 1, no adjuvant, IM
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 1, no adjuvant, IN
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IM
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IN
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 1, IM
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 1, IN
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 2, IM
Biological: ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001)
SARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 2, IN
Biological: 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
Adverses events
Frequency, duration and intensity of solicited local AEs reported during 7 days following vaccination: injection site pain, erythema/redness (including size), and swelling/induration (including size) after IM injection, or nose pain, ear pain, runny nose, sneezing, stuffy nose and throat pain after IN administration.
Time frame: through study completion, an average of 6 months
Immune responses
Humoral and mucosal immune responses
Time frame: through study completion, an average of 6 months
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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