Booster Dose Study to Assess the Safety and Immunogenicity of ACM-001 Administered Intramuscularly or Intranasally.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-08-22

Brief Summary

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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.

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Detailed Description

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* Open label, randomized, single dose study.
* The ACM-001 vaccine will be evaluated in a single ascending dose (administered IM in 4 groups of 5 subjects and IN in 4 groups of 5 subjects), which will explore the amount of SARS-CoV-2 spike protein derived from strain B.1.351 (5 µg and 15 µg) and adjuvant CpG7909 (25 µg and 125 µg) required to provide the optimum immunogenicity and safety, as a booster dose in subjects who were previously vaccinated (two, three or four doses) against SARS-CoV-2.
* Fourty (N=40) healthy adult volunteers aged 18-55 years, will be enrolled and randomized in the IN or IM cohorts if they meet eligibility criteria at baseline. Participants who benefited from a complete 2 dose-primary vaccination with or without one or two booster dose with registered and commercial COVID-19 vaccine(s), at least 3 months prior to study vaccination (maximum 5,000 BAU/mL of anti-S Ig), with or without previous infection by COVID-19 can be enrolled in this study.
* Participants of cohorts 1,3,5 and 7 will receive an IM injection into the deltoid region, consisting of 0.4 mL per dose on Day 1. In cohorts 2, 4, 6 and 8, the vaccine will be administered IN (2 x 0.2 mL per dose) on Day 1.
* Participants will be observed closely in the research unit for at least 2 hours following vaccination.
* As from Day 30 (following completion of Day 29 visit), subjects may receive an additional (3rd or 4th or 5th) commercial SARS-CoV-2 vaccine dose.
* All subjects (having received or not a commercial dose of a SARS-CoV-2 vaccine at any point of time during their study participation) will be followed up for safety and immunogenicity on Day 85 and Day 180 visits.
* Solicited local and systemic AEs will be collected for 7 days following the vaccination using a daily reactogenicity electronic diary (eDiary). Non-serious unsolicited AEs will be collected from administration until 28 days following vaccination. Serious AEs (SAEs) and AEs of special interest (AESI; list determined by the Safety Platform for Emergency Vaccines (SPEAC; Brighton collaboration)) will be collected throughout the whole 6-month study period.
* Sentinel dosing will be applied to all cohorts for the early detection of safety signals. Two subjects will be dosed ahead of the other volunteers (at least 48 hours), with an interval of at least 2 hours between them, to ensure there are no serious acute reactions following vaccination. After global evaluation by the Investigator (or the responsible physician) and phone contact with the subjects on Day 3, and providing there are no safety concerns, the rest of the cohort (N=3) will be dosed.
* Seven-day safety data of all subjects (N=10) of a given Ag/CpG dose level will be reviewed by an independent data safety monitoring board (DSMB). The interval between the last subject receiving his/her vaccine and vaccination of three sentinel subjects with the ascending dose levels will be at least 10 days.
* On Day 1 (pre-vaccination) and on Days 8 and 29 (28 days post-vaccination), blood samples will be drawn for analysis of safety parameters.
* At all timepoints, serum and saliva samples will be collected for analysis of the humoral immune responses (IgG, IgA and neutralizing antibodies).
* The duration of the study for each subject will be approximately 6 months.

Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Intervention Type BIOLOGICAL

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

Interventions

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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 Type BIOLOGICAL

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes