Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

- 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05385991
Study type Interventional
Source ACM Biolabs
Contact
Status Completed
Phase Phase 1
Start date July 1, 2022
Completion date August 22, 2023

See also
  Status Clinical Trial Phase
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04593641 - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) Phase 1
Recruiting NCT05200754 - Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19 Phase 2
Completed NCT04583995 - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom Phase 3
Recruiting NCT06255860 - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting NCT04516811 - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19 Phase 3
Recruiting NCT05012826 - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID N/A
Completed NCT05007236 - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. Phase 2
Recruiting NCT06026514 - Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults Phase 1
Completed NCT05523739 - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients Phase 1
Suspended NCT04738136 - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia Phase 2
Recruiting NCT04584658 - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting NCT04547114 - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed NCT05119348 - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments N/A
Completed NCT05096962 - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting NCT04534400 - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed NCT04527354 - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia Phase 2
Completed NCT04583982 - ImmuneSense™ COVID-19 Study
Completed NCT05077176 - Phase 3 Booster Vaccination Against COVID-19 Phase 3
Completed NCT05584189 - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability N/A