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

NCT05385991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-10-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ACM Biolabs

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-06-30
Completion
2023-08-22

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385991 on ClinicalTrials.gov