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Safety and Efficacy of Intranasal Administration of Avacc 10 Vaccine Against COVID-19 in Healthy Volunteers

NCT05604690 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-22

No results posted yet for this study

Summary

This study is a Phase I, first-in-human (FIH), double-blind, placebo- and OMV-controlled study of Avacc 10 in healthy adult male and female subjects to investigate the safety, tolerability, and immunogenicity of intranasally administered Avacc 10.

Conditions

Interventions

BIOLOGICAL

Avacc 10

Intranasal application of either low dose or high dose of Covid 19 vaccine.

COMBINATION_PRODUCT

Outer Membrane Vesicles (OMV) : OMV alone in vehicle

OMV will be administered via intranasal route.

OTHER

Placebo

Placebo will be administered via intranasal route.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Intravacc B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2023-08-09
Completion
2024-01-15

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 NCT05604690 on ClinicalTrials.gov