MedTrace Logo

Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects

NCT03594890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-09-22

No results posted yet for this study

Summary

The present study is a first-in-man clinical trial evaluating OVX836, a recombinant broad spectrum vaccine for Influenza.

This clinical trial will evaluate the safety and the immune response of increasing doses of OVX836 after intramuscular or intranasal administrations in healthy volunteers.

Conditions

Interventions

BIOLOGICAL

OVX836 (Intramuscular)

2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.

BIOLOGICAL

Placebo (Intramuscular)

2 consecutive administrations of placebo at Day 1 and Day 29.

BIOLOGICAL

OVX836 (Intranasal)

2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.

BIOLOGICAL

Placebo (Intranasal)

2 consecutive administrations of placebo at Day 1 and Day 29.

Sponsors & Collaborators

  • Aepodia

    collaborator INDUSTRY

  • Osivax

    lead INDUSTRY

Principal Investigators

  • Pierre Van Damme, MD, PhD · Centre for the Evaluation of Vaccination, University of Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2019-08-07
Completion
2019-08-07

Countries

  • Belgium

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 NCT03594890 on ClinicalTrials.gov