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Assess the Safety and Immunogenicity of M-001 as A Standalone Influenza Vaccine and as A H5N1 Vaccine Primer in Adults

NCT02691130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-02-09

No results posted yet for this study

Summary

"Multimeric-001" (M-001) contains conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to pandemic influenza vaccine in the adult population. The current clinical study was designed to assess M-001's standalone and priming action in subjects aged 18-60 years old.

This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.

Conditions

Interventions

BIOLOGICAL

Multimeric 001 (M-001)

Multimeric 001 is a recombinant protein comprising 9 conserved peptides from influenza A and B

BIOLOGICAL

H5N1 influenza vaccine

Alum adjuvanted whole virion inactivated H5N1 vaccine produced by FluArt (Hungary)

BIOLOGICAL

Saline

0.9% NaCl in double distilled water

Sponsors & Collaborators

  • Seventh Framework Programme

    collaborator OTHER

  • BiondVax Pharmaceuticals ltd.

    lead INDUSTRY

Principal Investigators

  • Dora Mathiasz, MD · St Istvan St Laszlo hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-10-31
Completion
2017-01-31

Countries

  • Hungary

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 NCT02691130 on ClinicalTrials.gov