Recombinant H7 Hemagglutinin Influenza Vaccine Trial

NCT03038776 | Completed Phase 1

• 1 other identifier: FLU007
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine, namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine

Conditions

Influenza, Avian

Keywords

vaccine

Outcome Measures

Primary Outcomes (3)

• Seroconversion

  1 month post immunization

• Seroprotection

  1 month post immunization

• Fold rise in geometric mean titer

  1 month post immunization

Secondary Outcomes (2)

• Safety: Frequency and severity of adverse events

  12 months post immunization

• T cell response

  1 month post-immunization

Study Arms (6)

1

EXPERIMENTAL

Two i.m. administrations 4 weeks apart of recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7 antigen)

Biological: Recombinant influenza hemagglutinin

2

EXPERIMENTAL

Two i.m. administrations 4 weeks apart of recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7 antigen) + Advax-1 adjuvant

Biological: Recombinant influenza hemagglutinin

3

EXPERIMENTAL

Two i.m. administrations 4 weeks apart of recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7 antigen) + Advax-2 adjuvant

Biological: Recombinant influenza hemagglutinin

4

EXPERIMENTAL

Two i.m. administrations 4 weeks apart of T cell epitope modified recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7m antigen) antigen

Biological: Recombinant influenza hemagglutinin

5

EXPERIMENTAL

Two i.m. administrations 4 weeks apart of T cell epitope modified recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7m antigen) + Advax-1 adjuvant

Biological: Recombinant influenza hemagglutinin

6

EXPERIMENTAL

Two i.m. administrations 4 weeks apart of T cell epitope modified recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7m antigen) + Advax-2 adjuvant

Biological: Recombinant influenza hemagglutinin

Interventions

Recombinant influenza hemagglutinin BIOLOGICAL

Avian H7N9 influenza vaccine

Also known as: Panblok-H7

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 18 years or over
• Able to provide written informed consent
• Willing and able to comply with the protocol for the duration of the study

You may not qualify if:

• History of serious vaccine allergy\*
• History of vasculitis, Wegener's granulomatosis, narcolepsy, Guillain Barre, SLE or other systemic autoimmune disease that in the opinion of the investigator would make the vaccine contraindicated
• History of chronic liver disease or liver transaminases elevated more than 3xULN
• Women of childbearing potential, unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, IUD or mechanical barrier device.
• Pregnant or lactating women.
• Any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
• Receipt of another investigational agent within 28 days preceding initiation of treatment.
• Individuals who have a past history of potential vaccine reactions will be assessed by the investigator, who will decide whether any past potential vaccine-related side are sufficiently minimal to allow vaccine administration to proceed.

Sponsors & Collaborators

• Vaxine Pty Ltd: lead
• Australian Respiratory and Sleep Medicine Institute: collaborator

Study Sites (1)

Flinders University

Adelaide, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases

Study Officials

• Dimitar Sajkov, MD, PhD

  Flinders University/ARASMI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: May 1, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)