A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine

NCT01265914 | Completed Phase 1 DMC

• 1 other identifier: FP-01.1_CS_01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, tolerability and immunogenicity of ascending doses of a novel, universal flu vaccine, in healthy volunteers.

Conditions

Influenza

Outcome Measures

Secondary Outcomes (1)

• Immunogenicity of FP-01.1.

Study Arms (2)

placebo

PLACEBO COMPARATOR

Biological: placebo

FP-01.1

EXPERIMENTAL

Biological: FP-01.1

Interventions

FP-01.1 BIOLOGICAL

Ascending doses of FP-01.1 will be administered

FP-01.1

placebo BIOLOGICAL

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 55 years inclusive at the time of consent
• Male and female subjects who are willing to comply with the applicable contraceptive requirements of the protocol
• Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation (haematology, biochemistry or urinalysis) as assessed by the Investigator.
• Ability to provide written, personally signed and dated informed consent to participate in the study.
• The subject has a body mass index within the range 19.0-32.0 kg/m2 and falls within the weight range of 50.0-100.0 kg.
• Subject is willing to refrain from consuming alcohol for 24h prior to all visits.

You may not qualify if:

• As a result of the medical screening process, the Principal Investigator or Co-Investigator considers the subject unfit for the study.
• Current or recurrent disease (e.g. cardiovascular, respiratory, endocrine, renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational medicinal product (IMP) or could affect clinical or laboratory assessments.
• Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
• Subjects with a history of allergies or allergic conditions including asthmatics, hay fever and eczema sufferers requiring medication which in the opinion of the Principal Investigator or Co-Investigator will affect their participation in the study.
• Concurrent use of any medication (including prescription, over the counter, herbal or homeopathic preparations and any vaccinations (including travel vaccinations).
• Known or suspected intolerance or hypersensitivity to the IMP/placebo, or closely related compounds or any of the stated ingredients.
• History of alcohol or other substance abuse within the last year. A positive screen for alcohol or drugs of abuse.
• Male subjects who consume more than 21 units of alcohol per week and female subjects who consume more than 14 units of alcohol per week.
• A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
• Subjects who have significant scarring, tattoos, abrasions, cuts or infections at the dose site that in the opinion of the Investigator could interfere with evaluation of injection site local reactions.
• Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to or intention to donate blood during the entire study.
• Use of another investigational medicinal product within 90 days prior to receiving the first dose of IMP or intention to enrol in another clinical study throughout the entire study including the follow up period.
• Subject with suspected recent (≤12 months) pre-exposure to the influenza A virus
• Subjects who have received a flu vaccine in the last 12 months or who anticipate receiving it within the duration of the study including follow up.
• Any clinically significant abnormalities, in the opinion of the Principal Investigator or Co-Investigator, on electrocardiograms

Sponsors & Collaborators

• Immune Targeting Systems Ltd: lead
• Hammersmith Medicines Research: collaborator

Study Sites (1)

Hammersmith Medicines Research Ltd

London, United Kingdom

Location

Related Publications (1)

• Francis JN, Bunce CJ, Horlock C, Watson JM, Warrington SJ, Georges B, Brown CB. A novel peptide-based pan-influenza A vaccine: a double blind, randomised clinical trial of immunogenicity and safety. Vaccine. 2015 Jan 3;33(2):396-402. doi: 10.1016/j.vaccine.2014.06.006. Epub 2014 Jun 10.

  PMID: 24928790 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Steve Warrington, MD

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

GB (1)