Trial record 3 of 16 for:    influenza and universal

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

This study has been completed.
Sponsor:
Collaborator:
Hammersmith Medicines Research
Information provided by (Responsible Party):
Immune Targeting Systems Ltd
ClinicalTrials.gov Identifier:
NCT01265914
First received: December 22, 2010
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: FP-01.1
Biological: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of an Influenza A Vaccine (FP-01.1)

Resource links provided by NLM:


Further study details as provided by Immune Targeting Systems Ltd:

Secondary Outcome Measures:
  • Immunogenicity of FP-01.1. [ Designated as safety issue: No ]
    Immunogenicity of ascending doses will be assessed


Enrollment: 49
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Biological: placebo
Experimental: FP-01.1 Biological: FP-01.1
Ascending doses of FP-01.1 will be administered

Detailed Description:

FP-01.1 is composed of a mixture of synthetic peptides, modified with a fluorocarbon vector, which is anticipated to enhance the immune properties of the drug, and allows differentiation from recent investigational interventions by avoiding the use of adjuvant. The peptide sequences, derived from internal influenza-A proteins, were selected based on the presence of CD4+ and CD8+ T cell epitopes and a high degree of conservation across all influenza strains, using a proprietary bioinformatics approach, and, it is proposed, will enable FP-01.1 to universally treat influenza-A -infected populations.

This study is the initial exploration of the safety, tolerability and immunogenicity response of FP-01.1 in healthy volunteers. Ascending doses of FP-01.1 will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 to 55 years inclusive at the time of consent
  2. Male and female subjects who are willing to comply with the applicable contraceptive requirements of the protocol
  3. 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.
  4. Ability to provide written, personally signed and dated informed consent to participate in the study.
  5. 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.
  6. Subject is willing to refrain from consuming alcohol for 24h prior to all visits.

Exclusion Criteria:

  1. As a result of the medical screening process, the Principal Investigator or Co-Investigator considers the subject unfit for the study.
  2. 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.
  3. Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
  4. 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.
  5. Concurrent use of any medication (including prescription, over the counter, herbal or homeopathic preparations and any vaccinations (including travel vaccinations).
  6. Known or suspected intolerance or hypersensitivity to the IMP/placebo, or closely related compounds or any of the stated ingredients.
  7. History of alcohol or other substance abuse within the last year. A positive screen for alcohol or drugs of abuse.
  8. 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.
  9. A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
  10. 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.
  11. Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to or intention to donate blood during the entire study.
  12. 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.
  13. Subject with suspected recent (≤12 months) pre-exposure to the influenza A virus
  14. 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.
  15. Any clinically significant abnormalities, in the opinion of the Principal Investigator or Co-Investigator, on electrocardiograms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265914

Locations
United Kingdom
Hammersmith Medicines Research Ltd
London, United Kingdom
Sponsors and Collaborators
Immune Targeting Systems Ltd
Hammersmith Medicines Research
Investigators
Principal Investigator: Steve Warrington, MD Hammersmith Medicines Research Ltd
  More Information

No publications provided

Responsible Party: Immune Targeting Systems Ltd
ClinicalTrials.gov Identifier: NCT01265914     History of Changes
Other Study ID Numbers: FP-01.1_CS_01
Study First Received: December 22, 2010
Last Updated: March 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014