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

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265914
• Other study ID #: FP-01.1_CS_01
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2010
• Last updated: March 23, 2012
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Immune Targeting Systems Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• FP-01.1
Ascending doses of FP-01.1 will be administered
• placebo

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Immune Targeting Systems Ltd	Hammersmith Medicines Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Immunogenicity of FP-01.1.	Immunogenicity of ascending doses will be assessed		No