Influenza Vaccine Challenge Study in Healthy Subjects

NCT01226758 | Completed Phase 1

• 1 other identifier: FLU-v-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the safety, tolerability and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus.

Conditions

Influenza

Keywords

Safety; Tolerability; Efficacy; Influenza; Flu; Virus; Vaccine

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  The primary safety endpoint for the vaccination phase of the study is the evaluation of all AEs occurring up to Day 28 (final follow-up). AE details will be collected by subject questioning and review of a subject self-assessment diary card (completed for Days -21 to -14) at the clinic visit on Day -2

  Day -21 to Day 28

Secondary Outcomes (5)

• Safety of FLU-v

  Days -21 to 28

• Post-innoculation symptoms

  Days 0 to 28

• Post-innoculation virology

  6 days following inoculation

• Post-innoculation fever

  Days -21 to 28

• Protective Efficacy (PE)

  Day 1 to 5 post-viral challenge

Study Arms (2)

FLU-v with adjuvant

EXPERIMENTAL

Biological: Influenza vaccine (FLU-v)

Placebo

PLACEBO COMPARATOR

Adjuvant only placebo

Biological: Placebo (adjuvant only)

Interventions

Influenza vaccine (FLU-v) BIOLOGICAL

FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection.

FLU-v with adjuvant

Placebo (adjuvant only) BIOLOGICAL

Single subcutaneous injection of adjuvant

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General good health determined by a screening evaluation ≤120 days prior to IMP administration and on the day of admittance to quarantine
• Using methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following study drug administration.
• Negative HIV, hepatitis B and C antibody screens
• Negative class A drugs, alcohol and nicotine screen
• Seronegative (≤10 HAI) for challenge virus
• Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza-like illness in the current season, defined as in the last 12 months

You may not qualify if:

• Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness, including but not exclusive to the conditions listed in Appendix 2, that in the view of the Investigator is associated with increased risk of complications of respiratory viral illness
• Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
• Presence of household member or close contact who is: less than 3 years of age; known immunodeficient; receiving immunosuppressants; undergoing/soon to undergo chemotherapy; diagnosed with emphysema or COPD; is elderly residing in a nursing home; severe lung disease or medical condition; received a transplant (bone marrow or solid organ)
• History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology
• Any laboratory test or ECG which is abnormal and deemed by the investigator to be clinically significant
• Venous access inadequate for phlebotomy demands
• Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time
• Subject is diabetic
• History or evidence of autoimmune disease or known impaired immune responsiveness
• Recent and/or recurrent history of autonomic dysfunction
• Receipt of systemic glucocorticoids, antiviral drugs, immunoglobulins or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to vaccination. Receipt of any systemic chemotherapy agent at any time
• Presence of any febrile illness or symptoms of upper or lower tract respiratory infection in the 28 days prior to viral inoculation
• Any anatomic or neurological abnormality impairing the gag reflex or associated with an increased risk of aspiration, or history suggestive of such a problem or any abnormality significantly altering the anatomy of the nose or nasopharynx
• Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome
• Nasal or sinus surgery within 30 days prior to vaccination

Sponsors & Collaborators

• PepTcell Limited: lead

Study Sites (1)

Retroscreen Virology Limited

London, NW1 0NH, United Kingdom

Location

Related Publications (2)

• Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Caparros-Wanderley W. Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans. Clin Vaccine Immunol. 2015 Aug;22(8):949-56. doi: 10.1128/CVI.00101-15. Epub 2015 Jun 17.

  PMID: 26084515 DERIVED

• Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Mann A, Gilbert A, Balaratnam G, Wilkinson T, Lambkin-Williams R, Oxford J, Caparros-Wanderley W. A Synthetic Influenza Virus Vaccine Induces a Cellular Immune Response That Correlates with Reduction in Symptomatology and Virus Shedding in a Randomized Phase Ib Live-Virus Challenge in Humans. Clin Vaccine Immunol. 2015 Jul;22(7):828-35. doi: 10.1128/CVI.00098-15. Epub 2015 May 20.

  PMID: 25994549 DERIVED

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anthony Gilbert, MBBCh, MICR

  Retroscreen Virology Limited

  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: October 21, 2010
• First Posted: October 22, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 2, 2012

Record last verified: 2012-11

Locations

GB (1)