A Study to Assess the Safety and Efficacy of a New Influenza Candidate Vaccine MVA-NP+M1 In Healthy Adults

NCT00993083 | Completed Phase 2 DMC

• 1 other identifier: Flu002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase IIa open label, non placebo controlled, non-randomised controlled challenge study. The primary objective of this study is to assess the safety of a new influenza vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers. Initially two volunteers will be vaccinated and challenged with Influenza, followed by vaccination of a further 12 volunteers and an Influenza challenge of those 12 along with 12 non-vaccinated controls.

Conditions

Influenza

Keywords

Influenza; Vaccine

Outcome Measures

Primary Outcomes (1)

• Safety of a new Influenza vaccine, MVA-NP+M1, when administered to healthy volunteers

  6 months

Secondary Outcomes (1)

• Cellular immune response generated by a new influenza vaccine MVA- NP+M1 when administered as a single dose to healthy adults.

  6 months

Study Arms (2)

Vaccinated

EXPERIMENTAL

14 volunteers (2 in lead safety group and 12 in main study group) to receive MVA-NP+M1 via the IM route. Volunteers will then be challenged with Influenza 30 days post vaccination.

Biological: MVA-NP+M1

Control

NO INTERVENTION

12 volunteers who will not receive vaccine but will also be challenged with Influenza on day 30

Interventions

MVA-NP+M1 BIOLOGICAL

Intramuscular injection at 1.5 x 10\^8 pfu/ml at day 0

Vaccinated

Eligibility Criteria

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

You may qualify if:

• Male or females aged 18 - 45 years
• HI titre of less than 10
• In general good health determined by a screening evaluation (medical history, physical examination, vital signs electrocardiogram (ECG) and clinical safety laboratory tests). ECG and spirometry will be performed at entry into quarantine rather than at screening visit
• Females should fulfil the following criteria: (i) not pregnant or breastfeeding for the duration of the study and (ii) agree to use a reliable form of contraception for the duration of the study if sexually active
• Negative HBsAg, HIV and HCV antibody screen
• Negative class A drugs of abuse screen
• Have not been vaccinated for Influenza virus in the current season or had a known influenza virus infection in the current season
• Give written informed consent to participate
• Willingness to remain in isolation during the challenge phase of the study and to comply with all study requirements
• Willing and able to communicate with the Investigator and understand the requirements of the study

You may not qualify if:

• Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use of an IMP during the study period
• Prior receipt of a recombinant MVA vaccine (vaccinees only)
• Administration of immunoglobulins and/or any blood products within the three months preceding date of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products. Any allergy to eggs or egg products
• Any history of anaphylaxis in reaction to vaccination
• Current cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• Serious current psychiatric condition
• Any other chronic illness requiring hospital specialist supervision
• Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
• Any other significant disease, disorder or finding, which, in the opinion of the Investigators, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.
• Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Table 1. Values outside the stated limits of Table 1 need written comment by a physician if considered clinically insignificant).
• Venous access inadequate for phlebotomy demands of the study
• Clinically significant abnormality on ECG
• History since age 13 of asthma of any aetiology

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (2)

Wellcome Trust Clinical Research Facility, University of Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• Lillie PJ, Berthoud TK, Powell TJ, Lambe T, Mullarkey C, Spencer AJ, Hamill M, Peng Y, Blais ME, Duncan CJ, Sheehy SH, Havelock T, Faust SN, Williams RL, Gilbert A, Oxford J, Dong T, Hill AV, Gilbert SC. Preliminary assessment of the efficacy of a T-cell-based influenza vaccine, MVA-NP+M1, in humans. Clin Infect Dis. 2012 Jul;55(1):19-25. doi: 10.1093/cid/cis327. Epub 2012 Mar 22.

  PMID: 22441650 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

• Adrian VS Hill, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 11, 2011

Record last verified: 2011-01

Locations

GB (2)