A Study to Assess the Safety and Immunogenicity of a New Influenza Vaccine Candidate MVA-NP+M1 in Healthy Adults
A Phase I Study to Assess the Safety and Immunogenicity of a New Influenza Vaccine Candidate MVA-NP+M1 in Healthy Adults
1 other identifier
interventional
58
1 country
1
Brief Summary
This is an open label phase I study, to assess the safety of a novel influenza vaccine, MVA-NP+M1. All volunteers recruited will be healthy. Twelve volunteers will be administered with a single dose of 5 x 10\^7 pfu of MVA-NP+M1 via the Intradermal (ID) route (group 1). Sixteen volunteers will receive Intramuscular (IM) MVA-NP+M1. The first 8 volunteers will be administered a single dose of 5 x 10\^7 pfu of MVA-NP+M1 followed by a further eight receiving 2.5 x 10\^8 pfu of MVA-NP+M1 (group 2). The 3rd group will be split into 3 groups of 10 volunteers in the age ranges 50-59, 60-69 and 70 and above and administered intramuscularly with a single dose of 1.5 x 10\^8 pfu of MVA-NP+M1. Safety data will be collected. The secondary aim of this study will be to assess the cellular immune responses generated by each dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2009
CompletedFirst Posted
Study publicly available on registry
July 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 29, 2012
November 1, 2012
4.3 years
July 16, 2009
November 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety of a new influenza vaccine, MVA-NP+M1, when administered to healthy volunteers.
24 months
Secondary Outcomes (1)
To assess the cellular immune response generated by a new influenza vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers.
24 months
Study Arms (3)
1. MVA-NP+M1 ID
EXPERIMENTAL12 volunteers to receive MVA-NP+M1 via ID route
2. MVA-NP+M1 IM
EXPERIMENTAL16 volunteers to receive MVA-NP+M1 via IM route
3. MVA-NP+M1 IM upper age group
EXPERIMENTAL30 volunteers to receive MVA-NP+M1 via IM route
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult aged 18 or over, no upper age limit
- Resident in or near Oxford for the duration of the vaccination study
- Able and willing (in the Investigators' opinions) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the duration of the study.
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
You may not qualify if:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of a recombinant MVA vaccine
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- 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 (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- Any history of anaphylaxis in reaction to vaccination
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any chronic illness requiring ongoing or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening.
- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- For females, pregnancy, lactation or willingness/intention to become pregnant during the study
- 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, as determined by the investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Wellcome Trustcollaborator
Study Sites (1)
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
Related Publications (2)
Ferrara F, Del Rosario JMM, da Costa KAS, Kinsley R, Scott S, Fereidouni S, Thompson C, Kellam P, Gilbert S, Carnell G, Temperton N. Development of Lentiviral Vectors Pseudotyped With Influenza B Hemagglutinins: Application in Vaccine Immunogenicity, mAb Potency, and Sero-Surveillance Studies. Front Immunol. 2021 May 24;12:661379. doi: 10.3389/fimmu.2021.661379. eCollection 2021.
PMID: 34108964DERIVEDAntrobus RD, Lillie PJ, Berthoud TK, Spencer AJ, McLaren JE, Ladell K, Lambe T, Milicic A, Price DA, Hill AV, Gilbert SC. A T cell-inducing influenza vaccine for the elderly: safety and immunogenicity of MVA-NP+M1 in adults aged over 50 years. PLoS One. 2012;7(10):e48322. doi: 10.1371/journal.pone.0048322. Epub 2012 Oct 31.
PMID: 23118984DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian VS Hill, D.Phil FRCP
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2009
First Posted
July 20, 2009
Study Start
August 1, 2008
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 29, 2012
Record last verified: 2012-11