A Phase I Study of Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1
A Phase I Study to Determine the Safety and Immunogenicity of Vaccination Regimens Employing the Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1
1 other identifier
interventional
72
1 country
3
Brief Summary
This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control for seasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community. The study has been extended to include 2 additional groups (group 5 \& 6), each containing 12 healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2013
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 15, 2015
December 1, 2015
2.6 years
March 18, 2013
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety of prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1.
Safety will be assessed by the nature, frequency, severity, seriousness and duration of adverse events arising during the study combined with analysis of hematology and biochemistry lab tests for abnormalities.
Up to 78 weeks post first vaccination.
Secondary Outcomes (1)
To assess the cellular immune response generated by prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1.
78 weeks after first vaccination
Study Arms (6)
Group 2
EXPERIMENTALChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 52 weeks later.
Group 3
EXPERIMENTALMVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 8 weeks later.
Group 4
EXPERIMENTALMVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 52 weeks later.
Group 1
EXPERIMENTALChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later.
Group 5
EXPERIMENTALChAdOx1 NP+M1 2.5 x 10¹⁰vp
Group 6
EXPERIMENTALChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later.
Interventions
MVA NP+M1 1.5 x 10⁸pfu intramuscularly.
ChAdOx1 NP+M1 2.5 x 10¹⁰vp intramuscularly.
Eligibility Criteria
You may qualify if:
- The volunteer must satisfy all the following criteria to be eligible for the study:
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
You may not qualify if:
- The volunteer may not enter the study if any of the following apply:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Previous receipt of any recombinant adenoviral or recombinant MVA vectored 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/topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Any history of anaphylaxis in reaction to vaccination
- History of cancer (except basal cell carcinoma and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any chronic illness requiring on-going 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 (HBsAg) or hepatitis C virus (antibodies to HCV)
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study
- No response / confirmation from GP regarding previous medical history
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Surrey Clinical Research Centre, University of Surrey
Guildford, GU2 7XP, United Kingdom
NIHR Wellcome Trust Clinical Research Facility Southampton
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian V S Hill, MD
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2013
First Posted
March 26, 2013
Study Start
April 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 15, 2015
Record last verified: 2015-12