A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1
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|ClinicalTrials.gov Identifier: NCT03277456|
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : November 14, 2017
This is a first in human, phase I, open label study of the MVA viral vector (produced in the novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone intramuscularly as a single dose.
There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered enrollment will apply for the first three volunteers within the group.
|Condition or disease||Intervention/treatment||Phase|
|Human Volunteers||Biological: MVA-NP+M1||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1, Manufactured on the AGE1.CR.pIX Novel Avian Cell Line, in Healthy Adult Volunteers.|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||November 2, 2017|
|Actual Study Completion Date :||November 2, 2017|
Experimental: Single intramuscular injection of MVA-NP+M1 vaccine
MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds.
Intramuscular injection of novel vaccine
- Measure of local reactogenicity following intramuscular injection of MVA-NP+M1 [ Time Frame: 7 days post vaccination ]Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.
- Measure of systemic reactogenicity following intramuscular injection of MVA-NP+M1 [ Time Frame: 7 days post vaccination ]Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.
- Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1 [ Time Frame: 28 days post vaccination ]Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.
- Assessment of safety laboratory assessments following intramuscular injection of MVA-NP+M1 [ Time Frame: 28 days post vaccination ]Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits
- Serious Adverse Events that occur during the study [ Time Frame: 28 days post vaccination ]Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277456
|Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Adrian Hill, MD||Director, The Jenner Institute, Oxford University|