Influenza Platform Study (VAV00019)
Research type
Research Study
Full title
Master Protocol – A Phase I, parallel, randomized, controlled study to assess safety and immunogenicity of modified mRNA vaccines encoding influenza hemagglutinin in adults 18 years of age and older. Substudy 01 Protocol – A Phase I, parallel, randomized, active-controlled, multi-center, dose-escalation study with early safety data reviews to assess safety and immunogenicity of one monovalent modified influenza mRNA vaccine encapsulated in ALC-0315-based LNP, in adults aged 18 to 49 years and 60 years and above.
IRAS ID
1007427
Contact name
N/A N/A
Contact email
Sponsor organisation
Sanofi Pasteur SA
Clinicaltrials.gov Identifier
Research summary
The messenger RNA (mRNA) vaccines, that has played a key role in controlling the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, represent a promising alternative to conventional vaccine approaches.
The objective of Substudy 01 is to evaluate the safety and immunogenicity of up to 5 dose levels of a monovalent modified mRNA encoding the Hemaglutinin antigen (HA) sequence of H3N2 influenza virus encapsulated in a new lipid-nano particle administered as a single intramuscular injection in adults 18 years of age and above, compared to an active control: a licensed quadrivalent influenza vaccine.
This study will allow to generate clinical data to provide learnings regarding the mRNA technology to support optimization of the mRNA platform including mRNA and LNP design and to support future projects.
Sanofi is the Sponsor of this study being be done in Australia and UK in sites experienced to conduct phase 1 studies.
Healthy adults aged between 18 and 49 years and 60 years and above, either male or female can participate to the study.
The enrolment of participants for the different mRNA doses will be performed in a stepwise manner, with enrolment of sentinel cohort followed by the enrolment of the main cohort based on the safety data review.
Participants will be in the study for about 6 months and will have to come to the study site up to 8 times.
A total of up to 225 participants aged 18 years and older are planned to take part in this study.
There is no guarantee that participants from each substudy get any benefit from it. Participants will contribute to the process of developing a new type of vaccine (mRNA vaccine) that may improve existing vaccines. In addition, they will benefit from medical evaluations/assessments associated with study procedures (eg, medical visits, laboratory parameter assessment, etc).REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0176
Date of REC Opinion
31 May 2023
REC opinion
Further Information Favourable Opinion