NCT03180801View on ClinicalTrials.gov

Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model

PHASE2CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

August 18, 2016

Primary Completion Date

March 31, 2017

Study Completion Date

May 25, 2017

Conditions
Influenza
Interventions
BIOLOGICAL

adjuvanted FLU-v

Subcutaneous injection in the upper arm with 500mcg of FLU-v as 0.5ml emulsion in 0.25ml of WFI and 0.25ml of adjuvant Montanide ISA-51

BIOLOGICAL

adjuvanted placebo

Subcutaneous injection in the upper arm with 0.5ml emulsion made of 0.25ml of WFI and 0.25ml of adjuvant Montanide ISA-51

OTHER

Influenza challenge

On day 0, administration with an intranasal sprayer of 1ml of PBS containing 10(7) TCID50 of Influenza A 2009 H1N1 human virus manufactured under GMP in certified Vero cells.

Trial Locations (1)

E1 2AX

hVIVO Services Limited, London

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

PepTcell Limited

INDUSTRY

NCT03180801 - Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model | Biotech Hunter | Biotech Hunter