* Three measures are currently being implemented to control Ebola outbreaks: * Monitoring of contacts * Isolation and treatment of sick people * Vaccination of the population in high-risk areas. * In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration. * Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD). * Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure. * A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs). PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
250
Human monoclonal antibody to Zaire strain GP (EBOV GP)
Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated) ≥ 72 million PFU, composed of the Indiana strain of recombinant vesicular stomatitis virus (rVSV) with a deletion of the envelope glycoprotein (G) of VSV replaced by the surface glycoprotein (GP) of the Kikwit 1995 strain of Ebola virus Zaire (ZEBOV)
Centre de Traitement Ebola de N'Zerekore
N'Zerekore, Guinea
Efficacy
Proportion of participants with negative RT-PCR
Time frame: Week 3
Immunological ancillary study
Anti-GP IgG level (FANG reference technique)
Time frame: 6 months after vaccination
Tolerance
Estimating adverse effects
Time frame: Day 7 post-PEP and day 7 post-vaccination
Lost of follow-up
Lost of follow-up rate
Time frame: Week 6
Humoral immune response
Anti-GP IgG level (FANG reference technique)
Time frame: 1 and 3 months after vaccination
Neutralizing antibodies
Neutralizing antibodies level
Time frame: 1, 3 and 6 months after vaccination
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