Guinea Research Perspectives on Ebola Outbreak Mandy Kader

Transcription

RÉPUBLIQUE LA GUINÉE
Travail-Justice-Solidarité
MINISTÈRE DE LA SANTE
22nd Canadian Conference on Global Health
Capacity Building for Global Health: Research & Pratice
Hotel Bonaventure, Montreal, 6-7 November 2015
Guinea Research Perspectives on
Ebola Outbreak
Mandy Kader KONDE, MD, MPH, PHD
Department of Public Health, University of Conakry
Chairman Guinea Ebola Research Commission
Executive Director Center of Research on Diseases (CEFORPAG)
COORDINATION NATIONALE DE LUTTE CONTRE LA MALADIE À VIRUS EBOLA
Outline
•
•
•
•
•
•
Background
Main Strategies for Ebola Outbreak Control
R & D Organizational Structure
Research Priorities & Preliminary Findings
Main Lessons learnt
Perspectives
Background
• Ebola Outbreak in West Africa unprecedented magnitude,
new Disease for Communities & Entiere Country
• High toll of death among frontline workers
• Ecosystem of forest region where people are more & more
agressive
• Intense migrations / movement accross West Africa Vs
Central Africa
• Most affected countries, are post-conflict (Sierra Leone,
Liberia, Guinea), weak health system
• lack of confidence in Public service delivery, poverty
• Perception/Acceptance of the Disease &
• Negative Impact of Mass media and communication (No
drug, No Vaccine, CFR high)
Update on Guinea Ebola Epidemic location
30 Dec 2013 – 03 Nov 2015
Main Strategies for Outbreak Control
• Case Management (MoH/MSF/WHO) – starting with
2 isolation Centers (Gueckedou, Conakry) to > 8 ETU
• Surveillance (MoH/WHO/CDC, PLAN-Guinea, Save
the Children)
• Contact tracing (MoH/WHO/CDC)
• Lab support (Institut Pasteur, UE Mobile Lab, Kaplan,
Canadian Mobile Lab, )
• Safe Burial intervention (Croix Rouge)
• Communication (MoH/Unicef)
• Prevention & Infection Control (MoH/WHO)
Guinea Ebola Epidemic Curve & Clinical Trial
30 Dec 2013- 06 Nov 2015
Favipiravir Study
180
confirmés (n=3351)
160
probables (n=453)
suspects (n=1)
120
Interferon Study
100
Convalescent Plasma
80
60
40
LAB+
21 March
20
0
1_14
3_14
5_14
7_14
9_14
11_14
13_14
15_14
17_14
19_14
21_14
23_14
25_14
27_14
29_14
31_14
33_14
35_14
37_14
39_14
41_14
43_14
45_14
47_14
49_14
51_14
1_15
3_15
5_15
7_15
9_15
11_15
13_15
15_15
17_15
19_15
21_15
23_15
25_15
27_15
29_15
31_15
33_15
35_15
37_15
39_15
41_15
43_15
45_15
Nombre de cas
140
Ring Vaccination Trial
23 March 2015
Semaine de début des signes
Epidemic Curve with 6 Waves
HCW Infection during Ebola Outbreak
Guinea, 30/12/2013 – 09/06/2015
90
79
80
70
60
50
40
Nb Confirmés = 187
Nb Probable = 15
Décès Confirmés=94
Décès Probable= 15
36
30
19
20
18
9
7
10
21
22
11
33
4
22
4
13
9
14
12
12
8
11
55
10
3
0
11
11
3
1
21
0
confirmes_probables
deces
21
Update as of 06 November 2015
Total Cases Total Death %
Total Confirmed cases
3 351
2 083
Total Probables cases
Total cas suspected
453
02
453
0
3 806
2 536
67%
115
55%
All Total cases (confirmed,
probables et suspected )
Survivors (estimated)
1 270
Health Care Workers
211
62%
R & D Organizational Structure
• Ebola Research Commission (CRE) (April 14)
– Coordination of research activities
– Research capacity building
• Ethical committee (CNERS)
– Assessment of compliance of the research to
international ethical standard
• National Regulatory Authority (NRA)
– Lot authorization importation
– Pharmaco vigilance
• NIH Collaboration Committee
– Established June 2015
Research Priorities
– Therapies, Vaccines, Diagnostics & others trial
– Social aspects (Perception & community
engagement, behavioral changes)
– Research training for local investigators (GCP,
virology, clinical research, anthropology and social
science…)
– Post-epidemic management (survivors, health
system recovery…)
– Environmental & Ecological study
Clinical Trial (CT) - Therapies
Product/Spon
sor
Trial Description
& Phase
Design
Location
Favipiravir
(JIKI)
INSERM-F
Safety & Efficacy
Phase 2
Non random, Open- Gueckedou,
label, Single arm,
Nzerekore,
Historical Control
Macenta, Coyah,
Forecariah
126/225
Prelimirary
data presented
Seattle, Oct 14
Convalescent
Plasma (CP)
Consortium
Ebloa Tx
Safety & Efficacy
Phase 2/3
Non random,
(based on CP
availability) Openlabel, 2 arms,
Control is SOC
102/130
Interferon
Beta 1 a (IFN)
University of
Toronto
Safety & Efficacy
Phase 1/2
Non random, Open- Coyah
label, Single arm,
historical Control
9/30
Favipiravir –
Zmap (JIKIMap)
INSERM & NIH
Safety & Efficacy
Phase 2
Non random, Open- Coyah,
label, 2 arms,
Forecariah
Control is SOC Jiki
12/
Conakry
Enrolled/ Goal
CT - Vaccine & Other Trials
Product/ Sponsor
Trial
Description &
Phase
Design
rVSV-ZEBOV
Efficacy & Safety
– Ring
Vaccination
Phase 3
Cluster-randomized, open Basse
label vaccines
Guinea
(Vaccination of contacts/
Contact of contacts) of
confirmed cases,
Immediate Vs Delayed
vaccination (21 days)
Consortium (WHO,
Norway, MSF, Canada,
Welcomme Trust, etc)
rVSV-ZEBOV
Consortium (WHO,
Norway, MSF, Canada,
Welcome Trust)
POSTEBOGUI
Safety &
Non-Random, open label,
Immunogenicity Single arm receiving
– Frontline
vaccine
workers
Ebola Survivor
study
Location
Basse
Guinea
Enrolled/
Goal
> 7 651
Preliminary
data
published
Lancet
1 200
22 months Follow up
Conakry,
300
INSERM
cohorte of survivors
Macenta
(socio-anthropology,
biochemical, immuno,
virological, Ophtamo,
COORDINATION NATIONALE DE LUTTE
Neuro CONTRE LA MALADIE À VIRUS EBOLA
Lancet. 2015 Aug 3. pii: S0140-6736(15)61117-5. doi: 10.1016/S0140-6736(15)61117-5.
14
All vaccinated adults assigned to immediate
vaccination versus all eligible individuals
assigned to delayed vaccination
†Four cases were vaccinated and developed symptoms on day 0, 2, 6, 6
15
CT-Diagnostic Products
Product
Manufacturer/
Sponsor
Technology
Samples
Platform
Location
BioThreat-E
BioFire Defense
IPP
Multiplex rRT-PCR
Blood, Urine
Film Array
Macenta
Xpert Ebola
Cepheid
MSF
rRT-PCR
Venous Blood
GeneXpert
Conakry
Oraquick
OraSure
Technolies
CDC-Atlanta
Ebola Rapid
Antigen Test (PN
3001-2812)
Blood, Swab
Conakry
Ebotest 2
Institut Pasteur
Rapid test RPA
Blood
Macenta
EBOV-RTRPA
Institut Pasteur
Dakar
928 post-mortem
swabs,
TR-RPA
Conakry
Case Management & Research
Coyah & Nongo ETU (Favipiravir &
Interferon are tested)
Visit Eleanor Fish University Toronto, Nongo
ETU (Co-PI Interferon Trial )
Secure Burial Process by Red Cross
Ring Vaccination Trial
with rVSV vaccine
Sub Regional Ebola Research
Partnership
Guinea
Sierra
Leone
Liberia
Research Collaboration: 1+1+1=1
Main Lessons learnt
• Need for long term collaboration on Institutional basis
• Real capacity building (strenghten Human ressources & lab
infrastructure) rather than just publications or colonial
consideration
• Influence Politic & Science, Need for better coordination
(complementary vs duplication/ competition)
• Lack of national leadership & Ownership
• Orientation of funds raised by partners
• Need for a regional framework for multicenter studies on
therapies, vaccines & Diagnostic test with neighboring’s
countries
• How Research on disease control could better prepare &
contribute for any new Ebola outbreak or emergent diseases ?
Perspectives
• Socio-Anthropological studies
• Long term Survivors Studies : Psychosocial, neuro
sensorial, Clinical, virological, biochemical, Immunological
studies
• Mapping & Virus variability and sequencies
• New infection routes/modes (investigation of cases
with no epidemiological links with identified chains)
• Persistance of virus on body fluids
• Bio-surveillance & Environmental study (Reservoirs
and animal transmission)
• Sub Regional Collaboration (Extension of Zmapp
clinical trial, Liberia/NIH Vaccine trial in Guinea)
• Guinea open to any other collaboration
Coyah Survivors Association
Thank you !

Guinea Research Perspectives on Ebola Outbreak Mandy Kader

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