guinea research perspectives on ebola outbreakvaccination phase 3 cluster-randomized, open label...

MINISTÈRE DE LA SANTE RÉPUBLIQUE LA GUINÉE Travail-Justice-Solidarité

COORDINATION NATIONALE DE LUTTE CONTRE LA MALADIE À VIRUS EBOLA

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)

22nd Canadian Conference on Global Health Capacity Building for Global Health: Research & Pratice

Hotel Bonaventure, Montreal, 6-7 November 2015





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)





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100

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180

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No

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Semaine de début des signes

confirmés (n=3351)

probables (n=453)

suspects (n=1)

Guinea Ebola Epidemic Curve & Clinical Trial 30 Dec 2013- 06 Nov 2015

Ring Vaccination Trial 23 March 2015

Favipiravir Study

Interferon Study

Convalescent Plasma

LAB+ 21 March

Epidemic Curve with 6 Waves





2 2

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confirmes_probables deces

HCW Infection during Ebola Outbreak Guinea, 30/12/2013 – 09/06/2015

Nb Confirmés = 187

Nb Probable = 15

Décès Confirmés=94

Décès Probable= 15





Total Cases Total Death %

Total Confirmed cases 3 351 2 083 62%

Total Probables cases 453 453

Total cas suspected 02 0

All Total cases (confirmed,

probables et suspected ) 3 806 2 536 67%

Health Care Workers

211

115

55%

Update as of 06 November 2015

Survivors (estimated) 1 270





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/Sponsor

Trial Description & Phase

Design Location Enrolled/ Goal

Favipiravir (JIKI) INSERM-F

Safety & Efficacy Phase 2

Non random, Open-label, Single arm, Historical Control

Gueckedou, Nzerekore, 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) Open-label, 2 arms, Control is SOC

Conakry 102/130

Interferon Beta 1 a (IFN) University of Toronto

Safety & Efficacy Phase 1/2

Non random, Open-label, Single arm, historical Control

Coyah 9/30

Favipiravir – Zmap (JIKI-Map) INSERM & NIH

Safety & Efficacy Phase 2

Non random, Open-label, 2 arms, Control is SOC Jiki

Coyah, Forecariah

12/





CT - Vaccine & Other Trials Product/ Sponsor Trial

Description & Phase

Design Location Enrolled/ Goal

rVSV-ZEBOV Consortium (WHO, Norway, MSF, Canada, Welcomme Trust, etc)

Efficacy & Safety – Ring Vaccination Phase 3

Cluster-randomized, open label vaccines (Vaccination of contacts/ Contact of contacts) of confirmed cases, Immediate Vs Delayed vaccination (21 days)

Basse Guinea

> 7 651 Preliminary data published Lancet

rVSV-ZEBOV Consortium (WHO, Norway, MSF, Canada, Welcome Trust)

Safety & Immunogenicity – Frontline workers

Non-Random, open label, Single arm receiving vaccine

Basse Guinea

1 200

POSTEBOGUI INSERM

Ebola Survivor study

22 months Follow up cohorte of survivors (socio-anthropology, biochemical, immuno, virological, Ophtamo, Neuro

Conakry, Macenta

300

Survivors Study Public Health England, CEFORPAG

Ebola Survivor study

Immunology Gueckedou Coyah

90 120



Lancet. 2015 Aug 3. pii: S0140-6736(15)61117-5. doi: 10.1016/S0140-6736(15)61117-5.



14



†Four cases were vaccinated and developed symptoms on day 0, 2, 6, 6

All vaccinated adults assigned to immediate vaccination versus all eligible individuals assigned to delayed vaccination

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-RT-RPA

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





Guinea Sierra Leone

Liberia

Sub Regional Ebola Research Partnership

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





Thank you !

Coyah Survivors Association

guinea research perspectives on ebola outbreakvaccination phase 3 cluster-randomized, open label...

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