Largest ever Lassa fever study expands to more countries in West Africa

July 28 2021, Oslo Norway, Cotonou Benin, Conakry Guinea, Monrovia Liberia, Abuja Nigeria, and Kenema Sierra Leone – The largest ever study created and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) to provide a more accurate assessment of the incidence of Lassa fever infections has launched in several more countries in West Africa.

CEPI is providing US$ 10.3 million in funding to partners in Benin, Guinea, Liberia, and Sierra Leone to participate in the epidemiological research programme Enable, which will enrol up to 23,000 participants, including Nigeria, which began collecting participant data in December 2020.  The in-country partners selected for the research are Fondation pour la Recherche Scientifique (FORS) in Benin, Phebe Hospital in partnership with the National Public Health Institute of Liberia (NPHIL) in Liberia, supported by University of North Carolina at Chapel Hill (UNC), Kenema Government Hospital in Sierra Leone (KGH) in cooperation with Tulane University, and Université Gamal Nasser de Conakry (UGANC) in Guinea, in partnership with Robert Koch Institut (RKI).

First identified in 1969, Lassa fever is a potentially deadly haemorrhagic illness occurring across West Africa, with an estimated 1% of cases proving fatal. It is listed on the World Health Organization (WHO) R&D Blueprint as an emerging infectious disease in urgent need of research and development and is also recognised in CEPI’s ambitious $3.5bn plan to tackle future epidemics and pandemics caused by known and unknown threats.

However, our current knowledge on the annual Lassa case rate is hindered by a lack of formal and standard clinical diagnoses for the illness and significant variability and severity in symptoms, with the majority of patients who become infected thought to be asymptomatic and failing to seek diagnosis. Cases may also occur in remote regions where there are difficulties in accessing health care services for testing. As a result, the true case count is unknown and likely to be much higher than current estimates of 100,000 to 300,000 cases per year.

The Enable study therefore aims to better understand the rate, location, and spread of Lassa virus across the region. Data collected in the countries will highlight any differences in the age and gender of people who become infected, while also providing a more accurate overview on the proportion of asymptomatic and symptomatic cases.

In addition, results from Enable will be crucial in supporting CEPI’s goal, as part of its five-year lookahead strategy, of producing a licenced Lassa vaccine for routine immunisation. As a leading funder of Lassa vaccine development, CEPI has already supported the development of six Lassa vaccine candidates. Two of these vaccines, developed by partners Inovio and Themis Bioscience, entered Phase I trials in 2019, and a further vaccine candidate, developed by IAVI, started in-human testing this year.

Data provided from the Enable research programme may therefore guide the location and implementation of future late-stage efficacy trials to evaluate these or other Lassa vaccine candidates. It could also help to define an appropriate vaccination strategy once a Lassa vaccine is approved for use, for example by helping to identify priority populations at risk.

The research will also support another goal in CEPI’s five-year plan assisting countries with developing the infrastructure and expertise to undertake the epidemiological and clinical studies needed to advance vaccine development and enable such countries to take full ownership of their national health security.

There have been a number of positive developments in the Lassa vaccine space over the past couple of years, with multiple candidates now moving into in-human testing. To continue this momentum and to meet CEPI’s goal to get a licensed Lassa vaccine for routine immunisation, we must therefore now advance our disease-assessment efforts to provide the critical data for future late-stage Lassa vaccine clinical trials.

The results produced by the Enable research programme will be vital in contributing to this endeavour, while also providing novel information to help support healthcare workers and researchers in the region working on this potentially deadly threat.

Melanie Saville
Director of Vaccine Research and Development, CEPI

Enable research partners will collect data on potential infections either through ‘active case follow-up’, whereby a field worker carries out repeat health assessments on study participants through home visits or phone meetings to assess the health status of participants, or ‘passive case detection’, where participants will be encouraged to report potential illness or to self-present at a health facility and the suspected or confirmed case is then recorded.

A subset of those enrolled will also take part in an additional assessment to look at the prevalence of Lassa fever antibodies–biomarkers of the immune response–among participants. This will act as an indicator to better guide estimates of how many individuals in the general population are likely to have previously been infected with the virus and are, at present, protected against (immune from) the disease; it is generally assumed that a single infection with Lassa fever virus will produce life-long protective immunity.

Enable research partners will collect data on potential infections either through ‘active case follow-up’, whereby a field worker carries out repeat health assessments on study participants through home visits or phone meetings to assess the health status of participants, or ‘passive case detection’, where participants will be encouraged to report potential illness or to self-present at a health facility and the suspected or confirmed case is then recorded.

A subset of those enrolled will also take part in an additional assessment to look at the prevalence of Lassa fever antibodies–biomarkers of the immune response–among participants. This will act as an indicator to better guide estimates of how many individuals in the general population are likely to have previously been infected with the virus and are, at present, protected against (immune from) the disease; it is generally assumed that a single infection with Lassa fever virus will produce life-long protective immunity.

I am delighted to be part of the Lassa fever study in West Africa. This rigorous scientific study will allow us to collect precise data to allow the country and partners to plan evidence-based interventions and controls.

Prof. Ayola Akim Adegnika
Principal Investigator, FORS Benin

The CEPI Enable epidemiological study is the largest Lassa haemorrhagic fever research project ever implemented in Guinea. In terms of public health, it will be of great interest both for the community to better understand the illness and for health authorities to appreciate the burden of Lassa fever. The community is grateful to CEPI for its support.

Dr. N’Faly Magassouba
Principal Investigator, Gamal Abdel Nasser University of Conakry, Guinea

There were challenges when we first started, and bottlenecks we’ve encountered, especially encouraging people in our culture to participate in research studies.

But our team has been working to enroll participants and we’re learning lessons as we go; in fact, as we go, our study is progressing better than we could have imagined. Our participants have expressed the pride they have in Liberia, and in their communities, for playing a role in a future that could ultimately be Lassa free.

Dr. Jefferson Sibley
Phebe Hospital Medical Director, Liberia

CEPI’s program to assess the incidence of Lassa virus infections in West Africa has been meticulously planned. These essential epidemiological studies will provide the foundation for clinical trials of promising Lassa vaccines that have to potential to achieve control of this massive public health threat.

Dr. Robert Garry
Tulane University, co-principal investigator working in cooperation with Kenema Government Hospital in Sierra Leone

Seven thousand participants have already been recruited into the Nigerian component of the Enable programme, led by the Nigeria Lassa fever Research Consortium consisting of the Nigeria Centre for Disease Control (NCDC) and supporting partners.

As part of CEPI’s access commitments, data for both the Nigerian study and programmes announced today will be made available to partners and the public via peer-reviewed open-access publications and via CEPI’s hub on The Global Health Network.

The Enable Lassa programme is building on collaboration among countries in West Africa most affected by Lassa fever to generate data and evidence that we urgently need for vaccine R&D. We are excited about the prospects of the project, not only in generating data for vaccine development, but also in strengthening our knowledge of the epidemiology of this disease and improving on the much-needed interventions for disease control.

Dr. Chikwe Ihekweazu
Director-General of Nigeria Centre for Disease Control

The study methodology and protocol were devised in collaboration with the coordinating partners who are now supporting the participating countries during implementation. All will follow a harmonised core protocol and methods to allow for standardised recording and comparability of data across the countries. Coordinating institutions supporting the overall Enable programme implementation include P-95, Margan Clinical Research Organization (MMARCRO), Epicentre, and the Bernard Nocht Institute for Tropical Medicine (BNITM).


The COVIDRIVE project has been officially launched

A new public-private partnership – COVIDRIVE – announced today that it will begin studies to assess the effectiveness of multiple COVID-19 vaccines in Europe to support the region’s public health response and to address the vaccine companies’ regulatory obligations. This multi-stakeholder partnership brings together public institutions, small medium enterprises and vaccine companies, including FISABIO (Spain), P95 (Belgium), THL (Finland), AstraZeneca (UK), CureVac (Germany), Janssen (Belgium), Sanofi-Pasteur (France) and GSK (Belgium).

The partnership will conduct several studies to analyse COVID-19 vaccine effectiveness in real-world conditions to complement what is known from robust clinical trials conducted for marketing authorisations. In addition to overall effectiveness for each brand of vaccine, key areas of interest include: duration of vaccine protection, effectiveness against disease caused by newly emerging SARS-CoV-2 strains, effectiveness against severe COVID-19 disease and effectiveness in special risk groups such as immunocompromised, frail individuals or subjects with chronic conditions or existing comorbidities.

COVIDRIVE will leverage an existing influenza vaccine effectiveness platform (DRIVE), which has provided annual brand-specific influenza vaccine effectiveness estimates to the European Medicines Agency (EMA) since 2017.

AstraZeneca and Janssen will be the first pharmaceutical companies in the partnership to launch their brand-specific COVID-19 vaccine effectiveness assessments through COVIDRIVE, starting in July 2021.
For more details on COVIDRIVE please check our website https://covidrive.eu

If you would like to request a COVID-19 vaccine effectiveness study and/or participate as a partner/study site in COVIDRIVE, send an email to COVIDRIVE Coordination team (info@covidrive.eu)

 

 

 

 


Philip joins P95 as Pharmacovigilance Expert

It is our pleasure to announce that Dr Philip has joined P95 as Pharmacovigilance Expert.

Before joining P95, Philip (Phil) worked for over 20 years at the UK regulatory authority, the MHRA, where he led on vaccine pharmacovigilance. In this position Phil led many national and EU benefit-risk reviews of vaccines and medicines, as well as the review and approval process of the safety and risk management aspects of several vaccine and other biologicals marketing authorization applications. Phil was also active in the EU pharmacovigilance network and co-authored several vaccine pharmacovigilance guidelines such as the Good Vigilance Practice (GVP) modules on vaccines and biologics.

In addition to his regulatory role, Phil was also working closely with the UK public health authorities with whom he planned and held oversight over several risk management strategies related to the implementation of new vaccination programs, notably the 2009 pandemic flu programme, HPV vaccine, Meningitis B vaccine and, most recently, the COVID-19 vaccine campaign.

Phil holds a Bachelors degree in Pharmacology and Physiology and a PhD in Physiology.  He has co-authored many peer-reviewed articles; including several vaccine safety related papers in lead journals such as the Lancet and BMJ.

Thomas Verstraeten, CEO of P95 said: We are very excited to have Phil join us at this key moment in our company’s development.  Boosted by the large demands related to the COVID-19 pandemic, P95 has more than doubled its workforce over the last year and we count on experts like Phil to help us maintain the highest quality standards in our work.  Phil will help us further develop the size and skills of the rapidly expanding PV group within P95 but also give valuable support to the other colleagues involved in any pre- or post-authorization risk management planning.

 

 

 

 

 


P95, Leuven-based company specialized in epidemiology and pharmacovigilance, acquires Rotterdam-based Pallas health research and consultancy (Pallas).

Thomas Verstraeten, CEO of P95: Thanks to our extensive expertise in the development and implementation of vaccines, we experienced a sharp increase in projects and associated growth during the COVID-19 pandemic. To allow us to further support the growing market of vaccination, we are looking for partners to sustain our growth. Pallas is a company with very similar expertise and clientele to P95. Judith van den Bosch and her team have developed a well-functioning and profitable company, close to the values of P95. This acquisition fits perfectly into our strategy to become an even more relevant player in the growing vaccination market.

Judith van den Bosch, founder of Pallas: Merging with P95 is a logical step in the development of Pallas. The types of projects and employees of Pallas and P95 are very similar, but the two companies also complement each other in terms of the research areas and customers.  By becoming part of P95, I expect to be able to offer my team more opportunities and, together with P95, to be able to increase our impact clout now and in the future.

About P95
P95 was founded in 2011 by the current CEO, Thomas Verstraeten, former Vice President of the vaccine department and head of pharmacovigilance and epidemiology at GSK. In 2021, P95 has become an important player on the international stage of vaccine development, working for almost all major vaccine producers and international institutions such as the World Health Organization, the Gates Foundation and the European Commission. With a team of epidemiologists, statisticians, medical writers and analysts, P95 conducts epidemiological studies to help clients plan the development of new vaccines and monitor the effects of vaccines on the market. P95 also contributes to the development of COVID-19 vaccines and follow-up of their effectiveness after approval.  (www.p-95.com)

About Pallas
Pallas health research and consultancy BV was founded in 1999 by Judith van den Bosch. Over the past 20 years, Pallas has become an established player on the contract research market in the field of epidemiology and health research. Pallas’ team consists of 12 epidemiologists with expertise in various disease fields and research methods. Pallas is based in Rotterdam, but has an international customer portfolio with a wide variety of organizations from the health sector and pharmaceutical industry. Pallas has been recognized in recent years for conducting systematic literature research in various contexts, such as clinical guidelines or drug development. (www.pallas-healthresearch.com)

 

 

 

 

 


P95 appoints Stefaan as Chief Financial Officer

Press Release – July 1st 2020

 

P95 appoints Stefaan as Chief Financial Officer

P95, a service provider specialized in epidemiology, statistics and pharmacovigilance, is happy to announce that Stefaan will be joining the management team as Chief Financial Officer, effective July 6th this year.

Stefaan is a senior executive with a proven track record in leading fast-growing companies.  He previously held CFO positions at MobileXpense and Luciad, two belgian PE backed software companies.  He began his career as an financial auditor at PwC.

Stefaan is a qualified accountant and holds a Masters’ degree in Applied Economics.

Thomas Verstraeten, managing director of P95 said ‘I’m very excited to have Stefaan join our management team. Stefaan brings us a wealth of experience in supporting SMEs like ours to achieve steady growth. Since we started 9 years ago we have seen our turnover, number of staff, diversity of expertise and scope of work significantly increase. Stefaan will be key in supporting us further on this growth trajectory and enabling us to better serve our ever increasing number of clients.’ Stefaan stated, ‘I look forward to joining P95 and leading its finance organization to contribute to P95’s future success as the company is rapidly scaling its operations.’

About P95.

P95 is a service provider, headquartered in Leuven, Belgium with staff in various European locations.  Specialised in the epidemiology of infectious diseases and vaccine development, P95 supports public health agencies, vaccine manufacturers and others in setting up, conducting and analysing epidemiological studies and real world data as well as pharmacovigilance related activities. P95 is part of several Innovative Medicines Innovation (IMI) projects, including DRIVE (www.drive-eu.org) and VITAL (www.vital-imi.eu) and has recently won an award for 196 thousand Euros from VLAIO to support its development of artificial intelligence to better interpret real life data in support of vaccine development.  P95 staff have co-authored over 65 peer reviewed publications.


European Project "Vaccines and InfecTious diseases in the Ageing popuLation" (VITAL) Kicks Off

P95 participates in VITAL!

After ADVANCE and DRIVE, this is the third IMI project in which P95 can showcase its capabilities. Colleagues Kaatje Bollaerts and Estelle Méroc even coordinate the work on the P95 side.

Read the article >


P95 supports HEARTSAVER

We care about people, public health and global health, and how we contribute it!

When Heartsaver contacted us to tell about their project, we immediately decided to join the project in Leuven as a sponsor. The Automated External Defibrillator (AED) has been installed in the Diestsestraat 163 , in Leuven.

P95 was invited  to join the official inauguration and we also got the chance to join a First Aid course. Check out their website: Heartsaver vzw !


DRIVE: A call for tenders

Measuring brand-specific influenza vaccine effectiveness in EU/EEA: A call for tenders

The IMI project DRIVE (Development of Robust and Innovative Vaccine Effectiveness) has issued a call for tenders to evaluate influenza vaccine effectiveness (IVE) by vaccine type and brand. Its purpose is to support the sharing of existing IVE data and to establish new IVE studies, including novel and innovative approaches. The call is open to any European organization, institution or network and closes on 10 June 2018; both existing and new IVE study sites may apply.

For more information, please contact info@drive-eu.org 

or visit: http://www.drive-eu.org/index.php/2018/05/02/call-for-tenders-2018-2019-influenza-season/


ECCMID 2018 - DRIVE is searching for new collaborators

DRIVE is searching for new collaborators for the next influenza season, to develop robust tools to measure influenza  vaccine effectiveness.

The DRIVE project for brand-specific influenza vaccine effectiveness studies will be presented at the ECCMID conference in Madrid, on 21-24 April 2018.

Find out more about DRIVE (Development of Robust and Innovative Vaccine Effectiveness)


P95 in Beijing

In collaboration with the Developing Countries Vaccine Manufacturers Network,  P95 has given a 4-day PharmacoVigilance training workshop in Beijing. 

Over 60 participants took part, representing vaccine manufacturers from China and various other countries in South East Asia.