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Marie-pierre Preziosi - One of the best experts on this subject based on the ideXlab platform.
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Lessons from the Meningitis Vaccine Project.
Viral immunology, 2017Co-Authors: F. Marc Laforce, Mamoudou H. Djingarey, Simonetta Viviani, Marie-pierre PreziosiAbstract:Abstract From 2001 to 2017 the Meningitis Vaccine Project (MVP), a Gates Foundation funded partnership between PATH and the World Health Organization (WHO), successfully developed, tested, licensed, and introduced an affordable new Group A meningococcal conjugate Vaccine, MenAfriVac®, in sub-Saharan Africa. The Vaccine was well received, and from 2010 to 2016, over 260 million Africans have received a dose of the Vaccine in campaigns largely directed at 1–29-year olds. The public health impact has been dramatic with the elimination of Group A meningococcal infections wherever the Vaccine has been used at public health scale. Over its 16-year life span, MVP faced many challenges, and lessons were learned that may be of interest to other groups seeking to develop Vaccine products for resource-poor countries. We have chosen to highlight six elements that were keys to the success of the project: (a) country and African regional engagement during all phases of the project; (b) the evolution of the WHO/PATH par...
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Influence of Age on Antibody Response and Persistence Following Immunization With MenAfriVac.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015Co-Authors: Yuxiao Tang, Marie-pierre Preziosi, Brian D Plikaytis, Ray BorrowAbstract:A meningococcal group A conjugate Vaccine, PsA-TT (MenAfriVac), developed through the Meningitis Vaccine Project and manufactured by the Serum Institute of India, Ltd, was tested in multiple clinical trials conducted mainly in Africa. The impact of age at which subjects were vaccinated on immune response and persistence postimmunization with PsA-TT was the main focus of the current analysis. Subjects who were vaccinated with a single dose of 10 µg of PsA-TT at 12-23 months or 22-33 months of age in study A conducted in Mali and The Gambia; at 2-10 years, 11-17 years, or 18-29 years of age in study B conducted in Mali, The Gambia, and Senegal; and at 14-18 weeks, 9-12 months, or 12-18 months of age in study C conducted in Ghana are included in the current analysis. Immunogenicity was measured by group A serum bactericidal antibody (SBA) titer with baby rabbit complement. Significant differences in SBA titers were found among the age groups in studies B and C both 28 days and 1 year postimmunization. A significant difference in SBA titers between age groups 12-23 months and 22-33 months was only observed 1 year postimmunization in study A. Antibody titers remained at similar levels from 1 to 2 years postimmunization for subjects vaccinated at 12-23 months in study A and at 9-12 months or 12-18 months of age in study C. Subjects immunized at different ages had different postimmunization immune responses as measured by SBA titers. Toddlers tended to have higher immune responses than infants. This pattern persisted at least 1 year postimmunization. ISRCTN78147026 (study A), ISRCTN87739946 (study B), and ISRCTN82484612 (study C). © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
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Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
Clinical Infectious Diseases, 2015Co-Authors: Fabien Diomandé, Mamoudou H. Djingarey, Simonetta Viviani, Marie-pierre Preziosi, Téné M. Yaméogo, Kirsten S. Vannice, Claude-roger Ouandaogo, Modibo Keita, Nehemie Mbakuliyemo, Bartholomew Dicky AkanmoriAbstract:A group A meningococcal conjugate Vaccine, PsA-TT, was developed by the Meningitis Vaccine Project and the Serum Institute of India, Ltd (SIIL). Clinical trials conducted among approximately 10 000 persons aged 1–29 years, in India and in Africa, confirmed a Vaccine safety profile similar to that of licensed polysaccharide Vaccines, as well as a stronger and more persistent immunological response against group A meningococcus (MenA) [1, 2]. The Vaccine was licensed by the Drug Controller General of India in January 2010 and prequalified by the World Health Organization (WHO) in June 2010, and a common regulatory dossier was submitted to the first 3 countries (Burkina Faso, Mali, and Niger) by SIIL prior to introducing the Vaccine , in accordance with regulatory requirements. The other countries that have used this Vaccine in mass campaigns received summary lot protocols and used an expedited review procedure to license the Vaccine [3, 4]. By 2013, 12 countries in the epidemic Meningitis belt had introduced PsA-TT, vaccinating >150 million eligible people. As a result, a significant decrease in MenA carriage was documented among vaccinated and unvaccinated individuals [5], and the burden of Meningitis from MenA dramatically decreased [6, 7]. Clinical trials are limited in their ability to detect rare and late-occurring adverse events associated with vaccination due to small sample sizes and limited participant follow-up time [8–10]. Careful monitoring for possible infrequent but serious adverse events following immunization (AEFIs) is thus desirable during postmarketing surveillance and widespread use of any Vaccine. The Global Advisory Committee on Vaccine Safety (GACVS), during its session in December 2009, recommended an initial phased approach to introduction of PsA-TT to carefully collect additional safety data [11]. Postmarketing surveillance for AEFIs after PsA-TT mass immunization campaigns was systematically conducted in all countries that used the Vaccine [12, 13]. This served as an opportunity for capacity building and to conduct postlicensure safety surveillance in the low- and middle-income countries of Africa where the Vaccine was used. Conducting postmarketing surveillance for AEFIs after PsA-TT introduction in these resource-constrained countries highlighted several challenges. This article describes how pharmacovigilance systems were set up in selected countries from 2010 to 2013, discusses the main constraints and challenges faced, and analyzes lessons learned.
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Conducting Vaccine clinical trials in sub-Saharan Africa: Operational challenges and lessons learned from the Meningitis Vaccine Project
Vaccine, 2012Co-Authors: Elisa Marchetti, Simonetta Viviani, Véronique Mazarin-diop, Julie Chaumont, Lionel Martellet, Marie-francoise Makadi, Prasad S. Kulkarni, Marie-pierre PreziosiAbstract:Abstract Group A Neisseria meningitidis epidemics have been an important and unresolved public health problem in sub-Saharan Africa for over a century. The Meningitis Vaccine Project (MVP) was established in 2001 with the goal of developing, testing, licensing, and introducing an affordable group A meningococcal conjugate Vaccine for Africa. A monovalent group A conjugate Vaccine, MenAfriVac™, was developed at the Serum Institute of India Ltd. and tested in clinical trials at multiple trial sites in sub-Saharan African countries. The setup and successful conduct of ICH-GCP standard Vaccine trials across multiple trial sites located in low-resource settings are challenging. We describe the main operational issues encountered in three randomized, observer-blind, active controlled studies to evaluate the safety and immunogenicity of MenAfriVac™. The studies were conducted in parallel among 2700 subjects aged between 2 months and 29 years of age enrolled across four trial sites located in Mali, The Gambia, Senegal, and Ghana between September 2006 and August 2009. Many important lessons were learned during the preparation, setup, and implementation of the Meningitis Vaccine Project clinical program. They are summarized here to help Vaccine development programs identify efficient pathways for successful implementation of clinical trials in low-resource settings.
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Development of a group A meningococcal conjugate Vaccine, MenAfriVacTM
Human vaccines & immunotherapeutics, 2012Co-Authors: Carl E. Frasch, Marie-pierre Preziosi, F. Marc LaforceAbstract:Group A meningococcal disease has been an important public health problem in sub-Saharan Africa for over a century. Outbreaks occur there annually, and large epidemics occur at intervals ranging between 8 and 12 y. The Meningitis Vaccine Project was established in 2001 with funding from the Gates Foundation with the goal of developing, testing, licensing, and introducing an affordable group A meningococcal conjugate Vaccine into Africa. From 2003 to 2009 a monovalent group A conjugate Vaccine, MenAfriVacTM, was developed at the Serum Institute of India, Ltd through an innovative public/private partnership. Preclinical studies of the new conjugate Vaccine were completed in 2004 and a Phase 1 study began in India in 2005. Phase 2/3 studies in African 1–29 y olds were completed in 2009 showing the new meningococcal A conjugate Vaccine to be as safe as currently licensed meningococcal polysaccharide Vaccines, but much more immunogenic. After Indian market authorization (December 2009) and WHO prequalification...
F. Marc Laforce - One of the best experts on this subject based on the ideXlab platform.
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Developmental strategy for a new Group A meningococcal conjugate Vaccine (MenAfriVacR).
Human vaccines & immunotherapeutics, 2017Co-Authors: Prasad S. Kulkarni, Suresh Jadhav, F. Marc LaforceAbstract:Until recently, periodic Group A meningococcal Meningitis outbreaks were a major public health problem in the sub-Saharan Africa. In 2001, the Meningitis Vaccine Project (MVP), a partnership between the World Health Organization (WHO) and PATH, a Seattle-based NGO, and the Serum Institute of India Pvt Ltd (SIIPL) initiated discussions aimed at establishing a collaboration to develop a Group A meningococcal conjugate Vaccine for this unmet medical need. Over the next 8 years the partnership made countless strategic decisions about product characteristics, raw materials, potential target populations, geographic prioritization and affordability of the Vaccine to name a few. These decisions evolved into detailed plans for preclinical development, extensive field trials in Africa and India and a focused regulatory strategy specific for the Men A conjugate Vaccine. Important characteristics of the process included, flexibility, transparency andeffective partnerships that included public agencies as well as private companies in Africa, Europe, the United States and India.
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Lessons from the Meningitis Vaccine Project.
Viral immunology, 2017Co-Authors: F. Marc Laforce, Mamoudou H. Djingarey, Simonetta Viviani, Marie-pierre PreziosiAbstract:Abstract From 2001 to 2017 the Meningitis Vaccine Project (MVP), a Gates Foundation funded partnership between PATH and the World Health Organization (WHO), successfully developed, tested, licensed, and introduced an affordable new Group A meningococcal conjugate Vaccine, MenAfriVac®, in sub-Saharan Africa. The Vaccine was well received, and from 2010 to 2016, over 260 million Africans have received a dose of the Vaccine in campaigns largely directed at 1–29-year olds. The public health impact has been dramatic with the elimination of Group A meningococcal infections wherever the Vaccine has been used at public health scale. Over its 16-year life span, MVP faced many challenges, and lessons were learned that may be of interest to other groups seeking to develop Vaccine products for resource-poor countries. We have chosen to highlight six elements that were keys to the success of the project: (a) country and African regional engagement during all phases of the project; (b) the evolution of the WHO/PATH par...
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The Evolution of the Meningitis Vaccine Project.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015Co-Authors: Kathleen Tiffay, Luis Jodar, Marie-paule Kieny, Muriel Socquet, F. Marc LaforceAbstract:In 2001, the Meningitis Vaccine Project (MVP) was tasked to develop, test, license, and introduce a group A meningococcal (MenA) conjugate Vaccine for sub-Saharan Africa. African public health officials emphasized that a Vaccine price of less than US$0.50 per dose was necessary to ensure introduction and sustained use of this new Vaccine. Initially, MVP envisioned partnering with a multinational Vaccine manufacturer, but the target price and opportunity costs were problematic and formal negotiations ended in 2002. MVP chose to become a "virtual Vaccine company," and over the next decade managed a network of public-private and public-public partnerships for pharmaceutical development, clinical development, and regulatory submission. MVP supported the transfer of key know-how for the production of group A polysaccharide and a new conjugation method to the Serum Institute of India, Ltd, based in Pune, India. A robust staff structure supported by technical consultants and overseen by advisory groups in Europe and Africa ensured that the MenA conjugate Vaccine would meet all international standards. A robust project structure including a team of technical consultants and 3 advisory groups in Europe and Africa ensured that the MenA conjugate Vaccine (PsA-TT, MenAfriVac) was licensed by the Drug Controller General of India and prequalified by the World Health Organization in June 2010. The Vaccine was introduced in Burkina Faso, Mali, and Niger in December 2010. The development, through a public-private partnership, of a safe, effective, and affordable Vaccine for sub-Saharan Africa, PsA-TT, offers a new paradigm for the development of Vaccines specifically targeting populations in resource-poor countries. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
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Challenges and Opportunities While Developing a Group A Meningococcal Conjugate Vaccine Within a Product Development Partnership: A Manufacturer's Perspective From the Serum Institute of India.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015Co-Authors: Prasad S. Kulkarni, F. Marc Laforce, Muriel Socquet, Suresh S Jadhav, Subhash V Kapre, Cyrus S PoonawallaAbstract:In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership (PDP) with the Meningitis Vaccine Project (MVP). MVP was a collaboration between PATH and the World Health Organization (WHO) to develop meningococcal conjugate Vaccines for sub-Saharan Africa. From the outset, SIIL recognized that a partnership with MVP carried some risk but also offered important opportunities for accessing new conjugate Vaccine technology and know-how. Over 3 years, SIIL successfully accepted technology transfer for the group A meningococcal polysaccharide from SynCo Bio Partners and a conjugation method from the US Food and Drug Administration. SIIL successfully scaled up production of a group A meningococcal conjugate Vaccine that used SIIL tetanus toxoid as the carrier protein. Phase 1 studies began in India in 2005, followed by phase 2/3 studies in Africa and India. A regulatory dossier was submitted to the Indian authorities in April 2009 and WHO in September 2009. Export license was granted in December 2009, and WHO prequalification was obtained in June 2010. Vaccine was introduced at public scale in Burkina Faso that December. The group A meningococcal conjugate Vaccine was named MenAfriVac, and is the first internationally qualified Vaccine developed outside of big pharma. The project proved to be a sound investment for SIIL and is a concrete example of the potential for PDPs to provide needed products for resource-poor countries. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
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The Evolution of the Meningitis Vaccine Project
Clinical Infectious Diseases, 2015Co-Authors: Kathleen Tiffay, Luis Jodar, Marie-paule Kieny, Muriel Socquet, F. Marc LaforceAbstract:The Meningitis Vaccine Project (MVP), a partnership between PATH and the World Health Organization (WHO), was created in 2001 through core funding from the Bill & Melinda Gates Foundation to eliminate epidemic Meningitis as a public health problem in sub-Saharan Africa through the development, testing, introduction, and widespread use of conjugate meningococcal Vaccines. This project was created in response to repeated and severe group A meningococcal (MenA) Meningitis epidemics in sub-Saharan Africa during the 1990s, and the potential offered by new meningococcal conjugate Vaccines to prevent such epidemics. African public health leaders issued a call for action as Meningitis rapidly became a public health priority given the high case fatality rates, high attack rates among young adults at the peak of their economic contributions, and the incapacitating sequelae seen in 10%–20% of survivors. Vaccination campaigns with a meningococcal C conjugate Vaccine in the United Kingdom in 1999 had demonstrated that conjugate Vaccines conferred herd protection within a targeted population once sufficient numbers had been vaccinated [1]. This experience demonstrated the possibility of preventing—and perhaps eliminating—MenA Meningitis epidemics in the African “Meningitis belt” through the development and widespread use of a MenA conjugate (PsA-TT) Vaccine. Because a monovalent MenA conjugate Vaccine would have limited commercial interest outside of Africa, public-sector support for Vaccine development, clinical evaluation, and pilot introduction was provided through the creation of MVP [2]. Conjugate meningococcal Vaccine development for Africa was initially envisaged as a partnership between MVP and a multinational “big pharma” company to produce a bivalent group A/C conjugate Vaccine. In this scenario, a small MVP team at WHO and PATH would focus on managing this partnership while working to improve Meningitis surveillance in Africa and planning for the Vaccine's introduction in Meningitis belt countries (Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Cote D'Ivoire, Democratic Republic of Congo, Ethiopia, Erithrea, Ghana, Guinea, Guinea Bissau, Kenya, Mali, Mauritania, Niger, Nigeria, Rwanda, Senegal, South Sudan, Tanzania, The Gambia, Togo, Uganda). Yet, 18 months after the project's starting date, MVP had evolved into a “virtual company” managing a new model for public sector Vaccine development that linked a network of partners with unique roles and responsibilities, and sought to transfer technology and know-how for all aspects of meningococcal conjugate Vaccine production to a developing country Vaccine manufacturer. This article describes the maturation of MVP's Vaccine development strategy, and the project structure, guiding principles, and values that ultimately led to the introduction of a safe, highly effective, and affordable MenA conjugate Vaccine for sub-Saharan Africa.
Blaise Genton - One of the best experts on this subject based on the ideXlab platform.
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Safety profile of the meningococcal conjugate Vaccine (Menafrivac™) in clinical trials and vaccination campaigns: a review of published studies.
Human vaccines & immunotherapeutics, 2019Co-Authors: Jerome Ateudjieu, Beat Stoll, Anne Cecile Bisseck, Ayok Maureen Tembei, Blaise GentonAbstract:The study aimed to assess the capacity of AEFI surveillance during vaccination campaigns with the new conjugate Meningitis Vaccine (MenAfrivac). A systematic review of studies on MenAfrivac™ published in English during 2001-2016 was done.AEFIs incidence (I) was estimated and compared between MenAfrivac™ clinical trials and immunization campaigns using incidence difference (Id). Nine studies were included with an overall local AEFI I of 11,496/100,000 doses administered per week in clinical trials and 0.72/100,000 doses in immunization campaigns. An Id of 11,497.92 [11,497.91-11,497.93] and 17,243.20 [17,241.80-17,245.90] per 100,000 doses administered per week for overall local and systemic AEFI, respectively, were observed with highest from clinical trials. The incidence of AEFIs after MenAfrivac™ vaccination was far lower in campaigns than in clinical trial studies. Current capacity of AEFI surveillance during vaccination campaigns requires extensive re-assessment of its structure and capacity.
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Vaccines safety; effect of supervision or SMS on reporting rates of adverse events following immunization (AEFI) with Meningitis Vaccine (MenAfriVac™): A randomized controlled trial
Vaccine, 2014Co-Authors: Jerome Ateudjieu, Beat Stoll, Georges Nguefack-tsague, Christoph Tchangou, Blaise GentonAbstract:To ensure Vaccines safety, given the weaknesses of the national pharmacovigilance system in Cameroon, there is a need to identify effective interventions that can contribute to improving AEFI reporting.; To assess the effect of: (i) sending weekly SMS, or (ii) weekly supervisory visits on AEFI reporting rate during a Meningitis immunization campaign conducted in Cameroon in 2012 using the Meningitis A conjugate Vaccine (MenAfriVac™).; Health facilities that met the inclusion criteria were randomly assigned to receive: (i) a weekly standardized SMS, (ii) a weekly standardized supervisory visits or (iii) no intervention. The primary outcome was the reported AEFI incidence rate from week 5 to 8 after the immunization campaign. Poisson regression model was used to estimate the effect of interventions after adjusting for health region, type of health facility, type and position of health workers as well as the cumulative number of AEFI reported from weeks 1 to 4.; A total of 348 (77.2%) of 451 health facility were included, and 116 assigned to each of three groups. The incidence rate of reported AEFI per 100 health facility per week was 20.0 (15.9-24.1) in the SMS group, 40.2 (34.4-46.0) in supervision group and 13.6 (10.1-16.9) in the control group. Supervision led to a significant increase of AEFI reporting rate compared to SMS [adjusted RR=2.1 (1.6-2.7); p>0.001] and control [RR=2.8(2.1-3.7); p>0.001)] groups. The effect of SMS led to some increase in AEFI reporting rate compared to the control group, but the difference was not statistically significant [RR=1.4(0.8-1.6); p=0.07)].; Supervision was more effective than SMS or routine surveillance in improving AEFI reporting rate. It should be part of any AEFI surveillance system. SMS could be useful in improving AEFI reporting rates but strategies need to be found to improve its effectiveness, and thus maximize its benefits.
Enricke Bouma - One of the best experts on this subject based on the ideXlab platform.
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Community Perspectives Associated With the African PsA-TT (MenAfriVac) Vaccine Trials.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015Co-Authors: Olubukola T. Idoko, Aldiouma Diallo, Samba O. Sow, Abraham Hodgson, Adebayo Akinsola, Bou Diarra, Fadima Cheick Haidara, Patrick Ansah, Beate Kampmann, Enricke BoumaAbstract:The Meningitis Vaccine Project (MVP) was established to address epidemic Meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate Vaccine, PsA-TT. Experiences in 4 clinical trial sites are described. Culturally sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death. The clinical trials were completed successfully through community acceptance and active community collaboration. The trials also strengthened the capacities in the participating communities, and actively worked to resolve community problems. The understanding and integration of sociocultural realities of communities were major assets in the conduct and acceptance of these trials. MVP succeeded in these sites and provided a sound example for future clinical studies in Africa. ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007). © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.
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Community Perspectives Associated With the African PsA-TT (MenAfriVac) Vaccine Trials.
Clinical Infectious Diseases, 2015Co-Authors: Olubukola T. Idoko, Aldiouma Diallo, Samba O. Sow, Abraham Hodgson, Adebayo Akinsola, Bou Diarra, Fadima Cheick Haidara, Patrick Ansah, Beate Kampmann, Enricke BoumaAbstract:Background. The Meningitis Vaccine Project (MVP) was established to address epidemic Meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate Vaccine, PsA-TT. Methods. Experiences in 4 clinical trial sites are described. Culturally sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death. Results. The clinical trials were completed successfully through community acceptance and active community collaboration. The trials also strengthened the capacities in the participating communities, and actively worked to resolve community problems. Conclusions. The understanding and integration of sociocultural realities of communities were major assets in the conduct and acceptance of these trials. MVP succeeded in these sites and provided a sound example for future clinical studies in Africa. Clinical Trials Registration. ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007).
Simonetta Viviani - One of the best experts on this subject based on the ideXlab platform.
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Lessons from the Meningitis Vaccine Project.
Viral immunology, 2017Co-Authors: F. Marc Laforce, Mamoudou H. Djingarey, Simonetta Viviani, Marie-pierre PreziosiAbstract:Abstract From 2001 to 2017 the Meningitis Vaccine Project (MVP), a Gates Foundation funded partnership between PATH and the World Health Organization (WHO), successfully developed, tested, licensed, and introduced an affordable new Group A meningococcal conjugate Vaccine, MenAfriVac®, in sub-Saharan Africa. The Vaccine was well received, and from 2010 to 2016, over 260 million Africans have received a dose of the Vaccine in campaigns largely directed at 1–29-year olds. The public health impact has been dramatic with the elimination of Group A meningococcal infections wherever the Vaccine has been used at public health scale. Over its 16-year life span, MVP faced many challenges, and lessons were learned that may be of interest to other groups seeking to develop Vaccine products for resource-poor countries. We have chosen to highlight six elements that were keys to the success of the project: (a) country and African regional engagement during all phases of the project; (b) the evolution of the WHO/PATH par...
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Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013
Clinical Infectious Diseases, 2015Co-Authors: Fabien Diomandé, Mamoudou H. Djingarey, Simonetta Viviani, Marie-pierre Preziosi, Téné M. Yaméogo, Kirsten S. Vannice, Claude-roger Ouandaogo, Modibo Keita, Nehemie Mbakuliyemo, Bartholomew Dicky AkanmoriAbstract:A group A meningococcal conjugate Vaccine, PsA-TT, was developed by the Meningitis Vaccine Project and the Serum Institute of India, Ltd (SIIL). Clinical trials conducted among approximately 10 000 persons aged 1–29 years, in India and in Africa, confirmed a Vaccine safety profile similar to that of licensed polysaccharide Vaccines, as well as a stronger and more persistent immunological response against group A meningococcus (MenA) [1, 2]. The Vaccine was licensed by the Drug Controller General of India in January 2010 and prequalified by the World Health Organization (WHO) in June 2010, and a common regulatory dossier was submitted to the first 3 countries (Burkina Faso, Mali, and Niger) by SIIL prior to introducing the Vaccine , in accordance with regulatory requirements. The other countries that have used this Vaccine in mass campaigns received summary lot protocols and used an expedited review procedure to license the Vaccine [3, 4]. By 2013, 12 countries in the epidemic Meningitis belt had introduced PsA-TT, vaccinating >150 million eligible people. As a result, a significant decrease in MenA carriage was documented among vaccinated and unvaccinated individuals [5], and the burden of Meningitis from MenA dramatically decreased [6, 7]. Clinical trials are limited in their ability to detect rare and late-occurring adverse events associated with vaccination due to small sample sizes and limited participant follow-up time [8–10]. Careful monitoring for possible infrequent but serious adverse events following immunization (AEFIs) is thus desirable during postmarketing surveillance and widespread use of any Vaccine. The Global Advisory Committee on Vaccine Safety (GACVS), during its session in December 2009, recommended an initial phased approach to introduction of PsA-TT to carefully collect additional safety data [11]. Postmarketing surveillance for AEFIs after PsA-TT mass immunization campaigns was systematically conducted in all countries that used the Vaccine [12, 13]. This served as an opportunity for capacity building and to conduct postlicensure safety surveillance in the low- and middle-income countries of Africa where the Vaccine was used. Conducting postmarketing surveillance for AEFIs after PsA-TT introduction in these resource-constrained countries highlighted several challenges. This article describes how pharmacovigilance systems were set up in selected countries from 2010 to 2013, discusses the main constraints and challenges faced, and analyzes lessons learned.
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Conducting Vaccine clinical trials in sub-Saharan Africa: Operational challenges and lessons learned from the Meningitis Vaccine Project
Vaccine, 2012Co-Authors: Elisa Marchetti, Simonetta Viviani, Véronique Mazarin-diop, Julie Chaumont, Lionel Martellet, Marie-francoise Makadi, Prasad S. Kulkarni, Marie-pierre PreziosiAbstract:Abstract Group A Neisseria meningitidis epidemics have been an important and unresolved public health problem in sub-Saharan Africa for over a century. The Meningitis Vaccine Project (MVP) was established in 2001 with the goal of developing, testing, licensing, and introducing an affordable group A meningococcal conjugate Vaccine for Africa. A monovalent group A conjugate Vaccine, MenAfriVac™, was developed at the Serum Institute of India Ltd. and tested in clinical trials at multiple trial sites in sub-Saharan African countries. The setup and successful conduct of ICH-GCP standard Vaccine trials across multiple trial sites located in low-resource settings are challenging. We describe the main operational issues encountered in three randomized, observer-blind, active controlled studies to evaluate the safety and immunogenicity of MenAfriVac™. The studies were conducted in parallel among 2700 subjects aged between 2 months and 29 years of age enrolled across four trial sites located in Mali, The Gambia, Senegal, and Ghana between September 2006 and August 2009. Many important lessons were learned during the preparation, setup, and implementation of the Meningitis Vaccine Project clinical program. They are summarized here to help Vaccine development programs identify efficient pathways for successful implementation of clinical trials in low-resource settings.
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The Meningitis Vaccine Project.
Vaccine, 2007Co-Authors: F. Marc Laforce, Simonetta Viviani, Kader Konde, Marie-pierre PreziosiAbstract:Epidemic meningococcal Meningitis is an important public health problem in sub-Saharan Africa. Current control measures rely on reactive immunizations with polysaccharide (PS) Vaccines that do not induce herd immunity and are of limited effectiveness in those under 2 years of age. Conversely, polysaccharide conjugate Vaccines are effective in infants and have consistently shown an important effect on decreasing carriage, two characteristics that facilitate disease control. In 2001 the Meningitis Vaccine Project (MVP) was created as a partnership between PATH and the World Health Organization (WHO) with the goal of eliminating meningococcal epidemics in Africa through the development, licensure, introduction, and widespread use of conjugate meningococcal Vaccines. Since group A Neisseria meningitidis (N. meningitidis) is the dominant pathogen causing epidemic Meningitis in Africa MVP is developing an affordable (US$ 0.40 per dose) meningococcal A (Men A) conjugate Vaccine through an innovative international partnership that saw transfer of a conjugation and fermentation technology to a developing country Vaccine manufacturer. A Phase 1 study of the Vaccine in India has shown that the product is safe and immunogenic. Phase 2 studies have begun in Africa, and a large demonstration study of the conjugate Vaccine is envisioned for 2008-2009. After extensive consultations with African public health officials a Vaccine introduction plan has been developed that includes introduction of the Men A conjugate Vaccine into standard Expanded Programme on Immunization (EPI) schedules but also emphasizes mass vaccination of 1-29 years old to induce herd immunity, a strategy that has been shown to be highly effective when the meningococcal C (Men C) conjugate Vaccine was introduced in several European countries. The MVP model is a clear example of the usefulness of a "push mechanism" to finance the development of a needed Vaccine for the developing world.