The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa
Fifteen years of investment in malaria control on Bioko Island, Equatorial Guinea (EG), dramatically reduced malaria-associated morbidity and mortality, but the impact has plateaued. To progress toward elimination, EG is investing in the development of a malaria vaccine. We assessed the unique publi...
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creator | Billingsley, Peter F Maas, Carl D Olotu, Ally Schwabe, Christopher García, Guillermo A Rivas, Matilde Riloha Hergott, Dianna E B Daubenberger, Claudia Saverino, Elizabeth Chaouch, Adel Embon, Oscar Chemba, Mwajuma Nyakarungu, Elizabeth Hamad, Ali Cortes, Carlos Schindler, Tobias Mpina, Maximillian Mtoro, Ali Sim, B Kim Lee Richie, Thomas L McGhee, Ken Tanner, Marcel Obiang Lima, Gabriel Mbaga Abdulla, Salim Hoffman, Stephen L Ayekaba, Mitoha Ondo'o |
description | Fifteen years of investment in malaria control on Bioko Island, Equatorial Guinea (EG), dramatically reduced malaria-associated morbidity and mortality, but the impact has plateaued. To progress toward elimination, EG is investing in the development of a malaria vaccine. We assessed the unique public-private partnership that has had such a significant impact on malaria on Bioko Island and now added a major effort on malaria vaccine development. As part of a $79M commitment, the EG government (75%) and three American energy companies (25%) have invested since 2012 greater than $55M in the Equatoguinean Malaria Vaccine Initiative (EGMVI) to support clinical development of Sanaria
PfSPZ vaccines (Sanaria Inc., Rockville, MD). In turn, the vaccine development program is building human capital and physical capacity. The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The EGMVI has completed three vaccine trials in EG, two vaccine trials in Tanzania, and a malaria incidence study, and initiated preparations for a 2,100-volunteer clinical trial. Personnel are training for advanced degrees abroad and have been trained in Good Clinical Practices and protocol-specific methods. A new facility has established the foundation for a national research institute. Biomedical research and development within this visionary, ambitious public-private partnership is fostering major improvements in EG. The EGMVI plans to use a PfSPZ Vaccine alongside standard malaria control interventions to eliminate Pf malaria from Bioko, becoming a potential model for elimination campaigns elsewhere. |
doi_str_mv | 10.4269/ajtmh.19-0966 |
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PfSPZ vaccines (Sanaria Inc., Rockville, MD). In turn, the vaccine development program is building human capital and physical capacity. The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The EGMVI has completed three vaccine trials in EG, two vaccine trials in Tanzania, and a malaria incidence study, and initiated preparations for a 2,100-volunteer clinical trial. Personnel are training for advanced degrees abroad and have been trained in Good Clinical Practices and protocol-specific methods. A new facility has established the foundation for a national research institute. Biomedical research and development within this visionary, ambitious public-private partnership is fostering major improvements in EG. The EGMVI plans to use a PfSPZ Vaccine alongside standard malaria control interventions to eliminate Pf malaria from Bioko, becoming a potential model for elimination campaigns elsewhere.</description><identifier>ISSN: 0002-9637</identifier><identifier>EISSN: 1476-1645</identifier><identifier>DOI: 10.4269/ajtmh.19-0966</identifier><identifier>PMID: 32458790</identifier><language>eng</language><publisher>United States: Institute of Tropical Medicine</publisher><subject><![CDATA[Adolescent ; Biomedical Research - organization & administration ; Child ; Child, Preschool ; Clinical trials ; Disease Eradication - trends ; Equatorial Guinea - epidemiology ; Female ; Humans ; Insecticide-Treated Bednets - supply & distribution ; Islands ; Malaria ; Malaria Vaccines - administration & dosage ; Malaria, Falciparum - epidemiology ; Malaria, Falciparum - parasitology ; Malaria, Falciparum - prevention & control ; Malaria, Falciparum - transmission ; Male ; Piece ; Plasmodium falciparum - pathogenicity ; Public-Private Sector Partnerships - organization & administration ; R&D ; Research & development ; Vaccines]]></subject><ispartof>The American journal of tropical medicine and hygiene, 2020-09, Vol.103 (3), p.947-954</ispartof><rights>Copyright Institute of Tropical Medicine Sep 2020</rights><rights>Copyright Institute of Tropical Medicine Aug 2020</rights><rights>The American Society of Tropical Medicine and Hygiene 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c443t-d5e0b7e19f30c7900c5e4f826efca109e249f25363ef91b003e1cb893e2939903</citedby><cites>FETCH-LOGICAL-c443t-d5e0b7e19f30c7900c5e4f826efca109e249f25363ef91b003e1cb893e2939903</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7470544/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7470544/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32458790$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Billingsley, Peter F</creatorcontrib><creatorcontrib>Maas, Carl D</creatorcontrib><creatorcontrib>Olotu, Ally</creatorcontrib><creatorcontrib>Schwabe, Christopher</creatorcontrib><creatorcontrib>García, Guillermo A</creatorcontrib><creatorcontrib>Rivas, Matilde Riloha</creatorcontrib><creatorcontrib>Hergott, Dianna E B</creatorcontrib><creatorcontrib>Daubenberger, Claudia</creatorcontrib><creatorcontrib>Saverino, Elizabeth</creatorcontrib><creatorcontrib>Chaouch, Adel</creatorcontrib><creatorcontrib>Embon, Oscar</creatorcontrib><creatorcontrib>Chemba, Mwajuma</creatorcontrib><creatorcontrib>Nyakarungu, Elizabeth</creatorcontrib><creatorcontrib>Hamad, Ali</creatorcontrib><creatorcontrib>Cortes, Carlos</creatorcontrib><creatorcontrib>Schindler, Tobias</creatorcontrib><creatorcontrib>Mpina, Maximillian</creatorcontrib><creatorcontrib>Mtoro, Ali</creatorcontrib><creatorcontrib>Sim, B Kim Lee</creatorcontrib><creatorcontrib>Richie, Thomas L</creatorcontrib><creatorcontrib>McGhee, Ken</creatorcontrib><creatorcontrib>Tanner, Marcel</creatorcontrib><creatorcontrib>Obiang Lima, Gabriel Mbaga</creatorcontrib><creatorcontrib>Abdulla, Salim</creatorcontrib><creatorcontrib>Hoffman, Stephen L</creatorcontrib><creatorcontrib>Ayekaba, Mitoha Ondo'o</creatorcontrib><title>The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa</title><title>The American journal of tropical medicine and hygiene</title><addtitle>Am J Trop Med Hyg</addtitle><description>Fifteen years of investment in malaria control on Bioko Island, Equatorial Guinea (EG), dramatically reduced malaria-associated morbidity and mortality, but the impact has plateaued. To progress toward elimination, EG is investing in the development of a malaria vaccine. We assessed the unique public-private partnership that has had such a significant impact on malaria on Bioko Island and now added a major effort on malaria vaccine development. As part of a $79M commitment, the EG government (75%) and three American energy companies (25%) have invested since 2012 greater than $55M in the Equatoguinean Malaria Vaccine Initiative (EGMVI) to support clinical development of Sanaria
PfSPZ vaccines (Sanaria Inc., Rockville, MD). In turn, the vaccine development program is building human capital and physical capacity. The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The EGMVI has completed three vaccine trials in EG, two vaccine trials in Tanzania, and a malaria incidence study, and initiated preparations for a 2,100-volunteer clinical trial. Personnel are training for advanced degrees abroad and have been trained in Good Clinical Practices and protocol-specific methods. A new facility has established the foundation for a national research institute. Biomedical research and development within this visionary, ambitious public-private partnership is fostering major improvements in EG. The EGMVI plans to use a PfSPZ Vaccine alongside standard malaria control interventions to eliminate Pf malaria from Bioko, becoming a potential model for elimination campaigns elsewhere.</description><subject>Adolescent</subject><subject>Biomedical Research - organization & administration</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Disease Eradication - trends</subject><subject>Equatorial Guinea - epidemiology</subject><subject>Female</subject><subject>Humans</subject><subject>Insecticide-Treated Bednets - supply & distribution</subject><subject>Islands</subject><subject>Malaria</subject><subject>Malaria Vaccines - administration & dosage</subject><subject>Malaria, Falciparum - epidemiology</subject><subject>Malaria, Falciparum - parasitology</subject><subject>Malaria, Falciparum - prevention & control</subject><subject>Malaria, Falciparum - transmission</subject><subject>Male</subject><subject>Piece</subject><subject>Plasmodium falciparum - pathogenicity</subject><subject>Public-Private Sector Partnerships - organization & administration</subject><subject>R&D</subject><subject>Research & development</subject><subject>Vaccines</subject><issn>0002-9637</issn><issn>1476-1645</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ks9rFDEcxYModl09epWAFy9T83smHoSybGthRZGqx5BNv9nJMpO0mZmCf4n_bjNuXdSDp0C-n_d4Dx5CLyk5FUzpt3Y_9u0p1RXRSj1CCypqVVEl5GO0IISwSiten6Bnw7AnhDaM0qfohDMhm1qTBfp51QJe3052TLspRLARf7SdzcHib9a58oMvYxiDHcMdvMPnOfV4LJKNnaJrQ9zh5LHFqy7E4GyHv8AANrsWf-7s6FMudDo6rrvQh1isUpzvMc76EPEK4piL-DsMIz7zuTg9R0-87QZ48fAu0dfz9dXqQ7X5dHG5OttUTgg-VtcSyLYGqj0nrhQiToLwDVPgnaVEAxPaM8kVB6_plhAO1G0bzYFprjXhS_T-4HszbXu4dock5iaH3uYfJtlg_r7E0JpdujO1qIksGZbozYNBTrdTKWD6MDjoSj1I02CYIDWnkilZ0Nf_oPs05VjqFUpSKXnDxf8poVlDFZu9qgPlchqGDP4YmRIzD8P8Goah2szDKPyrP3se6d9L4PerlbWe</recordid><startdate>20200901</startdate><enddate>20200901</enddate><creator>Billingsley, Peter F</creator><creator>Maas, Carl D</creator><creator>Olotu, Ally</creator><creator>Schwabe, Christopher</creator><creator>García, Guillermo A</creator><creator>Rivas, Matilde Riloha</creator><creator>Hergott, Dianna E B</creator><creator>Daubenberger, Claudia</creator><creator>Saverino, Elizabeth</creator><creator>Chaouch, Adel</creator><creator>Embon, Oscar</creator><creator>Chemba, Mwajuma</creator><creator>Nyakarungu, Elizabeth</creator><creator>Hamad, Ali</creator><creator>Cortes, Carlos</creator><creator>Schindler, Tobias</creator><creator>Mpina, Maximillian</creator><creator>Mtoro, Ali</creator><creator>Sim, B Kim Lee</creator><creator>Richie, Thomas L</creator><creator>McGhee, Ken</creator><creator>Tanner, Marcel</creator><creator>Obiang Lima, Gabriel Mbaga</creator><creator>Abdulla, Salim</creator><creator>Hoffman, Stephen L</creator><creator>Ayekaba, Mitoha Ondo'o</creator><general>Institute of Tropical Medicine</general><general>The American Society of Tropical Medicine and Hygiene</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200901</creationdate><title>The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa</title><author>Billingsley, Peter F ; Maas, Carl D ; Olotu, Ally ; Schwabe, Christopher ; García, Guillermo A ; Rivas, Matilde Riloha ; Hergott, Dianna E B ; Daubenberger, Claudia ; Saverino, Elizabeth ; Chaouch, Adel ; Embon, Oscar ; Chemba, Mwajuma ; Nyakarungu, Elizabeth ; Hamad, Ali ; Cortes, Carlos ; Schindler, Tobias ; Mpina, Maximillian ; Mtoro, Ali ; Sim, B Kim Lee ; Richie, Thomas L ; McGhee, Ken ; Tanner, Marcel ; Obiang Lima, Gabriel Mbaga ; Abdulla, Salim ; Hoffman, Stephen L ; Ayekaba, Mitoha Ondo'o</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c443t-d5e0b7e19f30c7900c5e4f826efca109e249f25363ef91b003e1cb893e2939903</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adolescent</topic><topic>Biomedical Research - organization & administration</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Clinical trials</topic><topic>Disease Eradication - trends</topic><topic>Equatorial Guinea - epidemiology</topic><topic>Female</topic><topic>Humans</topic><topic>Insecticide-Treated Bednets - supply & distribution</topic><topic>Islands</topic><topic>Malaria</topic><topic>Malaria Vaccines - administration & dosage</topic><topic>Malaria, Falciparum - epidemiology</topic><topic>Malaria, Falciparum - parasitology</topic><topic>Malaria, Falciparum - prevention & control</topic><topic>Malaria, Falciparum - transmission</topic><topic>Male</topic><topic>Piece</topic><topic>Plasmodium falciparum - pathogenicity</topic><topic>Public-Private Sector Partnerships - organization & administration</topic><topic>R&D</topic><topic>Research & development</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Billingsley, Peter F</creatorcontrib><creatorcontrib>Maas, Carl D</creatorcontrib><creatorcontrib>Olotu, Ally</creatorcontrib><creatorcontrib>Schwabe, Christopher</creatorcontrib><creatorcontrib>García, Guillermo A</creatorcontrib><creatorcontrib>Rivas, Matilde Riloha</creatorcontrib><creatorcontrib>Hergott, Dianna E B</creatorcontrib><creatorcontrib>Daubenberger, Claudia</creatorcontrib><creatorcontrib>Saverino, Elizabeth</creatorcontrib><creatorcontrib>Chaouch, Adel</creatorcontrib><creatorcontrib>Embon, Oscar</creatorcontrib><creatorcontrib>Chemba, Mwajuma</creatorcontrib><creatorcontrib>Nyakarungu, Elizabeth</creatorcontrib><creatorcontrib>Hamad, Ali</creatorcontrib><creatorcontrib>Cortes, Carlos</creatorcontrib><creatorcontrib>Schindler, Tobias</creatorcontrib><creatorcontrib>Mpina, Maximillian</creatorcontrib><creatorcontrib>Mtoro, Ali</creatorcontrib><creatorcontrib>Sim, B Kim Lee</creatorcontrib><creatorcontrib>Richie, Thomas L</creatorcontrib><creatorcontrib>McGhee, Ken</creatorcontrib><creatorcontrib>Tanner, Marcel</creatorcontrib><creatorcontrib>Obiang Lima, Gabriel Mbaga</creatorcontrib><creatorcontrib>Abdulla, Salim</creatorcontrib><creatorcontrib>Hoffman, Stephen L</creatorcontrib><creatorcontrib>Ayekaba, Mitoha Ondo'o</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The American journal of tropical medicine and hygiene</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Billingsley, Peter F</au><au>Maas, Carl D</au><au>Olotu, Ally</au><au>Schwabe, Christopher</au><au>García, Guillermo A</au><au>Rivas, Matilde Riloha</au><au>Hergott, Dianna E B</au><au>Daubenberger, Claudia</au><au>Saverino, Elizabeth</au><au>Chaouch, Adel</au><au>Embon, Oscar</au><au>Chemba, Mwajuma</au><au>Nyakarungu, Elizabeth</au><au>Hamad, Ali</au><au>Cortes, Carlos</au><au>Schindler, Tobias</au><au>Mpina, Maximillian</au><au>Mtoro, Ali</au><au>Sim, B Kim Lee</au><au>Richie, Thomas L</au><au>McGhee, Ken</au><au>Tanner, Marcel</au><au>Obiang Lima, Gabriel Mbaga</au><au>Abdulla, Salim</au><au>Hoffman, Stephen L</au><au>Ayekaba, Mitoha Ondo'o</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa</atitle><jtitle>The American journal of tropical medicine and hygiene</jtitle><addtitle>Am J Trop Med Hyg</addtitle><date>2020-09-01</date><risdate>2020</risdate><volume>103</volume><issue>3</issue><spage>947</spage><epage>954</epage><pages>947-954</pages><issn>0002-9637</issn><eissn>1476-1645</eissn><abstract>Fifteen years of investment in malaria control on Bioko Island, Equatorial Guinea (EG), dramatically reduced malaria-associated morbidity and mortality, but the impact has plateaued. 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PfSPZ vaccines (Sanaria Inc., Rockville, MD). In turn, the vaccine development program is building human capital and physical capacity. The EGMVI established regulatory and ethical oversight to ensure compliance with the International Conference on Harmonization and Good Clinical Practices for the first importation of investigational product, ethical approval, and conduct of a clinical trial in Equatoguinean history. The EGMVI has completed three vaccine trials in EG, two vaccine trials in Tanzania, and a malaria incidence study, and initiated preparations for a 2,100-volunteer clinical trial. Personnel are training for advanced degrees abroad and have been trained in Good Clinical Practices and protocol-specific methods. A new facility has established the foundation for a national research institute. Biomedical research and development within this visionary, ambitious public-private partnership is fostering major improvements in EG. The EGMVI plans to use a PfSPZ Vaccine alongside standard malaria control interventions to eliminate Pf malaria from Bioko, becoming a potential model for elimination campaigns elsewhere.</abstract><cop>United States</cop><pub>Institute of Tropical Medicine</pub><pmid>32458790</pmid><doi>10.4269/ajtmh.19-0966</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adolescent Biomedical Research - organization & administration Child Child, Preschool Clinical trials Disease Eradication - trends Equatorial Guinea - epidemiology Female Humans Insecticide-Treated Bednets - supply & distribution Islands Malaria Malaria Vaccines - administration & dosage Malaria, Falciparum - epidemiology Malaria, Falciparum - parasitology Malaria, Falciparum - prevention & control Malaria, Falciparum - transmission Male Piece Plasmodium falciparum - pathogenicity Public-Private Sector Partnerships - organization & administration R&D Research & development Vaccines |
title | The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa |
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