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1. Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: A phase I randomised trial.

Author

Selidji T Agnandji, José F Fernandes, Emmanuel B Bache, Régis M Obiang Mba, Jessica S Brosnahan, Lumeka Kabwende, Paul Pitzinger, Pieter Staarink, Marguerite Massinga-Loembe, Verena Krähling, Nadine Biedenkopf, Sarah Katharina Fehling, Thomas Strecker, David J Clark, Henry M Staines, Jay W Hooper, Peter Silvera, Vasee Moorthy, Marie-Paule Kieny, Akim A Adegnika, Martin P Grobusch, Stephan Becker, Michael Ramharter, Benjamin Mordmüller, Bertrand Lell, VEBCON Consortium, Sanjeev Krishna, and Peter G Kremsner more...

Subjects
Medicine
Abstract

BackgroundThe rVSVΔG-ZEBOV-GP vaccine prevented Ebola virus disease when used at 2 × 107 plaque-forming units (PFU) in a trial in Guinea. This study provides further safety and immunogenicity data.Methods and findingsA randomised, open-label phase I trial in Lambaréné, Gabon, studied 5 single intramuscular vaccine doses of 3 × 103, 3 × 104, 3 × 105, 3 × 106, or 2 × 107 PFU in 115 adults and a dose of 2 × 107 PFU in 20 adolescents and 20 children. The primary objective was safety and tolerability 28 days post-injection. Immunogenicity, viraemia, and shedding post-vaccination were evaluated as secondary objectives. In adults, mild-to-moderate adverse events were frequent, but there were no serious or severe adverse events related to vaccination. Before vaccination, Zaire Ebola virus (ZEBOV)-glycoprotein (GP)-specific and ZEBOV antibodies were detected in 11% and 27% of adults, respectively. In adults, 74%-100% of individuals who received a dose 3 × 104, 3 × 105, 3 × 106, or 2 × 107 PFU had a ≥4.0-fold increase in geometric mean titres (GMTs) of ZEBOV-GP-specific antibodies at day 28, reaching GMTs of 489 (95% CI: 264-908), 556 (95% CI: 280-1,101), 1,245 (95% CI: 899-1,724), and 1,503 (95% CI: 931-2,426), respectively. Twenty-two percent of adults had a ≥4-fold increase of ZEBOV antibodies, with GMTs at day 28 of 1,015 (647-1,591), 1,887 (1,154-3,085), 1,445 (1,013-2,062), and 3,958 (2,249-6,967) for the same doses, respectively. These antibodies persisted up to day 180 for doses ≥3 × 105 PFU. Adults with antibodies before vaccination had higher GMTs throughout. Neutralising antibodies were detected in more than 50% of participants at doses ≥3 × 105 PFU. As in adults, no serious or severe adverse events related to vaccine occurred in adolescents or children. At day 2, vaccine RNA titres were higher for adolescents and children than adults. At day 7, 78% of adolescents and 35% of children had recombinant vesicular stomatitis virus RNA detectable in saliva. The vaccine induced high GMTs of ZEBOV-GP-specific antibodies at day 28 in adolescents, 1,428 (95% CI: 1,025-1,989), and children, 1,620 (95% CI: 806-3,259), and in both groups antibody titres increased up to day 180. The absence of a control group, lack of stratification for baseline antibody status, and imbalances in male/female ratio are the main limitations of this study.ConclusionsOur data confirm the acceptable safety and immunogenicity profile of the 2 × 107 PFU dose in adults and support consideration of lower doses for paediatric populations and those who request boosting.Trial registrationPan African Clinical Trials Registry PACTR201411000919191. more...

Published
2017
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2. PS-003: EVIDENCE-INFORMED POLICY MAKING: CHALLENGES AND OPPORTUNITIES

Author

Makanga, Michael, Beattie, Pauline, Breugelmans, Gabrielle, Nyirenda, Thomas, Bockarie, Moses, Tanner, Marcel, Volmink, Jimmy, Hankins, Catherine, Walzl, Gerhard, Chegou, Novel, Malherbe, Stephanus, Hatherill, Mark, Scriba, Thomas J., Zak, Daniel E., Barry, Clifton E., Kaufmann, Stefan H.E., Noor, Abdisalan, Strub-Wourgaft, Nathalie, Phillips, Patrick, Munguambe, Khátia, Ravinetto, Raffaella, Tinto, Halidou, Diro, Ermias, Mahendrahata, Yodi, Okebe, Joseph, Rijal, Suman, Garcia, Coralith, Sundar, Shyam, Ndayisaba, Gilles, Sopheak, Thai, Ngoduc, Thang, Loen, Harry Van, Jacobs, Jan, D'Alessandro, Umberto, Boelaert, Marleen, Buvé, Anne, Kamalo, Patrick, Manda-Taylor, Lucinda, Rennie, Stuart, Mokgatla, Boitumelo, Bahati, Prince, Ijsselmuiden, Carel, Afolabi, Muhammed, Mcgrath, Nuala, Kampmann, Beate, Imoukhuede, Egeruan, Alexander, Neal, Larson, Heidi, Chandramohan, Daniel, Bojang, Kalifa, Kasaro, Margaret Phiri, Muluka, Brenda, Kaunda, Kaunda, Morse, Jill, Westfall, Andrew, Kapata, Nathan, Kruuner, Annika, Henostroza, German, Reid, Stewart, Alabi, Abraham, Foguim, Francis, Sankarganesh, Jeyaraj, Bruske, Ellen, Mfoumbi, Arnault, Mevyann, Chester, Adegnika, Ayola, Lell, Bertrand, Kranzer, Katharina, Kremsner, Peter, Grobusch, Martin, Sabiiti, Wilber, Ntinginya, Nyanda, Kuchaka, Davis, Azam, Khalide, Kampira, Elizabeth, Mtafya, Bariki, Bowness, Ruth, Bhatt, Nilesh, Davies, Gerry, Kibiki, Gibson, Gillespie, Stephen, Lejon, Veerle, Ilboudo, Hamidou, Mumba, Dieudonné, Camara, Mamady, Kaba, Dramane, Lumbala, Crispin, Fèvre, Eric, Jamonneau, Vincent, Bucheton, Bruno, Büscher, Philippe, Chisenga, Caroline, Sinkala, Edford, Chilengi, Roma, Chitundu, Hellen, Zyambo, Zude, Wandeler, Gilles, Vinikoor, Michael, Emilie, Dama, Camara, Oumou, Mathurin, Koffi, Guiguigbaza-Kossigan, Dayo, Philippe, Büscher, Regassa, Fikru, Hassane, Sakande, Bienvenu, Somda Martin, Fabrice, Courtin, Ouédraogo, Elie, Kouakou, Lingue, Owusu, Michael, Mensah, Eric, Enimil, Anthony, Mutocheluh, Mohamed, Ndongo, Francis Ateba, Tejiokem, Mathurin Cyrille, Texier, Gaetan, Penda, Calixte, Ndiang, Suzie, Ndongo, Jean-Audrey, Guemkam, Georgette, Sofeu, Casimir Ledoux, Afumbom, Kfutwa, Faye, Albert, Msellati, Philippe, Warszawski, Josiane, Vos, Alinda, Devillé, Walter, Barth, Roos, Klipstein-Grobusch, Kerstin, Tempelman, Hugo, Venter, François, Coutinho, Roel, Grobbee, Diederick, Ssemwanga, Deogratius, Lyagoba, Frederick, Magambo, Brian, Kapaata, Anne, Kirangwa, Joseph, Nannyonjo, Maria, Nassolo, Faridah, Nsubuga, Rebecca, Yebra, Gonzalo, Brown, Andrew, Kaleebu, Pontiano, Nylén, Hanna, Habtewold, Abiy, Makonnen, Eyasu, Yimer, Getnet, Burhenne, Jürgen, Diczfalusy, Ulf, Aklillu, Eleni, Steele, Duncan, Walker, Richard, Simuyandi, Michelo, Beres, Laura, Bosomprah, Samuel, Ansumana, Rashid, Taitt, C., Lamin, J.M., Jacobsen, K.H., Mulvaney, S.P., Leski, T., Bangura, U., Stenger, D., Vries, Sophie De, Zinsou, Frejus Jeannot, Honkpehedji, J, Dejon, Jean Claude, Loembe, Marguerite Massinga, Bache, Bache, Pakker, Nadine, Leeuwen, Remko Van, Hounkpatin, Aurore Bouyoukou, Yazdanbakhsh, Maria, Bethony, Jeffrey, Hotez, Peter, Diemert, David, Bache, Bache Emmanuel, Fernandes, José F., Mba, Régis M Obiang, Kabwende, Anita L., Grobusch, Martin P., Krishna, Sanjeev, Kremsner, Peter G., Todagbe, Agnandji Selidji, Nambozi, Michael, Kabuya, Jean-Bertin, Hachizovu, Sebastian, Mwakazanga, David, Kasongo, Webster, Buyze, Jozefien, Mulenga, Modest, Geertruyden, Jean-Pierre, Gitaka, Jesse, Chan, Chim, Kongere, James, Kagaya, Wataru, Kaneko, Akira, Kabore, Naomie, Barry, Nouhoun, Kabre, Zachari, Werme, Karidia, Fofana, Aminata, Compaore, Daniel, Nikiema, Frederic, Some, Fabrice, Djimde, Abdoulaye, Zongo, Issaka, Ouedraogo, Bosco, Kone, Aminatou, Sagara, Issaka, Björkman, Anders, Gil, Jose Pedro, Nchinda, Godwin, Bopda, Alain, Nji, Nadesh, Ambada, Georgia, Ngu, Loveline, Tchadji, Jules, Sake, Carol, Magagoum, Suzanne, Njambe, Ghislain D., Lisom, Abel, Park, Chae Gyu, Tait, Dereck, Sibusiso, Hlatjwako, Manda, Olga, Croucher, Kristin, Westhuizen, Anja Van Der, Mshanga, Isaac, Levin, Jonathan, Nanvubya, Annet, Kibengo, Freddie, Jaoko, Walter, Pala, Pietro, Perreau, Matthieu, Namuniina, Annemarie, Kitandwe, Paul, Tapia, Gonzalo, Serwanga, Jennifer, Yates, Nicole, Fast, Pat, Mayer, Bryan, Montefiori, David, Tomaras, Georgia, Robb, Merlin, Lee, Carter, Wagner, Ralf, Sanders, Edward, Kilembe, William, Kiwanuka, Noah, Gilmour, Jill, Kuipers, Hester, Vooij, Dani, Chinyenze, Kundai, Priddy, Frances, Ding, Song, Hanke, Tom, Pantaleo, Giuseppe, Ngasala, Billy, Jovel, Irina, Malmberg, Maja, Mmbando, Bruno, Premji, Zul, Mårtensson, Andreas, Mwaiswelo, Richard, Agbor, Lenshina, Apinjoh, Tobias, Mwanza, Sydney, Chileshe, Justin, Joshi, Sudhaunshu, Malunga, Phidelis, Manyando, Christine, Laufer, Miriam, Dara, Antoine, Niangaly, Amadou, Sinha, Indranil, Brodin, David, Fofana, Bakary, Dama, Souleymane, Dembele, Demba, Sidibe, Bakary, Diallo, Nouhoum, Thera, Mahamadou, Wright, Karin, Gil, Jose, Doumbo, Ogobara, Baraka, Vito, Nabasumba, Carolyn, Francis, Filbert, Lutumba, Pascal, Mavoko, Hypolite, Alifrangis, Michael, Geertruyden, Jean-Pierre Van, Sissoko, Sekou, Sangaré, Cheick, Toure, Sekou, Sanogo, Kassim, Diakite, Hamadoun, Toure, Siaka, Doumbia, Diagassan, Haidara, Kadiatou, Julé, Amélie, Ashurst, Hazel, Merson, Laura, Olliaro, Piero, Marsh, Vicki, Lang, Trudie, Guérin, Philippe, Awuondo, Kennedy, Njenga, Daniel, Nyakarungu, Elizabeth, Titus, Pauline, Sutamihardja, Awalludin, Lowe, Brett, Ogutu, Bernhards, Billingsley, Peter, Soulama, Issiaka, Kaboré, Moïse, Coulibaly, Aboubacar, Ouattara, Maurice, Sanon, Souleymane, Diarra, Amidou, Bougouma, Edith, Ouedraogo, Alphonse, Sombie, Benjamin, Ouedraogo, Amidou, Kargougou, Désiré, Ouattara, Daouda, Issa, Nebie, Tiono, Alfred, Sirima, Sodiomon, Chaponda, Mike, Dabira, Edgard, Dao, François, Dara, Nianwalou, Sidibe, Bouran, Coulibaly, Moctar, Tolo, Allaye, Maiga, Hamma, Ouologuem, Nouhoum, Niangaly, Hamidou, Botchway, Felix, Wilson, Nana, Dickinson-Copeland, Carmen M, Adjei, Andrew A., Wilson, Michael, Stiles, Jonathan K., Hamid, Muzamil Abdel, Awad-Elgeid, Mona, Nasr, Awad, Netongo, Palmer, Kamdem, Séverin, Velavan, Thirumalaisamy, Lasry, Estrella, Diarra, Modibo, Bamadio, Amadou, Traore, Aliou, Coumare, Samba, Soma, Bahonan, Dicko, Yeyia, Sangare, Boubou, Tembely, Aly, Traore, Djibril, Haidara, Aboubecrin, Dicko, Alassane, Diawara, Elisabeth, Beavogui, Abdoul, Camara, Daouda, Sylla, Malick, Yattara, Mohamed, Sow, Amadou, Camara, Gnèpou Camara, Diallo, Saliou, Mombo-Ngoma, Ghyslain, Remppis, Jonathan, Sievers, Moritz, Manego, Rella Zoleko, Endamne, Lilian, Hutchinson, David, Held, Jana, Supan, Christian, Salazar, Carmen L. Ospina, Bonkian, Léa Nadège, Nahum, Alain, Sié, Ali, Abdulla, Salim, Cantalloube, Cathy, Djeriou, Elhadj, Bouyou-Akotet, Marielle, Mordmüller, Benjamin, Siribie, Mohamadou, Sirima, Sodiomon B., Ouattara, San Maurice, Coulibaly, Sam, Kabore, Jean Moïse, Amidou, Diarra, Tekete, Mamadou, Burhenne, Juergen, Traore, Oumar, Haefeli, Walter, Borrmann, Steffen, Kaboré, Naomie, Kabré, Zachari, Nikèma, Fréderic, Compaoré, Daniel, Somé, Fabrice, Djimdé, Abdoulaye, Ouédraogo, Jean, Chalwe, Victor, Miller, John, Diakité, Hamadoun, Greco, Beatrice, Spangenberg, Thomas, Kourany-Lefoll, Elly, Oeuvray, Claude, Mulry, Jim, Tyagarajan, Kamala, Magsaam, Bettina, Barnes, Karen, Hodel, Eva Maria, Humphreys, Georgina, Pace, Cheryl, Banda, C.G, Denti, Paulo, Allen, Elizabeth, Lalloo, David, Mwapasa, Victor, Terlouw, Anja, Mwesigwa, Julia, Achan, Jane, Jawara, Musa, Ditanna, Gian, Worwui, Archibald, Affara, Muna, Koukouikila-Koussounda, Félix, Kombo, Michael, Vouvoungui, Christevy, Ntoumi, Francine, Etoka-Beka, Mandingha Kosso, Deibert, Julia, Poulain, Pierre, Kobawila, Simon, Gueye, Nerly Gampio, Koukouikila-Koussounda, Felix, Seda, Brian, Kwambai, Titus, Jangu, Phelix, Samuels, Aaron, ter Kuile, Feike, Kariuki, Simon, Barry, Aissata, Bousema, Teun, Okech, Brenda, Egwang, Thomas, Corran, Patrick, Riley, Eleanor, Ezennia, Ifeoma, Ekwunife, Obinna, Muleba, Mbanga, Stevenson, Jennifer, Mbata, Keith, Coetzee, Maureen, Norris, Douglas, Moneke-Anyanwoke, Ngozi, Momodou, Jasseh, Clarke, Ed, Scott, Susana, Tijani, Adelani, Djimde, Moussa, Vaillant, Michel, Samouda, Hanen, Mensah, Victorine, Roetynck, Sophie, Kanteh, Ebrima, Bowyer, Georgina, Ndaw, Amy, Oko, Francis, Bliss, Carly, Jagne, Ya Jankey, Cortese, Riccardo, Nicosia, Alfredo, Roberts, Rachel, D'Alessio, Flavia, Leroy, Odile, Faye, Babacar, Cisse, Badara, Gerry, Stephen, Viebig, Nicola, Lawrie, Alison, Ewer, Katie, Hill, Adrian, Nebie, Issa, Tiono, Alfred B, Sanou, Guillaume, Konate, Amadou T, Yaro, Baptiste J, Sodiomon, Sirima, Honkpehedji, Yabo, Agobe, Jean Claude Dejon, Zinsou, Frejus, Mengue, Juliana, Richie, Thomas, Hoffman, Stephen, Nouatin, Odilon, Ngoa, Ulysse Ateba, Edoa, Jean R, Homoet, Andreas, Engelhon, Julie Englhon, Massinga-Louembe, Marguerite, Esen, Meral, Theisen, Michael, Sim, Kim Lee, Luty, Adrian Jf, Moutairou, Kabirou, Dinko, Bismarck, King, Elizabeth, Targett, Geoffrey, Sutherland, Colin, Likhovole, Clement, Ouma, Collins, Vulule, John, Musau, Susan, Khayumbi, Jeremiah, Okumu, Albert, Murithi, Wilfred, Otu, Jacob, Gehre, Florian, Zingue, Dezemon, Kudzawu, Samuel, Forson, Audrey, Mane, Morto, Rabna, Paulo, Diarra, Bassirou, Kayede, Salako, Adebiyi, Emmanuel, Kehinde, Aderemi, Onyejepu, Nneka, Onubogu, Catherine, Idigbe, Emmanuel, Ba, Awa, Diallo, Aissatou, Mboup, Souleymane, Disse, Kodjo, Kadanga, Gerard, Dagnra, Yaotse, Baldeh, Ignatius, Corrah, Tumani, Jong, Bouke De, Antonio, Martin, Musanabaganwa, Clarisse, Musabyimana, Jean Pierre, Karita, Etienne, Diop, Blondin, Nambajimana, Abidan, Dushimiyimana, Valentine, Karame, Prosper, Russell, Jim, Ndoli, Jules, Hategekimana, Theobald, Sendegeya, Augustin, Condo, Jeannine, Binagwaho, Agnes, Okonko, Iheanyi, Okerentugba, Phillip, Opaleye, Oluyinka, Awujo, Ezinwanne, Frank-Peterside, Nnenna, Moyo, Sikhulile, Kotokwe, Kenanao, Mohammed, Terence, Boleo, Coretah, Mupfumi, Lucy, Chishala, Samuel, Gaseitsiwe, Simani, Tsalaile, Lesedi, Bussmann, Herman, Makhema, Joseph, Baum, Marianna, Marlink, Richard, Engelbretch, Susan, Essex, Max, Novitsky, Vladimir, Saka, Emmanuel, Kalipalire, Zex, Bhairavabhotla, Ravikiran, Midiani, Dalitso, Sherman, Judith, Mgode, Georgies, Cox, Christophe, Bwana, Dickens, Mtui, Leah, Magesa, Daniel, Kahwa, Amos, Mfinanga, Godfrey, Mulder, Christiaan, Borain, Nick, Petersen, Lizette, Plessis, Julianne Du, Theron, Grant, Holm-Hansen, Carol, Tekwu, Emmanuel Mouafo, Sidze, Larissa Kamgue, Assam, Jean Paul Assam, Eyangoh, Sarah, Niemann, Stefan, Beng, Veronique Penlap, Frank, Matthias, Atiadeve, Samuel, Hilmann, Doris, Awoniyi, Dolapo, Baumann, Ralf, Kriel, Belinda, Jacobs, Ruschca, Kidd, Martin, Loxton, Andre, Kaempfer, Susanne, Singh, Mahavir, Mwanza, Winnie, Milimo, Deborah, Moyo, Maureen, Kasese, Nkatya, Cheeba-Lengwe, Maina, Munkondya, Stembiso, Ayles, Helen, Haas, Petra De, Muyoyeta, Monde, Namuganga, Anna Ritah, Kizza, Harriet Mayanja, Mendy, Alieu, Tientcheu, Leopold, Ayorinde, Abigail, Coker, Edward, Egere, Uzochukwu, Coussens, Anna, Naude, Celeste, Chaplin, George, Noursadeghi, Mahdad, Martineau, Adrian, Jablonski, Nina, Wilkinson, Robert, Ouedraogo, Henri Gautier, Matteelli, Alberto, Regazzi, Mario, Tarnagda, Grissoum, Villani, Paola, Sulis, Giorgia, Diagbouga, Serge, Roggi, Alberto, Giorgetti, Francesco, Kouanda, Seni, Bidias, Amel, Ndjonka, Dieudonné, Olemba, Clémence, Souleymanou, Arabo, Mukonzo, Jackson, Kuteesa, Ronald, Ogwal-Okeng, Jasper, Gustafsson, Lars L., Owen, Joel, Bassi, Peter, Gashau, Wadzani, Olaf, Klungel, Dodoo, Alexander, Okonkwo, Prosper, Kanki, Phyllis, Maruapula, Dorcas, Seraise, Boitumelo, Einkauf, Kevin, Reilly, Amanda, Rowley, Christopher, Musonda, Rosemary, Framhein, Anna, Mpagama, Stella, Semvua, Hadija, Maboko, Leonard, Hoelscher, Michael, Heinrich, Norbert, Mulenga, Lloyd, Kaayunga, Callistus, Davies, Mary-Ann, Egger, Matthias, Musukuma, Kalo, Dambe, Rosalia, Usadi, Benjamin, Ngari, Moses, Thitiri, Johnstone, Mwalekwa, Laura, Fegan, Greg, Berkley, James, Nsagha, Dickson, Munamunungu, Virginia, Bolton, Carolyn, Siyunda, Alice, Shilimi, Jacinta, Bucciardini, Raffaella, Fragola, Vincenzo, Abegaz, Teshome, Lucattini, Stefano, Halifom, Atakilt, Tadesse, Eskedar, Berhe, Micheal, Pugliese, Katherina, Castro, Paola De, Terlizzi, Roberta, Fucili, Luca, Gregorio, Massimiliano Di, Mirra, Marco, Zegeye, Teame, Binelli, Andrea, Vella, Stefano, Abraham, Loko, Godefay, Hagos, Rakotoarivelo, Rivo, Raberahona, Mihaja, Randriamampionona, Njary, Andriamihaja, Rabezanahary, Rasamoelina, Tahinamandranto, Cornet, Muriel, Randria, Mamy Jean De Dieu, Benet, Thomas, Vanhems, Philippe, Andrianarivelo, Mala Rakoto, Chirwa, Uchizi, Michelo, Charles, Hamoonga, Raymond, Wandiga, Steve, Oduor, Patience, Agaya, Janet, Sharma, Aditya, Cavanaugh, Sean, Cain, Kevin, Mukisa, John, Mupere, Ezekiel, Worodria, William, Ngom, Justice Trésor, Koro, Francioli, Godwe, Celestin, Adande, Clemence, Ateugieu, Romaric, Onana, Tatiana, Ngono, Annie, Kamdem, Yannick, Ngo-Niobe, Sara, Etoa, François-Xavier, Kanengoni, Muchineripi, Ruzario, Sithembile, Ndebele, Paul, Shana, Melody, Tarumbiswa, Fadzai, Musesengwa, Rosemary, Gutsire, Rutendo, Fisher, Kevin, Thyagarajan, Bargavi, Akanbi, Olusola, Binuyo, Michael, Ssengooba, Willy, Respeito, Durval, Mambuque, Edson, Blanco, Silvia, Mandomando, Inacio, Cobelens, Frank, Garcia-Basteiro, Alberto, Tamene, Ayele, Topp, Stephanie, Mwamba, Chanda, Padian, Nancy, Sikazwe, Izukanji, Geng, Elvin, Holmes, Charles, Sikombe, Kombatende, Hantuba, Cardinal, Czaicki, Nancy, Simbeza, Sandra, Somwe, Paul, Umulisa, Michele, Ilo, Jennifer, Kestelyn, Evelyne, Uwineza, Mireille, Agaba, Stephen, Delvaux, Therese, Wijgert, Janneke, Gethi, Dickson, Odeny, Lazarus, Tamandjou, Cynthia, Kaindjee-Tjituka, Francina, Brandt, Laura, Cotton, Mark, Nel, Etienne, Preiser, Wolfgang, Andersson, Monique, Adepoju, Abiola, Magana, Musa, Etsetowaghan, Andrew, Chilikwazi, Mutinta, Sutcliffe, Catherine, Thuma, Philip, Sinywimaanzi, Kathy, Matakala, Hellen, Munachoonga, Passwell, Moss, William, Masenza, Issa Sabi, Geisenberger, Otto, Agrea, Peter, Rwegoshora, France, Mahiga, Hellen, Olomi, Willyhelmina, Kroidl, Arne, Kayode, Gbenga, Amoakoh-Coleman, Mary, Ansah, Evelyn, Uthman, Olalekan, Fokam, Joseph, Santoro, Maria-Mercedes, Musolo, Chrissie, Chimbiri, Isabel, Chikwenga, Gloria, Deula, Ruth, Massari, Riccardo, Lungu, Agness, Perno, Carlo-Federico, Ndzengue, Georgia, Loveline, Ngu, Lissom, Abel, Flaurent, Tchouangueu, Sosso, Samuel, Essomba, Claudine, Kpeli, Grace, Otchere, Isaac, Lamelas, Araceli, Buultjens, Andrew, Bulach, Dieter, Baines, Sarah, Seemann, Torsten, Giulieri, Stefano, Nakobu, Zuliehatu, Aboagye, Samuel, Owusu-Mireku, Evelyn, Danso, Emelia, Hauser, Julia, Hinic, Vladimira, Pluschke, Gerd, Stinear, Timothy, Yeboah-Manu, Dorothy, Elshayeb, Ayman, Siddig, Marmar El, Ahmed, Abdel Azim, Hussien, Adil El, Kabwe, Mwila, Tembo, John, Chilukutu, Lophina, Chilufya, Moses, Ngulube, Francis, Lukwesa, Chileshe, Enne, Virve, Wexner, Hannah, Mwananyanda, Lawrence, Hamer, Davidson, Sinyangwe, Sylvester, Ahmed, Yusuf, Klein, Nigel, Maeurer, Markus, Zumla, Ali, Bates, Matthew, Beyala, Landry, Etienne, Guenou, Anthony, Njimbia, Benjamin, Azike, Ateudjieu, Jerome, Chibwe, Bertha, Ojok, David, Tarr, Christine Attia, Perez, Guillermo Martinez, Omeonga, Senga, Kibungu, Fanta, Meyer, Ana, Lansana, Peter, Mayor, Alfredo, Onyango, Peter, Loggerenberg, François Van, Furtado, Tamzin, Boggs, Liam, Segrt, Alexis, Dochez, Carine, Burnett, Rosemary, Mphahlele, M. 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Subjects
Abstracts of Poster Presentations, Abstracts of Oral Presentations, Author Index, Abstracts of Presentations in Plenary Sessions, Article, Abstracts of the Eighth Edctp Forum, 6–9 November 2016
Published
2017

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3. Epidemiology of dengue fever in Gabon: Results from a health facility-based fever surveillance in Lambaréné and its surroundings

Author

José Francisco Fernandes, Peter G. Kremsner, So Hee Bae, Kang Sung Lee, Sl-Ki Lim, Neal Alexander, Suk Namkung, Meral Esen, Jacqueline Kyungah Lim, Bertrand Lell, In-Kyu Yoon, Selidji T Agnandji, Régis M Obiang, Jung-Seok Lee, Marguerite Massinga Loembe, and Jae Seung Yang more...

Subjects
RNA viruses, Male, Serotype, Viral Diseases, Pediatrics, Abdominal pain, RC955-962, Fevers, Artificial Gene Amplification and Extension, Dengue virus, Pathology and Laboratory Medicine, Antibodies, Viral, medicine.disease_cause, Polymerase Chain Reaction, Dengue Fever, Disease Outbreaks, Dengue fever, Geographical Locations, Dengue, Medical Conditions, Arctic medicine. Tropical medicine, Epidemiology, Medicine and Health Sciences, Public and Occupational Health, Prospective Studies, Child, education.field_of_study, Reverse Transcriptase Polymerase Chain Reaction, Transmission (medicine), Middle Aged, Vaccination and Immunization, Infectious Diseases, Medical Microbiology, Viral Pathogens, Child, Preschool, Viruses, Epidemiological Monitoring, Female, Pathogens, Public aspects of medicine, RA1-1270, medicine.symptom, Research Article, Neglected Tropical Diseases, Adult, medicine.medical_specialty, Adolescent, Fever, Immunology, Population, Pain, Enzyme-Linked Immunosorbent Assay, Research and Analysis Methods, Microbiology, Young Adult, Signs and Symptoms, medicine, Humans, Gabon, Molecular Biology Techniques, education, Microbial Pathogens, Molecular Biology, Biology and life sciences, Flaviviruses, business.industry, Organisms, Public Health, Environmental and Occupational Health, Infant, Outbreak, Reverse Transcriptase-Polymerase Chain Reaction, Dengue Virus, Tropical Diseases, medicine.disease, Abdominal Pain, Logistic Models, Immunoglobulin M, Immunoglobulin G, People and Places, Africa, Multivariate Analysis, Preventive Medicine, Health Facilities, Clinical Medicine, business
Abstract

Background In Africa, information on dengue is limited to outbreak reports and focused on some countries with continuing transmission in West and East Africa. To estimate the proportion of dengue-positive cases among febrile patients and identify clinical indicators of dengue cases, we conducted passive facility-based fever surveillance in a catchment area population of 70,000 residents of Lambaréné and its surroundings in Gabon. Methods Non-malarial febrile patients with current fever or history of fever (≤7 days) between 1 and 55 years of age, were enrolled at Albert Schweitzer Hospital (ASH). Acute (visit 1, day of enrollment) and convalescent blood samples were collected between 10 and 21 days after enrollment. Acute/convalescent samples were tested with IgM/IgG ELISA, and a selected subset of acute samples with RT-PCR. Results Among 682 non-malarial febrile patients enrolled, 119 (17.4%) were identified as dengue-positive (94 dengue-confirmed and 25 dengue-probable cases). Of these dengue-positive cases, 14 were confirmed with PCR, and based on serotyping, two infections were identified to be DENV-2 and two were DENV-3. The majority of our enrolled patients were, Author summary In Africa, information on dengue is limited to outbreak reports focused on some countries in West and East Africa. To estimate the proportion of dengue-positive cases among febrile patients and identify clinical indicators of dengue cases, we conducted passive health facility-based fever surveillance in a catchment area population of 70,000 residents of Lambaréné and its surroundings, Gabon. Among the patients with negative malaria RDT results, those with current fever or history of fever (≤7 days) between 1 and 55 years of age were enrolled at Albert Schweitzer Hospital (ASH). Two samples were collected with an interval of 10 to 21 days after enrollment. Samples underwent different testing for dengue confirmation. Among 682 febrile patients enrolled, 17.4% were identified as dengue-positive. Of these dengue-positive cases, we found DENV-2 and DENV-3 serotypes. Close to 80% of our dengue-positive cases were < 15 years old. Retro-orbital pain and abdominal pain were more commonly found among dengue-positive cases, compared to non-dengue cases. Lambaréné is not considered dengue-endemic. However, one in six non-malarial febrile episodes was found to be dengue-positive in the study period. Clinicians should consider dengue more frequently among non-malarial febrile patients. Given the lack of data on dengue in Gabon, more data should be generated to understand the burden and patterns of dengue for improved case detection. more...

Published
2021
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4. Fosmidomycin as an antimalarial drug: a meta-analysis of clinical trials

Author

Martin P. Grobusch, Selidji T Agnandji, José Francisco Fernandes, Benjamin Mordmüller, Régis M Obiang, Quique Bassat, Bertrand Lell, and Peter G. Kremsner

Subjects
Adult, Microbiology (medical), Drug, medicine.medical_specialty, media_common.quotation_subject, Plasmodium falciparum, Pharmacology, Microbiology, Antimalarials, Fosfomycin, Internal medicine, medicine, Humans, Malaria, Falciparum, Artemisinin, Child, media_common, Clinical Trials as Topic, biology, business.industry, biology.organism_classification, medicine.disease, Fosmidomycin, Malaria, Clinical trial, Drug development, Child, Preschool, Meta-analysis, Drug Therapy, Combination, business, medicine.drug
Abstract

With first indications of resistance against artemisinin compounds, the development of novel alternative antimalarials remains an urgent need. One candidate is fosmidomycin (Fos), a phosphonic acid derivative. This PRISMA guideline-adhering and PROSPERO-registered systematic review and meta-analysis provides an overview of the state-of-the-art of the clinical development of Fos as an antimalarial. Pooling six clinical trials of Fos against uncomplicated malaria in African children yielded an overall day 28 cure rate of 85% (95% CI: 71–98%); a parasite clearance time of 39 h; and a fever clearance time of 30 h. In four adult cohorts, the corresponding values were 70% (95% CI: 40–100%), 49 and 42 h, respectively. Data suggest that besides the partner drug, formulation determines efficacy. We advocate further clinical development of Fos-combinations. PROSPERO registration number: CRD42014013688 more...

Published
2015
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5. Tuberculosis Treatment Outcome and Drug Resistance in Lambaréné, Gabon: A Prospective Cohort Study

Author

Justin O. Beyeme, Cosme Kokou, Jonas Ehrhardt, Jonathan Remppis, Peter G. Kremsner, Stefan Niemann, Sabine Rüsch-Gerdes, Kara Osbak, Ayola A. Adegnika, Sanne Bootsma, Sabine Bélard, Marguerite Massinga Loembe, Harry Kaba, Arnaud Flamen, Saskia Janssen, Régis M Obiang, Abraham Alabi, Martin P. Grobusch, Matthias Frank, Elie G. Rossatanga, Emmanuel B. Bache, Bertrand Lell, Afsatou Ndama Traore, Davy U Kombila, Other departments, APH - Health Behaviors & Chronic Diseases, APH - Global Health, and Infectious diseases more...

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Tuberculosis, Adolescent, 030106 microbiology, Antitubercular Agents, HIV Infections, Drug resistance, Mycobacterium tuberculosis, 03 medical and health sciences, 0302 clinical medicine, Virology, Internal medicine, Drug Resistance, Multiple, Bacterial, Epidemiology, Tuberculosis, Multidrug-Resistant, Isoniazid, Medicine, Humans, 030212 general & internal medicine, Gabon, Prospective Studies, Child, Tuberculosis, Pulmonary, biology, business.industry, Coinfection, Mortality rate, Incidence (epidemiology), Incidence, HIV, Infant, Articles, Middle Aged, biology.organism_classification, medicine.disease, Survival Analysis, Infectious Diseases, Child, Preschool, Immunology, Streptomycin, Parasitology, Female, business, Mycobacterium africanum
Abstract

Despite overall global progress in tuberculosis (TB) control, TB remains one of the deadliest communicable diseases. This study prospectively assessed TB epidemiology in Lambarene, Gabon, a Central African country ranking 10th in terms of TB incidence rate in the 2014 World Health Organization TB report. In Lambarene, between 2012 and 2014, 201 adult and pediatric TB patients were enrolled and followed up; 66% had bacteriologically confirmed TB and 95% had pulmonary TB. The human immunodeficiency virus (HIV) coinfection rate was 42% in adults and 16% in children. Mycobacterium tuberculosis and Mycobacterium africanum were identified in 82% and 16% of 108 culture-confirmed TB cases, respectively. Isoniazid (INH) and streptomycin yielded the highest resistance rates (13% and 12%, respectively). The multidrug resistant TB (MDR-TB) rate was 4/91 (4%) and 4/13 (31%) in new and retreatment TB cases, respectively. Treatment success was achieved in 53% of patients. In TB/HIV coinfected patients, mortality rate was 25%. In this setting, TB epidemiology is characterized by a high rate of TB/HIV coinfection and low treatment success rates. MDR-TB is a major public health concern; the need to step-up in-country diagnostic capacity for culture and drug susceptibility testing as well as access to second-line TB drugs urgently requires action. more...

Published
2016

8. ONE-YEAR SAFETY OF THE RVSV∆G-ZEBOV-GP VACCINE IN ADOLESCENTS AND CHILDREN IN LAMBARENE, GABON

Author

Anita Lumeka Kabwende, Bache Emmanuel Bache, Martin P. Grobusch, Peter G. Kremsner, Agnandji Selidji Todagbe, Régis M Obiang, José Francisco Fernandes, and Sanjeev Krishna

Subjects
Pediatrics, medicine.medical_specialty, Reactogenicity, business.industry, Transmission (medicine), Health Policy, Public Health, Environmental and Occupational Health, Arthritis, medicine.disease, law.invention, Pneumonia, Randomized controlled trial, Tolerability, law, Medicine, business, Adverse effect, Malaria
Abstract

Background The rVSV∆G-ZEBOV-GP vaccine was safe and immunogenic in American, European and African adults. Few cases of transient, self-limiting arthritis have been reported in some adult participants in Geneva. We describe one-year safety of a single dose (2×107 plaque forming unit (PFU)) of the vaccine administered to adolescents and children living in Lambarene. Methods A phase I, open label randomized trial conducted in Lambarene, Gabon, to assess the clinical safety (adverse events (local/systemic symptoms, and laboratory anomalies)) for 365 days9 post injection. The primary objective was to assess the nature, frequency, and severity of adverse events (AEs) and/or serious adverse events (SAEs) associated with the administration of the vaccine. Results From 08-May 2015 to 07-Jul-2015, a total of 20 adolescents and 20 children aged 13–17 and 6–12 years respectively, were vaccinated with a single intramuscular dose of 2×107 PFU rVSV∆G-ZEBOV-GP vaccine. Two serious adverse events (SAE) were reported over one year of follow-up. Two adolescents were hospitalized for Plasmodium falciparium malaria and pneumonia infection. Up to 12 months9 (6 months of extended follow-up) of both active and passive reporting, the most frequently reported symptoms by vaccinees are classified under the following system organ classes (SOC): Gastrointestinal disorders 30%(6/20) and 40%(8/20), respiratory-thoracic and mediasternal disorders 5%(1/20) and 45%(9/20), and infections/infestations 20%(4/20) and 20%(4/20) for adolescents and children respectively. No case of arthritis was observed, few cases 13%(5/40) of mild to moderate arthralgia, unrelated to the vaccine were reported. No delayed reactogenicity symptoms were reported beyond the already mild to moderate intensity symptoms reported during the first 28 days9 post injection. No severe (grade 3) adverse event was reported. Median haematology and biochemistry values were within site normal ranges at month 12. Conclusion The vaccine dose of 2×107 PFU showed an acceptable safety and tolerability profile in our volunteers9 age 6–17 years, living in a setting endemic for Ebola virus transmission. This acceptable safety profile seen in adolescents and children is similar to that previously reported in adults. more...

Published
2017
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9. SAFETY OF RVSV EBOLA VACCINE, AFTER 6 MONTHS FOLLOW-UP, IN ADULTS: A PHASE 1 TRIAL CONDUCTED IN LAMBARÉNÉ, GABON

Author

Martin P. Grobusch, José Francisco Fernandes, Sanjeev Krishna, Anita L. Kabwende, Emmanuel B. Bache, Agnandji Selidji Todagbe, Peter G. Kremsner, Benjamin Mordmüller, and Régis M Obiang

Subjects
Pediatrics, medicine.medical_specialty, Ebola vaccine, business.industry, Health Policy, Public Health, Environmental and Occupational Health, Outbreak, medicine.disease, Clinical trial, Tolerability, Cohort, medicine, Adverse effect, business, Volunteer, Malaria
Abstract

Introduction The Centre de Recherches Medicales de Lambarene (CERMEL) in Gabon, member of the ‘VSV-EBola CONsortium’ (VEBCON), evaluated safety and immunogenicity of the rVSV∆G-ZEBOV-GP vaccine in African volunteers from an area with previous Ebola outbreaks before its use during the last outbreak in West Africa. Methods From November 2014 to April 2015 we performed an open-label, dose escalation phase 1 trial to assess safety, side-effect profile, and immunogenicity of rVSV-ZEBOV. A total of 115 healthy adults both male and non-pregnant or lactating female volunteers aged 18–50 years old living in Lambarene (Gabon) were included. Participants were allocated to five vaccine dose groups: 3×103 PFU (n=20), 3×104 PFU (n=20), 3×105 PFU (n=20), 3×106 PFU (n=39) and 2×107 PFU (n=16). Here, we present data on adverse events (AE) and serious adverse events (SAE) between days 180 and 365 after vaccine injection (Day 0). Results From Month six to Month 12, the proportion of volunteers with AE as well as number and grade of AEs per volunteer were similar in the five groups. A higher total number of events occurred in the cohort 3×106 PFU, the largest group. Most symptoms were mild to moderate. No clinically significant laboratory changes were observed. Three events - two episodes of P. falciparum malaria and one snake bite - were graded as serious, because they required hospitalizations. Both SAE were judged as non-related to the vaccine and resolved without sequelae. None of the adverse events was related to rVSV-ZEBOV vaccine. Conclusions Our results confirmed an acceptable profile of safety and tolerability of rVSV-ZEBOV up to 12 months of follow-up. In order to investigate possible late-stage safety signals follow-up period of the study was extended to five years. Integrating data (assessment until 60 months) from all the VEBCON study sites is the next key step allowing a final conclusion about safety of rVSV-ZEBOV. The trial was registered on the Pan African Clinical Trials Network website with the number PACTR201411000919191 more...

Published
2017
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10. Tuberculosis Treatment Outcome and Drug Resistance in Lambaréné, Gabon: A Prospective Cohort Study.

Author

Bélard, Sabine, Remppis, Jonathan, Bootsma, Sanne, Janssen, Saskia, Kombila, Davy U., Beyeme, Justin O., Rossatanga, Elie G., Kokou, Cosme, Osbak, Kara K., Mba, Régis M. Obiang, Kaba, Harry M., Traoré, Afsatou N., Ehrhardt, Jonas, Bache, Emmanuel B., Flamen, Arnaud, Rüsch-Gerdes, Sabine, Frank, Matthias, Adegnika, Ayôla A., Lell, Bertrand, and Niemann, Stefan more...

Published
2016
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