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Page 1
Template protocol for clinical trials investigating vaccines--focus on safety elements.
Bonhoeffer J, Imoukhuede EB, Aldrovandi G, Bachtiar NS, Chan ES, Chang S, Chen RT, Fernandopulle R, Goldenthal KL, Heffelfinger JD, Hossain S, Jevaji I, Khamesipour A, Kochhar S, Makhene M, Malkin E, Nalin D, Prevots R, Ramasamy R, Sellers S, Vekemans J, Walker KB, Wilson P, Wong V, Zaman K, Heininger U; Brighton Collaboration Clinical Trial Protocol Working Group. Bonhoeffer J, et al. Vaccine. 2013 Nov 12;31(47):5602-20. doi: 10.1016/j.vaccine.2013.02.041. Epub 2013 Mar 13. Vaccine. 2013. PMID: 23499603 Free PMC article.
Ad35.CS.01-RTS,S/AS01 Heterologous Prime Boost Vaccine Efficacy against Sporozoite Challenge in Healthy Malaria-Naïve Adults.
Ockenhouse CF, Regules J, Tosh D, Cowden J, Kathcart A, Cummings J, Paolino K, Moon J, Komisar J, Kamau E, Oliver T, Chhoeu A, Murphy J, Lyke K, Laurens M, Birkett A, Lee C, Weltzin R, Wille-Reece U, Sedegah M, Hendriks J, Versteege I, Pau MG, Sadoff J, Vanloubbeeck Y, Lievens M, Heerwegh D, Moris P, Guerra Mendoza Y, Jongert E, Cohen J, Voss G, Ballou WR, Vekemans J. Ockenhouse CF, et al. Among authors: guerra mendoza y. PLoS One. 2015 Jul 6;10(7):e0131571. doi: 10.1371/journal.pone.0131571. eCollection 2015. PLoS One. 2015. PMID: 26148007 Free PMC article. Clinical Trial.
Safety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa.
Otieno L, Guerra Mendoza Y, Adjei S, Agbenyega T, Agnandji ST, Aide P, Akoo P, Ansong D, Asante KP, Berkley JA, Gesase S, Hamel MJ, Hoffman I, Kaali S, Kamthunzi P, Kariuki S, Kremsner P, Lanaspa M, Lell B, Lievens M, Lusingu J, Malabeja A, Masoud NS, Mtoro AT, Njuguna P, Ofori-Anyinam O, Otieno GA, Otieno W, Owusu-Agyei S, Schuerman L, Sorgho H, Tanner M, Tinto H, Valea I, Vandoolaeghe P, Sacarlal J, Oneko M. Otieno L, et al. Among authors: guerra mendoza y. Vaccine. 2020 Jan 22;38(4):897-906. doi: 10.1016/j.vaccine.2019.10.077. Epub 2019 Nov 7. Vaccine. 2020. PMID: 31708182 Free PMC article. Clinical Trial.
Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa.
Guerra Mendoza Y, Garric E, Leach A, Lievens M, Ofori-Anyinam O, Pirçon JY, Stegmann JU, Vandoolaeghe P, Otieno L, Otieno W, Owusu-Agyei S, Sacarlal J, Masoud NS, Sorgho H, Tanner M, Tinto H, Valea I, Mtoro AT, Njuguna P, Oneko M, Otieno GA, Otieno K, Gesase S, Hamel MJ, Hoffman I, Kaali S, Kamthunzi P, Kremsner P, Lanaspa M, Lell B, Lusingu J, Malabeja A, Aide P, Akoo P, Ansong D, Asante KP, Berkley JA, Adjei S, Agbenyega T, Agnandji ST, Schuerman L. Guerra Mendoza Y, et al. Hum Vaccin Immunother. 2019;15(10):2386-2398. doi: 10.1080/21645515.2019.1586040. Epub 2019 Apr 23. Hum Vaccin Immunother. 2019. PMID: 31012786 Free PMC article. Clinical Trial.
Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial.
Tinto H, Otieno W, Gesase S, Sorgho H, Otieno L, Liheluka E, Valéa I, Sing'oei V, Malabeja A, Valia D, Wangwe A, Gvozdenovic E, Guerra Mendoza Y, Jongert E, Lievens M, Roman F, Schuerman L, Lusingu J. Tinto H, et al. Among authors: guerra mendoza y. Lancet Infect Dis. 2019 Aug;19(8):821-832. doi: 10.1016/S1473-3099(19)30300-7. Epub 2019 Jul 9. Lancet Infect Dis. 2019. PMID: 31300331 Clinical Trial.