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Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP1(42)) administered intramuscularly with adjuvant system AS01.
Otsyula N, Angov E, Bergmann-Leitner E, Koech M, Khan F, Bennett J, Otieno L, Cummings J, Andagalu B, Tosh D, Waitumbi J, Richie N, Shi M, Miller L, Otieno W, Otieno GA, Ware L, House B, Godeaux O, Dubois MC, Ogutu B, Ballou WR, Soisson L, Diggs C, Cohen J, Polhemus M, Heppner DG Jr, Ockenhouse CF, Spring MD. Otsyula N, et al. Among authors: cohen j. Malar J. 2013 Jan 23;12:29. doi: 10.1186/1475-2875-12-29. Malar J. 2013. PMID: 23342996 Free PMC article. Clinical Trial.
Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naïve adults at the Walter Reed Army Institute of Research.
Polhemus ME, Magill AJ, Cummings JF, Kester KE, Ockenhouse CF, Lanar DE, Dutta S, Barbosa A, Soisson L, Diggs CL, Robinson SA, Haynes JD, Stewart VA, Ware LA, Brando C, Krzych U, Bowden RA, Cohen JD, Dubois MC, Ofori-Anyinam O, De-Kock E, Ballou WR, Heppner DG Jr. Polhemus ME, et al. Among authors: cohen jd. Vaccine. 2007 May 22;25(21):4203-12. doi: 10.1016/j.vaccine.2007.03.012. Epub 2007 Mar 26. Vaccine. 2007. PMID: 17442466 Clinical Trial.
Recombinant Liver Stage Antigen-1 (LSA-1) formulated with AS01 or AS02 is safe, elicits high titer antibody and induces IFN-gamma/IL-2 CD4+ T cells but does not protect against experimental Plasmodium falciparum infection.
Cummings JF, Spring MD, Schwenk RJ, Ockenhouse CF, Kester KE, Polhemus ME, Walsh DS, Yoon IK, Prosperi C, Juompan LY, Lanar DE, Krzych U, Hall BT, Ware LA, Stewart VA, Williams J, Dowler M, Nielsen RK, Hillier CJ, Giersing BK, Dubovsky F, Malkin E, Tucker K, Dubois MC, Cohen JD, Ballou WR, Heppner DG Jr. Cummings JF, et al. Among authors: cohen jd. Vaccine. 2010 Jul 12;28(31):5135-44. doi: 10.1016/j.vaccine.2009.08.046. Epub 2009 Sep 6. Vaccine. 2010. PMID: 19737527 Clinical Trial.
Impact of RTS,S/AS02(A) and RTS,S/AS01(B) on genotypes of P. falciparum in adults participating in a malaria vaccine clinical trial.
Waitumbi JN, Anyona SB, Hunja CW, Kifude CM, Polhemus ME, Walsh DS, Ockenhouse CF, Heppner DG, Leach A, Lievens M, Ballou WR, Cohen JD, Sutherland CJ. Waitumbi JN, et al. Among authors: cohen jd. PLoS One. 2009 Nov 17;4(11):e7849. doi: 10.1371/journal.pone.0007849. PLoS One. 2009. PMID: 19924281 Free PMC article. Clinical Trial.
Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine.
Ockenhouse CF, Angov E, Kester KE, Diggs C, Soisson L, Cummings JF, Stewart AV, Palmer DR, Mahajan B, Krzych U, Tornieporth N, Delchambre M, Vanhandenhove M, Ofori-Anyinam O, Cohen J, Lyon JA, Heppner DG; MSP-1 Working Group. Ockenhouse CF, et al. Among authors: cohen j. Vaccine. 2006 Apr 5;24(15):3009-17. doi: 10.1016/j.vaccine.2005.11.028. Epub 2005 Nov 28. Vaccine. 2006. PMID: 16356603 Clinical Trial.
Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya.
Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D, Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA, Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs CL, Wittes J, Heppner DG Jr; MSP-1 Malaria Vaccine Working Group. Stoute JA, et al. Among authors: cohen j. Vaccine. 2007 Jan 2;25(1):176-84. doi: 10.1016/j.vaccine.2005.11.037. Epub 2005 Dec 7. Vaccine. 2007. PMID: 16388879 Clinical Trial.
Phase 1/2a study of the malaria vaccine candidate apical membrane antigen-1 (AMA-1) administered in adjuvant system AS01B or AS02A.
Spring MD, Cummings JF, Ockenhouse CF, Dutta S, Reidler R, Angov E, Bergmann-Leitner E, Stewart VA, Bittner S, Juompan L, Kortepeter MG, Nielsen R, Krzych U, Tierney E, Ware LA, Dowler M, Hermsen CC, Sauerwein RW, de Vlas SJ, Ofori-Anyinam O, Lanar DE, Williams JL, Kester KE, Tucker K, Shi M, Malkin E, Long C, Diggs CL, Soisson L, Dubois MC, Ballou WR, Cohen J, Heppner DG Jr. Spring MD, et al. Among authors: cohen j. PLoS One. 2009;4(4):e5254. doi: 10.1371/journal.pone.0005254. Epub 2009 Apr 23. PLoS One. 2009. PMID: 19390585 Free PMC article. Clinical Trial.
Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy.
Bennett JW, Yadava A, Tosh D, Sattabongkot J, Komisar J, Ware LA, McCarthy WF, Cowden JJ, Regules J, Spring MD, Paolino K, Hartzell JD, Cummings JF, Richie TL, Lumsden J, Kamau E, Murphy J, Lee C, Parekh F, Birkett A, Cohen J, Ballou WR, Polhemus ME, Vanloubbeeck YF, Vekemans J, Ockenhouse CF. Bennett JW, et al. Among authors: cohen j. PLoS Negl Trop Dis. 2016 Feb 26;10(2):e0004423. doi: 10.1371/journal.pntd.0004423. eCollection 2016 Feb. PLoS Negl Trop Dis. 2016. PMID: 26919472 Free PMC article. Clinical Trial.
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