Appendix A
Vaccine Trials



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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Appendix A Vaccine Trials

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program TABLE A-1 Phase 1 Trials of Malaria Vaccines That Did Not (or Have Not Yet) Progressed to Phase 2 Type of Vaccine Vaccine Details MIDRP Involvement Results References Preerythrocytic Vaccines CSP recombinant VaxSynCSA: full-length CSP, baculovirus expressed/alum No Minimally immunogenic (n = 20) Herrington et al., 1992   CVD 908-rCSP: CSP expressed in attenuated Salmonella No Immunogenic to 3/10 participants Gonzalez et al., 1994 DNA based CSP-DNA NMRC Good cellular but no antibody responses (n = 20) Le et al., 2000; Wang et al., 1998 DNA prime/protein boost PfCSP DNA/RTS,S AS02A boost NMRC Antibody, CD4 and CD8 T cells Epstein et al., 2004 Synthetic peptide MAP1NYU: PfCSP-repeats/alum/QS21 No Good antibody responses Nardin et al., 2000   PfCSP-repeats + T-cell epitopes + Pam3Cys polyoxime No Good antibody and CD4+ T-cell responses Nardin et al., 2001 Viruslike particle ICC-1132: HBcAg + CSP repeats + T-cell epitopes No Antibody, CD4+ T cells Nardin et al., 2004; Oliveira et al., 2005

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Erythrocytic Stage Vaccines Peptide MSP-3/alum or ISA 720 No Antibody, T cells, interferon Audran et al., 2005 Recombinant protein MSP-1/MSP-2 conjugated to diphtheria toxoid No Good antibody response; hypersensitivity to diphtheria toxoid Ramasamy et al., 1995   MSP-1/P30P2: two allelic forms of MSP119 plus tetanus toxoid T-cell epitopes WRAIR Good antibody response in 14/32 Keitel et al., 1999   AMA-1C (3D7 and FVO forms), Pichia pastoris expressed No Good antibody response to both forms Malkin et al., 2005   AMA-1/ISA 720 No Low antibody (vaccine instability) Saul et al., 2005

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program TABLE A-2 Phase 2 Trials of Malaria Vaccines Using Experimental Challenge of Adult Volunteers from Nonendemic Areas Type of Vaccine Vaccine Details MIDRP Involvement Results References Preerythrocytic Vaccines Irradiated sporozoites Whole parasites University of Maryland/NMRC/WRAIR 95% protection after > 1000 bites Clyde, 1975; Herrington et al., 1991; Hoffman et al., 2002; Rieckmann et al., 1979 Synthetic peptide NANP3-tetanus toxoid No 1/3 protected Herrington et al., 1987   CSP 102 (282-383): CSP C-terminus/alum or ISA 720 No No protection Genton et al., 2005; Lopez et al., 2001 CSP recombinant R32tet32 (FSV1): CSP repeats/alum WRAIR 1/6 protected Ballou et al., 1987   R32toxA: CSP repeats/Pseudomonas toxin A WRAIR 1/3 protected Fries et al., 1992   R32NS1-81: CSP repeats + 81aa flu A nonstructural protein in MPL/squalene/mycobacterial cell wall NMRC/WRAIR 2/11 protected Hoffman et al., 1994

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program   Repeatless form: CSP N- and C-terminus/liposomes/MPL/alum WRAIR 0/15 protected Heppner et al., 1996 Viruslike particle RTS,S: HBsAg/CSP repeat and C-terminus + adjuvant: 1. alum vs alum/MPL 2. MPL vs oil-in water vs oil-in water/MPL/QS21 3. oil-in-water/MPL/QS21 (AS02) WRAIR       1. 0/6 and 2/8 protected 2. 1/8, 2/7, and 6/7 protected 3. 18/41 protected Gordon et al., 1995 Stoute et al., 1997, 1998 Kester et al., 2001 ICC-1132/I SA 720 HBcAg + CSP repeats and T-epitopes Oxford/Apovia (WRAIR provided sporozoites) No protection (0/11) following single immunization Walther et al., 2005 Erythrocytic Stage Vaccines Recombinant protein MSP-1,2/RESA (combination B) with montanide ISA720 (blood-stage challenge) No 0/12 protected Lawrence et al., 2000 Multistage Vaccines Peptide/recombinant CSP NANP19/5.1(Exp-1) No 0/13 protected Sturchler et al., 1992 Recombinant protein CSP/MSP-2 (combination A)/alum No 0/33 protected Sturchler et al., 1995

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Type of Vaccine Vaccine Details MIDRP Involvement Results References DNA plasmids MuStDO5: CSP, SSP-2/TRAP, LSA-1, LSA-3, Exp-1 NMRC 0/31 protected Wang et al., 2005 Recombinant virus NYVAC-7: CSP, SSP-2/TRAP, LSA-1, MSP-1, SERA, AMA-1 WRAIR 1/35 protected Ockenhouse et al., 1998 Heterologous prime-boost RTS,S AS02A/CSP MVA or CSP MVA/RTS,S AS02A Oxford/WRAIR No increase in vaccine efficacy compared to RTS,S Dunachie et al., 2006   RTS,S AS02A/SSP-2/TRAP WRAIR Decreased vaccine efficacy compared to RTS,S Walsh et al., 2004; Heppner, 2006   RTS,S AS02A/MSP-142 WRAIR No increase in vaccine efficacy compared to RTS,S Heppner et al., 2005; Heppner, 2006   ME-TRAP DNA/MVA and ME-TRAP fowlpox/MVA No 20% protection Bejon et al., 2005; Keating et al., 2005; Webster et al., 2005

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program TABLE A-3 Summarized Results of Randomized Phase 2 Human Malaria Vaccine Trials Using Natural Challenge Conducted to Date (December 2005) Vaccine Type Vaccine Details MIDRP Involvement Trials and Results References Preerythrocytic Vaccines Synthetic peptide CSP (NANP)3-TT No One trial Burkina Faso, no effect Guiguemdé et al., 1990 Recombinant protein CSP R32toxA WRAIR/AFRIMS Two trials (Thailand, Kenya), no effect Brown et al., 1994; Sherwood et al., 1996 Viruslike particle RTS,S WRAIR One trial with adults in the Gambia: weak protection against clinical malaria in first year, boosted in second year to 63%. Two trials in children in Mozambique: weak protection against infection, 26% against clinical malaria, 56% against severe malaria. (see Figure 3-3) Alonso et al., 2004, 2005; Bojang et al., 2001 Heterologous prime-boost ME-TRAP DNA/MVA No One trial in adults (the Gambia), no effect Moorthy et al., 2004

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Vaccine Type Vaccine Details MIDRP Involvement Trials and Results References Erythrocytic Stage Vaccines Recombinant protein MSP-1/MSP-2/RESA (combination B) No One trial in Papua New Guinea children: reduction in parasite density 49%; reduction in incidence of infections of MSP-2/3D7 (as in vaccine). No effect on clinical malaria Genton et al., 2002 Multistage Vaccines Peptide/recombinant CSP NANP19/5.1(Exp-1) No No cases in either trial group Reber-Liske et al., 1995 Synthetic peptide SPf66 Limited WRAIR participation in three trials 10 trials: little effect in Africa (4 trials) or Asia (1 trial), weak effect in S America (5 trials) Acosta et al., 1999; Alonso et al., 1994; Amador et al., 1992; Bojang et al., 1997, 1998; D’Alessandro et al., 1995; Leach et al., 1995; Masinde et al., 1998; Nosten et al., 1996; Noya et al., 1994; Sempertegui et al., 1994; Urdaneta et al., 1998; Valero et al., 1993, 1996

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program APPENDIX A REFERENCES Acosta CJ, Galindo CM, Schellenberg D, Aponte JJ, Kahigwa E, Urassa H, Schellenberg JR, Masanja H, Hayes R, Kitua AY, Lwilla F, Mshinda H, Menendez C, Tanner M, Alonso PL. 1999. Evaluation of the SPf66 vaccine for malaria control when delivered through the EPI scheme in Tanzania. Tropical Medicine and International Health 4(5):368–376. Alonso PL, Smith T, Schellenberg JRMA, Masanja H, Mwankusye S, Urassa H, de Azevedo IB, Chongela J, Kobero S, Menendez C, Hurt N, Thomas MC, Lyimo E, Weiss NA, Hayes R, Kitua AY, Lopez MC, Kilama WL, Teuscher T, Tanner M. 1994. Randomized trial of efficacy of SPf66 vaccine against Plasmodium falciparum malaria in children in southern Tanzania [see comments]. Lancet 344(8931):1175–1181. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Milman J, Mandomando I, Spiessens B, Guinovart C, Espasa M, Bassat Q, Aide P, Ofori-Anyinam O, Navia MM, Corachan S, Ceuppens M, Dubois MC, Demoitie MA, Dubovsky F, Menendez C, Tornieporth N, Ballou WR, Thompson R, Cohen J. 2004. Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: Randomised controlled trial. Lancet 364(9443):1411–1420. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, Sigauque B, Milman J, Mandomando I, Bassat Q, Guinovart C, Espasa M, Corachan S, Lievens M, Navia MM, Dubois MC , Menendez C, Dubovsky F, Cohen J, Thompson R, Ballou WR. 2005. Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: Single-blind extended follow-up of a randomised controlled trial. Lancet 366(9502):2012–2018. Amador R, Moreno A, Valero V, Murillo L, Mora AL, Rojas M, Rocha C, Salcedo M, Guzman F, Espejo F, Nuñez F, Patarroyo M. 1992. The first field trials of the chemically synthesized malaria vaccine SPf66: Safety, immunogenicity and protectivity. Vaccine 10(3):179–184. Audran R, Cachat M, Lurati F, Soe S, Leroy O, Corradin G, Druilhe P, Spertini F. 2005. Phase I malaria vaccine trial with a long synthetic peptide derived from the merozoite surface protein 3 antigen. Infection and Immunity 73(12.):8017–8026. Ballou WR, Sherwood JA, Neva FA, Gordon DM, Wirtz RA, Wassermann GF, Diggs CL, Hoffman SL, Hollingdale MR, Schneider I, Young JF, Reeve P, Chulay JD 1987. Safety and efficacy of a recombinant DNA Plasmodium falciparum sporozoite vaccine. Lancet 1(8545):1277–1281. Bejon P, Andrews L, Andersen RF, Dunachie S, Webster D, Walther M, Gilbert SC, Peto T, Hill AV. 2005. Calculation of liver-to-blood inocula, parasite growth rates, andpreerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoites. Journal of Infectious Diseases 191(4):619–626. Bojang KA, Obaro SK, Leach A, D’Alessandro U, Bennett S, Metzger W, Ballou WR, Targett GA, Greenwood BM. 1997. Follow-up of Gambian children recruited to a pilot safetyand immunogenicity study of the malaria vaccine SPf66. Parasite Immunology 19(12):579–581. Bojang KA, Obaro SK, D’Alessandro U, Bennett S, Langerock P, Targett GA, Greenwood BM. 1998. An efficacy trial of the malaria vaccine SPf66 in Gambian infants—second year of follow-up. Vaccine 16(1):62–67. Bojang KA, Milligan PJ, Pinder M, Vigneron L, Alloueche A, Kester KE, Ballou WR, Conway DJ, Reece WH, Gothard P, Yamuah L, Delchambre M, Voss G, Greenwood BM, Hill A, McAdam KP, Tornieporth N, Cohen JD, Doherty T. 2001. Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: A randomised trial. Lancet 358(9297):1927–1934.

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