Phase I safety and immunogenicity testing of clinical lots of the synthetic Plasmodium falciparum vaccine SPF66 produced under good manufacturing procedure conditions in the United States

American Journal of Tropical Medicine and Hygiene

Volumn 55, Issue 1, 1996, Pages 63-68

  Gordon, Daniel M ^a,b   Duffy, Patrick E ^a,b   Heppner, D Gray ^a,c,d   Lyon, Jeffrey A ^a   Williams, Joseph S ^a   Scheumann, Dale ^a   Farley, Linda ^a   Stacey, Daniel ^a   Haynes, J David ^a   Sadoff, Jerald C ^a   Ballou, W Ripley ^a  

^a WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^b US Army Med Research Unit Kenya   (Indonesia)

^c ARMED FORCES RESEARCH INSTITUTE OF MEDICAL SCIENCES   (Thailand)

^d APO AP 96546 5000 ^*  (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

PLASMODIUM FALCIPARUM;

MALARIA VACCINE;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; DOSE RESPONSE; DRUG FORMULATION; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FEMALE; GOOD MANUFACTURING PRACTICE; HUMAN; HUMAN EXPERIMENT; INJECTION PAIN; MALARIA; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRURITUS; SEROCONVERSION; SUBCUTANEOUS DRUG ADMINISTRATION; SUBCUTANEOUS NODULE;

ADULT; ANIMALS; ANTIBODIES, PROTOZOAN; FEMALE; HUMANS; IMMUNOGLOBULIN G; INJECTIONS, SUBCUTANEOUS; MALARIA, FALCIPARUM; MALE; PLASMODIUM FALCIPARUM; PROTOZOAN PROTEINS; RECOMBINANT PROTEINS; UNITED STATES;

EID: 0029680736     PISSN: 00029637     EISSN: None     Source Type: Journal    
DOI: 10.4269/ajtmh.1996.55.63     Document Type: Article

References (16)

1. Valero MV, Amador LR, Galindo C, Figueroa J, Bello MS, Murillo LA, Mora AL, Patarroyo G, Rocha CL, Rojas M, Aponte JJ, Sarmiento LE, Lozada DM, Coronell CG, Ortega NM, Rosas JE, Alonso PL, Patarroyo ME, 1993. Vaccination with SPf66, a chemically synthesized vaccine, against Plasmodium falciparum malaria in Colombia. Lancet 341: 705-710.
2. Alonso PL, Smith T, Schellenberg JR, Masanja H, Mwankusye S, Urassa H, Bastos de Azevedo I, 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. Lancet 344: 1175-1181.
3. Amador R, Moreno A, Valero V, Murillo L, Mora AL, Rojas M, Rocha C, Salcedo M, Guzman F, Espejo F, Nunez F, Patarroyo ME, 1992. The first field trials of the chemically synthesized malaria vaccine SPf66: safety, immunogenicity and protectivity. Vaccine 10: 179-192.
4. Rocha CL, Murillo LA, Mora AL, Rojas M, Franco L, Cote J, Valero MV, Moreno A, Amador R, Nunez F, Coronell C, Patarroyo ME, 1992. Determination of the immunization schedule for field trials with the synthetic malaria vaccine SPf66. Parasite Immunol 14: 95-109.
5. Patarroyo G, Franco L, Amador R, Murillo LA, Rocha CL, Rojas M, Patarroyo ME, 1992. Study of the safety and immunogenicity of the synthetic malaria SPf66 vaccine in children aged 1-14 years. Vaccine 10: 175-178.
6. Amador R, Moreno A, Murillo LA, Sierra O, Saavedra D, Rojas M, Mora AL, Rocha CL, Alvarado F, Falla JC, Orozco M, Coronell C, Ortega N, Molano A, Velasquez JF, Valero MV, Franco L, Guzman F, Salazar LM, Espejo F, Mora E, Farfan R, Zapata N, Rosas J, Calvo JC, Castro J, Quinones T, Nunez F, Patarroyo ME, 1992. Safety and immunogenicity of the synthetic malaria vaccine SPf66 in a large field trial. J Infect Dis 166: 139-144.
7. Noya O, Berti YG, Noya BA, Borges R, Zerpa N, Urbaez JD, Madonna A, Garrido E, Jimenez MA, Borges RE, Garcia P, Reyes I, Prieto W, Colmenares C, Pabon R, Barraez T, Caceres LG, Godoy N, Sifontes R, 1992. A population-based clinical trial with the SPf66 synthetic Plasmodium falciparum malaria vaccine in Venezuela. J Infect Dis 170: 396-402.
8. Sempertegui F, Estrella B, Moscoso J, Piedrahita L, Hernandez D, Gaybor J, Naranjo P, Mancero O, Arias S, Bernai R, Cordova ME, Suarez J, Zicker F, 1993. Safety, immunogenicity and protective effect of the SPf66 malaria synthetic vaccine against Plasmodium falciparum infection in a randomized double-blind placebo-controlled field trial in an endemic area of Ecuador. Vaccine 12: 337-342.
9. Patarroyo ME, Amador R, Clavijo P, Moreno A, Guzman F, Romero P, Tascon R, Franco A, Murillo LA, Ponton G, Trujillo G, 1988. A synthetic vaccine protects humans against challenge with asexual blood stages of Plasmodium faiciparum malaria. Nature 332: 158-161.
10. Ballou WR, Rothbard J, Wirtz RA, Gordon DM, Williams JS, Gore RW, Schneider I, Hollingdaie MR, Beaudoin RL, Maloy WL, Miller LH, Hockmeyer WT, 1985. Immunogenicity of synthetic peptides from the circumsporozoite protein of Plasmodium falciparum. Science 228: 996-999.
11. Salcedo M, Barreto L, Rojas M, Moya R, Cote J, Patarroyo ME, 1991. Studies on the humoral immune response to a synthetic vaccine against Plasmodium falciparum malaria. Clin Exp Immunol 84: 122-128.
12. Towbin H, Staehelin T, Gordon J, 1979. Electrophoretic transfer of proteins from polyacrylamide gets to nitrocellulose sheets: procedure and some applications. Proc Natl Acad Sci USA 76: 4350-4355.
13. Lyon JA, Haynes JD, Diggs CL, Chulay JD, Haidaris CG, Pratt-Rossiter J, 1987. Monoclonal antibody characterization of the 195-kilodalton major surface glycoprotein of Plasmodium falciparum malaria schizonts and merozoites: identification of additional processed products and a serotype-restricted repetitive epitope. J Immunol 138: 895-901.
14. Vernes A, Haynes JD, Tapchaisri P, Williams JL, Dutoit E, Diggs CL, 1984. Plasmodium falciparum strain-specific human antibody inhibits merozoite invasion of erythrocytes. Am J Trop Med Hyg 33: 197-203.
15. Rockett KA, Targett GAT, Playfair JHL, 1988. Killing of blood-stage Plasmodium falciparum by lipid peroxides from tumor necrosis factor serum. Infect Immun 56: 3180-3183.
16. Tuescher T, Schellenberg JRMA, Azevedo IB, Hurt N, Smith T, Hayes R, Masanja H, Silva Y, Lopez MC, Kitua A, Kilama W, Tanner M, Alonso PL, 1993. SPf66, a chemically synthesized subunit malaria vaccine, is safe and immunogenic in Tanzanians exposed to intense malaria transmission. Vaccine 12: 328-336.