Safety, tolerability and humoral immune responses after intramuscular administration of a malaria DNA vaccine to healthy adult volunteers

Vaccine

Volumn 18, Issue 18, 2000, Pages 1893-1901

  Le, Thong P ^a   Coonan, Kevin M ^b   Hedstrom, Richard C ^a   Charoenvit, Yupin ^a   Sedegah, Martha ^a   Epstein, Judith E ^a   Kumar, Sanjai ^a   Wang, Ruobing ^a   Doolan, Denise L ^a   Maguire, Jason D ^c   Parker, Suezanne E ^d   Hobart, Peter ^d   Norman, Jon ^d   Hoffman, Stephen L ^a  

^a NAVAL MEDICAL RESEARCH CENTER   (United States)

^b UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

^c WALTER REED ARMY MEDICAL CENTER   (United States)

^d VICAL INC   (United States)

Author keywords

Clinical trial; DNA vaccine; Malaria

Indexed keywords

ANTIBODY; DNA VACCINE; MALARIA VACCINE; PARASITE ANTIGEN; PLASMID DNA; UNCLASSIFIED DRUG; VCL 2510;

ADULT; ANIMAL EXPERIMENT; ANTIBODY RESPONSE; ARTICLE; CLINICAL TRIAL; CYTOTOXIC T LYMPHOCYTE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FLUORESCENT ANTIBODY TECHNIQUE; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; IMMUNOGENICITY; MALARIA; MOUSE; NONHUMAN; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRIORITY JOURNAL; T LYMPHOCYTE;

ADULT; ANIMALS; ANTIBODIES, PROTOZOAN; FEMALE; HUMANS; INFANT, NEWBORN; MALARIA VACCINES; MALE; MICE; MICE, INBRED BALB C; MICE, INBRED C57BL; PILOT PROJECTS; PLASMODIUM FALCIPARUM; PREGNANCY; PROTOZOAN PROTEINS; VACCINES, DNA;

EID: 0034002258     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(99)00407-7     Document Type: Article

References (36)

1. Wolff J.A., Malone R.W., Williams P., Chong W., Acsadi G., Jani A., Felgner P.L. Direct gene transfer into mouse muscle in vivo. Science. 247:1990;1465-1468.
2. Tang D.C., DeVit M., Johnston S.A. Genetic immunization is a simple method for eliciting an immune response. Nature. 356:1992;152-154.
3. Ulmer J.B., Donnelly J.J., Parker S.E., Rhodes G.H., Felgner P.L., Dwarki V.J., Gromkowski S.H., Deck R.R., DeWitt C.M., Friedman A., Hawe L.A., Leander K.R., Martinez D., Perry H.C., Shiver J.W., Montgomery D.L., Liu M.A. Heterologous protection against influenza by injection of DNA encoding a viral protein. Science. 259:1993;1745-1749.
4. Sedegah M., Hedstrom R.C., Hobart P., Hoffman S.L. Protection against malaria by immunization with plasmid DNA encoding circumsporozoite protein. Proc. Natl. Acad. Sci. USA. 91:1994;9866-9870.
5. Donnelly J.J., Ulmer J.B., Shiver J.W., Liu M.A. DNA vaccines. Annu. Rev. Immunol. 15:1997;617-648.
6. Horn N., Meek J., Budahazi G., Marquet M. Cancer gene therapy using plasmid DNA: purification of DNA for human clinical trials. Hum. Gene Ther. 6:1995;565-573.
7. Nossal G. Living up to the legacy. Nature Med. 4(Suppl. 5):1998;475-476.
8. Nichols W.W., Ledwith B.J., Manam S.V., Troilo P.J. Potential DNA vaccine integration into host cell genome. Ann. NY Acad. Sci. 772:1995;30-39.
9. Martin T., Parker S.E., Hedstrom R., Le T., Hoffman S.L., Norman J., Hobart P., Lew D. Plasmid DNA malaria vaccine: the potential for genomic integration following intramuscular injection. Human Gene Ther. 10:1999;759-768.
10. Mor G., Singla M., Steinberg A.D., Hoffman S.L., Okuda K., Klinman D.M. Do DNA vaccines induce autoimmune disease? Hum. Gene Ther. 8:1997;293-300.
11. Doolan D.L., Hoffman S.L. Multi-gene vaccination against malaria: a multi-stage, multi-immune response approach. Parasitol. Today. 13:1997;171-178.
12. Hoffman S.L., Franke E.D., Hollingdale M.R., Druilhe P. Attacking the infected hepatocyte. Hoffman S.L. Malaria Vaccine Development. 1996;35-76 ASM Press, Washington, DC. [Chapter 3].
13. Hoffman S.L., Doolan D.L., Sedegah M., Aguiar J.C., Wang R., Malik M., Gramzinski R.A., Weiss W.R., Hobart P., Norman J.A., Margalith M., Hedstrom R. Strategy for development of a pre-erythrocytic Plasmodium falciparum DNA vaccine for human use. Vaccine. 15:1997;842-845.
14. Hoffman S.L., Doolan D.L., Sedegah M., Wang R., Scheller L.F., Kumar A., Weiss W.R., Le T.P., Klinman D.M., Hobart P., Norman J.A., Hedstrom R.C. Toward clinical trials of DNA vaccines against malaria. Immunol. Cell Biol. 75:1997;376-381.
15. Hedstrom R., Doolan D., Wang R., Kumar K., Sacci J., Gardner M., Aguiar J., Charoenvit Y., Sedegah M., Tine J., Margalith M., Hobart P., Hoffman S. In vitro expression and In vivo immunogenicity of Plasmodium falciparum pre-erythrocytic stage DNA vaccines. Int. J. Molec. Med. 2:1998;29-38.
16. Wang R., Doolan D.L., Charoenvit Y., Hedstrom R.C., Gardner M.J., Hobart P., Tine J., Sedegah M., Fallarme V., Sacci J.B., Kaur M., Klinman D.M., Hoffman S.L., Weiss W.R. Simultaneous induction of multiple antigen-specific cytotoxic T lymphocytes in nonhuman primates by immunization with a mixture of four Plasmodium falciparum DNA plasmids. Infect. Immun. 66:1998;4193-4202.
17. Doolan D.L., Hedstrom R.C., Gardner M.J., Sedegah M., Wang H., Gramzinski R.A., Margalith M., Hobart P., Hoffman S.L. DNA vaccination as an approach to malaria control: current status and strategies. Curr. Top. Microbiol. Immunol. 226:1998;37-56.
18. Donnelly J.J., Ulmer J.B., Liu M.A. DNA vaccines. Plotkin S., Brown F., Horaud F. Preclinical and clinical development of new vaccines. Dev. Biol. Stand. 95:1998;43-53 Karger, Basel.
19. Parker S.E., Borellini F., Wenk M.L., Hobart P., Hoffman S.L., Hedstrom R., Le T., Norman J.A. Plasmid DNA malaria vaccine: tissue distribution and safety studies in mice and rabbits. Human Gene Ther. 10:1999;741-758.
20. Calarota S., Bratt G., Nordlund S., Hinkula J., Leandersson A.C., Sandstrom E., Wahren B. Cellular cytotoxic response induced by DNA vaccination in HIV-1-infected patients. Lancet. 351:1998;1320-1325.
21. MacGregor R.R., Boyer J.D., Ugen K.E., Lacy K.E., Gluckman S.J., Bagarazzi M.L., Chattergoon M.A., Baine Y., Higgins T.J., Ciccarelli R.B., Coney L.R., Ginsberg R.S., Weiner D.B. First human trial of a DNA-based vaccine for treatment of human immunodeficiency virus type 1 infection: safety and host response. J. Infect. Dis. 178:1998;92-100.
22. Wang R., Doolan D.L., Le T., Hedstrom R.C., Coonan K.M., Charoenvit Y., Jones T.R., Hobart P., Margalith M., Ng J., Weiss W.R., Sedegah M., de Taisne C., Norman J.A., Hoffman S.L. Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine. Science. 282:1998;476-480.
23. Luke C.J., Carner K., Liang X., Barbour A.G. An OspA-based DNA vaccine protects mice against infection with Borrelia burgdorferi. J. Infect. Dis. 175:1997;91-97.
24. Le T.P., Church L.W.P., Corradin G., Hunter R.L., Charoenvit Y., Wang R., de la Vega P., Sacci J., Ballou W.R., Kolodny N., Kitov S., Glenn G.M., Richards R.L., Alving C.R., Hoffman S.L. Immunogenicity of Plasmodium falciparum circumsporozoite protein multiple antigen peptide vaccine formulated with different adjuvants. Vaccine. 16:1998;305-312.
25. Charoenvit Y., Fallarme V., Rogers W.O., Sacci J.B., Kaur M., Aguiar J.C., Yuan L.F., Corradin G., Andersen E., Wizel B., Houghten R.A., Oloo A., De la Vega P., Hoffman S.L. Development of two monoclonal antibodies against Plasmodium falciparum Sporozoite Surface Protein 2 and mapping of B-cell epitopes. Infect. Immun. 65:1997;3430-3437.
26. Charoenvit Y., Leef M.L., Yuan L.F., Sedegah M., Beaudoin R.L. Characterization of Plasmodium yoelii monoclonal antibodies directed against stage-specific sporozoite antigens. Infect. Immun. 55:1987;604-608.
27. Anderson WF, Brenner MK, Wilson JM, Bordignon C, Heard JM, Kaneko S (editors). Human gene marker/therapy clinical protocols. Hum Gene Ther 1998;9:935-976.
28. Parker S.E., Vahlsing H.L., Serfilippi L.M., Franklin C.L., Doh S.G., Gromkowski S.H., Lew D., Manthorpe C.M., Norman J. Cancer gene therapy using plasmid DNA: safety evaluation in rodents and non-human primates. Hum. Gene Ther. 6:1995;575-590.
29. Parker S., Vahlsing H., Lew D., Martin T., Hall B., Kornbrust D., Norman J. Cancer gene therapy using plasmid DNA: pharmacokinetics and safety evaluation of an IL-2 plasmid DNA expression vector in rodents and nonhuman primates. BioPharm. 12:1999;18-24.
30. Robertson J.S. Safety considerations for nucleic acid vaccines. Vaccine. 12:1994;1526-1528.
31. Rickman L.S., Gordon D.M., Wistar R., Krzych U., Gross M., Hollingdale M.R., Egan J.E., Chulay J.D., Hoffman S.L. Use of adjuvant containing mycobacterial cell-wall skeleton, monophosphoryl lipid A and squalane in malaria circumsporozoite protein vaccine. Lancet. 337:1991;998-1001.
32. Hoffman S.L., Edelman R., Bryan J., Schneider I., Davis J., Sedegah M., Gordon D., Church P., Gross M., Silverman C., Hollingdale M., Clyde D., Sztein M., Losonsky G., Paparello S., Jones T.R. Safety, immunogenicity and efficacy of a malaria sporozoite vaccine administered with monophosphoryl lipid A, cell wall skeleton of mycobacteria and squalene as adjuvant. Am. J. Trop. Med. Hyg. 51:1994;603-612.
33. Stoute J.A., Slaoui M., Heppner D.G., Monin P., Kester K., Desmons P., Wellde B.T., Garcon N., Krzych U., Marchand M., Ballou W.R., Cohen J.D. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N. Eng. J. Med. 336:1997;86-91.
34. Tan E., Feltkamp T., Smolen J., Butcher B., Dawkins R., Fritzler M., Gordan T., Hardin J., Kalden J., Lahita R., Maini R., McDougal J., Rothfield N., Smeenk R., Takasaki Y., Wiik A., Wilson M., Koziol J. Range of antinuclear antibodies in "healthy" individuals. Arthritis Rheum. 40:1997;1601-1611.
35. Emlen W., O'Neill L. Clinical significance of antinuclear antibodies: comparison of detection with immunofluorescence and enzyme-linked immunosorbent assays. Arthritis Rheum. 40:1997;1612-1618.
36. Gramzinski R.A., Maris D.C., Obaldia N., Rossan R., Sedegah M., Wang R., Hobart P., Margalith M., Hoffman S. Optimization of antibody responses of a malaria DNA vaccine in Aotus monkeys. Vaccine Res. 5:1996;173-183.