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Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. 2013
Robert A Seder, and
Lee-Jah Chang, and
Mary E Enama, and
Kathryn L Zephir, and
Uzma N Sarwar, and
Ingelise J Gordon, and
LaSonji A Holman, and
Eric R James, and
Peter F Billingsley, and
Anusha Gunasekera, and
Adam Richman, and
Sumana Chakravarty, and
Anita Manoj, and
Soundarapandian Velmurugan, and
MingLin Li, and
Adam J Ruben, and
Tao Li, and
Abraham G Eappen, and
Richard E Stafford, and
Sarah H Plummer, and
Cynthia S Hendel, and
Laura Novik, and
Pamela J M Costner, and
Floreliz H Mendoza, and
Jamie G Saunders, and
Martha C Nason, and
Jason H Richardson, and
Jittawadee Murphy, and
Silas A Davidson, and
Thomas L Richie, and
Martha Sedegah, and
Awalludin Sutamihardja, and
Gary A Fahle, and
Kirsten E Lyke, and
Matthew B Laurens, and
Mario Roederer, and
Kavita Tewari, and
Judith E Epstein, and
B Kim Lee Sim, and
Julie E Ledgerwood, and
Barney S Graham, and
Stephen L Hoffman, and
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20852, USA. rseder@mail.nih.gov
Consistent, high-level, vaccine-induced protection against human malaria has only been achieved by inoculation of Plasmodium falciparum (Pf) sporozoites (SPZ) by mosquito bites. We report that the PfSPZ Vaccine--composed of attenuated, aseptic, purified, cryopreserved PfSPZ--was safe and well tolerated when administered four to six times intravenously (IV) to 40 adults. Zero of six subjects receiving five doses and three of nine subjects receiving four doses of 1.35 × 10(5) PfSPZ Vaccine and five of six nonvaccinated controls developed malaria after controlled human malaria infection (P = 0.015 in the five-dose group and P = 0.028 for overall, both versus controls). PfSPZ-specific antibody and T cell responses were dose-dependent. These data indicate that there is a dose-dependent immunological threshold for establishing high-level protection against malaria that can be achieved with IV administration of a vaccine that is safe and meets regulatory standards.
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Stephen L Hoffman, and
June 1983,
Lancet (London, England),
