Protection Against Malaria by Intravenous Immunization with a Nonreplicating Sporozoite Vaccine
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...
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| Published in | Science (American Association for the Advancement of Science) Vol. 341; no. 6152; pp. 1359 - 1365 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Washington, DC
American Association for the Advancement of Science
20.09.2013
The American Association for the Advancement of Science |
| Subjects | |
| Online Access | Get full text |
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| Abstract | 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 × 10⁵ 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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| AbstractList | Malaria Sporozoite VaccineEach year, hundreds of millions of people are infected with Plasmodium falciparum, the mosquito-borne parasite that causes malaria. A preventative vaccine is greatly needed. Seder et al. (p. 1359, published online 8 August; see the Perspective by Good) now report the results from a phase I clinical trial where subjects were immunized intravenously with a whole, attenuated sporozoite vaccine. Three of 9 subjects who received four doses and zero of 6 subjects who received five doses of the vaccine went on to develop malaria after controlled malaria infection. Both antibody titers and cellular immune responses correlated positively with the dose of vaccine received, suggesting that both arms of the adaptive immune response may have participated in the observed protection. 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.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. Malaria Sporozoite Vaccine Each year, hundreds of millions of people are infected with Plasmodium falciparum , the mosquito-borne parasite that causes malaria. A preventative vaccine is greatly needed. Seder et al. (p. 1359, published online 8 August; see the Perspective by Good) now report the results from a phase I clinical trial where subjects were immunized intravenously with a whole, attenuated sporozoite vaccine. Three of 9 subjects who received four doses and zero of 6 subjects who received five doses of the vaccine went on to develop malaria after controlled malaria infection. Both antibody titers and cellular immune responses correlated positively with the dose of vaccine received, suggesting that both arms of the adaptive immune response may have participated in the observed protection. 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 × 10⁵ 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. Each year, hundreds of millions of people are infected with Plasmodium falciparum, the mosquito-borne parasite that causes malaria. A preventative vaccine is greatly needed. Seder et al. (p. 1359, published online 8 August; see the Perspective by Good) now report the results from a phase I clinical trial where subjects were immunized intravenously with a whole, attenuated sporozoite vaccine. Three of 9 subjects who received four doses and zero of 6 subjects who received five doses of the vaccine went on to develop malaria after controlled malaria infection. Both antibody titers and cellular immune responses correlated positively with the dose of vaccine received, suggesting that both arms of the adaptive immune response may have participated in the observed protection. [PUBLICATION ABSTRACT] 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 wel-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 × 105 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. [PUBLICATION ABSTRACT] Each year, hundreds of millions of people are infected with Plasmodium falciparum , the mosquito-borne parasite that causes malaria. A preventative vaccine is greatly needed. Seder et al. (p. 1359 , published online 8 August; see the Perspective by Good ) now report the results from a phase I clinical trial where subjects were immunized intravenously with a whole, attenuated sporozoite vaccine. Three of 9 subjects who received four doses and zero of 6 subjects who received five doses of the vaccine went on to develop malaria after controlled malaria infection. Both antibody titers and cellular immune responses correlated positively with the dose of vaccine received, suggesting that both arms of the adaptive immune response may have participated in the observed protection. Intravenous immunization with an attenuated whole malaria sporozoite vaccine protected volunteers in a phase I clinical trial. [Also see Perspective by Good ] 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 wel-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. 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. |
| Author | Manoj, Anita Richie, Thomas L. Hendel, Cynthia S. Fahle, Gary A. Sarwar, Uzma N. Enama, Mary E. James, Eric R. Roederer, Mario Plummer, Sarah H. Li, Tao Seder, Robert A. Chakravarty, Sumana Graham, Barney S. Novik, Laura Eappen, Abraham G. Holman, LaSonji A. Chang, Lee-Jah Sutamihardja, Awalludin Davidson, Silas A. Tewari, Kavita Stafford, Richard E. Sedegah, Martha Lyke, Kirsten E. Gordon, Ingelise J. Murphy, Jittawadee Sim, B. Kim Lee Ledgerwood, Julie E. Velmurugan, Soundarapandian Saunders, Jamie G. Richardson, Jason H. Gunasekera, Anusha Hoffman, Stephen L. Billingsley, Peter F. Mendoza, Floreliz H. Richman, Adam Epstein, Judith E. Nason, Martha C. Ruben, Adam J. Costner, Pamela J. M. Laurens, Matthew B. Li, MingLin Zephir, Kathryn L. |
| Author_xml | – sequence: 1 givenname: Robert A. surname: Seder fullname: Seder, Robert A. – sequence: 2 givenname: Lee-Jah surname: Chang fullname: Chang, Lee-Jah – sequence: 3 givenname: Mary E. surname: Enama fullname: Enama, Mary E. – sequence: 4 givenname: Kathryn L. surname: Zephir fullname: Zephir, Kathryn L. – sequence: 5 givenname: Uzma N. surname: Sarwar fullname: Sarwar, Uzma N. – sequence: 6 givenname: Ingelise J. surname: Gordon fullname: Gordon, Ingelise J. – sequence: 7 givenname: LaSonji A. surname: Holman fullname: Holman, LaSonji A. – sequence: 8 givenname: Eric R. surname: James fullname: James, Eric R. – sequence: 9 givenname: Peter F. surname: Billingsley fullname: Billingsley, Peter F. – sequence: 10 givenname: Anusha surname: Gunasekera fullname: Gunasekera, Anusha – sequence: 11 givenname: Adam surname: Richman fullname: Richman, Adam – sequence: 12 givenname: Sumana surname: Chakravarty fullname: Chakravarty, Sumana – sequence: 13 givenname: Anita surname: Manoj fullname: Manoj, Anita – sequence: 14 givenname: Soundarapandian surname: Velmurugan fullname: Velmurugan, Soundarapandian – sequence: 15 givenname: MingLin surname: Li fullname: Li, MingLin – sequence: 16 givenname: Adam J. surname: Ruben fullname: Ruben, Adam J. – sequence: 17 givenname: Tao surname: Li fullname: Li, Tao – sequence: 18 givenname: Abraham G. surname: Eappen fullname: Eappen, Abraham G. – sequence: 19 givenname: Richard E. surname: Stafford fullname: Stafford, Richard E. – sequence: 20 givenname: Sarah H. surname: Plummer fullname: Plummer, Sarah H. – sequence: 21 givenname: Cynthia S. surname: Hendel fullname: Hendel, Cynthia S. – sequence: 22 givenname: Laura surname: Novik fullname: Novik, Laura – sequence: 23 givenname: Pamela J. M. surname: Costner fullname: Costner, Pamela J. M. – sequence: 24 givenname: Floreliz H. surname: Mendoza fullname: Mendoza, Floreliz H. – sequence: 25 givenname: Jamie G. surname: Saunders fullname: Saunders, Jamie G. – sequence: 26 givenname: Martha C. surname: Nason fullname: Nason, Martha C. – sequence: 27 givenname: Jason H. surname: Richardson fullname: Richardson, Jason H. – sequence: 28 givenname: Jittawadee surname: Murphy fullname: Murphy, Jittawadee – sequence: 29 givenname: Silas A. surname: Davidson fullname: Davidson, Silas A. – sequence: 30 givenname: Thomas L. surname: Richie fullname: Richie, Thomas L. – sequence: 31 givenname: Martha surname: Sedegah fullname: Sedegah, Martha – sequence: 32 givenname: Awalludin surname: Sutamihardja fullname: Sutamihardja, Awalludin – sequence: 33 givenname: Gary A. surname: Fahle fullname: Fahle, Gary A. – sequence: 34 givenname: Kirsten E. surname: Lyke fullname: Lyke, Kirsten E. – sequence: 35 givenname: Matthew B. surname: Laurens fullname: Laurens, Matthew B. – sequence: 36 givenname: Mario surname: Roederer fullname: Roederer, Mario – sequence: 37 givenname: Kavita surname: Tewari fullname: Tewari, Kavita – sequence: 38 givenname: Judith E. surname: Epstein fullname: Epstein, Judith E. – sequence: 39 givenname: B. Kim Lee surname: Sim fullname: Sim, B. Kim Lee – sequence: 40 givenname: Julie E. surname: Ledgerwood fullname: Ledgerwood, Julie E. – sequence: 41 givenname: Barney S. surname: Graham fullname: Graham, Barney S. – sequence: 42 givenname: Stephen L. surname: Hoffman fullname: Hoffman, Stephen L. |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27784750$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23929949$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Loblein, Hayley Awe, Aderonke Clarke, Tanya Williams, Esther C Belmonte, Maria Fan, Richard King, Mary Antonara, Stella Dranchak, Patricia Renehan, Phyllis Zaia Williams, Pernell Yamshchikov, Galina Murshedkar, Tooba Berkowitz, Nina Orozco, Maria Socorro Jiang, Bing Luongo, Nicole Xu, Rui Decederfelt, Hope Nelson, Keith Chakiath, Chinnamma Wen, Yingda Brocious, Jeffery Kemp, Margaret Larkin, Brenda DiGiovanni, Cassandra Adams, Matthew Abebe, Yonas Inglese, James Vasilenko, Olga Abot, Esteban N Overby, James Kc, Natasha Komisar, Jack Plowe, Christopher Wilson, Brandon Starling, Judith Fomumbod, Enni Pich, Virak Mitchell, Jillian Sitar, Sandra Casazza, Joseph Ganeshan, Harini Pittman, Iris Patil, Asha Lau, Anna Diep, Ly Florez, Maria Burgos Gao, Lixin Huang, Jun Getachew, Yeab Matheny, Steve Padilla, Debbie Bailer, Robert T Reyes, Sharina Kunchai, Meghan Stanford, LaChonne Belmonte, Arnel |
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| Keywords | Human Protozoa Apicomplexa Protozoal disease Malaria Vaccination Sporozoit Vaccine Parasitosis Active immunization Infection Prevention Immunoprophylaxis Plasmodium falciparum Attenuated strain |
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| Snippet | Consistent high-level, vaccine-induced protection against human malaria has only been achieved by inoculation of Plasmodium falciparum (Pf) sporozoites (SPZ)... Each year, hundreds of millions of people are infected with Plasmodium falciparum , the mosquito-borne parasite that causes malaria. A preventative vaccine is... Consistent, high-level, vaccine-induced protection against human malaria has only been achieved by inoculation of Plasmodium falciparum (Pf) sporozoites (SPZ)... Each year, hundreds of millions of people are infected with Plasmodium falciparum, the mosquito-borne parasite that causes malaria. A preventative vaccine is... Malaria Sporozoite VaccineEach year, hundreds of millions of people are infected with Plasmodium falciparum, the mosquito-borne parasite that causes malaria. A... Malaria Sporozoite Vaccine Each year, hundreds of millions of people are infected with Plasmodium falciparum , the mosquito-borne parasite that causes malaria.... |
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| SubjectTerms | Administration, Intravenous Adult Animals Antibodies Antigens Aquatic insects Attenuation Biological and medical sciences cell-mediated immunity Cellular clinical trials Correlation Cytokines - immunology Dosage Female Human protozoal diseases Humans Immune response Immune system Immunity, Cellular Immunization Infectious diseases Insect bites intravenous injection Intravenous injections Malaria Malaria Vaccines - administration & dosage Malaria Vaccines - adverse effects Malaria Vaccines - immunology Malaria, Falciparum - prevention & control Male Medical research Medical sciences Mice Monoclonal antibodies Mosquitoes Parasites Parasitic diseases people Plasmodium falciparum Plasmodium falciparum - immunology Protozoal diseases RESEARCH ARTICLE Sporozoites Sporozoites - immunology T lymphocytes T-Lymphocytes - immunology Vaccination Vaccination - adverse effects Vaccination - methods Vaccines Vector-borne diseases |
| Title | Protection Against Malaria by Intravenous Immunization with a Nonreplicating Sporozoite Vaccine |
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