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Protection against Plasmodium falciparum malaria by PfSPZ Vaccine.
Epstein, Judith E; Paolino, Kristopher M; Richie, Thomas L; Sedegah, Martha; Singer, Alexandra; Ruben, Adam J; Chakravarty, Sumana; Stafford, April; Ruck, Richard C; Eappen, Abraham G; Li, Tao; Billingsley, Peter F; Manoj, Anita; Silva, Joana C; Moser, Kara; Nielsen, Robin; Tosh, Donna; Cicatelli, Susan; Ganeshan, Harini; Case, Jessica; Padilla, Debbie; Davidson, Silas; Garver, Lindsey; Saverino, Elizabeth; Murshedkar, Tooba; Gunasekera, Anusha; Twomey, Patrick S; Reyes, Sharina; Moon, James E; James, Eric R; Kc, Natasha; Li, Minglin; Abot, Esteban; Belmonte, Arnel; Hauns, Kevin; Belmonte, Maria; Huang, Jun; Vasquez, Carlos; Remich, Shon; Carrington, Mary; Abebe, Yonas; Tillman, Amy; Hickey, Bradley; Regules, Jason; Villasante, Eileen; Sim, B Kim Lee; Hoffman, Stephen L.
Affiliation
  • Epstein JE; Naval Medical Research Center (NMRC).
  • Paolino KM; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Richie TL; Sanaria Inc., Rockville, Maryland, USA.
  • Sedegah M; Naval Medical Research Center (NMRC).
  • Singer A; Naval Medical Research Center (NMRC).
  • Ruben AJ; Sanaria Inc., Rockville, Maryland, USA.
  • Chakravarty S; Sanaria Inc., Rockville, Maryland, USA.
  • Stafford A; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Ruck RC; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Eappen AG; Sanaria Inc., Rockville, Maryland, USA.
  • Li T; Sanaria Inc., Rockville, Maryland, USA.
  • Billingsley PF; Sanaria Inc., Rockville, Maryland, USA.
  • Manoj A; Sanaria Inc., Rockville, Maryland, USA.
  • Silva JC; Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA.
  • Moser K; Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, Maryland, USA.
  • Nielsen R; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Tosh D; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Cicatelli S; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Ganeshan H; Naval Medical Research Center (NMRC).
  • Case J; Statistics Collaborative Inc., Washington, DC, USA.
  • Padilla D; Sanaria Inc., Rockville, Maryland, USA.
  • Davidson S; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Garver L; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Saverino E; Sanaria Inc., Rockville, Maryland, USA.
  • Murshedkar T; Sanaria Inc., Rockville, Maryland, USA.
  • Gunasekera A; Sanaria Inc., Rockville, Maryland, USA.
  • Twomey PS; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Reyes S; Naval Medical Research Center (NMRC).
  • Moon JE; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • James ER; Sanaria Inc., Rockville, Maryland, USA.
  • Kc N; Sanaria Inc., Rockville, Maryland, USA.
  • Li M; Protein Potential, Rockville, Maryland, USA.
  • Abot E; Sanaria Inc., Rockville, Maryland, USA.
  • Belmonte A; Protein Potential, Rockville, Maryland, USA.
  • Hauns K; Naval Medical Research Center (NMRC).
  • Belmonte M; Naval Medical Research Center (NMRC).
  • Huang J; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Vasquez C; Naval Medical Research Center (NMRC).
  • Remich S; Naval Medical Research Center (NMRC).
  • Carrington M; Naval Medical Research Center (NMRC).
  • Abebe Y; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Tillman A; Naval Medical Research Center (NMRC).
  • Hickey B; Sanaria Inc., Rockville, Maryland, USA.
  • Regules J; Statistics Collaborative Inc., Washington, DC, USA.
  • Villasante E; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Sim BKL; Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA.
  • Hoffman SL; Naval Medical Research Center (NMRC).
JCI Insight ; 2(1): e89154, 2017 01 12.
Article in En | MEDLINE | ID: mdl-28097230
ABSTRACT

BACKGROUND:

A radiation-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) malaria vaccine, PfSPZ Vaccine, protected 6 of 6 subjects (100%) against homologous Pf (same strain as in the vaccine) controlled human malaria infection (CHMI) 3 weeks after 5 doses administered intravenously. The next step was to assess protective efficacy against heterologous Pf (different from Pf in the vaccine), after fewer doses, and at 24 weeks.

METHODS:

The trial assessed tolerability, safety, immunogenicity, and protective efficacy of direct venous inoculation (DVI) of 3 or 5 doses of PfSPZ Vaccine in non-immune subjects.

RESULTS:

Three weeks after final immunization, 5 doses of 2.7 × 105 PfSPZ protected 12 of 13 recipients (92.3% [95% CI 48.0, 99.8]) against homologous CHMI and 4 of 5 (80.0% [10.4, 99.5]) against heterologous CHMI; 3 doses of 4.5 × 105 PfSPZ protected 13 of 15 (86.7% [35.9, 98.3]) against homologous CHMI. Twenty-four weeks after final immunization, the 5-dose regimen protected 7 of 10 (70.0% [17.3, 93.3]) against homologous and 1 of 10 (10.0% [-35.8, 45.6]) against heterologous CHMI; the 3-dose regimen protected 8 of 14 (57.1% [21.5, 76.6]) against homologous CHMI. All 22 controls developed Pf parasitemia. PfSPZ Vaccine was well tolerated, safe, and easy to administer. No antibody or T cell responses correlated with protection.

CONCLUSIONS:

We have demonstrated for the first time to our knowledge that PfSPZ Vaccine can protect against a 3-week heterologous CHMI in a limited group of malaria-naive adult subjects. A 3-dose regimen protected against both 3-week and 24-week homologous CHMI (87% and 57%, respectively) in this population. These results provide a foundation for developing an optimized immunization regimen for preventing malaria. TRIAL REGISTRATION ClinicalTrials.gov NCT02215707.

FUNDING:

Support was provided through the US Army Medical Research and Development Command, Military Infectious Diseases Research Program, and the Naval Medical Research Center's Advanced Medical Development Program.
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Full text: 1 Database: MEDLINE Main subject: Plasmodium falciparum / Vaccines, Attenuated / Malaria, Falciparum / Sporozoites Limits: Adult / Female / Humans / Male Language: En Year: 2017 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Plasmodium falciparum / Vaccines, Attenuated / Malaria, Falciparum / Sporozoites Limits: Adult / Female / Humans / Male Language: En Year: 2017 Type: Article