This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided into two stages, Stage A and B. Stage A is an open label, single center, dose escalation study in 19 volunteers. Stage B is a multi-center, double blind, randomized, placebo-controlled trial in 48 volunteers. The primary objective of this study is to determine the safety and tolerability of direct venous inoculation (DVI) of PfSPZ-GA1 Vaccine in healthy adults.

Start Date12 May 2017

Sponsor / Collaborator

Sanaria, Inc.

[+2]

100 Clinical Results associated with PfSPZ-GA1

100 Translational Medicine associated with PfSPZ-GA1

100 Patents (Medical) associated with PfSPZ-GA1

Literatures (Medical) associated with PfSPZ-GA1

01 Dec 2021·Malaria JournalQ3 · MEDICINE

Transient knockdown of Anopheles stephensi LRIM1 using RNAi increases Plasmodium falciparum sporozoite salivary gland infections

Q3 · MEDICINE

ArticleOA

Author: Harrell, Robert A ; Li, Tao ; Billingsley, Peter F ; O'Brochta, David A ; Eappen, Abraham G ; Sim, B Kim Lee ; Chakravarty, Sumana ; Alford, Robert ; Hoffman, Stephen L ; George, Kasim I

AbstractBackgroundPlasmodium falciparum(Pf) sporozoites (PfSPZ) can be administered as a highly protective vaccine conferring the highest protection seen to date. Sanaria® PfSPZ vaccines are produced using aseptically rearedAnopheles stephensimosquitoes. The bionomics of sporogonic development ofP. falciparuminA. stephensito fully mature salivary gland PfSPZ is thought to be modulated by several components of the mosquito innate immune system. In order to increase salivary gland PfSPZ infections inA. stephensiand thereby increase vaccine production efficiency, a gene knock down approach was used to investigate the activity of the immune deficiency (IMD) signaling pathway downstream effector leucine-rich repeat immune molecule 1 (LRIM1), an antagonist toPlasmodiumdevelopment.MethodsExpression ofLRIM1inA. stephensiwas reduced following injection of double stranded (ds) RNA into mosquitoes. By combining the Gal4/UAS bipartite system with in vivo expression of short hairpin (sh) RNA coding forLRIM1reduced expression ofLRIM1was targeted in the midgut, fat body, and salivary glands. RT-qPCR was used to demonstrate fold-changes in gene expression in three transgenic crosses and the effects onP. falciparuminfections determined in mosquitoes showing the greatest reduction inLRIM1expression.ResultsLRIM1expression could be reduced, but not completely silenced, by expression ofLRIM1dsRNA. Infections ofP. falciparumoocysts and PfSPZ were consistently and significantly higher in transgenic mosquitoes than wild type controls, with increases in PfSPZ ranging from 2.5- to tenfold.ConclusionsPlasmodium falciparuminfections inA. stephensican be increased following reduced expression ofLRIM1.These data provide the springboard for more precise knockout of LRIM1 for the eventual incorporation of immune-compromisedA. stephensiinto manufacturing of Sanaria’s PfSPZ products.

20 May 2020·Science Translational MedicineQ1 · MEDICINE

A double-blind, placebo-controlled phase 1/2a trial of the genetically attenuated malaria vaccine PfSPZ-GA1

Q1 · MEDICINE

Article

Author: van Waardenburg, Youri M. ; Hoffman, Stephen L. ; Walk, Jona ; Manurung, Mikhael ; Abebe, Yonas ; van de Vegte-Bolmer, Marga ; Koopman, Jan Pieter R. ; Roestenberg, Meta ; Meij, Pauline ; Janse, Jacqueline J. ; van der Ven, André J. A. M. ; Langenberg, Marijke C. C. ; Hoogerwerf, Marie-Astrid ; Murshedkar, Tooba ; Janse, Chris J. ; Richie, Tom L. ; Visser, Leo G. ; Sauerwein, Robert W. ; van der Boor, Saskia C. ; Teelen, Karina ; García, Amanda Fabra ; Wessels, Els ; Khan, Shahid M. ; de Mast, Quirijn ; Yap, X. Zen ; Billingsley, Peter F. ; Sim, B. Kim Lee ; Natasha, K. C. ; van Gemert, Geert Jan

The genetically attenuated malaria vaccine PfSPZ-GA1 is safe, immunogenic, and has suboptimal protective efficacy in people.

01 Feb 2017·NatureQ1 · CROSS-FIELD

Sterile protection against human malaria by chemoattenuated PfSPZ vaccine

Q1 · CROSS-FIELD

Article

Author: Ishizuka, Andrew S ; Mordmüller, Benjamin ; Billingsley, Peter F ; Surat, Güzin ; Lalremruata, Albert ; Natasha, K C ; Li, Minglin ; Richie, Thomas L ; Hoffman, Stephen L ; Campo, Joseph J ; Kremsner, Peter G ; Gunasekera, Anusha ; Seder, Robert A ; Sim, B Kim Lee ; Gmeiner, Markus ; James, Eric R ; Held, Jana ; Li, Tao ; Ruben, Adam J ; Ibáñez, Javier ; Manoj, Anita ; Mengue, Juliana B ; Esen, Meral ; Eappen, Abraham G ; Sulyok, Mihály ; Gebru, Tamirat ; Murshedkar, Tooba ; Stafford, Richard E ; Felgner, Phil L ; Calle, Carlos Lamsfus ; Chakravarty, Sumana ; Lagler, Heimo

A highly protective malaria vaccine would greatly facilitate the prevention and elimination of malaria and containment of drug-resistant parasites. A high level (more than 90%) of protection against malaria in humans has previously been achieved only by immunization with radiation-attenuated Plasmodium falciparum (Pf) sporozoites (PfSPZ) inoculated by mosquitoes; by intravenous injection of aseptic, purified, radiation-attenuated, cryopreserved PfSPZ ('PfSPZ Vaccine'); or by infectious PfSPZ inoculated by mosquitoes to volunteers taking chloroquine or mefloquine (chemoprophylaxis with sporozoites). We assessed immunization by direct venous inoculation of aseptic, purified, cryopreserved, non-irradiated PfSPZ ('PfSPZ Challenge') to malaria-naive, healthy adult volunteers taking chloroquine for antimalarial chemoprophylaxis (vaccine approach denoted as PfSPZ-CVac). Three doses of 5.12 × 10⁴ PfSPZ of PfSPZ Challenge at 28-day intervals were well tolerated and safe, and prevented infection in 9 out of 9 (100%) volunteers who underwent controlled human malaria infection ten weeks after the last dose (group III). Protective efficacy was dependent on dose and regimen. Immunization with 3.2 × 10³ (group I) or 1.28 × 10⁴ (group II) PfSPZ protected 3 out of 9 (33%) or 6 out of 9 (67%) volunteers, respectively. Three doses of 5.12 × 10⁴ PfSPZ at five-day intervals protected 5 out of 8 (63%) volunteers. The frequency of Pf-specific polyfunctional CD4 memory T cells was associated with protection. On a 7,455 peptide Pf proteome array, immune sera from at least 5 out of 9 group III vaccinees recognized each of 22 proteins. PfSPZ-CVac is a highly efficacious vaccine candidate; when we are able to optimize the immunization regimen (dose, interval between doses, and drug partner), this vaccine could be used for combination mass drug administration and a mass vaccination program approach to eliminate malaria from geographically defined areas.

100 Deals associated with PfSPZ-GA1

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Indication	Highest Phase	Country/Location	Organization	Date
Malaria	Phase 2	-	Sanaria, Inc.	-

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