DSM-265

On August 14th, 2024, The Lancet Infectious Diseases released a publication entitled: "Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials."Read More In a report published on March 21, 2024 in EMBO Molecular Medicine (A replication competent Plasmodium falciparum parasite completely attenuated by dual gene deletion) investigators at Seattle Children’s Research Institute and Sanaria Inc. describe the development of a whole malaria parasite vaccine strain that infects the liver, develops to the late liver stage, and then gets completely stuck and cannot burst out of the liver to cause symptomatic blood infection.Read More Sanaria receives $1.5M from the Gates Foundation to make PfSPZ Challenge more accessible for future controlled human malaria infections (CHMIs) in the form of a repository.Read More Scientists from Sanaria Inc., and collaborators at multiple institutions publish results in Nature reporting “In vitro production of infectious Plasmodium falciparum sporozoites.”Read More ROCKVILLE, MD, USA – July 12, 2022 – Sanaria Inc., University of Maryland School of Medicine, Naval Medical Research Center, National Institutes of Health (USA), University of Bamako Malaria Research and Training Center (Mali), and University of Tübingen (Germany) published results in Nature Communications showing Plasmodium falciparum 7G8 human challenge trials provide a conservative prediction of efficacy of PfNF54-based PfSPZ Vaccine in Africa.Read More Sanaria Inc. announces that two new Phase 2 trials of its pioneering malaria vaccines have started. The first is in 6- to 10-year-old children living in Bancoumana, Mali, a malarious region of West Africa. The second is in Indonesian soldiers based in Sumatra, Indonesia. The soldiers will be deploying for six to nine months this coming August to an intensely malarious district in eastern Indonesia.Read More Sanaria Inc. and Seattle Children’s Research Institute are proud to announce the signing of an agreement to collaborate on the development and commercialization of next generation PfSPZ vaccines attenuated by genetic engineering.Read More In an article published today in Nature, Sanaria’s PfSPZ-CVac (CQ) vaccine is reported as being safe and protecting 100% of six subjects against a variant malaria parasite three months after their last dose in the company’s Phase 1 safety and efficacy trial. This is the first time complete protection against a variant malaria parasite has ever been achieved that long after vaccine administration.Read More Sanaria and its collaborators have had to take a step by step empirical approach to optimizing immunization with PfSPZ vaccines to achieve a safe, effective, durable, and broadly protective malaria vaccine. Two recent landmark malaria vaccine studies have moved the optimization process forward and highlighted the strong protective efficacy of Sanaria® PfSPZ-CVac in malaria-naïve adults. Read More Sanaria to receive €12.9M for the development of two Malaria vaccines, one Malaria prophylactic, and a SARS-CoV-2 vaccine from the EU Malaria Fund.Read More USPTO awards Sanaria with the 2020 Patents for Humanity Award for Sanaria's malaria vaccine.Read More Sanaria Inc. and the Government of Equatorial Guinea last week signed an agreement that continues their joint commitment to develop Sanaria® PfSPZ Vaccine as a tool for malaria elimination. This follows a new, broader agreement between the Government of Equatorial Guinea (EG) and industry partners, Marathon Oil Corporation, Noble Energy Inc. and Atlantic Methanol Production Company (AMPCO), to sponsor clinical development of Sanaria® PfSPZ Vaccine, including the Phase 3 clinical program starting in 2020. This long standing, successful partnership highlights the unique involvement of an African government and private-sector energy companies in developing a vaccine for a largely African problem.Read More Building upon publication of clinical trial results in Nature, PNAS, Lancet Infectious Diseases, and JCI Insight in 2017, Sanaria Inc. is highlighting the work of its many collaborators at a symposium entitled “Moving Toward a PfSPZ Malaria Vaccine for Protecting Travelers and Use in Elimination Campaigns” (session 133) at the 66th meeting of the American Society of Tropical Medicine and Hygiene in Baltimore, and then at the second 2017 International PfSPZ Consortium meeting held at the University of Maryland School of Medicine.Read More In a report published today in the Proceedings of the National Academy of Sciences, investigators from the National Institute of Allergy and Infectious Diseases (NIAID), NIH and the University of Maryland School of Medicine reported that nine of fourteen subjects (64%) immunized with three doses of Sanaria® PfSPZ Vaccine were protected against homologous challenge with Plasmodium falciparum malaria 19 weeks after their last vaccine dose. Moreover, five of six of the protected subjects who underwent a subsequent heterologous challenge with Plasmodium falciparum 33 weeks after their last vaccine dose were protected.Read More In a report published today in The Lancet Infectious Diseases, investigators reported that Sanaria® PfSPZ Vaccine protected against natural infections of Plasmodium falciparum, the leading cause of malaria deaths and that protection was sustained for the 24 weeks of the study in an area of intense malaria transmission.Read More In a report published today in Nature, investigators from the University of Tübingen reported all nine subjects (100%) immunized with three doses of Sanaria® PfSPZ-CVac malaria vaccine in a recently completed clinical trial were protected against Plasmodium falciparum malaria when exposed to the disease 10 weeks after last vaccine dose. Professor Peter Kremsner, MD, Director of the Institute of Tropical Medicine at the University, led the clinical team.Read More Sanaria Inc. continues to achieve success in its coordinated efforts to develop a safe, effective and affordable vaccine that delivers mass malaria protection in humans and promotes elimination of the disease worldwide. Research published today in JCI Insight by a team of clinical investigators at the Naval Medical Research Center and Walter Reed Army Institute of Research reports that Sanaria® PfSPZ Vaccine protected against Plasmodium falciparum malaria when clinical trial participants were exposed to two strains of parasites.Read More Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria® PfSPZ Vaccine. Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.Read More Results of a clinical trial of Sanaria® PfSPZ (Plasmodium falciparum sporozoite) Vaccine to prevent malaria infections, published today in the online issue of Nature Medicine magazine, show that the vaccine provided protection against infection with malaria parasites for at least 14 months in subjects who were exposed to Plasmodium falciparum parasites. The findings put the Sanaria vaccine on track to be the first malaria vaccine providing durable protection against infection with malaria parasites. Plasmodium falciparum is the malaria parasite that causes about 438,000 deaths and 214 million cases annually.Read More The Government of the Republic of Equatorial Guinea announced an agreement with industry partners, Marathon Oil Corporation, Noble Energy Inc. and AMPCO, to sponsor the clinical development of Sanaria® PfSPZ Vaccine against malaria, including a series of clinical trials from 2015 until 2018.Read More

A three-dose regimen of a whole-parasite vaccine against malaria -- called Plasmodium falciparum sporozoite (PfSPZ) vaccine -- demonstrated safety and efficacy when tested in adults living in Burkina Faso, West Africa, which has endemic malaria. A three-dose regimen of a whole-parasite vaccine against malaria -- called Plasmodium falciparum sporozoite (PfSPZ) vaccine -- demonstrated safety and efficacy when tested in adults living in Burkina Faso, West Africa, which has endemic malaria. That is the finding of a new study published on Dec. 7, 2022, in Science Translational Medicine. Researchers at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health (CVD) led the work. About 241 million people worldwide were infected with malaria in 2020, and 627,000 people died from their infections. Scientists have tried for decades to develop a highly effective malaria vaccine without much success. That is because the vaccines have been shown not to provide much protection in those who have already been infected with malaria earlier in life due to their acquired immunity. The first vaccine against malaria (RTS,S/AS01) was approved by the World Health Organization in October 2021, and it provides modest protection against malaria. The new study involved 80 participants in a randomized controlled clinical trial comparing three doses of the PfSPZ vaccine against a placebo. At six months follow up, vaccine efficacy was up to 48 percent; at 18 months follow up, vaccine efficacy was up to 46 percent. "Our study shows that the vaccine can be given to malaria-experienced adults in a highly endemic area and still provide protection, which is difficult and complicated as these individuals already have significant immune responses to malaria parasites that must be overcome by a vaccine for it to be successful," said study corresponding author Matthew B. Laurens, MD, MPH, Professor of Pediatrics at UMSOM and Director, International Clinical Trials Unit in the Malaria Research Group at CVD. PfSPZ Vaccine is made with a live-attenuated form of the malaria parasite Plasmodium falciparum sporozoite, which is transmitted by mosquitos. The vaccine is made by Rockville, Maryland-based Sanaria Inc. and has been shown to provide at least 90-percent protection in challenge studies where volunteers are infected with malaria (in a highly controlled way); these studies were conducted by CVD researchers in the U.S. and by other groups in Tanzania. In African adults who previously had malaria, PfSPZ provided 52 percent vaccine efficacy against naturally transmitted malaria infection. Protection lasted 8 to 14 months. In the new study, researchers wanted to reduce the number of required injections from five shots to three, while improving vaccine efficacy. They assessed safety, tolerability, immunogencity, and vaccine efficacy of three injections of the vaccine in a two-part study. The first part enrolled 32 adults in a dose-escalation phase in 2016 and the second enrolled 80 adults in a randomized trial in 2017. In the randomized trial, 39 received PfSPZ Vaccine and 41 received placebo. Study participants were healthy men and non-pregnant women ages 21 to 40. The vaccines were well tolerated and without concerning side effects. "New strategies are needed to achieve the United Nations sustainable development goal of a 90-percent reduction in malaria incidence and mortality by 2030," said UMSOM DeanMark T. Gladwin, MD, Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor. "Innovative vaccines that provide a higher level of protection against malaria are urgently needed to help to achieve this goal." Additional co-authors on the newly published research from UMSOM's Center for Vaccine Development and Global Health include: Kirsten E. Lyke, MD, Professor of Medicine; Sudhaunshu Joshi, MS, Laboratory Specialist; Biraj Shrestha, Laboratory Assistant; and Kathy Strauss, Laboratory Specialis. The new study reflects a long history of malaria vaccine development at UMSOM that started in the early 1970s with landmark research from David Clyde, MD, former head of malarial studies at CVD. His studies demonstrated that high-level protection against malaria infection is possible using a whole organism vaccine. Future research includes conducting additional clinical trials of the PfSPZ Vaccine in groups that would benefit most from vaccine-induced protection, including children, travelers, military personnel, and pregnant women. Many of these studies are underway, including an ongoing trial at UMSOM to administer a compressed schedule of three doses of PfSPZ Vaccine in one month, which is a feasible timeline for travelers and military populations. Results of this study are expected in 2023. The study was funded by NIH's National Institute of Allergy and Infectious Diseases grants U01AI112367 and 5R44AI055229.