Saturday, December 10, 2022

New genomic research reveals why in-clinic malaria vaccine testing is as rigorous as natural exposure in the field

Newswise – Malaria is the deadliest mosquito-borne parasitic infection of humans. After a century of research, the World Health Organization (WHO) approved the world’s first malaria vaccine in 2021. This vaccine reduces the incidence of malaria infection in young children aged 5-17 months by only 30 percent, which means it is important to continue developing and testing more effective vaccines.

WHO aims to find a vaccine that prevents infection as well as severe malaria cases. However, testing vaccines in this area is challenging and requires a large number of volunteers and a long follow-up. This process increases the cost and reduces the number of tests that the researcher can perform.

Now, scientists at the University of Maryland School of Medicine (UMSOM) Institute of Genome Sciences (IGS) And this UMSOM Center for Vaccine Development and Global Health (CVD), and his colleagues report a new method for testing vaccines that can be as harsh and stringent as exposure to regional strains of malaria. their studies . was published in the June issue of nature communication,

There are two major aspects to his method. First, they expose vaccinated volunteers to malaria in a controlled clinical environment. Second, for this test, they use a strain of malaria that is genetically very different from the strain used in the vaccine, as well as strains from the geographic region where the vaccine is intended.

This technology allows scientists to test how well the vaccine works under controlled settings and in a small number of volunteers in a rapid fashion and predict how well the vaccine might perform in the field. This lets researchers select the best vaccines for larger studies in the field. This method will increase the efficiency of vaccine trials and will accelerate the development of malaria vaccines.

“The standard for many investigators is to test vaccines with the same strain as used in vaccine development,” The lead author of the study explained, Joanna Carneiro da SilvaPHDProfessor of Microbiology and Immunology at UMSOM and IGS. “Using a strain that is genetically distant from the one in the vaccine – as well as from a strain circulating in the area where malaria is rampant and the vaccine will be used – is a more rigorous way of testing vaccine effectiveness. “

Researchers are studying the effectiveness of a vaccine (PfSPZ Vaccine) made by Sanaria, Inc., a company based in Rockville, Maryland. This vaccine uses a West African parasitic strain known as PFNF54, One purpose is to use this vaccine to protect people who have previously had little or no exposure to malaria, including people living in or traveling to Africa. The long-term goal is to use the vaccine in large-scale vaccination programs to eliminate malaria from specific areas in Africa.

For the study, researchers infected mosquitoes with a Brazilian malaria strain and then exposed US volunteers who received the Sanaria vaccine (as well as those who received a placebo) to the bites of infected mosquitoes in a controlled clinical setting. was vaccinated with. They also vaccinated research participants in Mali with similar doses of the vaccine to compare vaccine efficacy to that seen in the clinic. Through genomic sequencing, the researchers had shown that the Brazilian strain was significantly different from the 700 strains previously collected from across Africa, including those used to make the vaccine.

Researchers looked at nearly 200 volunteers in four trials — two in the United States and two in Mali. In all four, they looked at how many people became infected with malaria, as well as how long it took them to become infected, comparing farm to clinic. At the end of six months, they found that the vaccine was equally effective in both populations.

In addition, previous comparisons showed that volunteers who had never been exposed to malaria developed more antibodies than people in the area, proving that this worked well for first-time travelers to the area. Will do

The research team included Sanaria Inc. The scientists included; Naval Medical Research Center; University of Tübingen in Germany; Malaria Research and Training Center in Bamako, Mali; and NIAID, Laboratory of Malaria Immunology and Vaccinology at NIH.

The World Health Organization estimates that in 2020, 241 million cases and 627,000 deaths were caused by malaria worldwide, with 2,000 cases diagnosed in the United States from travelers and immigrants who were exposed elsewhere. The variety of malaria types globally makes vaccine development particularly difficult.

“Given the diversity of malaria strains around the world, this research demonstrates that the Brazilian strain is as diverse as any found in Africa,” Told Kirsten E. LikeeMDProfessor of Medicine at CVD and Director of the Malaria Vaccine and Challenges Unit and author of the paper.

Dr. da Silva noted that this new model could be used in the future to select challenge strains to test the efficacy of vaccines against other parasitic diseases, which are more carefully controlled clinical than field studies. ​Can be done using Settings.

Albert Rees, MD, PhD, MBAExecutive Vice President of Medical Affairs, UM, Baltimore, John Z. and Akiko K. Bowers Distinguished Professor, and Dean at the University of Maryland School of Medicine, said, ,The world has been waiting for decades for effective malaria vaccines. Dr. Silva and colleagues have found a way to accelerate our ability to test potential vaccine formulations in the clinic to identify the most promising candidates. This study also demonstrates how important genomics is to establish the efficacy of new vaccine formulations and guide vaccine development.”


This study was funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases Intramural Program and grants (U19AI110820, R01AI141900, 5R44AI058375-10, and 5R44AI055229-11), and the Department of Defense (W81XWH1420011).

University of Maryland School of Medicine author

Joanna C. da Silva, Ph.D., Professor, Microbiology and Immunology; Associate Professor, Institute of Genome Sciences

Ankit Dwivedi, PhDBioinformatics Analyst, Institute of Genome Sciences

Kara A. Moser, PhDPast Doctoral Student, Institute of Genome Sciences

Kirsten E. Laik, MDProfessor and Director of Medicine, Malaria Vaccine and Challenges Unit Center for Vaccine Development and Global Health

author conflicts of interest

Competing interests Thomas L. Richie, Toba Murshedkar b. Kim Lee Sim, and Stephen L. Hoffman are salaried employees of Sanaria Inc., the developer and owner of the PFSPZ Vaccine and PFSPZ Challenge (7G8). Also, Hoffman and Sim. Have a financial interest in Sanaria Inc. No other author declares competing interests.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues to this day as one of the fastest growing, top-tier biomedical research enterprises in the world – with 46 academic departments, centers, institutions and programs, and a network of more than 3,000 physicians, scientists and allied health professionals. Along with the faculty, which includes members of the National Academy of Medicine and the National Academy of Sciences, and the Albert E. Two-time coveted winner of the Lasker Award. With an operating budget of more than $1.3 billion, the School of Medicine works in partnership with the University of Maryland Medical Center and the Medical System to provide research-intensive, academic, and clinical-based care for approximately 2 million patients each year. can be provided. The School of Medicine has approximately $600 million in extramural funding, with most of its academic departments ranked highest among all medical schools in the country in research funding. As one of seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of approximately 9,000 faculty and staff, including 2,500 students, interns, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of more than $6 billion and an economic impact of approximately $20 billion on the state and local community. School of Medicine, which ranks as 8th Highest Research productivity in public medical schools (according to the Association of American Medical Colleges Profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies., in the latest US news and world report UM School of Medicine is a ranking of the best medical schools published in 2021 Rank #9 out of 92 public medical schools in the US, and in the top 15 percent (#27) All 192 . out of public and private US Medical School. The School of Medicine works locally, nationally and globally, with research and treatment facilities in 36 countries around the world. meeting

About the Institute of Genome Sciences

Institute of Genome Sciences (IGS) The University of Maryland School of Medicine has revolutionized genomic discoveries in medicine, agriculture, environmental science and biodefense since its founding in 2007. IGS investigators research the areas of genomics and the microbiome, including treatment, cure, and prevention, to better understand health and disease. IGS investigators also lead the development of the new field of microbial forensics. IGS is a major center for major organic initiatives that are currently NIH-funded . running with Human Microbiome Project (HMP) and NIAID-sponsored Genomic Sequencing Center for Infectious Diseases (GSCID), Follow us on Twitter @GenomeScience.

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