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Principal Investigator: Matthew Memoli
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2022
Award: $548,539
Funding agency: National Institute of Allergy and Infectious Diseases
Mosquito-borne diseases continue to cause significant morbidity and mortality worldwide despite on-going control efforts. In 2015, there were >200 million cases of malaria worldwide, causing nearly half a million deaths, with most of the deaths occurring among children under the age of 5 years. Mosquitoes also transmit arboviruses, including dengue, yellow fever, West Nile virus, chikungunya, Rift Valley fever, Japanese encephalitis, and Zika virus. The recent outbreak of Zika virus in Central and South America, as well as the Caribbean, serves as a reminder of how quickly these viruses can spread and how difficult they can be to control.
In 2020 we published a Phase I study of a novel universal mosquito-borne disease vaccine, AGS-V, that modulates the immune system after a mosquito feeding. This vaccine targets the vector saliva and may provide prophylaxis against multiple arboviral and protozoal diseases. The vaccine was found to be safe and immunogenic as described in our publication in Lancet. This publication marks the first time a vaccine targeting mosquito saliva has been tested in humans and the first-time clean mosquito feedings on humans have been performed in the NIH Clinical Center. This study we believe serves as a baseline for this type of vaccine to be developed and opens the door for these types of trials to be done.
As a continuation of our close collaboration with LMVR we were awarded an NIH Bench To Bedside award and in 2018 completed enrollment of a follow up clinical study in the NIH Clinical Center to evaluate the effect on the immune response of multiple exposures to the same vector. This study included the evaluation of two species of mosquito as well as sandflies, the vector of leishmania. We expect the final data from this study to be instrumental in further understanding how vaccination strategies that target vector saliva may work in individuals from endemic disease areas. During this past 2 years detailed laboratory analysis was performed, but due to COVID related delays we did not complete the work. We expect to have the results ready to publish early in this next year as work has resumed and should be completed soon.
Last year we completed analysis of a third clinical trial, a follow up study to our initial study of AGS-v an updated version of the vaccine, AGS-v Plus. This Phase Ib study completed in collaboration with LMVR and University of Maryland under a CRADA agreement. The study is currently under review and we expect publication in the coming months before the end of 2022. This study continues the important clinical development of this unique vaccine strategy we initiated studies with in 2018.
During this past year were continued to collaborate with LMVR, but with a different investigator Jessica Manning, an alumnus of our lab who now runs an excellent program in Cambodia. We published an important study evaluating SARS-CoV-2 Cross Reactivity in prepandemic serum from Rural Malaria infected persons in Cambodia. This study was published in Emerging Infectious Diseases in February of 2022.
Lastly this year we have begun to work closely With Joshua Lascina and the LMVR group to begin the development of a leishmania challenge model. This model will play a key role int he development of novel leishmania vaccines. We expect to work closely with them in the coming year to gain full funding and to develop a safe, ethical, and reproducible human model that will provide significant insights and benefit in the development of these important vaccines.
Terms: <0-11 years old><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><5 year old><5 years of age><Active Follow-up><Agreement><Arboviral><Arboviral infections><Arbovirus Infections><Arboviruses><Area><Arthropod-Born Viral Infection><Arthropod-Borne Viruses><Award><Bite><Blood Serum><COVID><COVID-19 virus><COVID19 virus><CRADA><Cambodia><Caribbean><Caribbean Sea Region><Caribbean region><Central America><Cessation of life><Child><Child Youth><Children (0-21)><Clinical><Clinical Research><Clinical Study><Clinical Trials><CoV disease><CoV-2><CoV2><Collaborations><Cooperative Research and Development Agreement><Culicidae><Data><Death><Dengue><Development><Disease><Disease Outbreaks><Disorder><Egypt 101 virus><Emerging Communicable Diseases><Emerging Infectious Diseases><Endemic Diseases><Enrollment><Ethics><Evaluation><Exposure to><Follow-Up Studies><Followup Studies><Funding><Generations><Goals><Grant><Human><Immune response><Immune system><Immunological response><Individual><Investigators><Japanese B Encephalitis Virus><Japanese encephalitis virus><Kampuchea><Khmer Republic><Laboratories><Leishmania><Leishmaniasis><Malaria><Maryland><Methods><Modeling><Modern Man><Morbidity><Morbidity - disease rate><Mosquito Control><Mosquito-borne disease><Mosquito-borne infectious disease><Mosquitoes><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Outbreaks><Paludism><Parasitic Diseases><Persons><Phase><Phase I Study><Phlebotominae><Plasmodium Infections><Play><Prophylactic treatment><Prophylaxis><Proteins><Protozoa><Protozoal><Publications><Publishing><Reproducibility><Research Personnel><Researchers><Rift Valley Fever><Running><Rural><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV2><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Saliva><Salivary><Scientific Publication><Serum><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><South America><Testing><Time><United States National Institutes of Health><Universities><Update><Vaccination><Vaccines><Vector-borne disease><Vector-borne infectious disease><Vector-transmitted disease><Vector-transmitted infectious disease><Virus><WNV><West Indies Region><West Nile><West Nile virus><Work><Wuhan coronavirus><Yellow Fever><ZIKA><ZIKV><Zika Virus><active followup><age 5 years><allergic/immunologic body system><allergic/immunologic organ system><arboviral disease><arbovirus disease><arthropod-borne disease><arthropod-borne infection><arthropodborne disease><arthropodborne infection><bench bed side><bench bedside><bench to bed side><bench to bedside><bench to clinic><chikungunya><clinical center><clinical development><corona virus disease><coronavirus disease><coronavirus disease 2019 virus><coronavirus disease-19 virus><cross reactivity><developmental><enroll><ethical><feeding><five year old><five years of age><follow up><follow-up><followed up><followup><hCoV19><host response><human model><immune system response><immunization strategy><immunogenic><immunoresponse><insight><malaria infection><malaria-infected><malarial infection><model of human><mortality><nCoV2><new vaccines><next generation vaccines><novel><novel vaccines><phase 1 study><prevent><preventing><programs><response><sandfly><translational study><vaccination strategy><vaccine strategy><vector><vector-borne illness><vectorborne disease><vectorborne illness><vectorborne infectious disease><youngster><zikav>