Biodefense/Emerging Infectious Diseases Research Description
The DoD and the NIAID Vaccine Research Center (VRC) actively investigates preventative measures for Category “A” Bioterrorism Agents, which are defined as: “…organisms that pose a risk to national security..” based on ease of dissemination, person to-person transmission, high case fatality rates, and potential for major public health impact/public panic/social disruption with requirement for special public health preparedness action. Agents causing viral hemorrhagic fevers, including Ebola and Marburg viruses, fall under this classification and are prioritized for vaccine development
Studies
Biodefense and Emerging Infectious Diseases research relevant to the Military and its beneficiaries
Ebola/Marburg Vaccines
Part I is a randomized, double-blind, placebo-controlled, study to evaluate safety, tolerability, and immunogenicity of two recombinant deoxyribonucleic acid (DNA) vaccines: one against Ebola virus and one against Marburg virus infections. Part II of this study is placebo-controlled and will evaluate concomitant administration of the Ebola and Marburg vaccines that are evaluated separately in Part I. The primary objectives are to evaluate the safety and tolerability of the investigational vaccines in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of each study vaccine.
Part I. Subjects will be simultaneously randomized in equal numbers to receive 3 study injections in Group 1 (Ebola DNA or placebo) or Group 2 (Marburg DNA or placebo) with a 5:1 ratio of vaccine:placebo within each Group.
Part II. Subjects in Group 3 will be randomized in 5:1 ratio of vaccine:placebo. At each of 3 injection timepoints vaccine recipients will receive Ebola DNA in the left arm and Marburg DNA in the right arm while placebo recipients will receive a placebo injection in each arm.
Rickettsia parkeri
Many patients presenting to health care facilities with fever of undetermined etiology are misdiagnosed or remain undiagnosed, but it is now recognized that many of these cases can be attributed to a rickettsial infection. The role of R. parkeri in such cases has not been defined. Therefore, the key component of the study will be identification of R. parkeri infection through culture and polymerase chain reaction (PCR) techniques from participant specimens including blood, swabs from eschars, and punch biopsies (adults only) of eschars and skin rashes. The secondary component will be to describe risk factors for infection and clinical presentation and course of infection. Identifying cases and describing the clinical aspects of R. parkeri infections among DoD beneficiaries with illness previously diagnosed as having "fevers and rashes of unknown etiology" will for the first time, better define the role of this emerging pathogen in this population and potentially identify clinical features that distinguish it from viral and other rickettsial illnesses that may present with fever with or without rash. The epidemiological information obtained from this survey will also have application for training and operational forces with activity associated risk in endemic areas.
Ebola/Marburg Vaccines
Part I is a randomized, double-blind, placebo-controlled, study to evaluate safety, tolerability, and immunogenicity of two recombinant deoxyribonucleic acid (DNA) vaccines: one against Ebola virus and one against Marburg virus infections. Part II of this study is placebo-controlled and will evaluate concomitant administration of the Ebola and Marburg vaccines that are evaluated separately in Part I. The primary objectives are to evaluate the safety and tolerability of the investigational vaccines in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of each study vaccine.
Part I. Subjects will be simultaneously randomized in equal numbers to receive 3 study injections in Group 1 (Ebola DNA or placebo) or Group 2 (Marburg DNA or placebo) with a 5:1 ratio of vaccine:placebo within each Group.
Part II. Subjects in Group 3 will be randomized in 5:1 ratio of vaccine:placebo. At each of 3 injection timepoints vaccine recipients will receive Ebola DNA in the left arm and Marburg DNA in the right arm while placebo recipients will receive a placebo injection in each arm.
Rickettsia parkeri
Many patients presenting to health care facilities with fever of undetermined etiology are misdiagnosed or remain undiagnosed, but it is now recognized that many of these cases can be attributed to a rickettsial infection. The role of R. parkeri in such cases has not been defined. Therefore, the key component of the study will be identification of R. parkeri infection through culture and polymerase chain reaction (PCR) techniques from participant specimens including blood, swabs from eschars, and punch biopsies (adults only) of eschars and skin rashes. The secondary component will be to describe risk factors for infection and clinical presentation and course of infection. Identifying cases and describing the clinical aspects of R. parkeri infections among DoD beneficiaries with illness previously diagnosed as having "fevers and rashes of unknown etiology" will for the first time, better define the role of this emerging pathogen in this population and potentially identify clinical features that distinguish it from viral and other rickettsial illnesses that may present with fever with or without rash. The epidemiological information obtained from this survey will also have application for training and operational forces with activity associated risk in endemic areas.