Tularaemia Clinical Trial
Official title:
A Phase II, Multi-Center, Double-Blind, Randomized Trial Comparing the Safety and Immunogenicity of a Francisella Tularensis Live Vaccine Strain (LVS) Vaccine Produced by DynPort Vaccine Company (DVC-LVS) to a LVS Vaccine in Use by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID-LVS)
The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection of placebo (inactive salt water). Study procedures include physical exam and blood and urine samples. Evaluation of the vaccination sites will be performed as well as blood samples to measure the body's response to the vaccine. Participants will be involved in the study for about 6 months.
Francisella (F.) tularensis is the organism responsible for tularemia. The organism can infect many different vertebrate and invertebrate hosts, but mostly rodents and lagomorphs. Transmission to humans is generally via an insect vector, such as ticks, mosquitoes, and biting flies, or from handling contaminated animal products or carcasses. F. tularensis is a highly infectious bacterium, with human infection and disease occurring with as few as 10 organisms, and mortality rates approaching 30 percent if untreated. Clinical presentation of tularemia varies in severity depending on the virulence of the organism, the route of entry, the extent of system involvement, and the immune status of the host. Following an incubation period of 3 to 5 days, individuals have an abrupt onset of fever, chills, headache, malaise, anorexia, and fatigue. The clinical presentation of the disease can include one or more the following forms: ulceroglandular (the most common form of the disease), glandular, oculoglandular, pharyngeal, gastrointestinal, pneumonic or typhoidal. This study is a Phase II, multi-center, double-blind, randomized, trial comparing the safety and immunogenicity of a Francisella tularensis live vaccine strain (LVS) vaccine produced by DynPort Vaccine Company (DVC-LVS) to a LVS vaccine in use by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID-LVS). Study Group A will include 110 volunteers who will be vaccinated with a single dose of the DVC LVS product in one arm and normal saline (NS) control in the other arm on Day 0. Group B will include 110 volunteers who will be vaccinated with a single dose of the USAMRIID-LVS product in one arm and normal saline (NS) control in the other arm on Day 0. Both vaccines will be administered by scarification. Approximately 100 microliters aliquot will be withdrawn and placed on the skin, a bifurcated needle will then be used to puncture the skin 15 times through the droplet. The primary objectives are: (Safety): assess the frequency of serious adverse events (SAEs) and Grade 3 and 4 laboratory values following vaccination with either DVC-LVS or USAMRIID-LVS vaccine; (Take): assess the frequency of "take" (defined as the development of an erythematous papule, vesicle, and/or eschar with or without underlying induration) following vaccination with either the DVC-LVS or USAMRIID-LVS vaccine; and (Immunogenicity): assess the rate of seroconversion following vaccination with either the DVC-LVS or the USAMRIID-LVS vaccine as measured by a tularemia-specific microagglutination assay. The secondary objectives are: (Safety): assess the incidence of adverse events (AEs) following vaccination with either the DVC-LVS or the USAMRIID-LVS vaccine; (Take): assess "take" frequency and difference between vaccine groups as assessed by an independent committee following vaccination with either the DVC-LVS or USAMRIID- LVS vaccine; and (Immunogenicity): assess antibody responses for each group following vaccination with DVC-LVS or USAMRIID-LVS vaccine as measured by a tularemia-specific microagglutination assay. Parent protocol to sub-study 10-0019. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention