Dengue Hemorrhagic Fever Clinical Trial
Official title:
Phase I Evaluation of the Safety and Immunogenicity of rDEN4delta30 Lot# 109A, a Live Attenuated DEN4 Vaccine, in Healthy Flavivirus-naïve Adult Volunteers.
Infection with dengue viruses is one of the leading causes of hospitalization and death in
children in several tropical Asian counties. The World Health Organization (WHO) estimates
that these viruses are responsible for more than 50 million cases of dengue fever (DF) and
approximately 0.5 million cases of the more severe disease, dengue hemorrhagic fever/ shock
syndrome (DHF/DSS) annually. Because dengue viruses are endemic in most tropical and
subtropical regions, keeping more than 2 billion persons at risk for acquiring dengue, the
WHO has made development of a dengue vaccine a top priority.
The purpose of this study is to evaluate the safety and effectiveness of a candidate DEN4
vaccine aimed at preventing infection with dengue virus serotype 4.
Dengue viruses are endemic in most tropical and subtropical regions of the world with more
than 2 billion persons at risk for acquiring dengue. There are four serotypes of dengue
virus (DEN 1, DEN 2, DEN 3, and DEN 4) each capable of causing dengue illness ranging from
mild, self-limited febrile illness to life-threatening disease. Because previous infection
with one dengue serotype can increase the risk for DHF/DSS following infection with a
different serotype, immunization would ideally provide immunity against all four dengue
viral serotypes.
Several live, attenuated dengue vaccines have been tested in Phase I and/or Phase II
clinical trials. Although some have appeared promising in early trials, none have been able
to meet the requirements for a safe and effective vaccine. Meeting these requirements has
been particularly difficult when testing vaccines containing all four serotypes. The vaccine
candidate in this study is live-attenuated rDEN4delta30, which will target the DEN4
serotype, it is a potential component for a future tetravalent dengue vaccine.
This is a double-blind, random assignment, placebo-controlled study in healthy, adult
volunteers. The purpose of this study is to evaluate the safety and effectiveness of a
single dose of DEN4 vaccine. Some participants will be receiving placebo as a comparative
measure, to better assess vaccine-associated versus non vaccine-associated adverse events.
To qualify for participation in the study, volunteers will undergo an eligibility screening
which will include medical history, physical exam, hematology testing, liver and renal
function testing, coagulation studies, human immunodeficiency virus (HIV) and hepatitis B
and C screening, urinalysis, and screening for pervious flavivirus infection. Urine
pregnancy testing will also be required for female volunteers.
Duration of individual participation in the study is approximately 26 weeks following
vaccination on Study Day 0. Volunteers will be randomly assigned to receive either
rDEN4delta30 or placebo; 50 participants will receive the vaccine, 20 will receive placebo.
On the day of vaccination, all volunteers will be reassessed by study personnel to ensure
continued eligibility, vital signs will be taken, and a physical exam will be performed.
Female participants will also have a pregnancy test and review of acceptable pregnancy
prevention methods. Eligible participants will receive a vaccination of Study Day 0,
followed by a 30 minute post vaccination assessment for adverse events. After vaccination,
volunteers will be evaluated in the clinic approximately every other day for the first 16
days if study.
During the course of study, volunteers will have blood drawn and clinical evaluations
performed on Study Days 21, 28, 42, and 180 post-vaccination. All participants will be asked
to record oral temperatures 3 times a day for the first 16 days post-vaccination.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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