Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1
rDEN1delta30
+ Placebo
Vector Borne Diseases+7
+ Mosquito-Borne Diseases
+ Arbovirus Infections
Prevention Study
Summary
Study start date: September 1, 2004
Actual date on which the first participant was enrolled.More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype. This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo. After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.28 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Willing to be followed for the duration of the study * Willing to use acceptable methods of contraception * Good general health Exclusion Criteria: * Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease * Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study * Liver, renal, or hematologic disease * Alcohol or drug abuse within 12 months of study entry * History of severe allergic reaction or anaphylaxis * Emergency room visit or hospitalization for severe asthma within 6 months of study entry * HIV-1 infected * HCV infected * Hepatitis B surface antigen positive * Known immunodeficiency syndrome * Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded. * Live vaccine within 4 weeks of study entry * Killed vaccine within 2 weeks of study entry * Blood products within 6 months of study entry * Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial * Previously received a licensed or experimental yellow fever or dengue vaccine * Surgical removal of spleen * History of dengue virus infection or other flavivirus infection * Other condition that, in the opinion of the investigator, would affect the participant's participation in the study * Pregnancy or breastfeeding * Plan to travel to an area where dengue infection is common
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, United StatesSee the location