Phase 1 Study of the Safety and Immunogenicity of rDEN2/4delta30(ME), a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dengue Fever
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Frequency and severity of vaccine-related adverse effects for each dose graded by severity
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Detailed Description
Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome. More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection, which 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 vaccine called rDEN2/4delta30(ME), which is derived from the DEN2 and DEN4 serotypes. This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN2/4delta30(ME) 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 rDEN2/4delta30(ME) or placebo. After vaccination, participants will be observed for at least 30 minutes for immediate adverse reactions. Participants will also 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.
Investigators
Eligibility 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
- •Hematologic disease
- •Alcohol or drug abuse within 12 months prior to study entry
- •History of severe allergic reaction or anaphylaxis
- •Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
- •HIV-1 infected
- •Hepatitis C virus infected
- •Hepatitis B surface antigen positive
- •Known immunodeficiency syndrome
Outcomes
Primary Outcomes
Frequency and severity of vaccine-related adverse effects for each dose graded by severity
Time Frame: Throughout study
Amount of dengue 2 neutralizing antibody induced by the vaccine
Time Frame: At Day 42
Secondary Outcomes
- To determine the number of vaccinees infected with rDEN2/4delta30(ME)(Throughout study)
- To assess the frequency, quantity, and duration of viremia in each dose cohort studied(Throughout study)
- To evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy(Throughout study)
- To assess the durability of the antibody response out to Day 180(Throughout study)
- To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN2/4delta30(ME) vaccine virus with that of uninfected volunteers and placebo recipients(Throughout study)
- If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups(At study completion)