A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dengue
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Frequency of trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.
Detailed Description
There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each capable of causing dengue illness ranging from a mild illness to life-threatening disease. This study will evaluate a trivalent live attenuated dengue admixture vaccine that contains 3 different monovalent dengue vaccine candidates, representing 3 of the 4 dengue serotypes (DENV-1, DENV-3, and DENV-4). Study researchers will evaluate the safety and protective efficacy of a single dose of the trivalent dengue vaccine against viremia and rash induced by infection with an attenuated DENV-2 virus (rDEN2Δ30-7169), administered 6 months after the trivalent dengue vaccine. This study will enroll healthy adults with no history of previous flavivirus infection. At Day 0 (study entry), participants will be randomly assigned to receive either the trivalent dengue vaccine admixture or placebo. On Day 180, all participants will receive the rDEN2Δ30-7169 vaccine. Study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 180, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Visits will include physical examinations and blood collection. All participants will record their temperature 3 times a day for 16 days after each vaccination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult male or female between 18 and 50 years of age, inclusive
- •Good general health as determined by physical examination, laboratory screening, and review of medical history
- •Available for the duration of the study, approximately 26 weeks post-second vaccination
- •Willingness to participate in the study as evidenced by signing the informed consent document
- •Females Only: Female participants of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence (6 months or longer since last sexual encounter). All female participants will be considered having child-bearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.
Exclusion Criteria
- •Females Only: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, or breastfeeding
- •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- •Behavioral, cognitive, psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- •Screening laboratory values of Grade 1 or above for absolute neutrophil (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
- •Any condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- •Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
- •History of a severe allergic reaction or anaphylaxis
- •Severe asthma (emergency room visit or hospitalization within the last 6 months)
- •HIV infection, by screening and confirmatory assays
- •Hepatitis C virus (HCV) infection, by screening and confirmatory assays
Outcomes
Primary Outcomes
Frequency of trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs)
Time Frame: Measured through Day 360
Classified by both severity and seriousness, through active and passive surveillance.
Dengue virus neutralizing antibody titers (measured through blood collection)
Time Frame: Measured through Day 360