Status:
ACTIVE_NOT_RECRUITING
Dengue Controlled Human Infection Model in Dhaka, Bangladesh
Lead Sponsor:
Beth Kirkpatrick
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Dengue
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The primary objective is to determine, among dengue-naïve adults in an endemic population, the protective efficacy of TetraVax-DV TV005 vaccine against dengue infection induced by a live recombinant a...
Detailed Description
This is a single center, Phase II, placebo-controlled, double-blind study to evaluate the ability of a single dose of TetraVax-DV TV005 vaccine to protect against infection induced by a live recombina...
Eligibility Criteria
Inclusion
- \-
- All of the following inclusion criteria must be met for a volunteer to be eligible for study participation:
- Adult male or female between 18 and 45 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 and willing to consent to a potential inpatient admission following receipt of the attenuated virus strain.
- Willing to participate in the study as evidenced by signing the informed consent document.
- Females of childbearing potential only: Willing to use effective contraception for at least 30 days prior to and 28 days following receipt of the investigational product.
Exclusion
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- A volunteer will not be eligible for study participation if any of the following criteria are met:
- Serologic evidence of previous wild-type dengue.
- Females Only: Currently lactating, breastfeeding or pregnant, as determined by positive urine human choriogonadotropin (CG) test.
- Positive test result on rapid point-of-care NS1 dengue test performed on study day 0.
- Interim history of fever without a known cause since screening visit.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, or platelets as defined in this protocol.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render them unable to comply with the protocol.
- Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by subject history.
- History of a severe allergic reaction or anaphylaxis.
- Hepatitis C virus (HCV) infection, by screening and confirmatory assays
- Hepatitis B virus (HBV) infection, by Hepatitis B surface antigen (HBsAg) screening.
- Self-reported or suspected immunodeficiency, or receipt of immunosuppressive therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- Current use of anticoagulant medications.
- Use of aspirin and/or non-steroidal anti-inflammatory medications within 7 days of vaccination or anticipated receipt within 14 days following vaccination.
- Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination.
- Previous receipt of a licensed or experimental dengue vaccine.
- Asplenia.
- Receipt of blood products, including transfusions or immunoglobulin within 90 days prior to receipt of investigational product or anticipated receipt during the study period.
- Anticipated receipt of any investigational agent in the 28 days before or after receipt of investigational product.
Key Trial Info
Start Date :
December 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05229354
Start Date
December 11 2021
End Date
July 1 2025
Last Update
July 17 2024
Active Locations (1)
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1
Icddr,B
Dhaka, Bangladesh