Dengue Controlled Human Infection Model in Dhaka, Bangladesh

Launched by BETH KIRKPATRICK · Jan 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called TetraVax-DV TV005 to see how well it protects against dengue fever in adults who have never had dengue before. The researchers are particularly interested in understanding how long the vaccine provides protection after it’s given and how safe it is for participants. The trial is taking place in Dhaka, Bangladesh, where dengue is common, and will involve giving a weakened form of the virus to see if the vaccine is effective.

To be eligible for this study, participants need to be healthy adults aged 18 to 45 years, willing to stay in the hospital for a short period after receiving the vaccine, and must agree to use birth control if they could become pregnant. Those with a history of dengue, certain health conditions, or specific medications will not be able to participate. Volunteers can expect regular check-ups and monitoring throughout the study to ensure their safety and to collect important information about the vaccine.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -
• All of the following inclusion criteria must be met for a volunteer to be eligible for study participation:
• • 1. Adult male or female between 18 and 45 years of age, inclusive.
• • 2. Good general health as determined by physical examination, laboratory screening, and review of medical history.
• • 3. Available for the duration of the study and willing to consent to a potential inpatient admission following receipt of the attenuated virus strain.
• • 4. Willing to participate in the study as evidenced by signing the informed consent document.
• • 5. 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 Criteria:
• • -
• A volunteer will not be eligible for study participation if any of the following criteria are met:
• • 1. Serologic evidence of previous wild-type dengue.
• • 2. Females Only: Currently lactating, breastfeeding or pregnant, as determined by positive urine human choriogonadotropin (CG) test.
• • 3. Positive test result on rapid point-of-care NS1 dengue test performed on study day 0.
• • 4. Interim history of fever without a known cause since screening visit.
• • 5. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
• • 6. 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.
• • 7. Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, or platelets as defined in this protocol.
• • 8. 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.
• • 9. Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by subject history.
• • 10. History of a severe allergic reaction or anaphylaxis.
• • 11. Hepatitis C virus (HCV) infection, by screening and confirmatory assays
• • 12. Hepatitis B virus (HBV) infection, by Hepatitis B surface antigen (HBsAg) screening.
• • 13. Self-reported or suspected immunodeficiency, or receipt of immunosuppressive therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
• • 14. Current use of anticoagulant medications.
• • 15. Use of aspirin and/or non-steroidal anti-inflammatory medications within 7 days of vaccination or anticipated receipt within 14 days following vaccination.
• • 16. 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.
• • 17. Previous receipt of a licensed or experimental dengue vaccine.
• • 18. Asplenia.
• • 19. Receipt of blood products, including transfusions or immunoglobulin within 90 days prior to receipt of investigational product or anticipated receipt during the study period.
• • 20. Anticipated receipt of any investigational agent in the 28 days before or after receipt of investigational product.