Dengue Clinical Trial
Official title:
A Phase 1, Open-Label Clinical Trial With Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC) Assessment of Healthy U.S. Adults Previously Primed With Tetravalent Dengue Virus Purified Inactivated Vaccine (TDEN-PIV) and Boosted With Tetravalent Dengue Virus Live Attenuated Vaccine Formulation (TDEN LAV)
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an experimental dengue virus challenge. The Investigators will also include people that have not received the study vaccine. The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge.
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an experimental dengue virus challenge. The Investigators will also include people that have not received the study vaccine. The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge. The information will help Investigators develop vaccines to protect people from dengue. Participation is voluntary. The duration of participation will last for 180 days (six months). After participants are exposed to the weakened dengue virus, the Investigators will follow them closely to measure their symptoms. Like the flu, participants might expect to have a headache, rash, body aches, fever and chills or they may experience no symptoms whatsoever. If a participant does develops symptoms, the Investigators will monitor him/her closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur. Participants will be compensated for their time. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05321264 -
Educational Intervention to Promote Control Behaviors and Prevention of Dengue
|
N/A | |
| Completed |
NCT01436396 -
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
|
Phase 3 | |
| Completed |
NCT01391819 -
Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
|
N/A | |
| Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
| Completed |
NCT02833584 -
Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
|
N/A | |
| Completed |
NCT02433652 -
Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
|
Phase 1 | |
| Enrolling by invitation |
NCT02016027 -
Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter
|
Phase 1 | |
| Completed |
NCT01477671 -
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
|
N/A | |
| Recruiting |
NCT00377754 -
Prospective Study of Infant Dengue
|
N/A | |
| Recruiting |
NCT05919277 -
A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
|
||
| Recruiting |
NCT04582474 -
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
|
N/A | |
| Completed |
NCT01983553 -
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
|
||
| Completed |
NCT03803618 -
Dengue Effectiveness Study in the Philippines
|
||
| Active, not recruiting |
NCT05967455 -
Homologous Re-infection With Dengue 1 or Dengue 3
|
Phase 1 | |
| Completed |
NCT03631719 -
Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
|
||
| Recruiting |
NCT02606019 -
The Use of Biomarkers in Predicting Dengue Outcome
|
N/A | |
| Completed |
NCT02372175 -
Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain
|
Phase 1 | |
| Active, not recruiting |
NCT01696422 -
Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine
|
Phase 2 | |
| Completed |
NCT00993447 -
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
|
Phase 2 | |
| Completed |
NCT00375726 -
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults
|
Phase 1 |