Dengue Clinical Trial
Official title:
Phase I Evaluation of the Safety and Immunogenicity of an Investigational Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naïve Adults 50 - 70 Years of Age
This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.
Dengue viruses (DENV) are widespread in most tropical and subtropical regions of the world.
There are four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4); each can cause
dengue infection. Infection with dengue viruses can range from mild illness to
life-threatening disease. TetraVax-DV TV005 (also referred to as TV005) is a live attenuated
recombinant tetravalent dengue virus vaccine developed to protect against all four dengue
virus serotypes. The purpose of this study is to evaluate the safety and immunogenicity of
TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.
Participants will be randomly assigned to receive a subcutaneous injection of either TV005 or
placebo at study entry (Day 0). After receiving the injection, participants will record their
temperature 3 times a day through Day 16. Additional study visits will occur on Days 4, 6, 8,
10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include a physical examination and blood
collection.
;
| 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 |