Dengue Fever Clinical Trial
Official title:
A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3delta30/31‐7164, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
More than 2 billion people living in tropical and subtropical regions of the world are at
risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more
severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading
cause of hospitalization and death in children in several tropical Asian countries. This
study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called
rDEN3delta30/31‐7164.
This study will consist of two groups, with Group 1 enrolling first. Group 1 participants
will be randomly assigned to receive either 10^3 PFU of rDEN3delta30/31-7164 or placebo
subcutaneously in their deltoid. Participants will be monitored at the clinic for 30 minutes
after receiving the immunization to monitor for adverse effects. After that, participants
will be asked to return to the clinic approximately every other day for the next 16 days,
and then on Day 21, 28, 42, and 180. At each visit participants will have physical and
clinical exams, vital signs, measures, blood drawn, and will be asked about any adverse
events they may have experience. Female participants will be given a pregnancy test. In
addition, participants will be asked to measure their temperature 3 times a day and record
it in a temperature diary for the first 16 days after immunization.
If less than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2A will be
enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^5 PFU
dose of rDEN3delta30/31-7164.
If more than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2B will be
enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^1 PFU
dose of rDEN3delta30/31-7164.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04514107 -
A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue)
|
N/A | |
| Completed |
NCT00788151 -
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
|
Phase 2 | |
| Completed |
NCT02510638 -
The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia
|
N/A | |
| Completed |
NCT01666652 -
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01477671 -
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
|
N/A | |
| Completed |
NCT01443247 -
Role of Andi-d in Dengue Fever: a Pilot Study
|
N/A | |
| Completed |
NCT00089908 -
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01983553 -
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
|
||
| Completed |
NCT01134263 -
Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
|
Phase 3 | |
| Completed |
NCT02741128 -
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
|
Phase 2 | |
| Completed |
NCT03620487 -
Detection of Dengue Virus in Plasma of Patients in Nepal
|
||
| Recruiting |
NCT02608047 -
Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou
|
N/A | |
| Completed |
NCT02510690 -
Factors Associated With Poor Dengue Outcomes in Malaysia
|
N/A | |
| Completed |
NCT01550016 -
International Research Consortium on Dengue Risk Assessment, Management, and Surveillance
|
N/A | |
| Completed |
NCT01421732 -
Laboratory Diagnosis and Prognosis of Severe Dengue
|
N/A | |
| Completed |
NCT00993447 -
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
|
Phase 2 | |
| Completed |
NCT01224639 -
Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever
|
Phase 1 | |
| Completed |
NCT01943825 -
Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
|
Phase 2 | |
| Active, not recruiting |
NCT03465254 -
Dengue Serostatus Study in the Philippines
|
||
| Completed |
NCT01702857 -
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)
|
Phase 1 |