Clinical Trials Logo
  1. Home
  2. Dengue Fever
  3. NCT00089908

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults

Dengue Fever Clinical Trial

Official title:
Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1

Clinical Trial Summary

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.

Clinical Trial Description

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 rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.

This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.

After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00089908
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date September 2004
Completion date November 2005
View Details
See also
  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 NCT00831012 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31‐7164) 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