Safety of & Immune Response to a Dengue Virus Vaccine

Status Completed

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

Dengue viruses cause dengue fever and the more severe dengue hemorrhagic fever/shock syndrome. More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection, which 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 vaccine called rDEN4delta30-200,201. This vaccine is derived from rDEN4delta30, another dengue virus vaccine candidate that has been shown to be safe and immunogenic in Phase I and II trials in healthy adults.

This study will last 180 days. There will be three cohorts in this dose de-escalation study. Participants in Cohort 1 will be randomly assigned to receive the highest dose of rDEN4delta30-200,201 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 lower dose of rDEN4delta30-200,201 or placebo. Cohort 3 will begin only after safety review of all participants in Cohort 2. Participants in Cohort 3 will receive the lowest dose of rDEN4delta30-200,201 or placebo.

After vaccination, participants will be asked to monitor their temperatures every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by four additional visits at selected days through Day 180. Blood collection, vital signs measurement, 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	NCT00270699
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Start date	June 2006
Completion date	December 2009

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	`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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-200,201) in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms