Dengue Clinical Trial - Safety of & Immune Response to a Dengue Virus

Status Completed

Clinical Trial Summary

Dengue fever, caused by dengue viruses, is a major health problem in the 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, which cause dengue fever and dengue shock syndrome, are a major cause of morbidity and mortality in several of the world's tropical and subtropical regions. The rDEN3/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective against dengue virus serotype 3 (DEN3). The purpose of this study is to evaluate the safety and immunogenicity of the rDEN3/4delta30(ME) vaccine in healthy adults.

This study will last 40 weeks. Participants will be randomly assigned to receive one of three doses of rDEN3/4delta30(ME) or placebo. Participants in Group 1 will receive the middle dose of rDEN3/4delta30(ME) or placebo at study entry. Group 2a will begin enrollment after the immunogenicity review of all participants in Group 1. Participants in Group 2a will receive the highest dose of rDEN4delta30(ME) or placebo at study entry. Group 2b will begin enrollment after the immunogenicity review of all participants in Group 2a. Participants in Group 2b will receive the lowest dose of rDEN4delta30(ME) or placebo.

After vaccination, participants in all groups will be followed closely every other day for the first 16 days of the study. Participants will take their temperature three times a day through Day 16 and record each measurement in a diary. After Day 16, participants will have study visits on Days 21, 28, 42, and 180; a physical exam and blood collection will occur at all visits. Some participants may be asked to join a skin biopsy substudy. ;

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

Dengue

Clinical Trial Details

NCT number	NCT00375726
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Start date	October 2006
Completion date	September 2008

View Details

See also
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	`NCT05153018` - Population Immunity AgaiNst mosquitO-borne Diseases in Vanuatu	N/A

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 (rDEN3/4delta30[ME]) in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms