Completed

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

What is being tested

rDEN1delta30

+ Placebo

Biological

Who is being recruted

Vector Borne Diseases+8

+ Mosquito-Borne Diseases

+ Arbovirus Infections

From 18 to 50 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-ControlledPhase 1

Interventional

Study Start: September 2004

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2004

Actual date on which the first participant was enrolled.

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.

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

NCT00089908

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesArbovirus InfectionsDengueHemorrhagic Fevers, ViralInfectionsRNA Virus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsSevere Dengue

Criteria

3 inclusion criteria required to participate

Willing to be followed for the duration of the study

Willing to use acceptable methods of contraception

Good general health

21 exclusion criteria prevent from participating

Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease

Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study

Liver, renal, or hematologic disease

Alcohol or drug abuse within 12 months of study entry

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

One subcutaneous vaccination with rDEN1delta30 vaccine (10\^3 PFU dose) into the deltoid region of either arm.

Group II

Experimental

One subcutaneous vaccination with rDEN1delta30 vaccine (10\^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.

Group III

Placebo

One subcutaneous vaccination with placebo into the deltoid region of either arm.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, United StatesOpen Center for Immunization Research, Johns Hopkins School of Public Health in Google Maps

CompletedOne Study Center