CClinicalTrials.gg
Sign In
CompletedNCT00712803Updated Jan 3, 2013

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults

A Phase 1 interventional study of rDEN3-3'D4delta30 and rDEN3-3'D4delta30 in Dengue, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 evaluate the safety of and immune response to a new dengue virus vaccine in healthy adults.

Read the detailed 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 rDEN3-3'D4delta30. 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.

There will be two groups in this study. Participants in Group 1 will be randomly assigned to receive rDEN3-3'D4delta30 vaccine or placebo at study entry. The dosing for Group 2 will be determined by a safety review of all participants in Group 1. If less than 90 % of the Group 1 participants seroconvert to DEN3 participants in Group 2 will receive a higher dose of rDEN3-3'D4delta30. If at least 90 % of Group 1 participants seroconvert to DEN3, participants in Group 2 will receive a lower dose of rDEN3-3'D4delta30.

All participants will be required to monitor their temperature three times each day for the first 16 days following each vaccination. Study visits will occur 30 minutes following each vaccination and 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.

02

Conditions studied

  • Dengue

Browse trials for

03

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 29 is below the median of 123 across 195 interventional studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • General good health
  • Available for the duration of the study
  • Willing to use accepted forms of contraception

Exclusion criteria

Exclusion Criteria:

  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
  • Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
  • Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry
  • History of severe allergy or anaphylaxis
  • Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry
  • HIV infected
  • Hepatitis C virus infected
  • Hepatitis B surface antibody positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
  • Receipt of live vaccine within 4 weeks of study entry
  • Receipt of killed vaccine within 2 weeks of study entry
  • Absence of spleen
  • Plan to travel to an area where dengue virus is common
  • Any investigational product within 30 days of study entry
  • Other condition that, in the opinion of the investigator, would interfere with the study
  • Pregnancy or breastfeeding
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    1

    One subcutaneous vaccination (10\^3 dose of vaccine) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.

    Biological: rDEN3-3'D4delta30

  • Experimental
    2

    One subcutaneous vaccination (10\^5 dose of vaccine or placebo) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm OR one subcutaneous vaccination (10\^1 dose of vaccine or placebo) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.

    Biological: rDEN3-3'D4delta30

Interventions

  • BiologicalrDEN3-3'D4delta30

    Live attenuated 10\^3 dose of rDEN3-3'D4delta30 vaccine.

  • BiologicalrDEN3-3'D4delta30

    Live attenuated 10\^5 dose of rDEN3-3'D4delta30 vaccine.

  • BiologicalrDEN3-3'D4delta30

    Live attenuated 10\^1 dose of rDEN3-3'D4delta30 vaccine.

06

What researchers measure

Primary outcomes

  1. Safety and immunogenicity, as assessed by neutralizing antibody titers

    Time frame: At 4 weeks and 6 weeks after vaccination

  2. Frequency of vaccine related adverse events as graded by severity

    Time frame: Throughout study

Secondary outcomes

  1. Frequency, quantity, and duration of viremia after a single dose of vaccine

    Time frame: Throughout study

  2. Number of vaccines infected with rDEN3-3'D4delta30

    Time frame: Throughout study

  3. Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine

    Time frame: Throughout study

  4. Durability of antibody response

    Time frame: At 26 Weeks after vaccination

  5. Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed

    Time frame: Throughout study

07

Study locations

2 sites
  • Center for Immunization Research, Johns Hopkins School of Public Health
    Washington, District of Columbia 20037, United States
  • Center for Immunization Research, Johns Hopkins University of Public Health
    Baltimore, Maryland 21205, United States
08

References and documents

Publications

  • Blaney JE Jr, Hanson CT, Firestone CY, Hanley KA, Murphy BR, Whitehead SS. Genetically modified, live attenuated dengue virus type 3 vaccine candidates. Am J Trop Med Hyg. 2004 Dec;71(6):811-21. PubMed 15642976 ↗
  • Chaturvedi UC, Shrivastava R, Nagar R. Dengue vaccines: problems and prospects. Indian J Med Res. 2005 May;121(5):639-52. PubMed 15937367 ↗
  • Guzman MG, Mune M, Kouri G. Dengue vaccine: priorities and progress. Expert Rev Anti Infect Ther. 2004 Dec;2(6):895-911. doi: 10.1586/14789072.2.6.895. PubMed 15566333 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00712803
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Jul 10, 2008
Start date
Dec 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jan 3, 2013

Study contacts

Anna Durbin, MD
principal investigator · Center for Immunization Research (CIR), Johns Hopkins School of Public Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dengue→

Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Start the discussion