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

Primary Purpose

Dengue

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rDEN3-3'D4delta30
rDEN3-3'D4delta30
rDEN3-3'D4delta30
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Center for Immunization Research, Johns Hopkins School of Public Health
  • Center for Immunization Research, Johns Hopkins University of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Safety and immunogenicity, as assessed by neutralizing antibody titers
Frequency of vaccine related adverse events as graded by severity

Secondary Outcome Measures

Frequency, quantity, and duration of viremia after a single dose of vaccine
Number of vaccines infected with rDEN3-3'D4delta30
Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine
Durability of antibody response
Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed

Full Information

First Posted
July 8, 2008
Last Updated
December 31, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00712803
Brief Title
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults
Official Title
A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3-3'Ddelta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
One subcutaneous vaccination (10^3 dose of vaccine) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
rDEN3-3'D4delta30
Intervention Description
Live attenuated 10^3 dose of rDEN3-3'D4delta30 vaccine.
Intervention Type
Biological
Intervention Name(s)
rDEN3-3'D4delta30
Intervention Description
Live attenuated 10^5 dose of rDEN3-3'D4delta30 vaccine.
Intervention Type
Biological
Intervention Name(s)
rDEN3-3'D4delta30
Intervention Description
Live attenuated 10^1 dose of rDEN3-3'D4delta30 vaccine.
Primary Outcome Measure Information:
Title
Safety and immunogenicity, as assessed by neutralizing antibody titers
Time Frame
At 4 weeks and 6 weeks after vaccination
Title
Frequency of vaccine related adverse events as graded by severity
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Frequency, quantity, and duration of viremia after a single dose of vaccine
Time Frame
Throughout study
Title
Number of vaccines infected with rDEN3-3'D4delta30
Time Frame
Throughout study
Title
Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine
Time Frame
Throughout study
Title
Durability of antibody response
Time Frame
At 26 Weeks after vaccination
Title
Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General good health Available for the duration of the study Willing to use accepted forms of contraception 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Durbin, MD
Organizational Affiliation
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Immunization Research, Johns Hopkins School of Public Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Center for Immunization Research, Johns Hopkins University of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15642976
Citation
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.
Results Reference
background
PubMed Identifier
15937367
Citation
Chaturvedi UC, Shrivastava R, Nagar R. Dengue vaccines: problems and prospects. Indian J Med Res. 2005 May;121(5):639-52.
Results Reference
background
PubMed Identifier
15566333
Citation
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.
Results Reference
background

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

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