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Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine

Primary Purpose

Dengue Virus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Investigational Vaccine for DEN1
Placebo injection
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 Virus focused on measuring Vaccine, Dengue Hemorrhagic Fever

Eligibility Criteria

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

Inclusion Criteria:

  • In good general health as determined by physical examination, laboratory screening, and review of medical history
  • Available for the duration of the study, including approximately 6 weeks post-vaccination
  • Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial

Exclusion Criteria:

  • Currently breast-feeding or pregnant
  • Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
  • Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
  • Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol
  • Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
  • Significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by participant history
  • History of a severe allergic reaction or anaphylaxis
  • Severe asthma (emergency room visit or hospitalization within the last 6 months)
  • Presence of HIV infection, determined by screening and confirmatory assays
  • Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
  • Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
  • Presence of any known immunodeficiency syndrome
  • Uses anticoagulant medications
  • Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
  • Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipated receipt of any vaccine during the 42 days following vaccination
  • Has no spleen
  • Received blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
  • History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
  • Has received a flavivirus vaccine (licensed or experimental)
  • Anticipates receipt of any investigational agent in the 42 days before or after vaccination
  • Participant has definite plans to travel to a dengue endemic area during the study

Sites / Locations

  • Fletcher Allen Health Care (FAHC) General Clinical Research Center (GCRC)
  • University of Vermont Vaccine Testing Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DEN1 Vaccine

Placebo

Arm Description

Participants will receive a single dose of investigational vaccine for dengue virus subtype 1.

Participants will receive a single dose of placebo vaccine.

Outcomes

Primary Outcome Measures

Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance
Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers

Secondary Outcome Measures

Frequency, quantity, and duration of viremia following vaccination
Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1
Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials

Full Information

First Posted
March 8, 2010
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
NCT01084291
Brief Title
Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
Official Title
A Phase I Evaluation of the Safety and Immunogenicity of the rDEN1∆30 Dengue Serotype 1 Vaccine Given at a Single Dose of 101 PFU in Healthy Flavivirus-naïve Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (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 viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. There are four types of dengue virus, and infection with one does not offer protection against the others. This study will test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes a response in people's immune system and is safe.
Detailed Description
The dengue virus causes approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing infection with DEN1. Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test, and then receive the vaccine. Participants will be given a thermometer and temperature card, and be told to record their temperature three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination, and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Virus
Keywords
Vaccine, Dengue Hemorrhagic Fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEN1 Vaccine
Arm Type
Experimental
Arm Description
Participants will receive a single dose of investigational vaccine for dengue virus subtype 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single dose of placebo vaccine.
Intervention Type
Biological
Intervention Name(s)
Investigational Vaccine for DEN1
Other Intervention Name(s)
rDEN1∆30 vaccine
Intervention Description
Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Intervention Type
Other
Intervention Name(s)
Placebo injection
Intervention Description
Subcutaneous injection of placebo
Primary Outcome Measure Information:
Title
Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance
Time Frame
Measured throughout study
Title
Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers
Time Frame
Measured 4 and 6 weeks after vaccination
Secondary Outcome Measure Information:
Title
Frequency, quantity, and duration of viremia following vaccination
Time Frame
Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42
Title
Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1
Time Frame
Measured at study completion
Title
Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials
Time Frame
Measured at study completion

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: In good general health as determined by physical examination, laboratory screening, and review of medical history Available for the duration of the study, including approximately 6 weeks post-vaccination Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial Exclusion Criteria: Currently breast-feeding or pregnant Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol Significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by participant history History of a severe allergic reaction or anaphylaxis Severe asthma (emergency room visit or hospitalization within the last 6 months) Presence of HIV infection, determined by screening and confirmatory assays Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening Presence of any known immunodeficiency syndrome Uses anticoagulant medications Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days. Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipated receipt of any vaccine during the 42 days following vaccination Has no spleen Received blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus) Has received a flavivirus vaccine (licensed or experimental) Anticipates receipt of any investigational agent in the 42 days before or after vaccination Participant has definite plans to travel to a dengue endemic area during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Durbin, MD
Organizational Affiliation
CIR, Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beth Kirkpatrick, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fletcher Allen Health Care (FAHC) General Clinical Research Center (GCRC)
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Vermont Vaccine Testing Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16553547
Citation
Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
Results Reference
background
PubMed Identifier
12502885
Citation
Whitehead SS, Falgout B, Hanley KA, Blaney JE Jr, Markoff L, Murphy BR. A live, attenuated dengue virus type 1 vaccine candidate with a 30-nucleotide deletion in the 3' untranslated region is highly attenuated and immunogenic in monkeys. J Virol. 2003 Jan;77(2):1653-7. doi: 10.1128/jvi.77.2.1653-1657.2003.
Results Reference
background

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Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine

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