Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
Primary Purpose
Dengue
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TetraVax-DV TV005
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Dengue focused on measuring Dengue Vaccine
Eligibility Criteria
Inclusion Criteria:
- Adult flavivirus-naive male or non-pregnant females 50 - 70 years of age, inclusive
- Good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study, approximately 26 weeks post-vaccination
- Willingness to participate in the study as evidenced by signing the informed consent document
- Females only: Female subjects of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (6 months or longer since last sexual encounter). All female subjects will be considered having childbearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.
Exclusion Criteria:
- Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test; or breastfeeding (females only)
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC) or alanine aminotransferase (ALT), as defined in this protocol
- Serum creatinine level above the laboratory-defined upper limit of normal
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
- Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the last 6 months)
- HIV infection, by screening and confirmatory assays
- Hepatitis C virus (HCV) infection, by screening and confirmatory assays
- Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening
- Any known immunodeficiency syndrome
- Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications)
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. 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.
- Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 21 days following vaccination
- Asplenia
- Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
- History and/or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, West Nile virus)
- Previous receipt of a flavivirus vaccine (licensed or experimental)
- Anticipated receipt of any investigational agent in the 28 days before or after vaccination
- Definite plan to travel to a dengue-endemic area during the study
- Refusal to allow storage of specimens for future research
Sites / Locations
- Center for Immunization Research, Johns Hopkins School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TetraVax-DV TV005
Placebo
Arm Description
Participants will receive a subcutaneous injection of TetraVax-DV TV005 at study entry (Day 0).
Participants will receive a subcutaneous injection of placebo at study entry (Day 0).
Outcomes
Primary Outcome Measures
Frequency of TV005-related adverse events (AEs)
AEs classified by both severity and seriousness, through active and passive surveillance
Secondary Outcome Measures
Full Information
NCT ID
NCT02879266
First Posted
August 22, 2016
Last Updated
March 30, 2018
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT02879266
Brief Title
Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
Official Title
Phase I Evaluation of the Safety and Immunogenicity of an Investigational Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naïve Adults 50 - 70 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
undefined (undefined)
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
This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.
Detailed Description
Dengue viruses (DENV) are widespread in most tropical and subtropical regions of the world. There are four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4); each can cause dengue infection. Infection with dengue viruses can range from mild illness to life-threatening disease. TetraVax-DV TV005 (also referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine developed to protect against all four dengue virus serotypes. The purpose of this study is to evaluate the safety and immunogenicity of TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.
Participants will be randomly assigned to receive a subcutaneous injection of either TV005 or placebo at study entry (Day 0). After receiving the injection, participants will record their temperature 3 times a day through Day 16. Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include a physical examination and blood collection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
Dengue Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TetraVax-DV TV005
Arm Type
Experimental
Arm Description
Participants will receive a subcutaneous injection of TetraVax-DV TV005 at study entry (Day 0).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a subcutaneous injection of placebo at study entry (Day 0).
Intervention Type
Biological
Intervention Name(s)
TetraVax-DV TV005
Other Intervention Name(s)
TV005
Intervention Description
Contains 10^3 plaque-forming units (PFUs) of rDEN1Δ30, 10^4 PFUs of rDEN2/4Δ30(ME), 10^3 PFUs of rDEN3Δ30/31-7164, and 10^3 PFUs of rDEN4Δ30; administered by subcutaneous injection in the deltoid region of the upper arm
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection in the deltoid region of the upper arm
Primary Outcome Measure Information:
Title
Frequency of TV005-related adverse events (AEs)
Description
AEs classified by both severity and seriousness, through active and passive surveillance
Time Frame
Measured through Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult flavivirus-naive male or non-pregnant females 50 - 70 years of age, inclusive
Good general health as determined by physical examination, laboratory screening, and review of medical history
Available for the duration of the study, approximately 26 weeks post-vaccination
Willingness to participate in the study as evidenced by signing the informed consent document
Females only: Female subjects of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (6 months or longer since last sexual encounter). All female subjects will be considered having childbearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.
Exclusion Criteria:
Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test; or breastfeeding (females only)
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol
Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC) or alanine aminotransferase (ALT), as defined in this protocol
Serum creatinine level above the laboratory-defined upper limit of normal
Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history
History of a severe allergic reaction or anaphylaxis
Severe asthma (emergency room visit or hospitalization within the last 6 months)
HIV infection, by screening and confirmatory assays
Hepatitis C virus (HCV) infection, by screening and confirmatory assays
Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening
Any known immunodeficiency syndrome
Current use of anticoagulant medications (this does not include anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications)
Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. 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.
Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 21 days following vaccination
Asplenia
Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
History and/or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, West Nile virus)
Previous receipt of a flavivirus vaccine (licensed or experimental)
Anticipated receipt of any investigational agent in the 28 days before or after vaccination
Definite plan to travel to a dengue-endemic area during the study
Refusal to allow storage of specimens for future research
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
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
We'll reach out to this number within 24 hrs