Status:
COMPLETED
Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Dengue
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses ...
Detailed Description
Dengue viruses cause dengue fever and the more severe condition, dengue hemorrhagic fever/shock syndrome. Dengue viruses are common in most tropical and subtropical regions of the world and infection ...
Eligibility Criteria
Inclusion
- In good general health, as determined by physical examination, laboratory screening, and review of medical history
- Documented history or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus \[YFV\], St. Louis encephalitis virus \[SLE\], West Nile virus \[WNV\], Japanese encephalitis virus \[JEV\], or tick-borne encephalitis virus \[TBEV\]) or documented previous receipt of a flavivirus vaccine (licensed or experimental)
- Available for the duration of the study, approximately 26 weeks post-second vaccination
- Willing to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial. More information on this criterion can be found in the protocol.
Exclusion
- Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, or breastfeeding
- 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 participant to understand and cooperate with the requirements of the study protocol
- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in the protocol
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Any significant alcohol or drug abuse in the 12 months prior to study entry that has caused medical, occupational, or family problems, as indicated by a participant's history
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the 6 months prior to study entry)
- 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
- Use of anticoagulant medications
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 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 42 days following vaccination
- Asplenia
- Receipt of blood products within the 6 months prior to study entry, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
- Anticipated receipt of any investigational agent in the 42 days before or after vaccination
- Has definite plans to travel to a dengue endemic area during the study
- Refusal to allow storage of specimens for future research
- Additional Inclusion Criteria for Second Dose of Vaccine:
- In good general health, as determined by physical examination and review of medical history
- Available for the duration of the study, approximately 6 months post-vaccination
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial. More information on this criterion can be found in the protocol.
- Exclusion Criteria for Second Dose of Vaccine:
- Anaphylaxis or angioedema following the first dose of vaccine
- Currently pregnant, as determined by positive beta-HCG test, or breastfeeding
- 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 participant to understand and cooperate with the requirements of the study protocol
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Any significant alcohol or drug abuse in the 12 months prior to study entry that has caused medical, occupational, or family problems, as indicated by a participant's history
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the 6 months prior to study entry)
- HIV infection, by screening and confirmatory assays
- HCV infection, by screening and confirmatory assays
- HBV infection, by HBsAg screening
- Any known immunodeficiency syndrome
- Use of anticoagulant medications
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 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 42 days following vaccination
- Asplenia
- Receipt of blood products within the 6 months prior to study entry, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
- Anticipated receipt of any other investigational agent in the 42 days before or after vaccination
- Has definite plans to travel to a dengue endemic area during the study
- Refusal to allow storage of specimens for future research
- Other Treatments and Ongoing
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01506570
Start Date
December 1 2011
End Date
September 1 2013
Last Update
August 20 2015
Active Locations (3)
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1
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland, United States
2
Fletcher Allen Health Care (FAHC), General Clinical Research Center (GCRC)
Burlington, Vermont, United States
3
University of Vermont Vaccine Testing Center
Burlington, Vermont, United States