A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children
The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children
- Do children still have dengue antibodies intended to provide protection against dengue infection one year after the two doses of vaccine given in study Dengue-003?
- Were there any major medical problems that appeared as dengue-like symptoms during the one year after vaccinations?
- Will a third dose of dengue help to further stimulate the part of the immune system intended to help protect against dengue infection?
- Is a third dose as safe as the first two doses?
- Are the local reactions to a third dose of the vaccine similar to what your child experienced after the first two doses?
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase I/II, Open, Five-year, Clinical Follow-up Study of Thai Children Who Participated in Dengue-003 ("A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children") With Evaluation of a Booster Dose Given One Year After Primary DEN Vaccination Series|
- Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates and geometric mean titers [GMTs] to each dengue virus serotype, 30 days after the DEN vaccine booster dose [ Time Frame: 30 days after the DEN vaccine booster dose ]
- Occurrence of solicited adverse events (AEs) within 21 days follow-up after the DEN vaccine dose [ Time Frame: 21 days ]
- Occurrence of unsolicited non-serious AEs within 31 days (Day 0-30) after the DEN vaccine dose [ Time Frame: 31 days ]
- Occurence of serious adverse events (SAE) within 31 days (Day 0-30) after the DEN dose [ Time Frame: 31 days ]
- Occurence of abnormal findings at dengue physical examination after each vaccine dose [ Time Frame: 5 years ]
- Biochemistry and hematology parameters at Visit 1 (Day 0, year 1 post dose 2), Visit 3 (Day 10), Visit 5 (Month 1) and Visit 6 (Year 2) [ Time Frame: 2 years ]
- To assess the immunogenicity of a booster dose of dengue vaccine administered approximately one year following the second dose [ Time Frame: 30 days ]
- Tetravalent neutralizing antibody, 30 days after the DEN vaccine booster dose [ Time Frame: 30 days ]
- Neutralizing antibodies to each dengue virus serotype, before the DEN vaccine booster dose at Visit 1 (Day 0, Year 1 post Dose 2 [ Time Frame: 1 Year ]
- Presence of dengue viremia 10 days after the dengue vaccine dose [ Time Frame: 10 days ]
- Tetravalent neutralizing antibody and neutralizing antibodies to each dengue virus serotype one and two years after the booster dose [ Time Frame: 2 years ]
- Neutralizing antibody titers to Japanese encephalitis virus at visit 1 (Day, 0 ,Year 1 post Dose 2), visit 5 (Month 1) and visit 6 ( Year 2) [ Time Frame: 2 years ]
- Flavivirus infection in terms of dengue immunoglobulin M and immunoglobulin G per subject (ATP cohort for immunogenicity) [ Time Frame: 2 years ]
|Study Start Date:||February 2005|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
Experimental: Total vaccinated
The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003
Biological: DEN vaccine F17
The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
Other Name: Live attenuated tetravalent dengue (DEN) vaccine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843621
|Department of Pediatrics, Phramongkutklao Hospital|
|Phayathai, Bangkok, Thailand, 10400|
|Principal Investigator:||Sriluck Simasathien, M.D.||Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand|
|Principal Investigator:||Robert Gibbons, M.D.||Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand|