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A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children

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ClinicalTrials.gov Identifier: NCT01843621
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

April 22, 2013
April 30, 2013
December 29, 2016
November 26, 2018
November 26, 2018
February 2005
February 2005   (Final data collection date for primary outcome measure)
  • Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) [ Time Frame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 ]
    Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
  • Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) [ Time Frame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 ]
    Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers [GMTs]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
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 ]
Complete list of historical versions of study NCT01843621 on ClinicalTrials.gov Archive Site
  • Solicited Local Adverse Events (AEs) Within 21 Day Follow-up [ Time Frame: 21 days ]
    Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
  • Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination [ Time Frame: 31 days ]
    Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
  • Serious Adverse Events (SAE) Within 31 Days Post Vaccination [ Time Frame: 31 days ]
    Occurrence of SAEs within 31 days (Day 0-30) after vaccination
  • Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination [ Time Frame: 31 days ]
    Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
  • Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster [ Time Frame: Prebooster year 1, 30 Days Post Booster, Year 2, Year 3 ]
    Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)
  • Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose [ Time Frame: 10 days ]
    Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
  • Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) [ Time Frame: 1 year, 30 Days Post Booster, 2 years ]
    The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized. Flavivirus immunity= ratio IgM on IgG <1.8 with either IgM or IgM >1:40 If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of <1.8.
  • Subject Biochemistry and Hematology Parameters Monitored for Alert Levels [ Time Frame: Year 1 (day 0); Year 1 (day 30); Year 2 ]
    Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000
  • 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 ]
Not Provided
Not Provided
 
A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children
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
One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose

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?
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Dengue
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
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
Intervention: Biological: DEN vaccine F17
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
Same as current
February 2009
February 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who received two doses of DEN vaccine in the Dengue-003 study
  • Subjects whos parents signed an informed consent form were eligible for participation in the five year follow-up study

Exclusion Criteria:

Sexes Eligible for Study: All
6 Years to 9 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01843621
A-13227
GSK 103795 ( Other Identifier: GSK )
WRAIR 1159 ( Other Identifier: WRAIR )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: GSK
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
GlaxoSmithKline
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
U.S. Army Medical Research and Materiel Command
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP