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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01843621
First received: April 22, 2013
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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?

Condition Intervention Phase
Dengue
Biological: F 17
Biological: Japanese encephalitis virus
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of solicited adverse events (AEs) within 21 days follow-up after the DEN vaccine dose [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited non-serious AEs within 31 days (Day 0-30) after the DEN vaccine dose [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]
  • Occurence of serious adverse events (SAE) within 31 days (Day 0-30) after the DEN dose [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]
  • Occurence of abnormal findings at dengue physical examination after each vaccine dose [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To assess the immunogenicity of a booster dose of dengue vaccine administered approximately one year following the second dose [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Tetravalent neutralizing antibody, 30 days after the DEN vaccine booster dose [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Presence of dengue viremia 10 days after the dengue vaccine dose [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Tetravalent neutralizing antibody and neutralizing antibodies to each dengue virus serotype one and two years after the booster dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Flavivirus infection in terms of dengue immunoglobulin M and immunoglobulin G per subject (ATP cohort for immunogenicity) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: February 2005
Study Completion Date: February 2009
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post-Transfection F17
Live attenuated tetravalent dengue (DEN) vaccine
Biological: F 17
Other Name: Live attenuated tetravalent dengue (DEN) vaccine
Experimental: JE
Japanese encephalitis virus
Biological: Japanese encephalitis virus

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843621

Locations
Thailand
Department of Pediatrics, Phramongkutklao Hospital
Phayathai, Bangkok, Thailand, 10400
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
GlaxoSmithKline
Investigators
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
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01843621     History of Changes
Obsolete Identifiers: NCT00318916
Other Study ID Numbers: A-13227, GSK 103795, WRAIR 1159
Study First Received: April 22, 2013
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration
Thailand: Ethical Review Committee, Royal Thai Army Medical Department
Thailand: The Ethical Review Committee for Research in Human Subjects. Ministry of Public Health

Keywords provided by U.S. Army Medical Research and Materiel Command:
Dengue, Vaccine, Thailand

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on April 16, 2014