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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014