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Sponsors and Collaborators: |
U.S. Army Medical Research and Materiel Command GlaxoSmithKline |
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Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
ClinicalTrials.gov Identifier: | NCT00384670 |
To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine
Condition | Intervention | Phase |
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Dengue Vaccine |
Biological: Dengue vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children |
Estimated Enrollment: | 10 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | May 2004 |
This study was a Phase I/II, open-label trial with one treatment group; 7, healthy, flavivirus naïve children between the ages of 6 and 7 years residing in Bangkok, Thailand. Seronegative status was determined by measuring neutralizing (N) antibody titers to dengue 1-4 and JE virus (JE) using HAI (1st) and PRNT (2nd) assays. Titers <10 and <10, respectively, were considered negative. Enrolled children received two doses of tetravalent dengue vaccine at study months 0 and 6, and two doses of JE vaccine (study benefit) at study months 7 and 7.5. Enrolled children attended 20 study visits, received 4 injections, and 7 venipunctures (one additional blood sample for screening). In the acute period (1 month) following vaccination, safety was assessed using symptom diary cards and clinical and laboratory evaluations. Viremia was measured 10 days post dengue vaccination. Solicited and unsolicited adverse events were assessed for 30 days following each dengue vaccination. Serious adverse events were assessed throughout the study period. In the case of illness, investigators would complete additional clinical and virologic evaluations. Dengue vaccine immunogenicity was assessed 30 days following each dengue vaccination using the PRNT50 assay. The According to Protocol (ATP) cohort was determined by evaluating the occurrence of intermittent natural dengue infection using ELISA IgM/IgG titer ratios. A long-term follow-up of dengue vaccine recipients is described in a separate protocol (Dengue-005 protocol).
Ages Eligible for Study: | 6 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
Department of Pediatrics, Pharamongkutklao Hospital | |
Bangkok, Thailand, 10400 |
Principal Investigator: | MAJ Stephen J Thomas, MD | Department of Virology USAMC-AFRIMS |
Study ID Numbers: | WRAIR 1048, HSRRB#A-12189, GSK Dengue-003 |
Study First Received: | October 4, 2006 |
Last Updated: | October 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00384670 |
Health Authority: | United States: Food and Drug Administration |
dengue vaccine |
Virus Diseases Fever Antibodies Hemorrhagic Fevers, Viral Dengue Hemorrhagic fever |
Viral hemorrhagic fever Dengue fever Arbovirus Infections Immunoglobulins Dengue Hemorrhagic Fever |
RNA Virus Infections Flaviviridae Infections Flavivirus Infections |