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

2014-08-27 03:42:13 | BioPortfolio

Summary

To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine

Description

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).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Dengue

Intervention

Dengue vaccine

Location

Department of Pediatrics, Pharamongkutklao Hospital
Bangkok
Thailand
10400

Status

Completed

Source

Walter Reed Army Institute of Research (WRAIR)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:13-0400

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Medical and Biotech [MESH] Definitions

An acute infectious, eruptive, febrile disease caused by four antigenically related but distinct serotypes of the DENGUE VIRUS. It is transmitted by the bite of infected Aedes mosquitoes, especially A. aegypti. Classical dengue (dengue fever) is self-limiting and characterized by fever, myalgia, headache, and rash. DENGUE HEMORRHAGIC FEVER is a more virulent form of dengue virus infection and a separate clinical entity. (From Dorland, 28th ed)

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A species of the genus FLAVIVIRUS which causes an acute febrile and sometimes hemorrhagic disease in man. Dengue is mosquito-borne and four serotypes are known.

Vaccines or candidate vaccines used to prevent infection with DENGUE VIRUS. These include live-attenuated, subunit, DNA, and inactivated vaccines.

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