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

U.S. Army Medical Research and Development Command7 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dengue

Interventions

DEN vaccine F17BIOLOGICAL

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).

Eligibility

Sex: ALLMin age: 6 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * None

Locations (1)

Department of Pediatrics, Phramongkutklao Hospital

Phayathai, Bangkok, Thailand

Outcomes

Primary Outcomes

Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)

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.

Time frame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3

Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)

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.

Time frame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3

Secondary Outcomes

Solicited Local Adverse Events (AEs) Within 21 Day Follow-up

Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).

Time frame: 21 days

Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination

Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)

Time frame: 31 days

Serious Adverse Events (SAE) Within 31 Days Post Vaccination

Occurrence of SAEs within 31 days (Day 0-30) after vaccination

Time frame: 31 days

Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination

Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)

Data from ClinicalTrials.gov

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