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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dengue

Treatments: Biological: DEN vaccine F17

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01843621

A-13227

WRAIR 1159 (Other Identifier)

GSK 103795 (Other Identifier)

Details and patient eligibility

About

One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose

Full description

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?

Enrollment: 7 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Total vaccinated

Experimental group

Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

Treatment:

Biological: DEN vaccine F17