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

Dengue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843621
• Other study ID #: A-13227
• Secondary ID: GSK 103795WRAIR
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2005
• Est. completion date: February 2009

Study information

• Verified date: May 2018
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Other known NCT identifiers

• NCT00318916

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2009
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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:

Related Conditions & MeSH terms

• Dengue

Intervention

Biological:
• DEN vaccine F17
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).

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Phramongkutklao Hospital	Phayathai	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	GlaxoSmithKline

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Primary	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.	Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Secondary	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).	21 days
Secondary	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)	31 days
Secondary	Serious Adverse Events (SAE) Within 31 Days Post Vaccination	Occurrence of SAEs within 31 days (Day 0-30) after vaccination	31 days
Secondary	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)	31 days
Secondary	Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster	Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)	Prebooster year 1, 30 Days Post Booster, Year 2, Year 3
Secondary	Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose	Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination	10 days
Secondary	Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)	The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized.; Flavivirus immunity= ratio IgM on IgG <1.8 with either IgM or IgM >1:40; If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component =40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of <1.8.	1 year, 30 Days Post Booster, 2 years
Secondary	Subject Biochemistry and Hematology Parameters Monitored for Alert Levels	Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717.; Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000	Year 1 (day 0); Year 1 (day 30); Year 2