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Completed

NCT Number: NCT01843621

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

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

Completed

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Pediatrics, Phramongkutklao Hospital

Phayathai, Bangkok, 10400, Thailand

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEN vaccine F17

Biological

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).

Other names: Live attenuated tetravalent dengue (DEN) vaccine

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

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

    Time frame: 21 days

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

  2. Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination

    Time frame: 31 days

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

  3. Serious Adverse Events (SAE) Within 31 Days Post Vaccination

    Time frame: 31 days

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

  4. Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination

    Time frame: 31 days

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

  5. Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster

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

    Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)

  6. Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose

    Time frame: 10 days

    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

  7. Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)

    Time frame: 1 year, 30 Days Post Booster, 2 years

    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.

  8. Subject Biochemistry and Hematology Parameters Monitored for Alert Levels

    Time frame: Year 1 (day 0); Year 1 (day 30); Year 2

    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

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2009
First posted
Apr 30, 2013
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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