DenguePhase 1/2NCT01843621

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

A Phase 1/2 study testing DEN vaccine F17 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 6 to 9 yearsHealthy volunteers can take part
Conditions the study is for: Dengue
What is being tested?: DEN vaccine F17
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteThailand
Study dates: Feb 2005to Feb 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Department of Pediatrics, Phramongkutklao Hospital
Phayathai, Bangkok, 10400

Other trials in Thailand

About this study

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

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

Read the detailed 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?

Conditions: Dengue
Being tested: DEN vaccine F17
Keywords: Dengue, Vaccine, Thailand
Medical subject headings: Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DEN vaccine F17Biological
Also called Live attenuated tetravalent dengue (DEN) vaccine
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).

Study groups in NCT01843621
Study group	Role	What they receive
Total vaccinated	Experimental	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 Receives: Biological: DEN vaccine F17

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3

Secondary outcomes (8)

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).
Measured: 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)
Measured: 31 days
Serious Adverse Events (SAE) Within 31 Days Post Vaccination
Occurrence of SAEs within 31 days (Day 0-30) after vaccination
Measured: 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)
Measured: 31 days
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)
Measured: Prebooster year 1, 30 Days Post Booster, Year 2, Year 3
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
Measured: 10 days
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.
Measured: 1 year, 30 Days Post Booster, 2 years
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
Measured: Year 1 (day 0); Year 1 (day 30); Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Feb 2009

First posted30 Apr 2013 (estimated)
Study startFeb 2005
Primary completionFeb 2005
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DengueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843621
Sponsor's protocol ID: A-13227
Other IDs: GSK 103795, WRAIR 1159
Status last verified: May 2018
First submitted: 22 Apr 2013
Last updated: 26 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: GSK

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs

All Dengue trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01843621
Acronym / sponsor ID: A-13227
Conditions: Dengue
Keywords: Dengue, Vaccine, Thailand
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: GlaxoSmithKline
Study start: Feb 2005
Primary completion: Feb 2005 (actual)
Study completion: Feb 2009 (actual)
First posted: 30 Apr 2013 (estimated)
Results: Posted 26 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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 design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Total vaccinated	Experimental	Biological: DEN vaccine F17The 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

Who may qualify

Ages: 6 to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DEN vaccine F17Also: Live attenuated tetravalent dengue (DEN) vaccineThe 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).	Biological	Total vaccinated

Primary outcome

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.
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.

8 secondary outcomes

Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Time frame: 21 days
Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Time frame: 31 days
Serious Adverse Events (SAE) Within 31 Days Post Vaccination
Time frame: 31 days
Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination
Time frame: 31 days
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
Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose
Time frame: 10 days
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
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Time frame: Year 1 (day 0); Year 1 (day 30); Year 2

Results and safety

Results posted to the registry on 26 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Vaccinated	7	7

Primary outcome: 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. Mean (95% Confidence Interval). Unit: % of subjects

Measure	> 10 ED50 n = 6
N lg to DEN-1: Prebooster Year 1	16.7 (0.4 to 64.1)
N lg to DEN-1: 30 Days Post Booster	83.3 (35.9 to 99.6)
N lg to DEN-1: Year 2	16.7 (0.4 to 64.1)
N lg to DEN-1: Year 3	66.7 (22.3 to 95.7)
N lg to DEN-2: Prebooster Year 1	50.0 (11.8 to 88.2)
N lg to DEN-2: 30 Days Post Booster	100 (54.1 to 100)
N lg to DEN-2: Year 2	66.7 (22.3 to 95.7)
N lg to DEN-2: Year 3	83.3 (35.9 to 99.6)

Population analysed: Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1

Primary outcome: 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. Mean (95% Confidence Interval). Unit: GMTs

Measure	Geometric Mean Titer (GMT) n = 6
N lg to DEN-1: Pre-booster Year 1	6.0 (3.8 to 9.6)
N lg to DEN-1: 30 Days Post-booster	28.2 (6.6 to 121.3)
N lg to DEN-1: Year 2	6.8 (3.1 to 15.1)
N lg to DEN-1: Year 3	18.0 (5.2 to 63.0)
N lg to DEN-2: Pre-booster Year 1	16.8 (3.4 to 82.5)
N lg to DEN-2: 30 Day Post-booster	94.4 (24.0 to 370.3)
N lg to DEN-2: Year 2	20.8 (4.6 to 92.9)
N lg to DEN-2: Year 3	36.3 (7.0 to 186.8)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 21 days post vaccination period following each dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Vaccinated	0 of 7 (0%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. GSK

Related trials for Dengue

Active, not recruitingPhase 3
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Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sriluck Simasathien, M.D. principal investigator

Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand

Robert Gibbons, M.D. principal investigator

Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DEN vaccine F17 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.