A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children
3 other identifiers
interventional
7
1 country
1
Brief Summary
To assess the safety, reactogenicity and immunogenicity of two doses of the dengue vaccine in Flavi-virus antibody-naive children between 6 and 9 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 4, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedResults Posted
Study results publicly available
February 24, 2014
CompletedFebruary 24, 2014
January 1, 2014
9 months
October 4, 2006
May 23, 2012
January 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.
Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).
21 days
Secondary Outcomes (6)
Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine
30 days
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine
21 Days (0-20) After the Second Dose of Dengue Vaccine
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.
30 days after the second dose of JE vaccine
Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.
Approximately Day 225 and Day 255
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine.
Approximately Day 225 and Day 255
- +1 more secondary outcomes
Study Arms (1)
Dengue and Japanese Encephalitis vaccine
EXPERIMENTAL1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Interventions
Tetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.
Produced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.
Eligibility Criteria
You may qualify if:
- A male or female child six to nine years of age (greater than or equal to 6 years of age and less than 10 years of age) at the time of the first vaccination.
- Free of obvious health problems as established by medical history and physical examination before entering into the study.
- Seronegative by HAI and screening PRNT for antibodies to dengue types 1-4 and Japanese Encephalitis (JE) virus
- Written informed consents by the parent of the subject for screening and enrollment into the study.
You may not qualify if:
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Use of any investigational or non-registered drug or vaccine other than the protocol-specified vaccines within 30 days preceding the administration of the first dengue vaccine dose or planned use during the study period.
- Planned administration of a vaccine not foreseen by the study protocol and within 30 days prior or after any dengue/JE vaccine administration.
- Any current medical condition determined to be serious by the investigator (e.g. seizures)
- History of chronic headaches or a first order family member (parent or sibling) with a history of chronic headaches
- Abnormal clinical laboratory screening test result (based on normal values set by the laboratory) that is deemed clinically significant by the investigator or Medical Monitor (including seropositivity for HBsAg or anti-HCV)
- Previous vaccination against yellow fever virus, JEV, or tick-borne encephalitis virus (TBE) or existence of any flavivirus antibody
- Any suspected or confirmed immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Family history of a congenital or hereditary immunodeficiency
- Acute illness at time of enrollment (defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infection without fever, i.e., oral temperature \<37.5°C.
- Administration of immunoglobulins and/or blood products within 6 months prior to study entry or planned administration during the study period
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines (including neomycin, streptomycin, gentamicin, amikacin, tobramycin, kanamycin and bacitracin; allergy to dogs or monkeys or hypersensitivity to proteins of rodent or neural origin or to thimerosal, allergy to porcine gelatin)
- Child whose parent has no easy access to a fixed or mobile telephone
- Plans to move from Bangkok during the first 8.5 months after initial vaccination
- Parental illiteracy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, Pharamongkutklao Hospital
Bangkok, 10400, Thailand
Related Publications (1)
Simasathien S, Thomas SJ, Watanaveeradej V, Nisalak A, Barberousse C, Innis BL, Sun W, Putnak JR, Eckels KH, Hutagalung Y, Gibbons RV, Zhang C, De La Barrera R, Jarman RG, Chawachalasai W, Mammen MP Jr. Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus naive children. Am J Trop Med Hyg. 2008 Mar;78(3):426-33.
PMID: 18337339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sriluck Simasathien ; Infectious Disease Consultant
- Organization
- Department of Pediatrics, Pharamongkutklao Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
MAJ Stephen J Thomas, MD
Department of Virology USAMC-AFRIMS
- PRINCIPAL INVESTIGATOR
Sriluck Simasathien, MD
Phramongkutklao College of Medicine and Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2006
First Posted
October 6, 2006
Study Start
August 1, 2003
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
February 24, 2014
Results First Posted
February 24, 2014
Record last verified: 2014-01