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A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children
This study is currently recruiting participants.
Verified by Walter Reed Army Institute of Research (WRAIR), January 2009
First Received: May 1, 2007   Last Updated: January 27, 2009   History of Changes
Sponsor: U.S. Army Office of the Surgeon General
Collaborator: GlaxoSmithKline
Information provided by: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier: NCT00468858
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.


Condition Intervention Phase
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Shock Syndrome
Biological: Tetravalent live attenuated dengue vaccine
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Two Doses of WRAIR Live Attenuated Tetravalent Dengue Vaccine Formulations, Administered Six Months Apart, to Healthy Adults and Children

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of any solicited local and general adverse events [ Time Frame: Within 21 days (days 0-20) f/up period after each vaccine dose ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of each type of solicited local and general adverse events [ Time Frame: Within the 21-day (days 0-20) follow-up period after each vaccine dose ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: Within the 31-day (days 0-30) follow-up period after each vaccine dose ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Throughout the entire study period ] [ Designated as safety issue: Yes ]
  • N antibody titers to each DEN serotype [ Time Frame: At month 7 in unprimed subjects ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of suspected and laboratory confirmed dengue [ Time Frame: Throughout the entire study period ] [ Designated as safety issue: Yes ]
  • N antibody titer above the assay cut off to each DEN serotype [ Time Frame: At months 0, 3, 6, and 7 ] [ Designated as safety issue: No ]
  • N antibody titer above the assay cut-off to all dengue serotypes [ Time Frame: At months 0, 3, 6, and 7 ] [ Designated as safety issue: No ]
  • N sero-response to each DEN serotype [ Time Frame: At months 0, 3, 6, and 7 ] [ Designated as safety issue: No ]
  • N antibody titer to each DEN serotype [ Time Frame: At months 0, 3, 6, and 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: April 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

In this study, children and adults at multiple sites in Puerto Rico will be randomly allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by age group (a specific number of subjects in each of 4 age groups [12 months to 50 years of age] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures. Safety follow-up for dengue may require unscheduled visits and venipunctures.

Multiple DEN virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for dengue. The results of this phase II study will provide a basis for identifying the vaccine formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a high proportion of vaccine recipients. The most immunogenic and well tolerated candidate formulation identified in this study will be considered for advancement to phase III development.

  Eligibility

Ages Eligible for Study:   12 Months to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • A healthy male or non-pregnant female between 12 months (mths) and 50 years (yrs) 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;
  • For children: 23mths of age, full compliance with the United States Advisory Committee on Immunization Practices (U.S. ACIP) recommended childhood immunization schedule;
  • Written informed consent obtained from the subject or a parent/guardian and assent for subjects 7-20 yrs of age;
  • If the subject is female, she must be of non-childbearing potential, i.e. either pre-menarcheal, surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; condom and spermicide combination, oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days (dys) prior to vaccination, have a negative pregnancy test within 48 hrs prior to vaccination and must agree to continue such precautions for 60 dys after completion of the vaccination series. Any child who begins menarche during the study period must follow the same precautions listed above, from menarche until 60 dys after the second vaccine dose.

Exclusion Criteria:

  • Pregnant or lactating female;
  • Female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
  • History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
  • History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;
  • Any confirmed or suspected immunosuppressive or immunodeficient condition;
  • Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever); note that vaccine can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., equivalent to an oral temperature <37.5°C/<99.5°F.
  • Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;
  • Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 dys preceding the first dose of study vaccine/placebo or planned use during the study period;
  • Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 dys before each dose of the study vaccine and ending 30 dys after; with the exception of standard infant and children "inactivated" vaccines or the inactivated influenza vaccine administered to adults or children;
  • A planned move to a location that will prohibit participating in the trial for the 12 mth duration;
  • Chronic administration (defined as more than 14 dys) of immunosuppressants or other immune-modifying drugs within 90 dys preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;
  • Administration of immunoglobulins and/or blood products within 90 dys preceding the first dose or planned administration during the study period;
  • Hypertension;
  • Chest pain, palpitations, dizziness, shortness of breath unrelated to asthma, arrhythmias or friction rubs;
  • Any chronic systemic drug therapy to be continued during the study period (except for vitamin/mineral supplements, routine treatment for gastro-esophageal reflux);
  • Potential adult volunteers, or parents of potential child volunteers, who do not have easy access to a fixed or mobile telephone;
  • History of chronic alcohol consumption and/or drug abuse.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468858

Contacts
Contact: Faina Rose, PhD 610-664-8986 Faina.v.rose@gsk.com
Contact: Maggie Schultz, PhD 610-787-3457 Maggie.schultz-1@gsk.com

Locations
Puerto Rico
RCMI Clinical Research Center Recruiting
Rio Piedras, Puerto Rico, 00935
Contact: Awilda Candelario     787-777-3535 ext 7230     awildacv@hotmail.com    
Contact: Janet Berrios-Montes     787-777-3535 ext 7230        
Principal Investigator: Jorge Bertran-Pasarell, MD            
Dept Pediatria, Esc. De Medicina Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Lizmarie Torres-Rodriguez     787-771-0056     litorres@rcm.upr.edu    
Contact: Jaime Perez-Martinez     787-759-9595        
Sub-Investigator: Clemente Diaz-Perez, MD            
Sub-Investigator: Ines O Esquilin-Rivera, MD            
Caparra Internal Medicine Research Center Recruiting
Rio Grande, Puerto Rico, 00745
Contact: Brenda Molina-Elicier     787-809-4025     bmolinacrc@yahoo.com    
Principal Investigator: Evelyn Matta-Fontanet, MD            
St Luke's Memorial Hospital Recruiting
Ponce, Puerto Rico, 00733
Contact: Maritza Santiago     787-403-0112     isa106@hotmail.com    
Principal Investigator: Domingo Chardon-Feliciano, MD            
Clinical Research PR Recruiting
San Juan, Puerto Rico, 00909-1711
Contact: Helvetia Negron     787-723-5945     crpr@coqui.net    
Principal Investigator: Javier Morales-Ramirez, MD            
San Juan Batista Medical School Recruiting
Caguas, Puerto Rico, 00725
Contact: Carmen Morales     787-653-0550 ext 11014        
Principal Investigator: Anna Quintero, MD            
Centro de Neumologia Pediatricia Recruiting
San Juan, Puerto Rico, 00917
Contact: Vivian Medina     787-439-2762     vm@pedasthma.com    
Principal Investigator: Jose Rodriguez-Santana, MD            
Private Practice Recruiting
Rio Piedras, Puerto Rico, 00926
Contact: Irma Sotomayor     787-764-8281     irmasotomayor@hotmail.com    
Contact: Myra Ayala     787-764-8281     myra.ayala@gmail.com    
Principal Investigator: Miguel Sosa-Padilla, MD            
Private Practice Recruiting
San Juan, Puerto Rico, 00921
Contact: Juan Ojeda     787-792-3203        
Contact: Priscilla Rivera, Ferlinda Arocho     787-792-9833        
Principal Investigator: Jose Tavarez-Valle, MD            
Torre Medica San Vicente de Paul Recruiting
San German, Puerto Rico, 00683
Contact: Carmen Burgos     787-892-1860 ext 4803, 4804        
Principal Investigator: Alberto Santiago-Cornier, MD            
Private Practice Recruiting
Carolina, Puerto Rico, 00983
Contact: Mildred Vega     787-782-7897     vegamaeva@aol.com    
Principal Investigator: Luis Rodriguez-Carrasquillo, MD            
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
GlaxoSmithKline
Investigators
Principal Investigator: Jorge Bertran-Pasarell, MD Dept Medicina Interna Seccion Enfermedades Infecciosas
Principal Investigator: Clemente Diaz-Perez, MD University of PR
Principal Investigator: Ines O. Esquilin-Rivera, MD University of PR
Principal Investigator: Evelyn Matta-Fontanet, MD Caparra Internal Medicine Research Center
Principal Investigator: Domingo Chardon-Feliciano, MD Ponce School of Medicine
Principal Investigator: Javier Morales-Ramirez, MD Clinical Research PR
Principal Investigator: Luis Rodriguez-Carrasquillo, MD Private Practice, PR
Principal Investigator: Jose Rodriguez-Santana, MD Centro de Neumologia pediatrica
Principal Investigator: Miguel Sosa-Padilla, MD Private Practice PR
Principal Investigator: Jose Tavarez-Valle, MD Private Practice, PR
Principal Investigator: Alberto Santiago-Cornier, MD Department of Molecular Medicine
Principal Investigator: Anna Quintero, MD San Juan Batista Medical School
  More Information

No publications provided

Study ID Numbers: GSK 106405, WIRB number20070071, HRPO 14040
Study First Received: May 1, 2007
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00468858     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Dengue
Virus
Live-attenuated
Vaccine
Dengue viral infection
Dengue Vaccine

Additional relevant MeSH terms:
Dengue Hemorrhagic Fever
Dengue
RNA Virus Infections
Disease
Flavivirus Infections
Flaviviridae Infections
Body Temperature Changes
Fever
Virus Diseases
Signs and Symptoms
Hemorrhagic Fevers, Viral
Pathologic Processes
Shock
Syndrome
Arbovirus Infections

ClinicalTrials.gov processed this record on November 30, 2009