A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00468858
First received: May 1, 2007
Last updated: June 4, 2012
Last verified: June 2012

May 1, 2007
June 4, 2012
April 2007
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Occurrence, intensity and relationship to vaccination of any solicited local and general adverse events (AEs) within the 21-day (days 0-20) follow-up period after each vaccine dose;
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs within the 31-day (days 0-30) follow-up period after each vaccine dose
  • Occurrence of serious adverse events (SAEs) throughout the entire study period.
  • N antibody titers to each DEN serotype at month 7 in unprimed subjects.
  • Safety
  • Immunogenicity
  • Occurrence, intensity and relationship to vaccination of each type of solicited local and general adverse events (AEs) within the 21-day (days 0-20) follow-up period after each vaccine dose
Complete list of historical versions of study NCT00468858 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety
  • Occurrence of suspected and laboratory confirmed dengue throughout the entire study period.
  • Immunogenicity
  • N antibody titer above the assay cut off, to each DEN serotype at months 0, 3, 6 and 7;
  • N antibody titer above the assay cut-off, to all dengue serotypes at months 0, 3, 6 and 7;
  • N sero-response to each DEN serotype at months 0, 3, 6 and 7
  • N antibody titer to each DEN serotype at months 0, 3, 6 and 7.
Not Provided
Not Provided
 
A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Shock Syndrome
  • Other: Placebo
    Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose; Vaccination schedule: 0,6 months
  • Biological: Post-Transfection F17
    Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
  • Biological: Post-Transfection F19
    Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
  • Experimental: Post-Transfection F17
    Post-Transfection F17, full dose
    Intervention: Biological: Post-Transfection F17
  • Experimental: Post-Transfection F19
    Post-Transfection F19, full dose
    Intervention: Biological: Post-Transfection F19
  • Placebo Comparator: Placebo
    Control
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
12 Months to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT00468858
GSK 106405, WIRB number20070071, HRPO 14040
Not Provided
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
GlaxoSmithKline
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
U.S. Army Medical Research and Materiel Command
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP