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

NCT ID: NCT00468858

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 636 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-04-30

Brief Summary

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.

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.>

Conditions

Dengue Fever; Dengue Hemorrhagic Fever; Dengue Shock Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

T-DEN-Post-Transfection F17

Post-Transfection F17, full dose

Group Type: EXPERIMENTAL

T-DEN-Post-Transfection F17

Intervention Type: BIOLOGICAL

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

T-DEN-Post-Transfection F19

Post-Transfection F19, full dose

Group Type: EXPERIMENTAL

T-DEN-Post-Transfection F19

Intervention Type: BIOLOGICAL

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Placebo

Control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Interventions

Placebo

Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Intervention Type: OTHER

T-DEN-Post-Transfection F17

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Intervention Type: BIOLOGICAL

T-DEN-Post-Transfection F19

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Bertran-Pasarell, MD

Role: PRINCIPAL_INVESTIGATOR

Dept Medicina Interna Seccion Enfermedades Infecciosas

Clemente Diaz-Perez, MD

Role: PRINCIPAL_INVESTIGATOR

University of PR

Ines O. Esquilin-Rivera, MD

Role: PRINCIPAL_INVESTIGATOR

University of PR

Evelyn Matta-Fontanet, MD

Role: PRINCIPAL_INVESTIGATOR

Caparra Internal Medicine Research Center

Domingo Chardon-Feliciano, MD

Role: PRINCIPAL_INVESTIGATOR

Ponce School of Medicine

Javier Morales-Ramirez, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research PR

Luis Rodriguez-Carrasquillo, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice, PR

Jose Rodriguez-Santana, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Neumologia pediatrica

Miguel Sosa-Padilla, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice PR

Jose Tavarez-Valle, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice, PR

Alberto Santiago-Cornier, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Molecular Medicine

Anna Quintero, MD

Role: PRINCIPAL_INVESTIGATOR

San Juan Batista Medical School

Locations

San Juan Batista Medical School

Caguas, , Puerto Rico

Private Practice

Carolina, , Puerto Rico

St Luke's Memorial Hospital

Ponce, , Puerto Rico

Private Practice

Rio Piedras, , Puerto Rico

RCMI Clinical Research Center

Rio Piedras, , Puerto Rico

Caparra Internal Medicine Research Center

Río Grande, , Puerto Rico

Torre Medica San Vicente de Paul

San Germán, , Puerto Rico

Clinical Research PR

San Juan, , Puerto Rico

Centro de Neumologia Pediatricia

San Juan, , Puerto Rico

Private Practice

San Juan, , Puerto Rico

Dept Pediatria, Esc. De Medicina

San Juan, , Puerto Rico

Countries

Puerto Rico

References

Bauer K, Esquilin IO, Cornier AS, Thomas SJ, Quintero Del Rio AI, Bertran-Pasarell J, Morales Ramirez JO, Diaz C, Carlo S, Eckels KH, Tournay E, Toussaint JF, De La Barrera R, Fernandez S, Lyons A, Sun W, Innis BL. A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico. Am J Trop Med Hyg. 2015 Sep;93(3):441-453. doi: 10.4269/ajtmh.14-0625. Epub 2015 Jul 14.

Reference Type: DERIVED

PMID: 26175027 (View on PubMed)

Other Identifiers

WIRB number 20070071

Identifier Type: OTHER

Identifier Source: secondary_id

106405

Identifier Type: OTHER

Identifier Source: secondary_id

T-DEN-003

Identifier Type: OTHER

Identifier Source: secondary_id

A-14040

Identifier Type: -

Identifier Source: org_study_id