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

NCT00468858 | Completed Phase 2 Results

• 4 other identifiers: A-14040WIRB number 20070071106405T-DEN-003
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 11

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.

Conditions

Dengue Fever; Dengue Hemorrhagic Fever; Dengue Shock Syndrome

Keywords

Dengue; Virus; Live-attenuated; Vaccine; Dengue viral infection; Dengue Vaccine

Outcome Measures

Primary Outcomes (3)

• Safety: Incidence of All and Grade 3 Solicited Local Symptoms

  Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)

  Within 21 days (days 0-20) f/up period after each vaccine dose

• Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period

  Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)

  Within the 31-day (days 0-30) follow-up period after each vaccine dose

• Safety: Occurrence of Serious Adverse Events (SAEs)

  Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose

  6 months + 30 day follow-up period after last vaccine dose

Secondary Outcomes (6)

• Incidence of Suspected and Laboratory Confirmed Dengue

  31-day (days 0-30) post-vaccination period and after 31-day period

• GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects

  at month 7 (one month post dose 2)

• Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes

  Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7

• Percent of Subjects With Neut. Sero-response to Each DEN Serotype

  Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7

• Vaccine Response to DEN Antibody at Post Dose 1, Month 3

  at month 3, post dose 1

Study Arms (3)

T-DEN-Post-Transfection F17

EXPERIMENTAL

Post-Transfection F17, full dose

Biological: T-DEN-Post-Transfection F17

T-DEN-Post-Transfection F19

EXPERIMENTAL

Post-Transfection F19, full dose

Biological: T-DEN-Post-Transfection F19

Placebo

PLACEBO COMPARATOR

Control

Other: Placebo

Interventions

Placebo OTHER

Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Placebo

T-DEN-Post-Transfection F17 BIOLOGICAL

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

T-DEN-Post-Transfection F17

T-DEN-Post-Transfection F19 BIOLOGICAL

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

T-DEN-Post-Transfection F19

Eligibility Criteria

• Age: 12 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.\>

You may not qualify if:

• 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;\>

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• GlaxoSmithKline: collaborator

Study Sites (11)

San Juan Batista Medical School

Caguas, 00725, Puerto Rico

Location

Private Practice

Carolina, 00983, Puerto Rico

Location

St Luke's Memorial Hospital

Ponce, 00733, Puerto Rico

Location

Private Practice

Rio Piedras, 00926, Puerto Rico

Location

RCMI Clinical Research Center

Rio Piedras, 00935, Puerto Rico

Location

Caparra Internal Medicine Research Center

Río Grande, 00745, Puerto Rico

Location

Torre Medica San Vicente de Paul

San Germán, 00683, Puerto Rico

Location

Clinical Research PR

San Juan, 00909-1711, Puerto Rico

Location

Centro de Neumologia Pediatricia

San Juan, 00917, Puerto Rico

Location

Private Practice

San Juan, 00921, Puerto Rico

Location

Dept Pediatria, Esc. De Medicina

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 26175027 DERIVED

MeSH Terms

Conditions

Dengue; Severe Dengue; Virus Diseases

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Results Point of Contact

• Title: Faina Rose, PhD
• Organization: GSK

faina.v.rose@gsk.com

610-664-8986

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2007
• First Posted: May 3, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 2, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

PR (11)