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Dengue FeverPhase 2NCT00468858

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

A Phase 2 study testing T-DEN-Post-Transfection F17 and T-DEN-Post-Transfection F19 in people with Dengue Fever and Dengue Hemorrhagic Fever, run by U.S. Army Medical Research and Development Command at 11 sites in Puerto Rico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 months to 50 yearsHealthy volunteers can take part
What is being tested?
T-DEN-Post-Transfection F17 and T-DEN-Post-Transfection F19
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
636 participants
Where
11 sitesPuerto Rico
Study dates
Jul 2007to Apr 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.>

Who cannot join

  • 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;>
Show all 19Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Puerto Rico11 sites

  • San Juan Batista Medical School

    Caguas, 00725

  • Private Practice

    Carolina, 00983

  • St Luke's Memorial Hospital

    Ponce, 00733

  • Caparra Internal Medicine Research Center

    Rio Grande, 00745

  • Private Practice

    Rio Piedras, 00926

  • RCMI Clinical Research Center

    Rio Piedras, 00935

  • Torre Medica San Vicente de Paul

    San German, 00683

  • Clinical Research PR

    San Juan, 00909-1711

  • Centro de Neumologia Pediatricia

    San Juan, 00917

  • Private Practice

    San Juan, 00921

  • Dept Pediatria, Esc. De Medicina

    San Juan, 00936-5067

Other trials in Puerto Rico

About this 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

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.

Read the 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.>

Being tested
Placebo, T-DEN-Post-Transfection F17, T-DEN-Post-Transfection F19
Keywords
Dengue, Virus, Live-attenuated, Vaccine, Dengue viral infection, Dengue Vaccine
Medical subject headings
Dengue, Severe Dengue, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Lyophilized, single dose vials and sterile water for

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

  • T-DEN-Post-Transfection F17Biological

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

  • T-DEN-Post-Transfection F19Biological

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

Study groups in NCT00468858
Study groupRoleWhat they receive
T-DEN-Post-Transfection F17ExperimentalPost-Transfection F17, full dose
Receives: Biological: T-DEN-Post-Transfection F17
T-DEN-Post-Transfection F19ExperimentalPost-Transfection F19, full dose
Receives: Biological: T-DEN-Post-Transfection F19
PlaceboPlacebo comparatorControl
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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)

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

  3. Safety: Occurrence of Serious Adverse Events (SAEs)

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

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

Secondary outcomes (6)

  1. Incidence of Suspected and Laboratory Confirmed Dengue

    Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period

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

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

    Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects

    Measured: at month 7 (one month post dose 2)

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

    Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects

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

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

    Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects

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

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

    Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody

    S- = seronegative subjects (antibody titer <10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer >10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination

    Vaccine response defined as: For initially seronegative subjects, antibody titer >10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) >4 fold the pre-vaccination antibody titer

    Measured: at month 3, post dose 1

  6. Vaccine Response to DEN Antibody at Post Dose 2, Month 7

    Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7

    Measured: at month 7, post dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00468858
Sponsor's protocol ID
A-14040
Other IDs
WIRB number 20070071, 106405, T-DEN-003
Status last verified
Jun 2017
First submitted
1 May 2007
Last updated
2 Jul 2017
Data monitoring committee
No
Individual data sharing
Yes: GlaxoSmithKline

Publications

  • 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.

    PubMed 26175027

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T-DEN-Post-Transfection F17 and T-DEN-Post-Transfection F19 in people with Dengue Fever and Dengue Hemorrhagic Fever, run by U.S. Army Medical Research and Development Command at 11 sites in Puerto Rico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Incidence of All and Grade 3 Solicited Local Symptoms (time frame: Within 21 days (days 0-20) f/up period after each vaccine dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00468858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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