NCT01666652

Brief Summary

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

August 8, 2012

Results QC Date

August 8, 2018

Last Update Submit

August 8, 2018

Conditions

Dengue Fever

Keywords

DengueDengue feverDengue Hemorrhagic FeverFlavivirus

Outcome Measures

Primary Outcomes (5)

  • Number of Subjects With Adverse Events Within the 28 Day Follow-up

    Number of subjects with adverse events occurring within days 0-28 following vaccination

    Days 0-28

  • Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)

    Overall incidence of any symptoms (solicited and unsolicited) reported during the 7-day (days 0-6) post vaccination period in TVC population

    Days 0-6 post vaccination

  • Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)

    Incidence of General Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period for TVC population. General symptoms are described as fatigue, gastrointestinal symptoms, headache, joint pain, muscle aches and increased temperature (oral).

    Days 0-6 post vaccination

  • Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)

    Incidence of Local Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period in TVC population. Local symptoms are described as pain, redness and swelling.

    Days 0-6 post vaccination

  • Summary of Subjects With Serious Adverse Events

    Summary of subjects with serious adverse events through out the study

    days 0-392

Secondary Outcomes (3)

  • Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit

    day 56 visit

  • Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)

    up to month 13

  • Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)

    up to month 13

Study Arms (5)

TDENV-PIV alum4

EXPERIMENTAL

4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

Biological: 4 µg TDENV-PIV with Alum adjuvant

TDENV-PIV AS01E1

EXPERIMENTAL

1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

Biological: 1 µg TDENV-PIV with AS01E1 adjuvant

TDENV-PIV AS03B1

EXPERIMENTAL

1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

Biological: 1 µg TDENV-PIV with AS03B1 adjuvant

Placebo

PLACEBO COMPARATOR

Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days

Other: Phosphate buffered saline

TDENV-PIV alum1

EXPERIMENTAL

1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days

Biological: 1 µg TDENV-PIV with Alum adjuvant

Interventions

4 µg TDENV-PIV with Alum adjuvantBIOLOGICAL
TDENV-PIV alum4
1 µg TDENV-PIV with AS03B1 adjuvantBIOLOGICAL
TDENV-PIV AS03B1
Phosphate buffered salineOTHER
Placebo
1 µg TDENV-PIV with Alum adjuvantBIOLOGICAL
TDENV-PIV alum1
1 µg TDENV-PIV with AS01E1 adjuvantBIOLOGICAL
TDENV-PIV AS01E1

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.)
  • A male or female between 18 and 39 years of age (inclusive) at the time of consent
  • Written informed consent obtained from the subject
  • Healthy subjects as established by medical history and clinical examination before entering into the study
  • Female subjects of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least three months prior to enrollment, hysterectomy, ovariectomy, or is post-menopause). See Definition of Terms for adequate contraception.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject has:
  • Practiced adequate contraception for 30 days prior to vaccination, and
  • A negative urine pregnancy test on the day of vaccination, and
  • Agreed to continue adequate contraception until two months after completion of the vaccination series

You may not qualify if:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)
  • Planned administration of any flavivirus vaccine for the entire study duration
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Family history of congenital or hereditary immunodeficiency
  • History of, or current auto-immune disease
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/placebo or related to a study procedure
  • Major congenital defects or serious chronic illness
  • History of any neurological disorders or seizures
  • Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment (a subject with a minor illness, i.e., mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator)
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality,as determined by physical examination or laboratory screening tests
  • Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period
  • History of chronic alcohol consumption and/or drug abuse
  • Pregnant or lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WRAIR, Clinical Trials Center

Silver Spring, Maryland, 20910-7500, United States

Location

Related Publications (1)

  • Schmidt AC, Lin L, Martinez LJ, Ruck RC, Eckels KH, Collard A, De La Barrera R, Paolino KM, Toussaint JF, Lepine E, Innis BL, Jarman RG, Thomas SJ. Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States. Am J Trop Med Hyg. 2017 Jun;96(6):1325-1337. doi: 10.4269/ajtmh.16-0634.

    PMID: 28719287DERIVED

MeSH Terms

Conditions

DengueSevere Dengue

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAluminum CompoundsAnionsIonsElectrolytes

Results Point of Contact

Title
Robin Nielsen, RN
Organization
WRAIR
trials.clinical@amedd.army.mil
301-319-9063

Study Officials

  • Leyi Lin, MD

    Walter Reed Army Institute of Research (WRAIR)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 16, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

November 1, 2017

Last Updated

January 25, 2019

Results First Posted

January 25, 2019

Record last verified: 2018-08

Locations

US(1)