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DenguePhase 1NCT03110952

TDENV PIV and LAV Dengue Prime-boost Strategy Using AS03B Adjuvant

A Phase 1 study testing TDENV-PIV and TDENV-F17 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with the GSK AS03B adjuvant and tetravalent dengue live… Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Dengue
What is being tested?
TDENV-PIV and TDENV-F17
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2016to Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., document events in memory aid, return for follow-up visits, etc.)
  • 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.

Who cannot join

  • 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 or administration of a vaccine/product not foreseen by the study protocol during the period starting 30 days before or after each scheduled dose of an investigational product or placebo.
  • 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 an approved/cleared 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).
Show all 21Show fewer
  • Family history of congenital or hereditary immunodeficiency
  • History and family history of a bleeding disorder
  • History of past flavivirus infection or vaccination (Yellow Fever, tick-borne encephalitis virus (TBEV), Japanese encephalitis virus (JEV), West Nile virus (WNV), dengue (DENV)
  • 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 (≥ 100.4° ◦F / 38.0° ◦C, 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
  • A planned move to a location that will prohibit participating in the trial until study end for the participant
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
  • Safety laboratory test results that are outside the acceptable values at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Upstate Medical University, SUNY

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Single-Center, Study of TDENV-PIV and TDENV-F17 Dengue Vaccine Platforms in a Heterologous Prime Boost Strategy in Healthy Adults in a Non-Endemic Region

The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with the GSK AS03B adjuvant and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.

This study is being done to evaluate the safety and immune reaction of administering one dose of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine compared to two doses of inactivated vaccine.

Conditions
Dengue
Being tested
TDENV-PIV, TDENV-F17, Placebo
Medical subject headings
Dengue

What participants receive

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

  • TDENV-PIVBiological

    Also called Tetravalent dengue virus, purified inactivated vaccine, TDENV-PIV with AS03B adjuvant, Inactivated dengue virus types 1-4 (1 µg/serotype) with AS03B adjuvant

    Single-dose vial with pre-filled syringe, subcutaneous injection

  • TDENV-F17Biological

    Also called Tetravalent dengue virus, live, attenuated vaccine, TDENV-F17, Live attenuated dengue virus types 1-4

    Single-dose vial with pre-filled syringe 0.5 mL administered intramuscularly

  • PlaceboOther

    Also called Placebo, sterile phosphate-buffered saline solution for injection

    0.5 mL vial

Study groups in NCT03110952
Study groupRoleWhat they receive
TDENV-PIV x2Experimental2 doses of TDENV-PIV on Day 0 and Day 28
Receives: Biological: TDENV-PIV
TDENV-F17/TDENV-PIVExperimental1 dose TDENV-F17 on Day 0 and 1 dose TDENV-PIV on Day 28
Receives: Biological: TDENV-PIV; Biological: TDENV-F17
TDENV-PIV/TDENV-F17Experimental1 dose TDENV-PIV on Day 0 and 1 dose TDENV-F17 on Day 28
Receives: Biological: TDENV-PIV; Biological: TDENV-F17
PlaceboPlacebo comparator2 doses placebo (phosphate buffered saline) Day 0 and Day 28
Receives: Other: Placebo

What is being measured

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

  1. Number of and intensity of solicited local and general adverse events (AEs) during the 7-day follow-up period after each vaccination

    Measured: Day 7 and Day 35

  2. Number of and intensity of unsolicited adverse events (AEs) during the 7-day follow-up period after each vaccination

    Measured: Day 7 and Day 35

  3. Number of serious adverse events (SAEs)

    Measured: Day 35

  4. Number of potential immune-mediated diseases (pIMDs) and medicall attended AEs

    Measured: Day 56

  5. Geometric mean titers (GMTs) of neutralizing antibodies to each DENV serotype

    Assessment of neutralizing antibodies against DENV type 1-4 will be performed by a validated microneutralizing antibody assay.

    Measured: Day 56

  6. Number of participants seropositive for each DENV serotype

    Seropositive will be determined by 50% reduction in viral infection (MN50)

    Measured: Day 56

  7. Number of participants trivalent and tetravalent seropositive

    Seropositive will be determined by 50% reduction in viral infection (MN50)

    Measured: Day 56

Timeline

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

  1. First posted12 Apr 2017
  2. Study startJan 2016
  3. Primary completionApr 2017 (estimated)
  4. Study completionApr 2018 (estimated)

Why it stopped: lack of materials, not moving forward

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110952
Sponsor's protocol ID
S-14-08
Other IDs
DPIV-020, 201126
Status last verified
Apr 2017
First submitted
28 Apr 2015
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TDENV-PIV and TDENV-F17 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in United States.

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 4 inclusion and 21 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: withdrawn, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of and intensity of solicited local and general adverse events (AEs) during the 7-day follow-up period after each vaccination (time frame: Day 7 and Day 35). The study lists 7 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 NCT03110952.

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 12 Apr 2017.

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