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DenguePhase 1NCT02239614

TDENV PIV and LAV Dengue Prime-boost Strategy

A Phase 1 study testing TDENV-LAV and TDENV-PIV 4 µg + alum adjuvant in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in United States.

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 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 alum and tetravalent dengue live attenuated virus… Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Dengue
What is being tested?
TDENV-LAV and TDENV-PIV 4 µg + alum adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Dec 2014to 17 Feb 2017
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female between 18 and 49 years of age (inclusive) at the time of consent
  • Able to provide written informed consent
  • Healthy as established by medical history and clinical examination before entering into the study
  • Able and willing to comply with the requirements of the protocol (eg, document events in memory aid, return for follow-up visits, etc.)
  • Female subject of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least 3 months prior to enrollment or a history of a hysterectomy, ovariectomy, or is post-menopause)
  • Female subject is not breastfeeding and agrees not to breastfeed for 3 months after last vaccination
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  • Female subject of childbearing potential may be enrolled in the study, if the subject has:
  • Practiced adequate contraception for 30 days prior to vaccinations, and
  • A negative urine pregnancy test on each day of vaccination, and
  • Agreed to continue adequate contraception until 3 months after completion of the vaccination series.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days preceding the first dose of study vaccine 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 dose
  • For corticosteroids, this will mean prednisone ≥ 20 mg/d 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 14 days before or after each scheduled dose of an investigational product
  • Planned administration of any flavivirus vaccine for the entire study duration
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  • 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 or related to a study procedure
  • Major congenital defects or serious chronic illness
  • History of any neurological disorders or seizures. (except for a childhood febrile seizures)
  • Acute disease and/or fever (oral body temperature ≥ 100.4°F/38.0°C) at the time of enrollment (a subject with a minor illness, ie, 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 or planned administration during the study period
  • History of chronic alcohol and/or drug abuse
  • Pregnant or breastfeeding female or female planning to become pregnant or planning to discontinue contraceptive precautions
  • A planned move to a location that will prohibit participating in the trial prior to the study end for the participant
  • 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:
  • > 110% upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, creatinine, serum urea nitrogen (SUN) and bilirubin (total and direct)
  • < 100% lower limit of normal (LLN) or > 120% ULN for hemoglobin, hematocrit and platelet count
  • < 75% LLN or >110% ULN for total white blood cell count (WBC)
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Trials Center, Walter Reed Army Institute of Research (CTC, WRAIR)

    Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-label, Single-center, Study of TDENV-PIV and LAV Dengue Vaccine Platforms as Part of a Heterologous Prime-boost Strategy in Healthy Adults in a Nonendemic 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 alum 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.

Conditions
Dengue
Being tested
TDENV-LAV, TDENV-PIV 4 µg + alum adjuvant
Keywords
dengue fever, dengue
Medical subject headings
Dengue

What participants receive

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

  • TDENV-LAVBiological

    Also called TDENV-LAV F17, Tetravalent dengue live attenuated virus formulation 17

    0.5 mL of the post-transfection LAV F17 vaccine

  • TDENV-PIV 4 µg + alum adjuvantBiological

    Also called Tetravalent dengue virus purified inactivated vaccine with alum adjuvant

    0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant

Study groups in NCT02239614
Study groupRoleWhat they receive
Group 1: LAV (T=0), PIV (T=28)ExperimentalTetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 0 of the study. Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 28 of the study.
Receives: Biological: TDENV-LAV; Biological: TDENV-PIV 4 µg + alum adjuvant
Group 2: PIV (T=0), LAV (T=28)ExperimentalTetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 0 of the study. Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 28 of the study.
Receives: Biological: TDENV-LAV; Biological: TDENV-PIV 4 µg + alum adjuvant
Group 3: LAV (T=0), PIV (T=180)ExperimentalTetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 0 of the study. Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 180 of the study.
Receives: Biological: TDENV-LAV; Biological: TDENV-PIV 4 µg + alum adjuvant
Group 4: PIV (T=0), LAV (T=180)ExperimentalTetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 0 of the study. Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 180 of the study.
Receives: Biological: TDENV-LAV; Biological: TDENV-PIV 4 µg + alum adjuvant

What is being measured

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

  1. Number of solicited adverse events

    Measured: 21 days after each vaccination

  2. Number of unsolicited adverse events

    Measured: 28 days after each vaccination

  3. Number of hematological and biochemistry abnormalities

    Measured: 7 and 28 days and each vaccination

  4. Number of serious adverse events

    Measured: Day 208 or day 360

  5. Number of potential immune-mediated diseases

    Measured: Day 208 or day 360

  6. Number of medically attended adverse events

    Measured: Day 208 or day 360

Secondary outcomes (1)

  1. Microneutralizing (MN) dengue antibody titers

    Measured: Up to 1 year

Timeline

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

  1. First posted15 Sep 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion17 Feb 2016
  4. Study completion17 Feb 2017

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
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02239614
Sponsor's protocol ID
S-13-10
Other IDs
ADVP-003, WRAIR #2136
Status last verified
Aug 2018
First submitted
10 Sep 2014
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Lin L, Koren MA, Paolino KM, Eckels KH, De La Barrera R, Friberg H, Currier JR, Gromowski GD, Aronson NE, Keiser PB, Sklar MJ, Sondergaard EL, Jasper LE, Endy TP, Jarman RG, Thomas SJ. Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial. J Infect Dis. 2021 May 28;223(10):1707-1716. doi: 10.1093/infdis/jiaa603.

    PubMed 32966573

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TDENV-LAV and TDENV-PIV 4 µg + alum adjuvant 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 10 inclusion and 25 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 15 Aug 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 solicited adverse events (time frame: 21 days after each vaccination). The study lists 6 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 NCT02239614, 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 15 Aug 2018.

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