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Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults

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ClinicalTrials.gov Identifier: NCT02421367
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Tracking Information
First Submitted Date  ICMJE April 15, 2015
First Posted Date  ICMJE April 20, 2015
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
  • Number of solicited local adverse events related to product [ Time Frame: 7-day follow-up period after each dose ]
  • Intensity of solicited local adverse events related to product [ Time Frame: 7-day follow-up period after each dose ]
  • Number of unsolicited adverse events related to product [ Time Frame: 28-day follow-up period after each dose ]
  • Intensity of unsolicited adverse events related to product [ Time Frame: 28-day follow-up period after each dose ]
  • Number of Grade 2 laboratory abnormalities [ Time Frame: 7-day follow-up period after each dose ]
  • Number of Grade 3 laboratory abnormalities [ Time Frame: 7-day follow-up period after each dose ]
  • Number of serious adverse events from day 0 through 28 days after the last dose [ Time Frame: 7 months after first dose ]
  • Number of potential immune-mediated diseases from Day 0 through 28 days after the last dose [ Time Frame: 7 months after first dose ]
  • Neutralizing antibody titers to each DENV type [ Time Frame: Day 0 and 28 days after the second and third doses of TDENV-PIV ]
  • Number of general adverse events related to product [ Time Frame: 7-day follow-up period after each dose ]
  • Intensity of solicited general adverse events related to product [ Time Frame: 7-day follow-up period after each dose ]
  • Number of medically attended AEs related to product [ Time Frame: Day 0 through 28 days after the last dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
  • Number of potential immune-mediated diseases from post Month 7 to Study End [ Time Frame: 7 months after first dose to the end of study ]
  • Number of serious adverse events related to product [ Time Frame: 7 months after first dose to the end of study ]
  • Neutralizing antibody titers to each DENV type [ Time Frame: 56 days after the second dose of active vaccine ]
  • Seropositivity status for each DENV type [ Time Frame: 28 days after the second dose of active vaccine for all groups ]
  • Number of medically attended AEs from post Month 7 to Study End [ Time Frame: 7 months after first dose to the end of study ]
  • Neutralizing antibody titers to each DENV type for the TDENV-PIV (0-1-6) group [ Time Frame: 56 days after the third dose of active vaccine ]
  • Neutralizing antibody titers to each DENV type [ Time Frame: 4 months after the last dose of active vaccine ]
  • Neutralizing antibody titers to each DENV type [ Time Frame: 6 months after the last dose of active vaccine ]
  • Neutralizing antibody titers to each DENV type [ Time Frame: 9 months after the last dose of active vaccine ]
  • Neutralizing antibody titers to each DENV type [ Time Frame: 12 months after the last dose of active vaccine ]
  • Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group [ Time Frame: 28 days after the third dose of active vaccine ]
  • Seropositivity status for each DENV type for the TDENV-PIV (0-1-6) group [ Time Frame: 56 days after the third dose of active vaccine ]
  • Seropositivity status for each DENV type [ Time Frame: 4 months after the last dose of active vaccine for all groups ]
  • Seropositivity status for each DENV type [ Time Frame: 6 months after the last dose of active vaccine for all groups ]
  • Seropositivity status for each DENV type [ Time Frame: 9 months after the last dose of active vaccine for all groups ]
  • Seropositivity status for each DENV type [ Time Frame: 12 months after the last dose of active vaccine for all groups ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults
Official Title  ICMJE A Phase 1/2, Randomized, Observer-blind Study of Varying Injection Schedules of a Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) With AS03B Adjuvant and Placebo in Healthy Adults in the US
Brief Summary This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dengue
Intervention  ICMJE Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)
Study Arms  ICMJE
  • Experimental: TDENV-PIV (0-1)

    The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.

    The placebo is sodium chloride.

    TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.

    The intervention will be administered on Day 0 and Day 28. The placebo will be administered on Day 84 and Day 168.

    Intervention: Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
  • Experimental: TDENV-PIV (0-1-6)

    The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.

    The placebo is sodium chloride.

    TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.

    The intervention will be administered on Day 0, Day 28, and Day 168. The placebo will be administered on Day 84.

    Intervention: Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
  • Experimental: TDENV-PIV (0-3)

    The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.

    The placebo is sodium chloride.

    TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.

    The intervention will be administered on Day 84 and Day 168. The placebo will be administered on Day 0 and Day 28.

    Intervention: Biological: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
Publications * Lin L, Lyke KE, Koren M, Jarman RG, Eckels KH, Lepine E, McArthur MA, Currier JR, Friberg H, Moris P, Keiser PB, De La Barrera R, Vaughn DW, Paris RM, Thomas SJ, Schmidt AC. Safety and Immunogenicity of an AS03B-Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study. Am J Trop Med Hyg. 2020 Jul;103(1):132-141. doi: 10.4269/ajtmh.19-0738. Epub 2020 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2015)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must be able to provide written informed consent.
  2. Subjects must be healthy as established by medical history and clinical examination at study entry
  3. 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.)
  4. Subjects at WRAIR CTC must be able to pass Department of Defense (DoD) base entry requirements, including the possession of a valid government issued ID card.
  5. Male or non-pregnant, non-breastfeeding female between 20 and 49 years of age (inclusive) at the time of consent
  6. Female subjects of non-childbearing potential (non-childbearing potential is defined as having had one of the following: a tubal ligation at least 3 months prior to enrollment, a hysterectomy, an ovariectomy, or is post-menopausal).
  7. Female subjects of childbearing potential may be enrolled in the study, if all of the following apply:

    • Practiced adequate contraception (see Definition of Terms, section 5) for 30 days prior to vaccination
    • Has a negative urine pregnancy test on the day of vaccination
    • Agrees to continue adequate contraception until two months after completion of the vaccination series.

Exclusion Criteria:

  1. 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
  2. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone >=5mg/day or equivalent; inhaled, intranasal and topical steroids are allowed)
  3. Planned administration or administration of a vaccine/product not planned in the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until 30 days after the last dose of study vaccine/placebo (routine influenza vaccination will be allowed as long as it is not administered within 14 days of the vaccine/placebo, and will not lead to study exclusion although it should be reported to the PI)
  4. History of dengue infection or dengue illness, or history of flavivirus vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese encephalitis, and dengue)
  5. Planned administration of any flavivirus vaccine for the entire study duration
  6. 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)
  7. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
  8. Family history of congenital or hereditary immunodeficiency
  9. Autoimmune disease or history of autoimmune disease
  10. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine/placebo or related to a study procedure
  11. Major congenital defects or serious chronic illness
  12. History of any neurological disorders or seizures
  13. Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least 1 month) or narcolepsy; or history of narcolepsy in a subject's parent, sibling, or child
  14. Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment: note that a subject with a minor illness such as mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator
  15. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
  16. 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
  17. Recent history of chronic alcohol consumption (more than 2 drinks per day and/or drug abuse (based on subject reported history)
  18. Pregnant or breastfeeding female or female currently planning to become pregnant or planning to discontinue adequate contraception
  19. A planned move to a location that will prohibit participating in the trial until Study End for the participant
  20. Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  21. Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
  22. Safety laboratory test results at screening that are deemed clinically significant or more than Grade 1 deviation from normal
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02421367
Other Study ID Numbers  ICMJE S-14-13
WRAIR # 2195 ( Other Identifier: WRAIR )
201658 ( Other Identifier: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party U.S. Army Medical Research and Development Command
Original Responsible Party Same as current
Current Study Sponsor  ICMJE U.S. Army Medical Research and Development Command
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Walter Reed Army Institute of Research (WRAIR)
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Leyi Lin, M.D. USAMRMC/WRAIR
PRS Account U.S. Army Medical Research and Development Command
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP