Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine

NCT03141138 | Unknown Phase 1 FDA Drug

• 1 other identifier: S-16-23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to define the potential tradeoff between potential immunogenicity, including cell-mediated immunity, and a more practical dosing schedule.

Conditions

Dengue Virus

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With At Least One Local Solicited Adverse Events (AE) during the 28 Day Follow-up After Prime and Boost Vaccinations

  The number of subjects with at least one local solicited adverse event (AE), at least one general solicited AE and any solicited AE during the 28-day follow-up period for prime and boost vaccination will be tabulated with 95% confidence interval (CI) after each vaccine dose and overall.

  28 day follow-up period

Secondary Outcomes (1)

• Number of subjects reporting at least one of each type of unsolicited AE during the 28-day follow-up period after each vaccination

  28 day follow-up period

Other Outcomes (6)

• The proportion of subjects with at least one report of any SAE during the 28 day follow-up period after each vaccination

  28 day follow-up period

• The proportion of subjects with abnormal hematological or biochemical laboratory values

  Days 0, 7 and 28 after each vaccination

• Number of withdrawals due to potential immune-mediated diseases (pIMDs), SAEs and AEs during the entire study

  up to 18 months

Study Arms (4)

Group 1: TDENV-PIV on Day 0

EXPERIMENTAL

Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible

Biological: TDENV-PIV

Group 1: TDENV-LAV F17 on Day 180

EXPERIMENTAL

Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible

Biological: TDENV-LAV F17

Group 2: TDENV-PIV on Day 0

EXPERIMENTAL

Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible

Biological: TDENV-PIV

Group 2:TDENV-LAV F17 on Day 90

EXPERIMENTAL

Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible

Biological: TDENV-LAV F17

Interventions

TDENV-PIV BIOLOGICAL

Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible

Group 1: TDENV-PIV on Day 0; Group 2: TDENV-PIV on Day 0

TDENV-LAV F17 BIOLOGICAL

Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible.

Group 1: TDENV-LAV F17 on Day 180; Group 2:TDENV-LAV F17 on Day 90

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 42 years of age (inclusive) at the time of consent
• Able to provide written informed consent
• Healthy as established by medical history and clinical examination and basic hematologic laboratory analysis 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.)
• Dengue exposure naïve as established by pre-enrollment dengue PRNT testing and questioning of volunteer
• Female subject of non-childbearing potential (non-childbearing potential is defined as having either a current bilateral tubal ligation at least 3 months prior to enrollment or a history of an hysterectomy, bilateral oophorectomy, or is post-menopause(12 months or more since last menstrual period)) or 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 through at least 3 months following last vaccination

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine or device) 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 prescription immunosuppressants or other prescription 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
• History of or active use of cancer chemotherapy or radiation therapy for the treatment of cancer
• Receipt or planned receipt of a vaccine/product outside the study protocol within 30 days of each scheduled dose of an investigational product
• Planned administration of any flavivirus vaccine, to include licensed vaccines for Yellow Fever or Japanese Encephalitis Virus as well as other investigational vaccines for dengue, Zika, West Nile, other flavivirus, for the entire study duration
• Previous receipt of a foreign or investigational dengue vaccine
• 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
• History of, or current, auto-immune disease
• History of any reaction or hypersensitivity likely to be triggered by any component of the vaccines or related to a study procedure (This includes hypersensitivity reactions to alum, streptomycin, neomycin, or any other flavivirus vaccine, such as Yellow Fever virus and Japanese Encephalitis virus vaccines)
• Major congenital defects or serious chronic illness
• History of any chronic neurological disorders or chronic and/or uncontrolled seizures
• Acute infectious 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)

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

WRAIR, Clinical Trials Center

Silver Spring, Maryland, 20910-7500, United States

Location

Study Officials

• Simon D Pollett

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This will be an open-label study. The laboratories in charge of testing will be blinded to the experimental arm, and codes will be used to link the subject and study (without any link to the experimental arm attributed to the subject) to each sample.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 4, 2017
• Study Start: November 8, 2017
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)