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

NCT ID: NCT03110952

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-04-30

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TDENV-PIV x2

2 doses of TDENV-PIV on Day 0 and Day 28

Group Type: EXPERIMENTAL

TDENV-PIV

Intervention Type: BIOLOGICAL

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

TDENV-F17/TDENV-PIV

1 dose TDENV-F17 on Day 0 and 1 dose TDENV-PIV on Day 28

Group Type: EXPERIMENTAL

TDENV-PIV

Intervention Type: BIOLOGICAL

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

TDENV-F17

Intervention Type: BIOLOGICAL

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

TDENV-PIV/TDENV-F17

1 dose TDENV-PIV on Day 0 and 1 dose TDENV-F17 on Day 28

Group Type: EXPERIMENTAL

TDENV-PIV

Intervention Type: BIOLOGICAL

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

TDENV-F17

Intervention Type: BIOLOGICAL

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

Placebo

2 doses placebo (phosphate buffered saline) Day 0 and Day 28

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0.5 mL vial

Interventions

TDENV-PIV

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

Intervention Type: BIOLOGICAL

TDENV-F17

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

Intervention Type: BIOLOGICAL

Placebo

0.5 mL vial

Intervention Type: OTHER

Other Intervention Names

Tetravalent dengue virus, purified inactivated vaccine, TDENV-PIV with AS03B adjuvant; Inactivated dengue virus types 1-4 (1 µg/serotype) with AS03B adjuvant; Tetravalent dengue virus, live, attenuated vaccine, TDENV-F17; Live attenuated dengue virus types 1-4; Placebo, sterile phosphate-buffered saline solution for injection

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Polhemus

Role: PRINCIPAL_INVESTIGATOR

Upstate Medical University, SUNY

Locations

Upstate Medical University, SUNY

Syracuse, New York, United States

Countries

United States

Other Identifiers

DPIV-020

Identifier Type: OTHER

Identifier Source: secondary_id

201126

Identifier Type: OTHER

Identifier Source: secondary_id

S-14-08

Identifier Type: -

Identifier Source: org_study_id