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

U.S. Army Medical Research and Development Command2 sites in 1 country140 target enrollmentAugust 2015

ConditionsDengue

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Dengue
Sponsor: U.S. Army Medical Research and Development Command
Enrollment: 140
Locations: 2
Primary Endpoint: Number of unsolicited adverse events related to product
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

March 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

U.S. Army Medical Research and Development Command

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be able to provide written informed consent.
•Subjects must be healthy as established by medical history and clinical examination at study entry
•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.)
•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.
•Male or non-pregnant, non-breastfeeding female between 20 and 49 years of age (inclusive) at the time of consent
•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).
•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

•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 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)
•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)
•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)
•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 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
•Autoimmune disease or history of autoimmune disease
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine/placebo or related to a study procedure

Outcomes

Primary Outcomes

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 solicited local adverse events related to product