Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine

NCT02684383 | Completed Phase 1 DMC

• 1 other identifier: CIR 304
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous flavivirus infection.

Conditions

Dengue

Keywords

Dengue Vaccine

Outcome Measures

Primary Outcomes (2)

• Frequency of vaccine-related adverse events (AEs)

  Measured through Day 28 post-vaccination

• Level of anti-DENV-3 neutralizing antibody

  Measured through Day 180

Study Arms (2)

rDEN3∆30 vaccine

EXPERIMENTAL

Participants will receive the rDEN3∆30 vaccine at Day 0.

Biological: rDEN3∆30

Placebo

PLACEBO COMPARATOR

Participants will receive placebo at Day 0.

Biological: Placebo

Interventions

rDEN3∆30 BIOLOGICAL

10\^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm

rDEN3∆30 vaccine

Placebo BIOLOGICAL

Administered by subcutaneous injection in the deltoid region of the upper arm

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male or female between 18 and 50 years of age, inclusive.
• Good general health as determined by physical examination, laboratory screening, and review of medical history.
• Available for the duration of the study, approximately 26 weeks post-vaccination.
• Willingness and availability for potential inpatient admission in the inpatient unit following receipt of rDEN3Δ30.
• Willingness to participate in the study as evidenced by signing the informed consent document.
• Females Only: Female subjects of childbearing potential willing to use effective contraception beginning long enough before dosing to ensure method specific efficacy for the duration of the trial. Reliable methods of contraception include hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (greater than or equal to 6 months since last sexual encounter). All female subjects will be considered having childbearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.

You may not qualify if:

• Females Only: Currently pregnant, as determined by positive beta-human chorionic gonadotropin (HCG) test, or breastfeeding.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the requirements of the study protocol.
• Confirmed screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol. Confirmation will be obtained by repeating the test to ensure the abnormal value was not due to aberrancy.
• Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
• Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational or family problems, as indicated by subject history.
• History of a severe allergic reaction or anaphylaxis.
• Severe asthma (emergency room visit or hospitalization within the last 6 months).
• HIV infection, by screening and confirmatory assays.
• Hepatitis C virus (HCV) infection, by screening and confirmatory assays.
• Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening.
• Any known immunodeficiency syndrome.
• Use of anticoagulant medications.
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
• Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Center for Immunization Research (CIR), Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Kristen Pierce, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 18, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-11

Locations

US (2)