Evaluating the Safety and Immunogenicity of a Live Attenuated West Nile Virus Vaccine for West Nile Encephalitis in Adults 50 to 65 Years of Age

NCT02186626 | Completed Phase 1 DMC

• 2 other identifiers: CIR 290WIRB/20140078
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

West Nile virus (WNV) is considered an emerging virus in the United States, and infection can lead to severe illness in older adults. This study will evaluate the safety of and immune response to a live West Nile virus vaccine (WN/DEN4Δ30) for the prevention of West Nile encephalitis in adults 50 to 65 years old.

Conditions

West Nile Virus

Keywords

West Nile Virus, vaccine

Outcome Measures

Primary Outcomes (2)

• Frequency of vaccine-related adverse events (AEs)

  As classified by both intensity and severity through active and passive surveillance

  Measured through Day 360

• Measurement of anti-WNV neutralizing antibody

  Measured through Day 360

Study Arms (2)

WN/DEN4Δ30 Vaccine

EXPERIMENTAL

Participants will receive one dose of the WN/DEN4Δ30 vaccine at study entry and one dose at Day 180.

Biological: WN/DEN4Δ30 Vaccine

Placebo

PLACEBO COMPARATOR

Participants will receive one dose of the placebo at study entry and one dose at Day 180.

Biological: Placebo

Interventions

WN/DEN4Δ30 Vaccine BIOLOGICAL

WN/DEN4Δ30 vaccine is a live attenuated, recombinant, chimeric virus. Dose: 10\^4 plaque-forming units (PFUs); delivered by subcutaneous injection in the deltoid region of the upper arm.

WN/DEN4Δ30 Vaccine

Placebo BIOLOGICAL

Delivered by subcutaneous injection in the deltoid region of the upper arm.

Placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and non-pregnant, non-breastfeeding females between 50 and 65 years of age, inclusive. Children will not be recruited or enrolled in this study for safety considerations.
• Good general health, as determined by means of the screening procedures
• Available for the duration of the trial
• Willingness to participate in the study as evidenced by signing the informed consent form (ICF)

You may not qualify if:

• Pregnancy, as determined by positive beta-human choriogonadotropin (HCG) test (if female)
• Currently lactating and breastfeeding (if female)
• Participant is unwilling to use reliable contraception methods for the duration of the trial (reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; intrauterine device; abstinence; and post-menopausal documented for at least 1 year). All female participants will be considered as having childbearing potential except for those with documented hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or who are post-menopausal for at least 1 year since last menstrual period.
• 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 participant to understand and cooperate with the study protocol
• Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
• Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• History of a severe allergic reaction or anaphylaxis
• Severe asthma (emergency room visit or hospitalization within the last 6 months)
• Positive HIV-1 serology by screening and confirmatory assays
• Positive for hepatitis C virus (HCV) by screening and confirmatory assays
• Hepatitis B virus (HBV) infection, by positive hepatitis B surface antigen (HBsAg)
• Any confirmed or suspected immunosuppressive or immune modulating disorder (e.g., asplenia, lupus, rheumatoid arthritis, vasculitis, scleroderma, and diabetes mellitus)
• Chronic administration (greater than or equal to 14 days) of steroids (defined as prednisone equivalent of greater than or equal to 10 mg per day), immunosuppressants, or other immune-modifying drugs initiated during the 28-day period post-vaccination (topical and nasal steroids are allowed)

Sponsors & Collaborators

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

Study Sites (2)

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

Baltimore, Maryland, 21205, United States

Location

Vaccine Testing Center, University of Vermont College of Medicine (UVM)

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Durbin AP, Wright PF, Cox A, Kagucia W, Elwood D, Henderson S, Wanionek K, Speicher J, Whitehead SS, Pletnev AG. The live attenuated chimeric vaccine rWN/DEN4Delta30 is well-tolerated and immunogenic in healthy flavivirus-naive adult volunteers. Vaccine. 2013 Nov 19;31(48):5772-7. doi: 10.1016/j.vaccine.2013.07.064. Epub 2013 Aug 19.

  PMID: 23968769 BACKGROUND

Study Officials

• Anna Durbin, MD

  Johns Hopkins Bloomberg School of Public Health

  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: July 8, 2014
• First Posted: July 10, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (2)