West Nile VirusPhase 1NCT02186626
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
A Phase 1 study testing WN/DEN4Δ30 Vaccine in people with West Nile Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- West Nile Virus
- What is being tested?
- WN/DEN4Δ30 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Good general health, as determined by physical examination and review of medical history
- Available for the duration of the study, approximately 26 weeks after the second dose
- Ongoing willingness to participate in the study
- Females only: female participants of childbearing potential willing to use effective contraception 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 6 months since last sexual encounter). 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 least 1 year since last menstrual period.
Who cannot join
- 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
Show all 41Show fewer
- 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)
- 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
- History of a surgical splenectomy
- Receipt of blood products within the past 3 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
- History or serologic evidence of previous WNV infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis virus, and dengue virus)
- Previous receipt of yellow fever, WNV, or dengue vaccine (licensed or investigational)
- Receipt of any investigational agent in the past 28 days or anticipation of receipt of any investigational agent within 28 days following vaccination
- Refusal to allow storage of specimens for future research
- Anaphylaxis or angioedema following the first dose of vaccine
- Females only: currently pregnant, as determined by positive beta-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 participant to understand and cooperate with the requirements of the study protocol
- Any 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
- Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant 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
- HCV infection, by screening and confirmatory assays
- HBV infection, by HBsAg screening
- Any confirmed or suspected immunosuppressive or immune modulating disorder (e.g., asplenia, lupus, rheumatoid arthritis, vasculitis, scleroderma, or diabetes mellitus)
- Current use of anticoagulant medications
- 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)
- 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
- History of surgical splenectomy
- Receipt of blood products within the past 3 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination
- Receipt of any other investigational agent in the 28 days before vaccination or anticipated within 28 days following vaccination
- Refusal to allow storage of specimens for future research
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Vaccine Testing Center, University of Vermont College of Medicine (UVM)
Burlington, Vermont, 05401
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of a 2-Dose Regimen of West Nile/Dengue 4-3´Δ30 Chimeric Virus Vaccine (WN/DEN4Δ30), a Live Attenuated Vaccine for West Nile Encephalitis, in Flavivirus-naïve Adults 50-65 Years of Age
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.
Read the detailed description
WNV is the leading vector-borne cause of viral encephalitis in the United States. Severe illness is most common in older adults, and in this population, the virus can cause hepatitis, meningitis, and encephalitis leading to paralysis, coma, and death. WNV illness is a public health issue and is an emerging disease in the United States. This study will evaluate the safety and immunogenicity of a live attenuated West Nile/dengue chimeric virus vaccine (WN/DEN4Δ30) for the prevention of West Nile encephalitis in adults 50 to 65 years old.
This study will enroll healthy adults, 50 to 65 years old, who have no history of previous flavivirus infection. Participants will be randomly assigned to receive the WN/DEN4Δ30 vaccine or placebo vaccine at study entry (Day 0). At the entry visit, participants will undergo a medical history review, physical examination, blood collection, and vital sign measurements; female participants will also take a pregnancy test. Participants will then receive their assigned vaccine, and they will remain in the clinic for 30 minutes after the vaccination for monitoring. Participants will record their temperature and symptoms 3 times a day for 16 days after each vaccination. Additional study visits will occur on Days 3, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 150. These visits may include the same study procedures that occurred at the entry visit. At a study visit on Day 180, participants will receive another dose of their assigned vaccine. Additional study visits will occur on Days 183, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. All study procedures after the second vaccination will be the same that occurred after the first vaccination.
- Conditions
- West Nile Virus
- Being tested
- WN/DEN4Δ30 Vaccine, Placebo
- Keywords
- West Nile Virus, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WN/DEN4Δ30 VaccineBiological
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.
PlaceboBiological
Delivered by subcutaneous injection in the deltoid region of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| WN/DEN4Δ30 Vaccine | Experimental | Participants will receive one dose of the WN/DEN4Δ30 vaccine at study entry and one dose at Day 180. Receives: Biological: WN/DEN4Δ30 Vaccine |
| Placebo | Placebo comparator | Participants will receive one dose of the placebo at study entry and one dose at Day 180. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related adverse events (AEs)
As classified by both intensity and severity through active and passive surveillance
Measured: Measured through Day 360
Measurement of anti-WNV neutralizing antibody
Measured: Measured through Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for West Nile VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anna Durbin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186626
- Sponsor's protocol ID
- CIR 290
- Other IDs
- WIRB/20140078
- Status last verified
- Jan 2017
- First submitted
- 8 Jul 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23968769
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Immunogenicity of a 2-Dose Regimen of West Nile/Dengue 4-3´Δ30 Chimeric Virus Vaccine (WN/DEN4Δ30), a Live Attenuated Vaccine for West Nile Encephalitis, in Flavivirus-naïve Adults 50-65 Years of Age
- ClinicalTrials.gov ID
- NCT02186626
- Acronym / sponsor ID
- CIR 290
- Conditions
- West Nile Virus
- Keywords
- West Nile Virus, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
WNV is the leading vector-borne cause of viral encephalitis in the United States. Severe illness is most common in older adults, and in this population, the virus can cause hepatitis, meningitis, and encephalitis leading to paralysis, coma, and death. WNV illness is a public health issue and is an emerging disease in the United States. This study will evaluate the safety and immunogenicity of a live attenuated West Nile/dengue chimeric virus vaccine (WN/DEN4Δ30) for the prevention of West Nile encephalitis in adults 50 to 65 years old.
This study will enroll healthy adults, 50 to 65 years old, who have no history of previous flavivirus infection. Participants will be randomly assigned to receive the WN/DEN4Δ30 vaccine or placebo vaccine at study entry (Day 0). At the entry visit, participants will undergo a medical history review, physical examination, blood collection, and vital sign measurements; female participants will also take a pregnancy test. Participants will then receive their assigned vaccine, and they will remain in the clinic for 30 minutes after the vaccination for monitoring. Participants will record their temperature and symptoms 3 times a day for 16 days after each vaccination. Additional study visits will occur on Days 3, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 150. These visits may include the same study procedures that occurred at the entry visit. At a study visit on Day 180, participants will receive another dose of their assigned vaccine. Additional study visits will occur on Days 183, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. All study procedures after the second vaccination will be the same that occurred after the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WN/DEN4Δ30 Vaccine | Experimental | Biological: WN/DEN4Δ30 VaccineParticipants will receive one dose of the WN/DEN4Δ30 vaccine at study entry and one dose at Day 180. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive one dose of the placebo at study entry and one dose at Day 180. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- Good general health, as determined by physical examination and review of medical history
Key exclusion criteria (41 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WN/DEN4Δ30 VaccineWN/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. | Biological | WN/DEN4Δ30 Vaccine |
| PlaceboDelivered by subcutaneous injection in the deltoid region of the upper arm. | Biological | Placebo |
Primary outcome
Frequency of vaccine-related adverse events (AEs)
Time frame: Measured through Day 360
As classified by both intensity and severity through active and passive surveillance
Measurement of anti-WNV neutralizing antibody
Time frame: Measured through Day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 23968769Durbin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Durbin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WN/DEN4Δ30 Vaccine in people with West Nile Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vaccine-related adverse events (AEs) (time frame: Measured through Day 360). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.