- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02337868
Phase 1 Trial of Inactivated West Nile Virus Vaccine
A Double Blind, Randomized, Placebo-Controlled, Phase I Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine, HydroVax-001, in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27704
- Duke Human Vaccine Institute - Duke Clinical Vaccine Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1.Age >/=18 years and < 50 years 2.Able to read, sign, and date the informed consent document 3. Available and willing to participate for the planned duration of the study 4.Are in good health, as judged by the investigator and determined by vital signs, medical history, and physical examination 5.Sexually active males must agree to use a medically acceptable form of contraception* in order to be in this study and must agree to continue such use until day 30 after the last vaccination.Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. 6.Women of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination *Not sterilized via tubal ligation, bilateral oophorectomy, or hysterectomy and still menstruating or < 1 year of the last menses if menopausal 7. Women of childbearing potential must have used an acceptable method of contraception* in the 30 days prior to enrollment and must agree to continue such use until day 30 after the last vaccination. *Includes, but is not limited to, abstinence from sex with men,barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure, and licensed hormonal methods such as implants, injectables, or oral contraceptives
Exclusion Criteria:
1. Any clinically significant acute or chronic medical condition* or need for chronic medications** that, in the opinion of the investigator, will interfere with immunity or affect safety *Includes, but is not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions ** Receipt of systemic, prescription medications for the treatment of chronic medical conditions or variations of normal physiologic functions are permissible if, in the opinion of the investigator, they are used for conditions that are not clinically significant and would not impact the safety of the subject or the safety and immunogenicity outcomes of the protocol. Use of systemic, over-the-counter medications and PRN systemic, prescription medication are allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Topical (except corticosteroid) medications, nasal (including corticosteroid) medications, vitamins, and supplements are permissible 2. Asthma, other than mild, well-controlled asthma* *Cold or exercise induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Participants should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year 3. Diabetes mellitus 4. Unstable depression or bipolar disorder* *Has received <3 months of the same anti-depressant or bipolar disorder medication(s) (and dose) or has had a decompensating event during the previous 3 months or has depression or bipolar disorder that in the opinion of the investigator will compromise the subject's ability to comply with protocol requirements 5. Unstable seizure disorder (defined as requiring medication for seizure control or with seizure activity within the past 3 years) 6. Autoimmune disease (lupus, multiple sclerosis, rheumatoid arthritis, autoimmune thyroid disease, etc.); vitiligo, and mild eczema or mild psoriasis not requiring chronic therapy are permissible. 7. Known or suspected congenital or acquired immunodeficiency including anatomic or functional asplenia or immunosupppression as a result of underlying illness or treatment 8. Abuse of alcohol or drugs that, in the opinion of the investigator, may interfere with the subject's ability to comply with the protocol 9. Unstable hypertension (well-controlled hypertension with medication is permissible) 10. Body mass index (BMI) >/= 35 11. Known allergy to components of the study product .Including the following: aluminum hydroxide, sorbitol, potassium chloride, sodium chloride 12. Seropositive to West Nile virus 13. History of a visit to South America or sub-Saharan Africa lasting one month or more 14. History of military service 15. History of vaccination against yellow fever, tick-borne encephalitis, or Japanese encephalitis 16. History of vaccination with West Nile virus candidate vaccines. 17. Attended primary (grade) school in Austria, Germany, Japan, South Korea, India, Thailand, Nepal, Vietnam, or Taiwan (where tick-borne encephalitis vaccine is given) 18. History of dengue fever or receipt of a dengue fever vaccine 19. Active neoplastic disease* *Participants with a history of malignancy may be included if treated by surgical excision or if treated by chemotherapy or radiation therapy has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure (not less than 36 months) 20. Chronic topical or systemic corticoste roid use* *Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a topical corticosteroid for a limited duration for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed. Oral or parenteral (intravenous, subcutaneous or intramuscular) corticosteroids given for non-chronic conditions not expected to recur are permissible if, within the year prior to enrollment, the longest course of therapy was no more than 14 days and no oral or parenteral corticosteroids were given within 30 days prior to enrollment. Intraarticular, bursal, tendon, or epidural injections of corticosteroids are permissible if the most recent injection was at least 30 days prior to enrollment. 21. Are breastfeeding or plan to breastfeed at any time throughout the study 22. Receipt or planned receipt of inactivated vaccine or allergy desensitization injection 14 days before or after a study vaccination 23. Receipt or planned receipt of live attenuated vaccine 30 days before or after a study vaccination 24. Receipt of any other experimental agent within 30 days prior to vaccination or planned receipt prior to the end of the study 25. Plans to enroll in another clinical trial* that could interfere with safety assessment of the investigational product at any time during the study period *Includes trials that have a study intervention such as a drug, biologic, or device 26 Receipt of blood products or immunoglobulin within six months prior enrollment 27. Donation of a unit of blood within 56 days prior to enrollment or intends to donate blood during the study period 28. Systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg 29.Resting heart rate <40 or >100 beats per minute 30.Oral temperature >/= 38 degrees C (100.4 degrees F) 31.Positive serology for HIV 1/2* *If the enzyme linked immunosorbent assay (ELISA) is positive, HIV confirmation should be performed. If the HIV Western Blot is not consistent with HIV infection, the volunteer may be enrolled. A past participant in an HIV vaccine trial who has a positive antibody ELISA may participate if the Western Blot is not consistent with pending seroconversion or positive or an HIV polymerase chain reaction (PCR) assay result is below the level of detection of HIV. 32. Positive hepatitis B surface antigen (HBsAg) 33. Positive antibody to hepatitis C virus (HCV) 34. Any Grade 1 or higher screening clinical lab value* (see Toxicity Table Appendix B) *Screening clinical labs include blood tests (white blood cell [WBC] count, hemoglobin level, platelet count, creatinine, blood urea nitrogen, non-fasting glucose, potassium, alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin) and urine tests (protein, glucose). 35. Plan to have a major change in exercise routine from 72 hours before any dose of study vaccine/placebo through 15 days after that dose 36. Acute febrile illness (oral temperature >/= 38 deg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Dose Expanded
15 subjects will receive 4 mcg of HydroVax-001 IM and 4 subjects will receive placebo IM on Days 1 and 29.
|
HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29
0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29
|
Experimental: High Dose Sentinel
5 subjects will receive 4 mcg of HydroVax-001 IM and 1 subject will receive placebo IM on Days 1 and 29.
|
HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29
0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29
|
Experimental: Low Dose Expanded
15 subjects will receive 1 mcg of HydroVax-001 IM and 4 subjects will receive placebo IM on Days 1 and 29.
|
HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29
0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29
|
Experimental: Low Dose Sentinel
5 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-001 and 1 subject will receive placebo IM on Days 1 and 29.
|
HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29
0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of any AE related to the study vaccine through day 57 after the second vaccination
Time Frame: Day 1 post first vaccination to Day 57 post second vaccination
|
Day 1 post first vaccination to Day 57 post second vaccination
|
Occurrence of Grade 3 laboratory toxicities related to the study vaccine from first vaccination through day 15 after the second vaccination
Time Frame: Day 1 post first vaccination to Day 15 post second vaccination
|
Day 1 post first vaccination to Day 15 post second vaccination
|
Occurrence of Grade 3 unsolicited adverse events related to the study vaccine from first vaccination through day 57 after the second vaccination
Time Frame: Day 1 post first vaccination to Day 57 post second vaccination
|
Day 1 post first vaccination to Day 57 post second vaccination
|
Occurrence of SAEs related to the study vaccine at any time during the study
Time Frame: Day 1 post first vaccination to Day 365 post second vaccination
|
Day 1 post first vaccination to Day 365 post second vaccination
|
Occurrence of solicited local AE and reactogenicity signs and symptoms in the 14 days after each vaccination
Time Frame: Day 1 post first vaccination to Day 14 post first and second vaccination
|
Day 1 post first vaccination to Day 14 post first and second vaccination
|
Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 14 days after each vaccination
Time Frame: Day 1 post first vaccination to Day 14 post first and second vaccination
|
Day 1 post first vaccination to Day 14 post first and second vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric mean PRNT50 titer at days 15 and 29 after first vaccination and at days 15, 29, 57, 180, and 365 following second vaccination
Time Frame: Days 15 and 29 post first vaccination and Days 15, 29, 57, 180, and 365 post second vaccination
|
Days 15 and 29 post first vaccination and Days 15, 29, 57, 180, and 365 post second vaccination
|
Percentage of subjects achieving seroconversion in PRNT50 titer (fourfold or greater increase in titer from baseline) at day 29 after first vaccination and at day 57 after second vaccination
Time Frame: Day 29 post first vaccination and Day 57 post second vaccination
|
Day 29 post first vaccination and Day 57 post second vaccination
|
The reverse cumulative distribution curve of PRNT50 titer on Days 15 and 29 after first vaccination and at days 15, 29, 57, 180, and 365 after the second vaccination for each dose group and for all dose groups combined
Time Frame: Days 15 and 29 post first vaccination and Days 15, 29, 57, 180, and 365 post second vaccination
|
Days 15 and 29 post first vaccination and Days 15, 29, 57, 180, and 365 post second vaccination
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0020
- HHSN272201300017I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on West Nile Viral Infection
-
Institute of Tropical Medicine, BelgiumUniversiteit Antwerpen; Victor Babes Hospital, Bucharest, RomaniaWithdrawnOxidative Stress | West Nile Virus | West Nile Fever | West Nile Fever Encephalitis | West Nile Fever Meningitis | West Nile Meningitis | West Nile Virus Meningoencephalitis | West Nile Fever Meningoencephalitis | West Nile Fever With Neurologic ManifestationRomania
-
MacroGenicsNational Institute of Allergy and Infectious Diseases (NIAID)TerminatedEncephalitis | Meningitis | West Nile Virus Infection | West Nile Fever | West Nile Neuroinvasive Disease | Acute Flaccid Paralysis
-
National Institutes of Health Clinical Center (CC)CompletedEncephalitis | Myelitis | West Nile VirusUnited States
-
MacroGenicsNational Institute of Allergy and Infectious Diseases (NIAID)No longer available
-
National Institute of Allergy and Infectious Diseases...Completed
-
MacroGenicsNational Institute of Allergy and Infectious Diseases (NIAID)CompletedWest Nile VirusUnited States
-
Sarepta Therapeutics, Inc.CompletedWest Nile VirusUnited States
-
National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthCompletedWest Nile Fever EncephalitisUnited States
-
Leiden University Medical CenterUMC Utrecht; Erasmus Medical Center; Leiden University; Netherlands Institute of...Completed
-
Hawaii Biotech, Inc.Completed
Clinical Trials on HydroVax-001
-
Najit Technologies, Inc.National Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Toll Biotech Co. Ltd. (Beijing)Recruiting
-
IntegoGen, LLCWithdrawnHidradenitis SuppurativaUnited States
-
Patagonia Pharmaceuticals, LLCCompletedCongenital IchthyosisUnited States
-
Frontera TherapeuticsRecruitingBiallelic RPE65 Mutation-associated Retinal DystrophyChina
-
StimuSILAnkara City Hospital Bilkent; Istanbul University - Cerrahpasa (IUC)RecruitingAndrogenetic Alopecia | Hair Loss | Male Pattern Baldness | Hair Loss/Baldness | Pattern BaldnessTurkey
-
MediciNovaCompletedInterstitial CystitisUnited States
-
Longbio PharmaActive, not recruitingMyelodysplastic Syndrome (MDS)China
-
JANSSEN Alzheimer Immunotherapy Research & Development...TerminatedAlzheimer's DiseaseUnited States
-
Heartseed Inc.RecruitingHeart Failure | Ischemic Heart DiseaseJapan