ACTIVE_NOT_RECRUITING

Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy Adults

Conditions

West Nile Viral Infection Healthy Adults HydroVax-001B WNV Immunogenicity Safety Vaccine West Nile Virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized, placebo controlled, double-blind (within dosing group), sequential dose escalation study. This phase 1 trial addresses the urgent need for a vaccine to prevent disease resulting from infection with West Nile virus (WNV), a virus that is primarily spread to people by the bite of an infected mosquito. The purpose of this Phase 1 trial is to evaluate the safety and immunogenicity of the HydroVax-001B WNV vaccine in healthy adult volunteers. The study Population will consist of healthy male and non-pregnant, non-breastfeeding female adults, 18 to 49 years of age, inclusive. Potential participants with a history of prior flavivirus infection or receipt of any flavivirus vaccine or monoclonal antibody, and those who likely had a prior flavivirus infection based on exposure history will be ineligible for the study. Participants will be randomized to receive HydroVax-001B WNV vaccine or placebo in a 12:3 ratio within a dosage group. Participants will be sequentially enrolled into two dosage groups. The primary objective is to assess the safety and reactogenicity of 4 mcg versus 10 mcg dose of the HydroVax-001B WNV vaccine administered intramuscularly (IM) on Days 1, 29 and 181.

Official Title

A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine, HydroVax-001B WNV in Healthy Adults

Quick Facts

Study Start:2025-02-24

Study Completion:2027-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06745921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Provides written informed consent prior to initiation of any study procedures. 2. Is able to understand and agrees to comply with planned study procedures including being available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Is a male or non-pregnant, non-lactating female 18 to 49 years of age, inclusive at time of enrollment. 5. Is in good health.\* \Good health is defined by the absence of a medical condition described in the exclusion criteria. If the participant has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) was first diagnosed within 3 months of enrollment with a clinically significant condition, in the opinion of investigator that has worsened within 3 months of enrollment; (2) had non-elective surgery, clinically significant medical procedure, or hospitalization within 3 months of enrollment; (3) received new prescription for systemic medication within 30 days of enrollment, unless the new prescription is in the same class of agent or a transition from generic to/from brand name equivalent; or (4) takes medication that may pose a risk to participant's safety or impede assessment of adverse events or study endpoints if they participate in the study. 6. Oral temperature is less than 100.4 degrees Fahrenheit at screening. 7. Pulse is 51 to 100 beats per minute, inclusive at screening. 8. Systolic blood pressure is 90 to 140 mmHg, inclusive at screening. 9. Diastolic blood pressure is 55 to 90 mmHg, inclusive at screening. 10. Screening labs must be within acceptable parameters at screening.\ 11. Tests for human immunodeficiency virus (HIV) antigens/antibodies, hepatitis B virus (HBV) surface antigen, and hepatitis C virus (HCV) antibodies must be negative at screening. 12. Females who are of childbearing potential\* must agree not to become pregnant during trial. 13. Females of childbearing potential must agree to use an acceptable contraception method\* from at least 30 days before the first study vaccination and for the duration of the trial. 14. Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each study vaccination. 15. Has body mass index (BMI) 18.5 kg/m\^2 to 34.9 kg/m\^2, inclusive.	1. Has an acute illness\* (with or without fever \>/= 38 degrees Celsius \[100.4 degrees Fahrenheit\]) as determined by the PI or appropriate sub-investigator within 72 hours prior to study product administration. 2. Has medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation.\* 3. Received systemic anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to enrollment. 4. Has active or recently active (in the 12 months prior to enrollment) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted. 5. Has known allergy to components of the study product.\* 6. Has history of idiopathic urticaria. 7. Has history of chronic or acute severe neurologic condition.\* 8. Has history of alcohol or drug abuse within 5 years prior to study vaccination per investigator's discretion. 9. Has any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere\* with participant compliance or safety evaluations. 10. Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. 11. Has moderate to severe asthma.\* 12. Has diabetes mellitus type I or II.\* 13. Is immunosuppressed.\* 14. Have taken high-dose inhaled corticosteroids\* within 30 days prior to study vaccination. 15. Received or plan to receive a licensed, live vaccine within 30 days before or after each study vaccination. 16. Has received or plans to receive a licensed, inactivated vaccine, including influenza, COVID booster, or allergy desensitization shot, within 14 days before or after study vaccination. 17. Received an experimental agent\* within 30 days prior to the study vaccination or expect to receive another experimental agent\\ during the trial-reporting period. 18. Are participating or plan to participate in another clinical trial with an interventional agent\* that will be received during the trial-reporting period. 19. Receipt of blood products or immunoglobulin within six months prior enrollment. 20. Donation of a unit of blood within 60 days prior to enrollment or intends to donate blood during the study period. 21. History of WNV infection or other flavivirus infection (e.g., DENV, ZIKV or other flavivirus). 22. History of travel or residency for one month or more in a non-WNV flavivirus-endemic area such as Mexico, Central/South America, the Caribbean, sub-Saharan Africa, South/Southeast Asia, or Polynesia. 23. Plans to visit a flavivirus-endemic country during the study trial period (refer to CDC website for areas with active ZIKV, DENV, YFV, or JEV transmission). 24. History of vaccination with WNV candidate vaccine. 25. History of military service in a flavivirus-endemic region (refer to CDC website for areas with active ZIKV, DENV, YFV, or JEV transmission). 26. History of vaccination against YFV, DENV, TBEV, JEV, ZIKV, WNV, or other licensed or investigational flavivirus vaccines or receipt of monoclonal antibodies against a flavivirus. 27. Attended primary (grade) school in Austria, Germany, Japan, South Korea, India, Thailand, Nepal, Vietnam, or Taiwan (where TBEV vaccine is given). 28. Plan to perform non-routine highly strenuous exercise within 3 days before any clinical safety laboratories.\* 29. Has contraindication to intramuscular vaccination of both upper arms.\* 30. Has tattoos, scars, or other marks on both upper arms which would, in the opinion of the investigator, interfere with assessment of the vaccination site.

Inclusion Criteria

Exclusion Criteria

1. Provides written informed consent prior to initiation of any study procedures.
2. Is able to understand and agrees to comply with planned study procedures including being available for all study visits.
3. Agrees to the collection of venous blood per protocol.
4. Is a male or non-pregnant, non-lactating female 18 to 49 years of age, inclusive at time of enrollment.
5. Is in good health.\* \*Good health is defined by the absence of a medical condition described in the exclusion criteria. If the participant has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) was first diagnosed within 3 months of enrollment with a clinically significant condition, in the opinion of investigator that has worsened within 3 months of enrollment; (2) had non-elective surgery, clinically significant medical procedure, or hospitalization within 3 months of enrollment; (3) received new prescription for systemic medication within 30 days of enrollment, unless the new prescription is in the same class of agent or a transition from generic to/from brand name equivalent; or (4) takes medication that may pose a risk to participant's safety or impede assessment of adverse events or study endpoints if they participate in the study.
6. Oral temperature is less than 100.4 degrees Fahrenheit at screening.
7. Pulse is 51 to 100 beats per minute, inclusive at screening.
8. Systolic blood pressure is 90 to 140 mmHg, inclusive at screening.
9. Diastolic blood pressure is 55 to 90 mmHg, inclusive at screening.
10. Screening labs must be within acceptable parameters at screening.\*
11. Tests for human immunodeficiency virus (HIV) antigens/antibodies, hepatitis B virus (HBV) surface antigen, and hepatitis C virus (HCV) antibodies must be negative at screening.
12. Females who are of childbearing potential\* must agree not to become pregnant during trial.
13. Females of childbearing potential must agree to use an acceptable contraception method\* from at least 30 days before the first study vaccination and for the duration of the trial.
14. Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each study vaccination.
15. Has body mass index (BMI) 18.5 kg/m\^2 to 34.9 kg/m\^2, inclusive.

1. Has an acute illness\* (with or without fever \>/= 38 degrees Celsius \[100.4 degrees Fahrenheit\]) as determined by the PI or appropriate sub-investigator within 72 hours prior to study product administration.
2. Has medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation.\*
3. Received systemic anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to enrollment.
4. Has active or recently active (in the 12 months prior to enrollment) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
5. Has known allergy to components of the study product.\*
6. Has history of idiopathic urticaria.
7. Has history of chronic or acute severe neurologic condition.\*
8. Has history of alcohol or drug abuse within 5 years prior to study vaccination per investigator's discretion.
9. Has any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere\* with participant compliance or safety evaluations.
10. Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
11. Has moderate to severe asthma.\*
12. Has diabetes mellitus type I or II.\*
13. Is immunosuppressed.\*
14. Have taken high-dose inhaled corticosteroids\* within 30 days prior to study vaccination.
15. Received or plan to receive a licensed, live vaccine within 30 days before or after each study vaccination.
16. Has received or plans to receive a licensed, inactivated vaccine, including influenza, COVID booster, or allergy desensitization shot, within 14 days before or after study vaccination.
17. Received an experimental agent\* within 30 days prior to the study vaccination or expect to receive another experimental agent\*\* during the trial-reporting period.
18. Are participating or plan to participate in another clinical trial with an interventional agent\* that will be received during the trial-reporting period.
19. Receipt of blood products or immunoglobulin within six months prior enrollment.
20. Donation of a unit of blood within 60 days prior to enrollment or intends to donate blood during the study period.
21. History of WNV infection or other flavivirus infection (e.g., DENV, ZIKV or other flavivirus).
22. History of travel or residency for one month or more in a non-WNV flavivirus-endemic area such as Mexico, Central/South America, the Caribbean, sub-Saharan Africa, South/Southeast Asia, or Polynesia.
23. Plans to visit a flavivirus-endemic country during the study trial period (refer to CDC website for areas with active ZIKV, DENV, YFV, or JEV transmission).
24. History of vaccination with WNV candidate vaccine.
25. History of military service in a flavivirus-endemic region (refer to CDC website for areas with active ZIKV, DENV, YFV, or JEV transmission).
26. History of vaccination against YFV, DENV, TBEV, JEV, ZIKV, WNV, or other licensed or investigational flavivirus vaccines or receipt of monoclonal antibodies against a flavivirus.
27. Attended primary (grade) school in Austria, Germany, Japan, South Korea, India, Thailand, Nepal, Vietnam, or Taiwan (where TBEV vaccine is given).
28. Plan to perform non-routine highly strenuous exercise within 3 days before any clinical safety laboratories.\*
29. Has contraindication to intramuscular vaccination of both upper arms.\*
30. Has tattoos, scars, or other marks on both upper arms which would, in the opinion of the investigator, interfere with assessment of the vaccination site.

Contacts and Locations

Study Locations (Sites)

Saint Louis University Center for Vaccine Development

Saint Louis, Missouri, 63104-1015

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24

Study Completion Date2027-11-01

Study Record Updates

Study Start Date2025-02-24

Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

Healthy Adults
HydroVax-001B WNV
Immunogenicity
Safety
Vaccine
West Nile Virus

Additional Relevant MeSH Terms

West Nile Viral Infection