A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine, HydroVax-001B WNV in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- HydroVax-001B WNV
- Conditions
- West Nile Viral Infection
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Frequency of any unsolicited adverse events (AEs)
- Status
- Active, not recruiting
- Last Updated
- yesterday
Overview
Brief Summary
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.
Detailed 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. The secondary objective is to assess immunogenicity of 4 mcg versus 10 mcg dose of HydroVax-001B WNV vaccine given IM on Days 1, 29 and 181 as measured by WNV-specific focus reduction neutralizing test (FRNT50) after each vaccination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provides written informed consent prior to initiation of any study procedures.
- •Is able to understand and agrees to comply with planned study procedures including being available for all study visits.
- •Agrees to the collection of venous blood per protocol.
- •Is a male or non-pregnant, non-lactating female 18 to 49 years of age, inclusive at time of enrollment.
- •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.
- •Oral temperature is less than 100.4 degrees Fahrenheit at screening.
- •Pulse is 51 to 100 beats per minute, inclusive at screening.
- •Systolic blood pressure is 90 to 140 mmHg, inclusive at screening.
- •Diastolic blood pressure is 55 to 90 mmHg, inclusive at screening.
- •Screening labs must be within acceptable parameters at screening.\*
- •\*Hematology (white blood cell count \[WBC\], hemoglobin and platelet count), serum creatinine, blood urea nitrogen, potassium and liver panel (ALT, AST, and total bilirubin) should fall within the normal range of the clinical reference lab. A low creatinine value, low total bilirubin, or a low ALT value are acceptable for trial inclusion as they are not considered to be clinically significant. If screening lab values are within the normal range of the clinical reference lab but fall within the Grade 1 FDA toxicity table range, these will be considered acceptable for enrollment. Urine glucose must be negative and urine protein \<1+ (trace urine protein is acceptable) at screening to be eligible for the study. Abnormal urine protein in females on their menses can be repeated after menses is finished.
- •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.
- •Females who are of childbearing potential\* must agree not to become pregnant during trial.
- •\*Not of childbearing potential includes post-menopausal females (defined as no menses for at least 12 consecutive months without an alternative medical cause for amenorrhea), or surgically sterile females with documented per volunteer report history of hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement and at least 3 months have passed since sterilization procedure.
Arms & Interventions
Group 1A
A single, low dose, of 4 mcg of HydroVax-001B West Nile Virus (WNV) vaccine administered intramuscularly once on Day 1, Day 29, and Day 181. N=12
Intervention: HydroVax-001B WNV
Group 1A
A single, low dose, of 4 mcg of HydroVax-001B West Nile Virus (WNV) vaccine administered intramuscularly once on Day 1, Day 29, and Day 181. N=12
Intervention: Sodium Chloride, 0.9%
Group 1B
A single, high dose, of 10 mcg of HydroVax-001B West Nile Virus (WNV)vaccine administered intramuscularly once on Day 1, Day 29, and Day 181. N=12
Intervention: HydroVax-001B WNV
Group 1B
A single, high dose, of 10 mcg of HydroVax-001B West Nile Virus (WNV)vaccine administered intramuscularly once on Day 1, Day 29, and Day 181. N=12
Intervention: Sodium Chloride, 0.9%
Group 2A
A 0.5 mL dose of placebo, consisting of 0.9 % of NaCl, administered intramuscularly once on Day 1, Day 29, Day 181. N=3
Intervention: Placebo
Group 2B
A 0.5 mL dose of placebo, consisting of 0.9 % of NaCl, administered intramuscularly once on Day 1, Day 29, Day 181. N=3
Intervention: Placebo
Outcomes
Primary Outcomes
Frequency of any unsolicited adverse events (AEs)
Time Frame: Day 1 through Day 29
Frequency of related Grade 3 laboratory toxicities
Time Frame: Day 1 through Day 15
Frequency of related serious adverse events (SAE) overall and in each dose group through the end of the study
Time Frame: Day 1 through study completion, approximately 13 months
Frequency is the number of discontinuous events
Frequency of solicited local adverse events (AEs)
Time Frame: Day 1 through Day 8
Frequency of solicited systemic adverse events (AEs)
Time Frame: Day 1 through Day 8
Incidence of any unsolicited adverse events (AEs)
Time Frame: Day 1 through Day 29
Incidence of related Grade 3 laboratory toxicities
Time Frame: Day 1 through Day 15
Incidence of related serious adverse events (SAE) overall and in each dose group through the end of the study
Time Frame: Day 1 through study completion, approximately 13 months
Incidence is the number of participants with an event
Incidence of solicited local adverse events (AEs)
Time Frame: Day 1 through Day 8
Incidence of solicited systemic adverse events (AEs)
Time Frame: Day 1 through Day 8
Severity of any unsolicited adverse events (AEs)
Time Frame: Day 1 through Day 29
Severity of solicited local adverse events (AEs)
Time Frame: Day 1 through Day 8
Severity of solicited systemic adverse events (AEs)
Time Frame: Day 1 through Day 8
Secondary Outcomes
- Percentage of participants seroconverting(Day 1 through Day 29)
- West Nile Virus (WNV)-specific focus reduction neutralizing test (FRNT50) geometric mean titer (GMT)(Day 15 through Day 181)