A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.
This is a randomized, placebo-controlled, observer-blind, phase 1 trial in healthy male and non-pregnant female adults 18 through 49 years of age designed to assess the safety and immunogenicity of three ascending doses of HeV-sG-V. Different dosing regimens and number of doses will also be explored. The study plans to accrue eligible subjects into three successive dosage escalation cohorts consisting of 12, 72, and 108 subjects, respectively (total of 192 subjects). The three HeV-sG-V dosages will be 10 mcg, 30 mcg, and 100 mcg. In the first cohort, subjects will receive two doses of the investigational product (IP) at 28-day intervals. Subjects will be randomized in a 5:1 ratio, with 10 receiving two doses of HeV-sG-V (10 mcg dosage) and two subjects will receive placebo. In the second cohort, subjects will be randomized in a 5:5:2 ratio with 30 receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), 30 receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while 12 subjects will receive placebo at each of the same visits. The third cohort will be randomized in a 5:5:5:3 ratio so that 30 subjects are assigned to each of three different regimens consisting of a 100 mcg dosage of HeV-sG-V and placebo administered as three doses, HeV-sG-V on Visit 1 (Day 1) with placebo on Visits 2 and 3 (Days 8 and 29), or HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), or HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while the remaining 18 will receive a dose of placebo at each of the same visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
192
A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.
0.9% Saline
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States
Rate of local and systemic solicited adverse events
e.g., headache, fatigue, fever, etc.that are specifically asked about by the doctor
Time frame: for 1 week after each innoculation
Incidence of clinically significant abnormalities in clinical safety laboratory test results reported as unsolicited AEs.
e.g. hemoglobin, white blood cell count, neutrophil count, creatinine, etc.
Time frame: for 1 week after each innoculation
Incidence of unsolicited adverse events
Adverse events that are reported to the doctor beyond what is asked about by the doctor. An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Time frame: for 1 month after the last vaccination
Incidence of medically attended adverse events and serious adverse events
A reaction to the vaccine that require medical attention. Serious adverse events can include death, hospitalization, disability, and death.
Time frame: through Day 197
Determine number of doses and timing of doses required
Quantitative measurement of antibody response to virus
Time frame: through day 57
Determine number of doses and timing of doses required
Qualitative measurement of antibody response to virus
Time frame: through day 57
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