The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
18
Souseikai PS Clinic ( Site 0001)
Fukuoka, Japan
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.
Time frame: Up to 5 days after each vaccination
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.
Time frame: Up to 14 days after each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported
Time frame: Up to 14 days after each vaccination
Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)
The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.
Time frame: 1 month after third vaccination (at 7 months)
Number of Participants With Viral Detection of V160 in Plasma
The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.
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Time frame: Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14
Number of Participants With Wild-Type CMV Detection in Urine and Saliva
The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.
Time frame: Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab
The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.
Time frame: Day 1: 0, 10, 20, and 30 minutes postvaccination