The purpose of this study is to assess the safety, reactogenicity and immune response of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
339
Three doses of the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Long Beach, California, United States
Number of participants reporting solicited administration site events
The solicited administration site events include pain, redness and swelling.
Time frame: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting solicited systemic events
The solicited systemic events include fever, myalgia, fatigue, arthralgia and headache. The preferred location for measuring temperature is the oral cavity. Fever is defined as body temperature ≥38.0°C/100.4°F by any route.
Time frame: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting unsolicited adverse events (AEs) within 7 days after each dose
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Time frame: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting serious adverse events (SAEs) within 7 days after each dose
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time frame: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting unsolicited AEs up to 30 days after each dose
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
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Three doses of the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Hallandale, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Dearborn, Michigan, United States
GSK Investigational Site
Springfield, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
...and 8 more locations
Time frame: Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting SAEs up to 30 days after each dose
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time frame: Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting medically attended AEs (MAEs) up to 30 days after each dose
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time frame: Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time frame: At Day 1
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 8
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time frame: At Day 8
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 61
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time frame: At Day 61
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 68
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time frame: At Day 68
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time frame: At Day 181
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 188
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time frame: Day 188
Number of participants reporting unsolicited AEs from Dose 1 to end of study (Month 18)
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Time frame: From Dose 1 (Day 1) to end of study (Month 18)
Number of participants reporting MAEs from Dose 1 to end of study (Month 18)
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time frame: From Dose 1 (Day 1) to end of study (Month 18)
Number of participants reporting SAEs from Dose 1 to end of study (Month 18)
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time frame: From Dose 1 (Day 1) to end of study (Month 18)
Number of participants reporting potential immune-mediated disease (pIMDs) from Dose 1 to end of study (Month 18)
PIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From Dose 1 (Day 1) to end of study (Month 18)
Neutralizing antibodies (nAbs) titers against epithelial cell infection
The humoral immune response is measured in terms of nAbs against epithelial cell infection and expressed as geometric mean titers (GMT). Serological assays for the determination of antibodies against CMV are performed by neutralization assay.
Time frame: On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546)
Anti-pentamer immunoglobulin G (IgG) and anti-gB IgG concentrations
The vaccine-induced anti-gB and anti-pentamer humoral immune response is measured in terms of anti-pentamer IgG and anti-gB IgG geometric mean concentrations (GMCs) determined by enzyme linked immunosorbent assay (ELISA) and expressed in EU/ml.
Time frame: On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546)