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A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
Sponsor: GlaxoSmithKline
Summary
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 is conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine are administered in a step-wise dose escalation manner, based upon safety adjudication.
Official title: A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2021-10-14
Completion Date
2025-04-02
Last Updated
2026-07-17
Healthy Volunteers
Yes
Conditions
Interventions
Pentamer (low)/gB(low)/Adjuvant vaccine
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.
Pentamer (med)/gB(low)/Adjuvant vaccine
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.
Pentamer (med)/gB(med)/Adjuvant vaccine
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.
Pentamer (high)/gB(med)/Adjuvant vaccine
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.
Placebo (saline solution)
Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Locations (18)
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Long Beach, California, United States
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
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Newark, New Jersey, United States
GSK Investigational Site
Secaucus, New Jersey, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Cedar Park, Texas, United States
GSK Investigational Site
Galveston, Texas, United States
GSK Investigational Site
Puyallup, Washington, United States