A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

339

Participants

Timeline

Start Date

October 14, 2021

Primary Completion Date

April 2, 2025

Study Completion Date

April 2, 2025

Conditions
Cytomegalovirus Infections
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

COMBINATION_PRODUCT

Placebo (saline)

Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.

Trial Locations (18)

10065

GSK Investigational Site, New York

33009

GSK Investigational Site, Hallandale

33143

GSK Investigational Site, Miami

48127

GSK Investigational Site, Dearborn

65802

GSK Investigational Site, Springfield

68134

GSK Investigational Site, Omaha

68510

GSK Investigational Site, Lincoln

77573

GSK Investigational Site, Galveston

78613

GSK Investigational Site, Cedar Park

89109

GSK Investigational Site, Las Vegas

90017

GSK Investigational Site, Los Angeles

90806

GSK Investigational Site, Long Beach

92806

GSK Investigational Site, Anaheim

98371

GSK Investigational Site, Puyallup

40536-0084

GSK Investigational Site, Lexington

07103

GSK Investigational Site, Newark

07094

GSK Investigational Site, Secaucus

78744-1645

GSK Investigational Site, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT05089630 - A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults | Biotech Hunter | Biotech Hunter