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COMPLETED
NCT05089630
PHASE1/PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

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 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