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

Cytomegalovirus Infections Clinical Trial

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

Clinical Trial Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05089630
Study type Interventional
Source GlaxoSmithKline
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date October 14, 2021
Completion date June 19, 2029
View Details
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