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A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT05089630•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 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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•Written informed consent obtained from the participant prior to performance of any study specific procedure.
•A healthy adult (woman or man), 18 to 50 years of age at the time of the first study intervention administration.
•Healthy participants as established by medical history and clinical examination before entering the study.
•Participants who are women of non-childbearing potential may be enrolled in the study.
•Participants who are women of child-bearing potential may be enrolled in the study, if the participant:
•* has practiced adequate contraception for 30 days prior to study intervention administration, and
•* has a negative pregnancy test on the day of study intervention administration and
•* has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the study intervention administration series.
•Participants who agree to take appropriate infection control measures to prevent becoming infected with SARS-CoV2 during the study.
+6 more criteria

Exclusion Criteria

•Medical conditions
•Known documented medical history of or viral hepatitis B or C infection.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
•Any confirmed or suspected immunosuppressive or immunodeficient condition.
•Family history of congenital or hereditary immunodeficiency.
•History of or current autoimmune disease.
•Lymphoproliferative disorder or malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer).
•Hypersensitivity to latex.
•Major congenital defects
•Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
+25 more criteria

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

Key Dates

Start Date

October 14, 2021

Primary Completion Date

April 2, 2025

Completion Date

April 2, 2025

Last Updated

March 2, 2026

Enrollment

339

ACTUAL participants

Conditions

Cytomegalovirus Infections

Interventions

Pentamer (low)/gB(low)/Adjuvant vaccine

BIOLOGICAL

Pentamer (med)/gB(low)/Adjuvant vaccine

BIOLOGICAL

Pentamer (med)/gB(med)/Adjuvant vaccine

BIOLOGICAL

Pentamer (high)/gB(med)/Adjuvant vaccine

BIOLOGICAL

Placebo (saline)

COMBINATION_PRODUCT

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

NCT07294547

Kidney Transplantation, Cytomegalovirus InfectionsEBV Infection+1 more

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RECRUITINGPHASE1

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

NCT06926894

Epstein-Barr VirusCytomegalovirus Infections+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection