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NCT05089630 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cytomegalovirus Infections, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
339
Enrollment target
18
Study locations

NCT05089630 is a Phase 1 study of Cytomegalovirus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 339 participants, above the 188-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (80% higher). The trial reports 18 study locations across 11 states.

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The verdict

NCT05089630, a Phase 1 study of Cytomegalovirus Infections, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
339 participants
Enrollment target
18
Study locations

Study 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.

Conditions Studied

Cytomegalovirus Infections

Interventions

  • BIOLOGICAL 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
  • COMBINATION_PRODUCT Placebo (saline)

Study Locations (18)

California

  • GSK Investigational Site - Anaheim
  • GSK Investigational Site - Long Beach
  • GSK Investigational Site - Los Angeles

Texas

  • GSK Investigational Site - Austin
  • GSK Investigational Site - Cedar Park
  • GSK Investigational Site - Galveston

Florida

  • GSK Investigational Site - Hallandale
  • GSK Investigational Site - Miami

Nebraska

  • GSK Investigational Site - Lincoln
  • GSK Investigational Site - Omaha

New Jersey

  • GSK Investigational Site - Newark
  • GSK Investigational Site - Secaucus

Kentucky

  • GSK Investigational Site - Lexington

Michigan

  • GSK Investigational Site - Dearborn

Missouri

  • GSK Investigational Site - Springfield

Trial Details

FieldValue
Enrollment Target 339 participants
Start Date 2021-10-14
Est. Completion 2025-04-02
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT05089630

The ClinicalTrials.gov registry entry for NCT05089630 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 188-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (80% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 5 interventions - of which Pentamer (low)/gB(low)/Adjuvant vaccine is the first listed.

NCT05089630 reports 18 study locations spanning 11 distinct geographic areas - top geographies include California, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT05089630 about?

NCT05089630 is a clinical study titled "A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults". 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...

What is the current status of trial NCT05089630?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 339 participants. The study started on 2021-10-14. Estimated completion is 2025-04-02.

What conditions does trial NCT05089630 study?

This clinical trial studies the following conditions: Cytomegalovirus Infections.

What interventions are being tested in trial NCT05089630?

The interventions under investigation include: 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).

Who is sponsoring clinical trial NCT05089630?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05089630 being conducted?

This trial has 18 study locations across California, Florida, Kentucky, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.