Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Cytomegalovirus Infections, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The assessed solicited administration site adverse events were erythema (injection site redness), pain and swelling.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2025-04-02 |
| Phase | Phase 1 |
What the finished NCT05089630 record still lists
NCT05089630 is an interventional study that assigns participants to a tested intervention. The registered 339 participants enrollment target is mid-sized for trials with a published cap, above the 188-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (80% higher).
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 lists 18 locations in 11 states (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.
Learn More About Clinical Trials
Similar trials for Cytomegalovirus Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05089630's enrollment target sits among peer trials
339 5th of 24 higher than 20 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cytomegalovirus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
R-MVST Cells for Treatment of Viral Infections
RECRUITING · Phase 1
-
Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity
RECRUITING · Phase 1
-
R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
RECRUITING · Phase 1
-
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
ACTIVE NOT RECRUITING · Phase 1
-
Viral Specific T-Lymphocytes to Treat Adenovirus or CMV
ACTIVE NOT RECRUITING · Phase 1
-
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04176172 · 340 participants · Phase 3
Optimizing Tobacco Use Treatment for PLWHA
- NCT04545424 · 340 participants · Phase 2
Trial of Therapeutic Hypothermia in Patients With ARDS
- NCT04806958 · 340 participants · NA
The PulsePoint Study
- NCT05323409 · 340 participants · NA
Improving Comprehensive Care of Cancer Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI