A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
Public ClinicalTrials.gov record NCT05089630. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05089630
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 333 participants
Conditions and interventions
Conditions
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 solution) Combination Product
Biological · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2021 (Actual)
- Primary completion
- Apr 2, 2025 (Actual)
- Completion
- Apr 2, 2025 (Actual)
- Last update posted
- Jul 17, 2026
2021 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Anaheim | California | 92806 | — |
| GSK Investigational Site | Long Beach | California | 90806 | — |
| GSK Investigational Site | Los Angeles | California | 90017 | — |
| GSK Investigational Site | Hallandale | Florida | 33009 | — |
| GSK Investigational Site | Miami | Florida | 33143 | — |
| GSK Investigational Site | Lexington | Kentucky | 40536-0084 | — |
| GSK Investigational Site | Dearborn | Michigan | 48127 | — |
| GSK Investigational Site | Springfield | Missouri | 65802 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68510 | — |
| GSK Investigational Site | Omaha | Nebraska | 68134 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89109 | — |
| GSK Investigational Site | Newark | New Jersey | 07103 | — |
| GSK Investigational Site | Secaucus | New Jersey | 07094 | — |
| GSK Investigational Site | New York | New York | 10065 | — |
| GSK Investigational Site | Austin | Texas | 78744-1645 | — |
| GSK Investigational Site | Cedar Park | Texas | 78613 | — |
| GSK Investigational Site | Galveston | Texas | 77573 | — |
| GSK Investigational Site | Puyallup | Washington | 98371 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05089630, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05089630 live on ClinicalTrials.gov.