A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
Phase 1/2
Completed
NCT05089630
| Condition | Cytomegalovirus Infections |
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| Phase | Phase 1/2 |
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| Sponsor | GlaxoSmithKline |
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| Status | Completed |
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| Enrollment | 333 participants |
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| Interventions | Pentamer (low)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(med)/Adjuvant vaccine, Pentamer (high)/gB(med)/Adjuvant vaccine, Placebo (saline solution) |
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| Start date | Oct 14, 2021 |
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| Completion date | Apr 2, 2025 |
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| Results posted | Jul 17, 2026 |
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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 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.
Number of Participants With Solicited Administration Site Adverse Events Post Each Dose Administration
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181) · Participants
| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 3 Participants |
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| Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group | 3 Participants |
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| Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group | 3 Participants |
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| Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group | 2 Participants |
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| Placebo Group | 0 Participants |
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| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 4 Participants |
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Number of Participants With Solicited Systemic Adverse Events Post Each Dose Administration
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181) · Participants
| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 5 Participants |
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| Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group | 4 Participants |
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| Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group | 7 Participants |
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| Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group | 9 Participants |
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| Placebo Group | 1 Participants |
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| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 13 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs) Within 7 Days Post Each Dose Administration
Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181) · Participants
| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 4 Participants |
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| Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group | 8 Participants |
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| Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group | 3 Participants |
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| Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group | 6 Participants |
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| Placebo Group | 4 Participants |
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| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 9 Participants |
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Open in BENITIONS
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