A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
Фаза 1/2
Завершено
NCT05089630
| Заболевание | Cytomegalovirus Infections |
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| Фаза | Фаза 1/2 |
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| Спонсор | GlaxoSmithKline |
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| Статус | Завершено |
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| Участники | 333 участн. |
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| Вмешательство | 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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| Дата начала | 14.10.2021 |
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| Дата завершения | 2.04.2025 |
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| Публикация результатов | 17.07.2026 |
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Кратко
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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