A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
1/2期
已完成
NCT05089630
| 适应症 | Cytomegalovirus Infections |
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| 分期 | 1/2期 |
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| 申办方 | GlaxoSmithKline |
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| 状态 | 已完成 |
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| 受试者人数 | 333 人 |
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| 干预（药物） | 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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| 开始日期 | 2021年10月14日 |
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| 完成日期 | 2025年4月2日 |
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| 结果公布日 | 2026年7月17日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。