A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
第1/2相
完了
NCT05089630
| 対象疾患 | Cytomegalovirus Infections |
|---|
| 相 | 第1/2相 |
|---|
| スポンサー | GlaxoSmithKline |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 333 名 |
|---|
| 介入（薬剤） | 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) |
|---|
| 開始日 | 2021年10月14日 |
|---|
| 完了日 | 2025年4月2日 |
|---|
| 結果公開日 | 2026年7月17日 |
|---|
概要
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 |
|---|
| Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group | 3 Participants |
|---|
| Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group | 3 Participants |
|---|
| Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group | 2 Participants |
|---|
| Placebo Group | 0 Participants |
|---|
| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 4 Participants |
|---|
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 |
|---|
| Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group | 4 Participants |
|---|
| Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group | 7 Participants |
|---|
| Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group | 9 Participants |
|---|
| Placebo Group | 1 Participants |
|---|
| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 13 Participants |
|---|
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 |
|---|
| Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group | 8 Participants |
|---|
| Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group | 3 Participants |
|---|
| Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group | 6 Participants |
|---|
| Placebo Group | 4 Participants |
|---|
| Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group | 9 Participants |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。