A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
1/2상
완료
NCT05089630
| 대상 질환 | Cytomegalovirus Infections |
|---|
| 임상 단계 | 1/2상 |
|---|
| 스폰서 | GlaxoSmithKline |
|---|
| 상태 | 완료 |
|---|
| 참여자 수 | 333 명 |
|---|
| 중재(약물) | 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) |
|---|
| 시작일 | 2021년 10월 14일 |
|---|
| 완료일 | 2025년 4월 2일 |
|---|
| 결과 공개일 | 2026년 7월 17일 |
|---|
요약
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 |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.