이전 폐렴구균 백신 접종력을 가진 50세 이상 성인에서 VAX-31의 안전성, 내약성 및 면역원성
VAX-31의 안전성, 내약성 및 면역원성을 평가하기 위한 이전 폐렴구균 백신 접종 경험이 있는 50세 이상 건강한 피험자를 대상으로 한 3상 무작위 배정 이중 맹검 능동 대조군 임상시험
The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Arizona
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Chinle, Arizona, 미국, 86503
- Chinle Center for Indigenous Health
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Phoenix, Arizona, 미국, 85044
- Avacare (CCT Research)
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Whiteriver, Arizona, 미국, 85941
- Whiteriver Center for Indigenous Health
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Connecticut
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Waterbury, Connecticut, 미국, 06708
- Chase Medical Research
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Florida
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Hollywood, Florida, 미국, 33024
- CenExel (RCA)
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Jupiter, Florida, 미국, 33458
- Eximia (Health Awareness)
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Port Saint Lucie, Florida, 미국, 34952
- Eximia (Health Awareness)
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Sunrise, Florida, 미국, 33351
- Precision Clinical Research
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The Villages, Florida, 미국, 32162
- The Villages
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Georgia
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Stockbridge, Georgia, 미국, 30281
- DelRicht Clinical Research
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Indiana
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Valparaiso, Indiana, 미국, 46383
- Velocity Clinical Valparaiso
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Kansas
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Lenexa, Kansas, 미국, 66219
- Johnson County Clin-Trials, LLC
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Louisiana
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New Orleans, Louisiana, 미국, 70115
- DelRicht Clinical Research
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Maryland
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Rockville, Maryland, 미국, 20854
- Velocity (Meridian Clinical Research)
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Michigan
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Southfield, Michigan, 미국, 48076
- DM Clinical Research-Detroit
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Missouri
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Kansas City, Missouri, 미국, 64114
- AMR
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Springfield, Missouri, 미국, 65807
- DelRicht Research (Command Family Medicine)
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Nebraska
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Omaha, Nebraska, 미국, 68114
- Quality Clinical Research
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New Mexico
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Gallup, New Mexico, 미국, 87301
- Center of American Indian Health
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Shiprock, New Mexico, 미국, 87420
- Shiprock Center for Indigenous Health
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New York
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Wilmington, North Carolina, 미국, 28403
- Headlands (Trial Management Associates)
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Oklahoma
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Edmond, Oklahoma, 미국, 73013
- Tekton Research
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Tennessee
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Hendersonville, Tennessee, 미국, 37075
- DelRicht Research
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Texas
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Austin, Texas, 미국, 78745
- Tekton Research
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Beaumont, Texas, 미국, 77701
- REX Clinical Trials
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San Antonio, Texas, 미국, 78229
- Flourish Research
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Sugar Land, Texas, 미국, 77478
- DM Clinical Research
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Virginia
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Charlottesville, Virginia, 미국, 22911
- Alcanza (Charlottesville Medical Research)
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Newport News, Virginia, 미국, 23606
- Health Research of Hampton Roads, Inc.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female ≥50 years of age (inclusive) at the time of randomization into the study.
- Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed).
- Able and willing to complete the informed consent process.
- Available for clinical follow-up through the last study visit.
- In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
- Willing to have blood samples collected and used for research purposes.
- Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
- Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
- Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Exclusion Criteria:
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Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
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Previous receipt of an investigational pneumococcal vaccine at any age.
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Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
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Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1.
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Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
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Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C.
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History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
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Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
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Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
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Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
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Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study.
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Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to ≤10 mg/day and ≥2 weeks of prednisone equivalent >10 mg/day).
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Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccination
• History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
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Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
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Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cohort 1 (VAX-31): Prior PPSV23
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
활성 비교기: Cohort 1 (PCV20): Prior PPSV23
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
|
실험적: Cohort 2 (VAX-31): Prior PCV20
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
활성 비교기: Cohort 2 (PCV20): Prior PCV20
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
|
실험적: Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combination
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
활성 비교기: Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combination
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
주사 부위 발적, 부종 및 통증을 포함한 유도된 국소 이상반응(AE)을 보고한 대상자의 백분율
기간: 백신 접종 후 최대 7일까지
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백신 접종 후 최대 7일까지
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발열, 두통, 피로, 근육통 및 관절통과 같은 요구된 전신 이상반응을 보고한 참가자 비율
기간: 접종 후 최대 7일까지
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접종 후 최대 7일까지
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자발적 이상반응을 보고한 참가자의 백분율
기간: 백신 접종 후 최대 31일 동안
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백신 접종 후 최대 31일 동안
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혈청형 특이적 OPA 기하평균 역가(GMT)
기간: VAX-31 백신 접종 후 1개월
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VAX-31 백신 접종 후 1개월
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기준선 대비 혈청형별 OPA 기하평균 상승배수(GMFR)
기간: VAX-31 백신 접종 후 1개월
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VAX-31 백신 접종 후 1개월
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만성질환 신규 발병(NOCI), 의료진 방문 이상반응(MAAE) 및 중대한 이상반응(SAE)을 보고한 대상자의 비율
기간: 접종 후 최대 6개월
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접종 후 최대 6개월
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
혈청형 특이 IgG 기하 평균 농도(GMC)
기간: VAX-31 백신 접종 후 1개월
|
VAX-31 백신 접종 후 1개월
|
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기준선 대비 혈청형 특이적 IgG 기하 평균 상승 배율 (GMFR)
기간: VAX-31 백신 접종 후 1개월
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VAX-31 백신 접종 후 1개월
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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