Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Florida
-
South Miami, Florida, 미국, 33143
- Miami Research Associates, Inc.
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:
- Male or female subjects between the ages of 18 and 40.
- Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
- Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:
- Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
- Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
- Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.
Exclusion Criteria:
None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 1
rLP2086 vaccine 60 mcg
|
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
|
|
실험적: 2
rLP2086 vaccine 120 mcg
|
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
|
|
실험적: 3
rLP2086 vaccine 200 mcg
|
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
|
|
활성 비교기: 4
Tdap vaccine - normal saline - normal saline
|
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
|
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
기간: Baseline up to Month 7
|
Baseline up to Month 7
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
기간: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3
|
Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
- Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 6108A1-1004
- B1971004 (기타 식별자: Alias Study Number)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .