- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01188512
First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine
A Phase 1, Single Centre, Dose-escalating, Placebo-controlled Study of a Genetically Modified B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Male Volunteers
The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers.
Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most vulnerable age group), preferably after a single administration very early in life. The successful outcome of this project would constitute an important milestone towards nasal vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our ultimate aim is to protect infants in the most vulnerable age group, before the regular vaccination schedule using already available vaccines is applied. The ultimate aim is thus not to replace current vaccination schedules with available vaccines, but to add a first nasal vaccination to protect very early in life.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
-
Solna, 스웨덴, 171 76
- Karolinska University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Subject will be included in the study if he meets all the following criteria:
- Healthy male born between 1979 and 1991 who has not experienced clinical pertussis (lab. Verified) during the past 10 years and who has not been vaccinated with any pertussis vaccine.
- Informed consent form signed by the subject.
- Subject shall be able to attend all scheduled visits and to understand and comply with the study procedures (e.g. able to read and write Swedish).
Exclusion Criteria:
If any of the following criteria are met, the subject must not be included in the study:
- Individuals with pertussis toxin serum IgG antibodies ≥20 units/mL.
- Blood pressure after resting ≥ 150/90 mmHg.
- Heart rate after resting ≥80 bpm.
- Respiratory rate after resting ≥ 20/minute.
- Unwillingness to refrain from the use of nicotine products from screening through day 28.
- Use of narcotic drugs/alcohol and/or a history of previous use of drug/alcohol abuse whitin the past 2 years prior to screening
- The subject has donated blood or suffered from blood loss of at least 450 ml (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening.
- Receipt of immunoglobulin, blood derived products, systemic corticosteroids or other immunosuppressant drugs within 90 days prior to day 0.
- Use of corticosteroids in the respiratory tract(e.g. nasal steroids, inhaled steroids) whitin 30 days prior to day 0.
- Use of herbal medications or dietary supplements within 7 days prior to day 0 at the discretion of the investigator. Unwillingness to refrain from herbal medications or dietary supplements within 30 days after day 0 at the discretion of the investigator.
- Receipt of a vaccine within the last 30 days prior to day 0 or planned vaccination within the next 30 days after day 0.
- Evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine.
- Known hypersensitivity to any component of the study vaccine.
- Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0.
- Inability to adhere to the protocol, including plans to move from the area.
- Family history of congenital or hereditary immunodeficiency (first degree).
- Infection with HIV, hepatitis B or C.
- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Clinically significant abnormal laboratory values at the discretion of the investigator.
- Person in frequent contact with children less than 1 year of age (father, childcare worker, nurse, etc…) or residence in the same household as persons with known immunodeficiency.
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 |
---|---|
위약 비교기: 위약
제형 버퍼
|
Individuals will get placebo once intranasally.
Dose 2 x 0.1 mL (0.1 mL per nostril).
|
실험적: BPZE1 - Low dose
1,000 colony forming units (cfu) of BPZE1
|
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
|
실험적: BPZE1- middle dose
100,000 colony forming units (cfu) of BPZE1
|
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
|
실험적: BPZE1 - High dose
10,000,000 colony forming units (cfu) of BPZE1
|
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
General safety and local tolerability in the respiratory tract of a single ascending dose of the genetically modified B. pertussis strain
기간: 6 months
|
To determine
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Attachment of the BPZE1 strain to the nasopharyngeal mucosa
기간: Up to 50 days after vaccination
|
Detection of colonizing BPZE1 bacteria in nasopharyngeal culture
|
Up to 50 days after vaccination
|
Immunogenicity
기간: 6 months
|
Immune responses will be determined by serum IgG and IgA, IgG and IgA in saliva and nasopharyngeal aspirate, cytokines and numbers of effector and memory T and B cells after stimulation with the various B. pertussis antigens.
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nabil Al-Tawil, MD, PhD, Karolinska Trial Alliance
- 연구 책임자: Camille Locht, PhD, Institut National de la Santé Et de la Recherche Médicale, France
- 수석 연구원: Rigmor Thorstensson, PhD, Swedish Institute for Infectious Disease Control
간행물 및 유용한 링크
일반 간행물
- Feunou PF, Ismaili J, Debrie AS, Huot L, Hot D, Raze D, Lemoine Y, Locht C. Genetic stability of the live attenuated Bordetella pertussis vaccine candidate BPZE1. Vaccine. 2008 Oct 23;26(45):5722-7. doi: 10.1016/j.vaccine.2008.08.018. Epub 2008 Aug 30.
- Mielcarek N, Debrie AS, Raze D, Bertout J, Rouanet C, Younes AB, Creusy C, Engle J, Goldman WE, Locht C. Live attenuated B. pertussis as a single-dose nasal vaccine against whooping cough. PLoS Pathog. 2006 Jul;2(7):e65. doi: 10.1371/journal.ppat.0020065.
- Mielcarek N, Debrie AS, Mahieux S, Locht C. Dose response of attenuated Bordetella pertussis BPZE1-induced protection in mice. Clin Vaccine Immunol. 2010 Mar;17(3):317-24. doi: 10.1128/CVI.00322-09. Epub 2010 Jan 27.
- Skerry CM, Cassidy JP, English K, Feunou-Feunou P, Locht C, Mahon BP. A live attenuated Bordetella pertussis candidate vaccine does not cause disseminating infection in gamma interferon receptor knockout mice. Clin Vaccine Immunol. 2009 Sep;16(9):1344-51. doi: 10.1128/CVI.00082-09. Epub 2009 Jul 22.
- Kavanagh H, Noone C, Cahill E, English K, Locht C, Mahon BP. Attenuated Bordetella pertussis vaccine strain BPZE1 modulates allergen-induced immunity and prevents allergic pulmonary pathology in a murine model. Clin Exp Allergy. 2010 Jun;40(6):933-41. doi: 10.1111/j.1365-2222.2010.03459.x. Epub 2010 Feb 22.
- Jahnmatz M, Amu S, Ljungman M, Wehlin L, Chiodi F, Mielcarek N, Locht C, Thorstensson R. B-cell responses after intranasal vaccination with the novel attenuated Bordetella pertussis vaccine strain BPZE1 in a randomized phase I clinical trial. Vaccine. 2014 Jun 5;32(27):3350-6. doi: 10.1016/j.vaccine.2014.04.048. Epub 2014 Apr 29.
- Thorstensson R, Trollfors B, Al-Tawil N, Jahnmatz M, Bergstrom J, Ljungman M, Torner A, Wehlin L, Van Broekhoven A, Bosman F, Debrie AS, Mielcarek N, Locht C. A phase I clinical study of a live attenuated Bordetella pertussis vaccine--BPZE1; a single centre, double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally to healthy adult male volunteers. PLoS One. 2014 Jan 8;9(1):e83449. doi: 10.1371/journal.pone.0083449. eCollection 2014.
- Schnoeller C, Roux X, Sawant D, Raze D, Olszewska W, Locht C, Openshaw PJ. Attenuated Bordetella pertussis vaccine protects against respiratory syncytial virus disease via an IL-17-dependent mechanism. Am J Respir Crit Care Med. 2014 Jan 15;189(2):194-202. doi: 10.1164/rccm.201307-1227OC.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BT06-04
- 2010-019936-11 (EudraCT 번호)
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. .
백일해에 대한 임상 시험
-
Institut PasteurHopital Universitaire Robert-Debre; Hospices Civils de Lyon; Centre Hospitalier Intercommunal... 그리고 다른 협력자들아직 모집하지 않음
-
ILiAD Biotechnologies모집하지 않고 적극적으로
-
University of TurkuGlaxoSmithKline; Sanofi Pasteur, a Sanofi Company완전한
-
Institut PasteurAgence de Médecine Préventive, France; Institut Pasteur de Madagascar; Institut Pasteur,...완전한
-
Institut PasteurSanofi Pasteur, a Sanofi Company; Institut Pasteur of Cote d'Ivoire완전한
-
University Hospital, GhentGlaxoSmithKline; Sanofi Pasteur, a Sanofi Company; Novartis Vaccines; University of Surrey; Innovative... 그리고 다른 협력자들완전한
-
ILiAD Biotechnologies완전한
-
DiaSorin Molecular LLC아직 모집하지 않음코로나바이러스 질병 2019 | 인플루엔자 A | 호흡기 세포융합 바이러스(RSV) | 아데노바이러스 | B형 인플루엔자 | 엔테로바이러스 | 마이코플라스마 폐렴 | 보르데텔라 파라페르투시스 감염 | 클라미디아 폐렴 | 파라 인플루엔자 | Bordetella Pertussis 감염, 호흡기호주
BPZE1에 대한 임상 시험
-
National Institute of Allergy and Infectious Diseases...완전한
-
Institut National de la Santé Et de la Recherche...완전한
-
ILiAD Biotechnologies모집하지 않고 적극적으로
-
ILiAD BiotechnologiesPPD완전한
-
ILiAD Biotechnologies완전한