NCT03700242已完成3 期
Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 570
- 试验地点
- 2
- 主要终点
- Seroconversion of participant
研究概览
简要总结
The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate.
The secondary objectives of the study are:
- To describe the immunogenicity of the PrEP regimen in each group
- To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination
- To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group
- To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group
详细描述
Study duration per participant is approximately 403 to 436 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 2 years on the day of inclusion
- •Participant aged < 18 years: Assent form has been signed and dated by the subject (as appropriate, according to country-specific institution requirements), and informed consent form (ICF) signed and dated by the parent or another legally acceptable representative
- •Participant aged ≥ 18 years: ICF signed and dated by the subject
- •The participant (and parent/legally acceptable representative, if applicable) is able to attend all scheduled visits and to comply with all trial procedures
排除标准
- •Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- •Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- •Previous vaccination at any time against rabies with either the trial vaccine or another vaccine
- •Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- •Self-reported thrombocytopenia, contraindicating IM vaccination
- •Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Current alcohol abuse or drug addiction
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- •Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- •History of Guillain-Barré syndrome
- •Receipt of chloroquine or other medications used for malaria chemoprophylaxis, with or without other anti-malarial treatment, for more than 4 weeks (duration of anti-malarial course) and part of the treatment received within the 2 weeks before vaccination, contraindicating intradermal vaccination
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 4
Experimental
1 IM dose of purified Vero cell rabies vaccine (PVRV) on D0 and D7 (short PVRV IM PrEP regimen), followed by 1 IM dose of PVRV on Y1 and Y1 + 3 days
干预措施: PVRV (Biological)
Group 5
Experimental
2 ID doses of PVRV on D0 and D7 (short PVRV ID PrEP regimen), followed by 1 ID dose of PVRV on Y1 and Y1 + 3 days
干预措施: PVRV (Biological)
Group 3
Experimental
2 intradermal (ID) doses of HDCV on D0 and D7 (short HDCV ID PrEP regimen), followed by 1 ID dose of HDCV on Y1 and Y1 + 3 days
干预措施: HDCV (Biological)
Group 2
Active Comparator
1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days
干预措施: HDCV (Biological)
Group 1
Experimental
1 IM dose of human diploid cell vaccine (HDCV) on D0 and D7 (short HDCV IM PrEP regimen), followed by 1 IM dose of HDCV on Year (Y)1 and Y1 + 3 days
干预措施: HDCV (Biological)
结局指标
主要结局
Seroconversion of participant
时间窗: 14 days after the last PrEP vaccination
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
次要结局
- Participant RVNA titer ratios(14 days after last PrEP vaccination)
- Persistence of seropositivity(6 months and 1 year after the last PrEP vaccination)
- Seropositivity of participant after simulated PEP vaccination(7 and 14 days after the first simulated PEP vaccination)
- Persistence of RVNA titer(6 months and 1 year after the last PrEP vaccination)
- Seroconversion of participant after simulated PEP vaccination -(7 and 14 days after the first simulated PEPvaccination)
- Participant RVNA titer ratios (persistence assessment)(6 months and 1 year after the last PrEP vaccination)
- Solicited injection site and systemic reactions after simulated PEP vaccination(7 days after simulated PEP vaccination)
- Participant RVNA titer(Day 0 and 14 days after the last PrEP vaccination)
- Seropositivity of participant(Day 0 and 14 days after the last PrEP vaccination)
- Participant RVNA titer after simulated PEP vaccination(1 year after the last PrEP vaccination)
- Seroconversion of participant(Day 0 and 14 days after the last PrEP vaccination)
- Persistence of seroconversion(6 months and 1 year after the last PrEP vaccination)
- Solicited injection site and systemic reactions after PrEP vaccination(7 days after PrEP vaccination)
- Participant RVNA titer after simulated PEP vaccination(7 and 14 days after the first simulated PEP vaccination)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis RegimenRabiesNCT01930357Sanofi Pasteur, a Sanofi Company342
已完成
1 期
Vaccine Responsiveness After CAR-T Cell TherapyB-Cell NeoplasmNCT04410900Fred Hutchinson Cancer Center49
已完成
1 期
HER-2 Protein Vaccine in Treating Women With Breast CancerBreast CancerNCT00068614Case Comprehensive Cancer Center
Unknown
不适用
Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 InhibitorsNon Small Cell Lung CancerInfluenza VaccineNCT04355806Shanghai Pulmonary Hospital, Shanghai, China160
已完成
1 期
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult VolunteersHIV SeronegativityHIV InfectionsNCT00121121French National Agency for Research on AIDS and Viral Hepatitis70