NCT01622062已完成3 期
Verorab® Immunogenicity and Safety After a One-week, 4-site, Intradermal (ID) Post-exposure Prophylaxis Regimen (4-4-4-0-0) Followed by a One-visit, 4-site, ID Booster at Five Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Percentage of participants with seroconversion on Day 14
研究概览
简要总结
The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.
Primary objective:
- To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen.
Secondary objectives:
- Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90.
- Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group.
- Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5.
- Safety: To describe the safety profile of each group after the primary and booster vaccinations.
详细描述
Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen. Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®. All participants will receive a "single-visit, 4-site" booster vaccination five years later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all patients:
- •Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site.
- •For adults:
- •Informed consent form has been signed and dated.
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •For children:
- •For children under 18 years of age, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative.
- •For children under 18 years, assent form or informed consent form has been signed and dated by the appropriate age-range patient, according to country specific institution requirement as detailed in each country specific assent form or informed consent form.
- •Patient and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •For all patients:
- •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.
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial immunization
- •Planned participation in another clinical trial during the present trial period
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination and tetanus immunization (related only to current animal bite exposure
- •Planned receipt of any vaccine in the 4 weeks following the trial primary and booster vaccination
- •Previous immunization against rabies at any time in the past with either the trial vaccine and immunoglobulin or another rabies immunobiological product (in pre-or post-exposure regimen)
- •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •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)
- •Self-reported seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
- •Patient with clinical signs of encephalitis
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
- •Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
- •Prior history of mammal animal bite within the past 5 years.
- •For infants or toddlers :
- •Known personal or maternal seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus, as reported by the parent/guardian
- •Prior history of seizures .
结局指标
主要结局
Percentage of participants with seroconversion on Day 14
时间窗: Day 14 post vaccination
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
次要结局
- GMTs after booster vaccination(Year 5 + 11 days)
- GMTs after primary vaccination (antibody persistence)(Year 1 to Year 5)
- Percentage of participants with seroconversion after primary vaccination (antibody persistence)(Year 1 to Year 5)
- Percentage of participants with seroconversion after booster vaccination(Year 5 + 11 days)
- Geometric mean titers (GMTs) before and after primary vaccination(Day 0, Day 14, Day 90)
- Number of participants reporting solicited systemic reactions following primary and booster vaccination(From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections)
- Number of participants reporting solicited injection site reactions following primary and booster vaccination(7 days after each and any injection)
- Percentage of participants with seroconversion before and after primary vaccination(Day 0, Day 14, Day 90)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPVHealthyNCT03310073PT Bio Farma143
招募中
Unknown
Evaluation of a post-exposure prophylaxis using Remdesivir against Ebola virus disease, a single-arm interventional trialEbola virus diseaseJPRN-jRCTs031220480Shinichiro Morioka5
已完成
3 期
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)Rabies Post-exposure ProphylaxisNCT00345319Novartis Vaccines630
已完成
4 期
Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix HexaVaccines, PneumococcalInfantFever, Chemically InducedDrug Therapy, CombinationNCT00294294Wyeth is now a wholly owned subsidiary of Pfizer300
已完成
不适用
ncontrolled study of post-exposure prophylaxis for influenza by peramivirPatients exposed to influenzaJPRN-UMIN000014519Hokkaido University Hospital, Infection Control Team10