Immunogenicity and safety study of Rabies G protein Vaccine administered as a simulated post-exposure immunization in healthy volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- Subjects with seroprotection at 14 days post 1st dose of study vaccine
研究概览
简要总结
This study is a randomized, Open labeled assessorblind, Phase-III, parallel design comparative clinical trial. Objective of study is to assess safety and immunogenicity of Rabies G protein Vaccine(investigational vaccine) 10 µg at Day 0, 3 versus marketed Rabipur vaccine(comparator vaccine) 2.5 IU/ml, at Days 0, 3, 7, 14 & 28 to be administeredas a simulated post-exposure (PEP) immunization.
The sero-negative volunteers at screening (by ELISA method) will be randomized in a ratio of 2:1 to receive either test or comparator vaccine, respectively. Vaccination will be done in the deltoid muscle.On vaccination day, volunteers will remain at the hospital for a period of at least 6 hours for observation and assessment of local injection site reactions and the occurrence of any adverse events (AEs).
The primary outcomemeasures will be Subjects withseroprotection at 14 days post 1st dose of study vaccine & the secondaryoutcomes will be Subjects with seroprotection at day 42 post 1st dose of studyvaccine and Safety by monitoring subjects with adverse events [Time frame:0-180 days]
Window period of ±2 days will be allowed for day 14 and day 42. An exploratory analysis will be done to compare seroprotection rate at day 90 & 180. Rabies Virus Neutralizing Antibody (RVNA) titers will be analyzed by rapid fluorescent focus inhibition test (RFFIT) for Immunogenicity results.
Final Clinical Study Report will include data of safety & immunogenicity up to day 180 & will be submitted to DCGI for market authorization. Volunteer will be considered to have completed the study if they are
followed through 180 days ±7 days after first vaccination. Additionally on day 365±14 post first vaccination, one additional blood sample will be obtained for immunogenicity analysis. Separate supplementary report will be prepared for safety & immunogenicity data up to day 365.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Healthy human volunteers of 18 to 65 years.
- •â€¢Volunteers with seronegative status for Rabies Virus Neutralizing Antibody (RVNA) titers at screening (by ELISA method) •Volunteers who are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator.
- •â€¢Volunteers willing to comply with the requirements of protocol (willing to be available for all study visits as well blood drawing).
- •â€¢Volunteer who has signed Institutional Review Board (IRB) approved informed consent form (ICF) •Documented negative test for human immunodeficiency virus (HIV-1/2), HBsAg or HCV.
- •â€¢Negative urine pregnancy test for female volunteer of child-bearing potential.
- •â€¢Female volunteer of child bearing potential or sexually active male volunteer with partners of childbearing potential must practice acceptable barrier contraception (e.g., condoms, intrauterine contraceptive devices, or sterilization) during treatment and at least 2 months after the last dose of vaccine.
排除标准
- •â€¢History of potential rabies exposure or receipt of rabies vaccination (active/passive).
- •â€¢History of known hypersensitivity/allergy to egg proteins, animal cell product, insect proteins or NP9 (The VLP vaccine to be used in this study does not contain egg proteins, but comparators in randomized trials may) or any excipients of vaccine formulation.
- •â€¢Receipt of any other vaccines within 1 month prior to enrollment.
- •â€¢Body temperature ≥38.0°C (≥ 100.4° F) prior to first vaccination.
- •â€¢Volunteer with any acute infectious disease at the time of enrollment.
- •â€¢Volunteer with any chronic illness.
- •â€¢Administration of immunomodulating agents within six months prior to administration of study medications.
- •â€¢Volunteers on concomitant anti-malarials or treatment with an anti-malarial drug, up to two months prior to the study.
- •â€¢History or current use of drugs of abuse or alcohol.
- •â€¢Volunteer with deficiency of IgG, IgM & IgA.
- •â€¢Volunteer with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor.
- •â€¢Pregnant or lactating female volunteer or planning to become pregnant during the projected duration of the clinical trial, or who cannot provide a credible history of reliable contraceptive practices.
结局指标
主要结局
Subjects with seroprotection at 14 days post 1st dose of study vaccine
时间窗: 14 days
次要结局
- Safety by monitoring subjects with adverse events(Time frame 0 to 180 days)