Safety and Immunogenicity Study of Rabies G Protein VaccineAdministered as a Simulated Post-exposure Immunization in Healthy Volunteers
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- - Proportion of volunteers with solicited adverse events, unsolicited adverse events and
研究概览
简要总结
Cadila Pharmaceuticals Limited, India has successfully tested VLP-based Rabies G Protein Vaccine in preclinical models and to take the development further, it needs to be tested in humans. Present study is the FIH trial involving Rabies G Protein Vaccine to evaluate its safety and immunogenicity. When new rabies vaccines are introduced, their immunogenicity is evaluated by comparing the RABV neutralizing antibody titres induced by the vaccine being tested with those induced by a vaccine of demonstrated efficacy. As rabies is a fatal disease, randomized controlled human trials involving untreated comparison groups could not be carried out for ethical reasons.
8 Lesser doses (2 or 3) of post-exposure prophylaxis might see savings to healthcare system and individuals in terms vaccine cost and additional medical visits, in addition to overall better treatment compliance. Based on our preclinical experience and above statements, we postulate that Rabies G Protein Vaccine will provide faster and similar seroprotection against rabies in comparison to worldwide approved Rabipur vaccine as a simulated post-exposure immunization in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human volunteers of 18 to 65 years.
- •During the first stage-I of the study, only male volunteers will be recruited.
- •Volunteers with seronegative status for anti-rabies antibodies at baseline.
- •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.
- •Volunteers willing to comply with the requirements of protocol (volunteer for simulated post-exposure immunization and, willing to be available for all study visits as well blood drawing).
- •Volunteer who has signed or Institutional Review Board (IRB) approved informed consent form (ICF).
- •Volunteer available by phone.
- •Documented negative test for human immuno virus (HIV-1/2), HBsAg or HCV.
- •Negative urine pregnancy test for female volunteer of child-bearing potential.
- •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
- •History of potential rabies exposure or who has received rabies vaccination(active/passive) -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.
- •Who has received any other vaccines within 6 months prior to enrollment.
- •Body temperature ≥38.0°C (≥ 100.4° F) prior to first vaccination.
- •Volunteer with any acute infectious disease at the time of enrollment.
- •Volunteer with any chronic illness.
- •Administration of immunomodulating agents within six months prior to administration of study medications.
- •Volunteers on concomitant antimalarials or treatment with an anti-malarial drug, up to two months prior to the study.
- •History or currently consuming drugs of abuse or alcohol.
- •Volunteer with deficiency of IgG, IgM & IgA.
- •Volunteer with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor. 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
- Proportion of volunteers with solicited adverse events, unsolicited adverse events and
时间窗: 0-42 days
serious adverse events
时间窗: 0-42 days
- Proportion of volunteers with seroprotection levels
时间窗: 0-42 days
- Geometric mean titers of anti-rabies antibodies
时间窗: 0-42 days
次要结局
- Safety & Immunogenicity(0-180 days)