Immunogenicity and safety study of Rabies G protein Vaccine administered as a simulated post-exposure immunization in healthy volunteers

Cadila Pharmaceuticals Limited0 个研究点目标入组 800 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Healthy human volunteers of 18 to 65 years.
•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.
•Volunteers willing to comply with the requirements of protocol (willing to be available for all study visits as well blood drawing).
•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.
•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.

•History of potential rabies exposure or receipt of 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.
•Receipt of any other vaccines within 1 month prior to enrollment.
•Body temperature >=38.0Â°C (>= 100.4Â° 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 anti-malarials or treatment with an anti-malarial drug, up to two months prior to the study.
•History or current use of drugs of abuse or alcohol.
•Volunteer with deficiency of IgG, IgM & IgA.
•Volunteer with abnormal clinical chemistry, hematology or urinalysis results that are 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.
•Participation in another clinical trial in the past 3 months.

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