Safety and Immunogenicity Study of Rabies G Protein VaccineAdministered as a Simulated Post-exposure Immunization in Healthy Volunteers

Cadila Pharmaceuticals Limited0 个研究点目标入组 170 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
•- 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.

•- History of potential rabies exposure or who has received rabies vaccination(active/passive)
•-ï?§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 >=38.0Â°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 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
•- Participation in another clinical trial in the past 3 months

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