Rabies G Protein Vaccine study for immunization against Rabies
- Registration Number
- CTRI/2014/04/004538
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
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 >=38.0°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
- Participation in another clinical trial in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method