None listed
Conditions
Interventions
Intervention1: Rabies G Protein Vaccine: 0.5 ml Intramuscular Vaccine will be given of different concentration of 5mcg, 10mcg, 20mcg & 50mcg of Rabies G Protein vaccine on different day schedules like
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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 - Participation in another clinical trial in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Proportion of volunteers with solicited adverse events, unsolicited adverse events and serious adverse eventsï?§ - Proportion of volunteers with seroprotection levels - Geometric mean titers of anti-rabies antibodiesTimepoint: 0-42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety & ImmunogenicityTimepoint: 0-180 days | — |
Countries
India
Contacts
Public ContactDr Deepak Sawhney
CRO-Cadila Pharmaceuticals Ltd
Outcome results
None listed