Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis
Condition: Rabies
MeSH terms: Rabies
Intervention: Rabies vaccine; Placebo
Intervention description: Compare dose schedule and route of administration; Placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the effectiveness of a two dose versus a three dose
      schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

        Male and non-pregnant females aged ≥ 18 to ≤ 60 years on the day of inclusion Able to
        comprehend and give informed consent Able to attend all scheduled visits and to comply with
        all trial procedures Subject in good health, based on medical history and physical
        examination

        Exclusion Criteria:

          1. Subject is pregnant, or lactating, or of childbearing potential (to be considered of
             non-childbearing potential, a female must be post- menopausal for at least 1 year,
             surgically sterile, or using an effective method of contraception or abstinence from
             at least 4 weeks prior to the first vaccination and until at least 4 weeks after the
             last vaccination).

          2. Participation in the 4 weeks preceding the first trial vaccination, or planned
             participation during the present trial period, in another clinical trial investigating
             a vaccine, drug, medical device, or medical procedure.

          3. Previous history of receiving the rabies vaccine.

          4. Previous history of receiving rabies immune globulin.

          5. Any major psychiatric disorder, such as severe depression, severe anxiety disorder,
             psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of
             mild depression or anxiety disorder that is well controlled is not an exclusion
             criteria.

          6. Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block,
             SVT, PAC, VF, VT, or any other conduction abnormalities.

          7. Use of any immunosuppressive drug , including topical steroids of potency groups I, II
             or III within 30 days of the study period.

          8. Any immunosuppressive disorder, such as HIV, common variable, active cancers or
             chemotherapy.

          9. History of renal insufficiency or requiring dialysis.

         10. Any condition that would, in the opinion of the site investigator, place the subject
             at an unacceptable risk of injury or render the subject unable to meet the
             requirements of the protocol.

         11. Identified as an employee of the Investigator or study center, with direct involvement
             in the proposed study or other studies under the direction of that Investigator or
             study center, as well as family members (i.e., immediate, husband, wife and their
             children, adopted or natural) of the employee or the Investigator.