Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
Condition: Rabies
MeSH terms: Rabies
Intervention: Chloroquine; Atovaquone and Proguanil; Doxycycline; Rabies Vaccine
Intervention description: FDA approve dosing schedule; FDA approve dosing schedule; FDA approve dosing schedule; FDA approve dosing schedule
Intervention MeSH terms: Doxycycline; Chloroquine; Chloroquine diphosphate; Atovaquone; Proguanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune
      response generated by rabies vaccine when administered for post-exposure prophylaxis. This
      study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies
      immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide signed and dated informed consent form.

          2. Willing to comply with all study procedures and be available for the duration of the
             study.

          3. Male or female, aged ≥ 18 to ≤ 60 years on day of inclusion.

          4. In good general health based on medical history and physical exam

        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 are well controlled are not exclusion
             criteria.

          6. Use of any immunosuppressive drug at the time of the study or 30 days previously.
             Topical steroids will not be considered an immunosuppressive drug and their use will
             not be considered an exclusion criteria.

          7. Any immunosuppressive disorder, such as HIV infection, common variable
             immunodeficiency, active cancers or chemotherapy.

          8. History of renal insufficiency or requiring dialysis.

          9. Have 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.

         10. 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.

         11. Previous adverse reaction to any of the antimalarial drugs used in this study.

        Temporary Exclusion Criteria: Moderate or severe acute illness/infection (according to
        investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on day 0.. A
        prospective subject should not be included in the study until the condition has resolved or
        the febrile event has subsided. If the delay for the febrile illness exceeds the window
        between screening and vaccination, or if deemed necessary by the investigator, a
        prospective subject may be re-screened once the fever has resolved.

        Recent or scheduled receipt of any vaccine 4 weeks prior to day 0.