Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis. (NCT02564471) | Clinical Trial Compass
CompletedPhase 4
Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
United States103 participantsStarted 2016-11-11
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Provide signed and dated informed consent form.
✓. Willing to comply with all study procedures and be available for the duration of the study.
✓. Male or female, aged ≥ 18 to ≤ 60 years on day of inclusion.
✓. In good general health based on medical history and physical exam
Exclusion criteria
✕. 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.
✕. 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.
✕. Previous history of receiving the rabies vaccine.
✕. Previous history of receiving rabies immune globulin.
✕. 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.
✕. 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.
What they're measuring
1
Geometric Mean Titer (GMT) 14 Days Post Fourth Dose Post Exposure Prophylaxis (PEP) With Purified Chick Embryo Cell Vaccine (PCECV) in Each Malaria Prophylaxis Group Compared to Control to Determine if a Fifth Dose of PEP Would Add Value
Timeframe: 6 weeks for Chloroquine, Atovaquone and Proguanil (Malarone) and Doxycycline Groups and at 4 weeks for Rabies Group
Trial details
NCT IDNCT02564471
SponsorState University of New York - Upstate Medical University