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Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.

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Disease Information

Descriptive Information
Brief Title † Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
Official Title † Effect of Antimalarial Drugs on the Immune Response to Rabies Vaccine for Post-exposure Prophylaxis. A Randomized, Open Label, Trial in Healthy US Adults Age 18-60 Years
Brief 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.
Detailed Description Rabies is present on all continents where U.S. military personnel deploy, including countries where malaria is also endemic and where U.S. military personnel are required to take malaria prophylaxis. Rabies post-exposure prophylaxis in unvaccinated individuals who are not on malaria prophylaxis consists of four, 1.0-mL intramuscular (IM) injections of the purified chick embryo cell (PCECV) rabies vaccine on days 0, 3, 7, and 14. The current Advisory Committee on Immunization Practices (ACIP) guidelines recommend that exposed persons who are taking malaria prophylaxis should receive a fifth dose of rabies vaccine 28 days after the exposure. These guidelines do not differentiate between drugs used for malaria prophylaxis This study will administer the post-exposure regimen to volunteers from a US population of military age who are taking one of three malaria prophylaxis regimens or no malaria prophylaxis. The goal of this study is to asses if individuals on malaria prophylaxis achieve the required rabies titer after completion of the four dose regimen. Obtaining rabies vaccine and rabies immune globulin in a deployed setting can be challenging. A full understanding of the requirements for protecting exposed individuals is necessary for appropriate decision making in a resource-constrained environment.
Study Phase Phase 4
Study Type † Interventional
Study Design †
Primary Outcome Measure † Geometric Mean Titer (GMT) at 14 days post completion of four dose post exposure prophylaxis (PEP) with PCECV in each of the malaria prophylaxis groups with control to determine if a fifth dose of PEP at that point would be of any added value
Secondary Outcome Measure † GMT over protective titer prior to third dose and fourth dose and 28 days post fourth dose of PCECV
Condition † Rabies
Intervention † DrugChloroquine
Study Arms / Comparison Groups Chloroquine Chloroquine Phosphate tablet for oral administration 500 mg chloroquine phosphate (equivalent to 300 mg base) Atovaquone and Proguanil (Malarone) Malarone tablet for oral administration 250 mg atovaquone and 100 mg proguanil hydrochloride. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Doxyclycline Doxycycline hyclate tablet for oral administration, contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. RabAvert rabies vaccine, at least 2.5 IU of rabies antigen. Rabies RabAvert rabies vaccine, at least 2.5 IU of rabies antigen.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 100
Start Date † April 2016
Completion Date December 2017
Primary Completion Date December 2017
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.
Gender All
Ages 18 Years - 60 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Lisa A Ware, MS, 315-464-4398, warel@upstate.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02564471
Organization ID 790117
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † State University of New York - Upstate Medical University
Collaborators †† Walter Reed Army Institute of Research (WRAIR)
Investigators † Principal Investigator: Mark E Polhemus, MD, State University of New York - Upstate Medical University
Information Provided By
Verification Date May 2017
First Received Date † September 29, 2015
Last Updated Date May 1, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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