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Trial record 27 of 76 for:    "Rabies" | "Immunologic Factors"

Immunogenicity of Rabies Vaccine for Pre Exposure (RABVAX)

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ClinicalTrials.gov Identifier: NCT02374814
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Mark Polhemus, State University of New York - Upstate Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Rabies Drug: Rabies vaccine Drug: Placebo Phase 4

Detailed Description:
This is an exploratory vaccine trial to evaluate immunogenicity of a non-licensed dosing schedule and route of administration for a currently FDA licensed rabies vaccine for pre-exposure prophylaxis against rabies infection. The goal of this study is to characterize the immune response and persistence of immunity to a shortened dose schedule and intradermal (ID) administration, relative to the current licensed dosing schedule of the rabies vaccine (3 dose (0, 7, 21 days) IM). Rabies virus is endemic throughout the world due to high rates of both wild and domestic animal rabies and the risk to deployed military in endemic areas is considerable. Currently the commonly supported pre-exposure prophylaxis regimen for rabies, in the United States is comprised of three, 1.0 ml intramuscular (IM) injections of the human diploid cell vaccine (HDCV) or purified chick embryo cell (PCEC) rabies vaccine on days 0, 7, and 21 or 28. Modified, two and three dose schedules of intradermal (ID) injections of 0.1 ml of HDCV and PCEC are utilized outside the US. These two and three dose intradermal schedules share a similar safety and immunogenicity profile to intramuscular vaccinations and are easily boosted at one year after vaccination. A death, from rabies, of a US Soldier returned from Afghanistan underscores the importance of rabies pre-exposure prophylaxis for soldiers and the need to evaluate the safest, most effective means of vaccinating large deploying forces. While the current three dose, 1 ml IM rabies series is effective, a shortened, equally effective vaccination series with significantly smaller dose per injection would greatly improve the logistics and cost associated with universal or even targeted coverage of deploying soldiers. Evaluation of a shorter, smaller-dose, pre-exposure vaccination series for rabies is the goal of this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity of a Two vs Three Dose, Intradermal (ID) vs Intramuscular (IM) Administration of a Licensed Rabies Vaccine for Pre-Exposure Vaccination
Actual Study Start Date : March 24, 2015
Actual Primary Completion Date : September 22, 2016
Actual Study Completion Date : September 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Active Comparator: Rabies vaccine IM 3 dose
This is standard FDA approved schedule
Drug: Rabies vaccine
Compare dose schedule and route of administration
Other Name: Rabavert

Experimental: Rabies vaccine ID 3 dose
This is using alternative administration method
Drug: Rabies vaccine
Compare dose schedule and route of administration
Other Name: Rabavert

Experimental: Rabies vaccine IM 2 dose
This is using alternative dose schedule
Drug: Rabies vaccine
Compare dose schedule and route of administration
Other Name: Rabavert

Experimental: Rabies vaccine ID 2 dose
This is using alternative dose schedule and administration
Drug: Rabies vaccine
Compare dose schedule and route of administration
Other Name: Rabavert

Placebo Comparator: Placebo IM 1 dose
Albumin and saline comparator
Drug: Placebo
Placebo
Other Name: Albumin

Placebo Comparator: Placebo ID 1 dose
Albumin and saline comparator
Drug: Placebo
Placebo
Other Name: Albumin




Primary Outcome Measures :
  1. To describe the percentage of subjects achieving a protective humoral immune response, across immunization routes, 7 days after boost given 12 months after completion of initial series. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To describe the percentage of subjects maintaining a protective humoral immune response at 12 months across immunization routes. [ Time Frame: 1 year ]
  2. Percentage of subjects in each group with titer of IgG antibodies above the protective limits ( > or = 0.5 IU/ml) at 12 months, prior to boost. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374814


Locations
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United States, New York
State University of New York, Upstate Medical University (SUNY-UMU)
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Walter Reed Army Institute of Research (WRAIR)
Investigators
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Principal Investigator: Mark Polhemus, MD State University of New York - Upstate Medical University

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Responsible Party: Mark Polhemus, Director, Center for Global Health, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT02374814     History of Changes
Other Study ID Numbers: 568085
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs