- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374814
Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis (RABVAX)
June 10, 2022 updated by: Timothy Endy, MD MPH, State University of New York - Upstate Medical University
Immunogenicity of a Two vs Three Dose, Intradermal (ID) vs Intramuscular (IM) Administration of a Licensed Rabies Vaccine for Pre-Exposure Vaccination
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- State University of New York, Upstate Medical University (SUNY-UMU)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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 is well controlled is not an exclusion criteria.
- Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities.
- Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period.
- Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy.
- History of renal insufficiency or requiring dialysis.
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rabies vaccine IM 3 dose
Intramuscular injection: 1mL at 0, 7 and 21 days.
An additional 1 mL intramuscular dose at day 365
|
Compare dose schedule and route of administration
Other Names:
|
Experimental: Rabies vaccine ID 3 dose
Intradermal injection: 0.1mL at 0, 7 and 21 days.
A single intramuscular 1 mL dose at day 365
|
Compare dose schedule and route of administration
Other Names:
|
Experimental: Rabies vaccine IM 2 dose
Intramuscular injection: 1mL at 0, 7 days.
An additional 1 mL intramuscular dose at day 365
|
Compare dose schedule and route of administration
Other Names:
|
Experimental: Rabies vaccine ID 2 dose
Intradermal injection: 0.1mL at 0, 7 days.
A single intramuscular 1 mL dose at day 365
|
Compare dose schedule and route of administration
Other Names:
|
Placebo Comparator: Placebo IM 1 dose
Albumin and saline comparator, Intramuscular injection: 1mL
|
Placebo
Other Names:
|
Placebo Comparator: Placebo ID 1 dose
Albumin and saline comparator, Intradermal injection: 0.1mL
|
Placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protective Humoral Immune Response at 1 Month Post First Vaccination.
Time Frame: 1 month post first vaccination
|
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus
|
1 month post first vaccination
|
Protective Humoral Immune Response 12 Months Post First Vaccination.
Time Frame: 12 months post first vaccination
|
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus 12 months post vaccinations (prior to boost).
|
12 months post first vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protective Humoral Immune Response 7 Days Post Booster at 12 Months Post First Vaccination.
Time Frame: up to 13 months post first vaccination
|
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus at 7 days post boost.
|
up to 13 months post first vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark Polhemus, MD, State University of New York - Upstate Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2015
Primary Completion (Actual)
September 22, 2016
Study Completion (Actual)
September 22, 2016
Study Registration Dates
First Submitted
February 23, 2015
First Submitted That Met QC Criteria
February 27, 2015
First Posted (Estimate)
March 2, 2015
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 568085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rabies
-
The Methodist Hospital Research InstituteGrifols Biologicals, LLCCompletedRabies | Rabies Human | Rabies Virus InfectionUnited States
-
The Methodist Hospital Research InstituteGrifols Biologicals, LLCRecruitingRabies | Rabies Human | Pediatrics | Rabies Virus InfectionUnited States
-
Centers for Disease Control and PreventionCompletedRabies Prevention | Rabies ExposureUnited States
-
Changchun Zhuoyi Biological Co., LtdEnrolling by invitation
-
Sanofi Pasteur, a Sanofi CompanyActive, not recruiting
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Synermore Biologics Co., Ltd.inVentiv Health ClinicalCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Provincial Public Health Office, PhetchabunCompleted
-
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Sponsor GmbHCompletedRabies Vaccine Adverse ReactionChina
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States