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Immunogenicity and Safety of a Purified Vero Rabies Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03145766
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:
This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.

Condition or disease Intervention/treatment Phase
Rabies Virus Biological: VRVg 2 Biological: VRVg 1 Biological: Imovax Rabies Phase 2

Detailed Description:
This study will assess different formulations of the modified formulation of VRVg (VRVg 2) to be tested in parallel to the initial VRVg formulation (VRVg 1) and Imovax rabies. Immune responses will be assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events will also be reported.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine Serum Free When Administered According to a Simulated Rabies Post Exposure Regimen in Healthy Adults
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : January 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: Group 1
Participants who receive five vaccine injections of VRVg 2 at D0, D3, D7, D14, and D28. All patients also received human rabies immunoglobulins (HRIG) at D0.
Biological: VRVg 2
Modified formulation 1 of Purified Vero Rabies Vaccine Serum Free

Experimental: Group 2
Participants who receive five vaccine injections of VRVg 2 at D0, D3, D7, D14, and D28. All patients also received human rabies immunoglobulins (HRIG) at D0.
Biological: VRVg 2
Modified formulation 2 of Purified Vero Rabies Vaccine Serum Free

Experimental: Group 3
Participants who receive five vaccine injections of VRVg 2 at D0, D3, D7, D14, and D28. All patients also received human rabies immunoglobulins (HRIG) at D0.
Biological: VRVg 2
Modified formulation 3 of Purified Vero Rabies Vaccine Serum Free

Experimental: Group 4 (VRVg 1)
Participants who receive five vaccine injections of VRVg 1 at D0, D3, D7, D14, and D28. All patients also received human rabies immunoglobulins (HRIG) at D0.
Biological: VRVg 1
Initial formulation of Purified Vero Rabies Vaccine Serum Free

Experimental: Group 5 (Imovax Rabies, control)
Participants who receive five vaccine injections of Imovax Rabies (control) at D0, D3, D7, D14, and D28. All patients also received human rabies immunoglobulins (HRIG) at D0.
Biological: Imovax Rabies
Purified inactivated rabies vaccine prepared on human diploid cell cultures




Primary Outcome Measures :
  1. Summary of rabies virus neutralizing antibody (RVNA) titers against rabies virus assessed by the rapid fluorescent focus inhibition test (RFFIT) [ Time Frame: Month 7 post vaccination ]
    Change in RVNA titers from Day 0 (before vaccination) up to Month 7 in all participants

  2. Percentage of participants with complete neutralization at the starting dilution (1/5) of the RFFIT assay at each timepoint [ Time Frame: Month 7 post vaccination ]
    Participants with complete neutralization

  3. Percentage of participants with solicited injection site and systemic reactions [ Time Frame: Day 7 post each injection ]
    Percentage of patients with solicited injection site and systemic reactions starting on day of vaccination through Day 7 post each vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:

  1. Aged 18 to <65 years on the day of inclusion
  2. Informed consent form has been signed and dated
  3. Able to attend all scheduled visits and to comply with all trial procedures
  4. Body Mass Index (BMI): 18.5 Kg/m2 ≤ BMI ≤ 30 Kg/m2 Exclusion Criteria:

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:

  1. Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
  2. Participation at the time of study enrollment or, planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  3. Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 6
  4. Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
  5. Receipt of immune globulins, blood or blood-derived products in the past 3 months
  6. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  7. At high risk for rabies infection during the trial (e.g., veterinarians and staff, animal handlers, rabies researchers, or any others whose activities may bring them into frequent contact with rabies virus or animals who have the rabies virus)
  8. Known systemic hypersensitivity to any of the vaccine or HRIG components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  9. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
  10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  11. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  12. Current alcohol abuse or drug addiction
  13. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (e.g., cardiac disorders, renal disorders, auto immune disorders, diabetes, psychiatric disorders or chronic infection)
  14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  15. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  16. History of Guillain-Barré syndrome

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): NCT03145766


Locations
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United States, California
Investigational Site
Redding, California, United States, 96001
Investigational Site
San Diego, California, United States, 92117
United States, Florida
Investigational Site
South Miami, Florida, United States, 33143
United States, Nebraska
Investigational Site
Omaha, Nebraska, United States, 68134
United States, Nevada
Investigational Site
Las Vegas, Nevada, United States, 89104
Sponsors and Collaborators
Sanofi

Additional Information:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03145766     History of Changes
Other Study ID Numbers: VRV11
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanofi:
Rabies virus

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