Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use
Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in Pre-exposure Use in Healthy Adults
2 other identifiers
interventional
408
1 country
6
Brief Summary
The aim of this study is to generate data on immunogenicity and safety of Purified Vero Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the registration of VRVg in the USA. Primary Objectives:
- To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42.
- To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%. Secondary Objectives:
- To assess the clinical safety of VRVg each vaccine after each vaccine injection when administered in a pre-exposure schedule.
- To describe the immune response induced by each vaccine 21 days after two vaccinations (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of the primary vaccination series.
- To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects, and at 18 and 24 months in a subset of subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2013
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 9, 2018
February 1, 2018
1.2 years
February 4, 2013
February 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series).
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
Day 42 post-vaccination
Antibody Persistence in terms of rabies virus neutralizing antibody titers at 6 months and 12 months after the first vaccination
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
6 and 12 months post-vaccination
Secondary Outcomes (1)
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Day 0 up to 12 months post-vaccination
Study Arms (2)
Purified Vero Rabies Vaccine Group
EXPERIMENTALParticipants will receive the Purified Vero Rabies Vaccine (VRVg) Serum Free
Imovax® Rabies Vaccine Group
EXPERIMENTALParticipants will receive the Imovax® Rabies
Interventions
0.5 mL, Intramuscular
1.0 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures.
You may not qualify if:
- 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 last vaccination)
- Participation at the time of study enrollment (or 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
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- 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)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- At high risk for rabies exposure during the trial
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances as the vaccines used in the study
- Self-reported thrombocytopenia, contraindicating intra muscular (IM) vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Redding, California, 96001, United States
Unknown Facility
Sacramento, California, 95815, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Fort Worth, Texas, 76135, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Related Publications (1)
Pichon S, Moureau A, Petit C, Chu L, Essink B, Muse D, Saleh J, Guinet-Morlot F, Minutello AM. Safety and immunogenicity of a serum-free purified Vero rabies vaccine in healthy adults: A randomised phase II pre-exposure prophylaxis study. Vaccine. 2022 Aug 5;40(33):4780-4787. doi: 10.1016/j.vaccine.2022.06.040. Epub 2022 Jun 28.
PMID: 35778281DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur SA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
February 1, 2013
Primary Completion
April 1, 2014
Study Completion
December 1, 2015
Last Updated
February 9, 2018
Record last verified: 2018-02