Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults

Last updated: February 7, 2024
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Purified vero rabies vaccine - serum free - VRVg-2

Purified inactivated rabies vaccine - Verorab®

Purified inactivated rabies vaccine - Imovax® Rabies

Clinical Study ID

NCT04127786
VRV12
U1111-1217-3241
2019-000973-22
  • Ages > 1
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of this study is:

To demonstrate the Purified Vero Rabies Vaccine - Serum Free (VRVg-2) is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose pre-exposure prophylaxis (PrEP) regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 IU/mL at Day (D) 42, i.e., 14 days after the 3rd injection (for Primary Series Cohort 1).

The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested.

To demonstrate that:

  • the observed proportion of participants in the VRVg-2 (VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97%

  • VRVg is non-inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28

  • 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group

  • the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97%

  • 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort 1)

To describe:

  • the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups

  • the immune response induced by VRVg at D14 after a booster dose of VRVg administered at Month (M) 12 (Cohort 1) and between M24 up to M36 (Cohort 2)

  • the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort 2)

  • safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged >=1 year on the day of inclusion
  • Cohort 1 - pediatrics (>=1 to 17 years old) and adults (>=18 years old)
  • Cohort 2 - all adults (>=18 years old)
  • Informed consent form has been signed and dated by the participant and /or andparent(s) or legally acceptable representative (LAR) and by an independent witness (ifrequired by local regulations), as necessary; and assent form has been signed anddated by the participant, as required
  • Participant (adult >=18 years) or participant and parent/LAR (1 year to less than [<]18 years) are able to attend all scheduled visits and to comply with all studyprocedures.

Exclusion

Exclusion Criteria:

  • Participant is pregnant, or lactating, or of childbearing potential and not using aneffective method of contraception or abstinence from at least 4 weeks prior to thefirst vaccination until 1 month after each vaccination. To be considered ofnon-childbearing potential, a female must be pre-menarche or post-menopausal for atleast 1 year, or surgically sterile.
  • Participation at the time of study enrollment or, planned participation during thepresent study period in another clinical study investigating a vaccine, drug, medicaldevice, or medical procedure.
  • Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccinationor planned receipt of any vaccine prior to Visit 5 for pediatric participants andadult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort
  • Previous vaccination against rabies (in pre- or post-exposure regimen) with either thestudy vaccines or another vaccine.
  • Bite by, or exposure to a potentially rabid animal in the previous 6 months with orwithout post-exposure prophylaxis.
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months.
  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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).
  • At high risk for rabies exposure during the study.
  • Known systemic hypersensitivity to any of the study/control vaccine components, orhistory of a life-threatening reaction to the vaccines used in the study or to avaccine containing any of the same substances.
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating intramuscular vaccination.
  • Deprived of freedom by an administrative or court order, or in an emergency setting,or hospitalized involuntarily.
  • Current alcohol or substance abuse that, in the opinion of the investigator, mightinterfere with the study conduct or completion.
  • Chronic illness(1) that, in the opinion of the Investigator, is at a stage where itmight interfere with study conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on theday of vaccination or febrile illness (temperature >=38.0°C). A prospectiveparticipant should not be included in the study until the condition has resolved orthe febrile event has subsided.
  • Personal history of Guillain-Barré syndrome.
  • Identified as an Investigator or employee of the Investigator or study center withdirect 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 withdirect involvement in the proposed study.
  1. Chronic illness may include, but is not limited to, neurological,cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic,auto-immune, or psychiatric disorders or infection

Study Design

Total Participants: 1708
Treatment Group(s): 3
Primary Treatment: Purified vero rabies vaccine - serum free - VRVg-2
Phase: 3
Study Start date:
October 21, 2019
Estimated Completion Date:
May 12, 2025

Study Description

The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months.

For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period).

For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months.

Connect with a study center

  • Investigational Site Number :7640001

    Bangkok, 10330
    Thailand

    Site Not Available

  • Investigational Site Number :7640003

    Bangkok, 10700
    Thailand

    Site Not Available

  • Investigational Site Number :7640004

    Bangkok, 10400
    Thailand

    Site Not Available

  • Investigational Site Number :7640002

    Khon Kaen, 40002
    Thailand

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.