Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Post-Exposure Prophylaxis Regimen at One Year

NCT03700242 | Completed Phase 3

• 2 other identifiers: VAJ00001U1111-1216-6210
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate. The secondary objectives of the study are:

• To describe the immunogenicity of the PrEP regimen in each group
• To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination
• To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group
• To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group

Conditions

Healthy Volunteers (Rabies Immunization)

Outcome Measures

Primary Outcomes (1)

• Seroconversion of participant

  Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL

  14 days after the last PrEP vaccination

Secondary Outcomes (14)

• Participant RVNA titer

  Day 0 and 14 days after the last PrEP vaccination

• Persistence of RVNA titer

  6 months and 1 year after the last PrEP vaccination

• Participant RVNA titer after simulated PEP vaccination

  7 and 14 days after the first simulated PEP vaccination

• Seroconversion of participant

  Day 0 and 14 days after the last PrEP vaccination

• Persistence of seroconversion

  6 months and 1 year after the last PrEP vaccination

Study Arms (5)

Group 1

EXPERIMENTAL

1 IM dose of human diploid cell vaccine (HDCV) on D0 and D7 (short HDCV IM PrEP regimen), followed by 1 IM dose of HDCV on Year (Y)1 and Y1 + 3 days

Biological: HDCV

Group 2

ACTIVE COMPARATOR

1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days

Biological: HDCV

Group 3

EXPERIMENTAL

2 intradermal (ID) doses of HDCV on D0 and D7 (short HDCV ID PrEP regimen), followed by 1 ID dose of HDCV on Y1 and Y1 + 3 days

Biological: HDCV

Group 4

EXPERIMENTAL

1 IM dose of purified Vero cell rabies vaccine (PVRV) on D0 and D7 (short PVRV IM PrEP regimen), followed by 1 IM dose of PVRV on Y1 and Y1 + 3 days

Biological: PVRV

Group 5

EXPERIMENTAL

2 ID doses of PVRV on D0 and D7 (short PVRV ID PrEP regimen), followed by 1 ID dose of PVRV on Y1 and Y1 + 3 days

Biological: PVRV

Interventions

HDCV BIOLOGICAL

Pharmaceutical form:Solution for injection Route of administration: Intramuscular

Group 1; Group 2

PVRV BIOLOGICAL

Pharmaceutical form:Solution for injection Route of administration: Intramuscular

Group 4

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged \< 18 years: Assent form has been signed and dated by the subject (as appropriate, according to country-specific institution requirements), and informed consent form (ICF) signed and dated by the parent or another legally acceptable representative
• Participant aged ≥ 18 years: ICF signed and dated by the subject
• The participant (and parent/legally acceptable representative, if applicable) is able to attend all scheduled visits and to comply with all trial procedures

You may not qualify if:

• Participant 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 pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
• 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 except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination at any time against rabies 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)
• Known systemic hypersensitivity to any of the vaccine 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
• Self-reported thrombocytopenia, contraindicating 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
• 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 ≥ 38.0 C). 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
• History of Guillain-Barré syndrome
• Receipt of chloroquine or other medications used for malaria chemoprophylaxis, with or without other anti-malarial treatment, for more than 4 weeks (duration of anti-malarial course) and part of the treatment received within the 2 weeks before vaccination, contraindicating intradermal vaccination

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Investigational Site Number 002

Cebu City, 6000, Philippines

Location

Investigational Site Number 001

City of Muntinlupa, 1770, Philippines

Location

Related Publications (1)

• Quiambao BP, Lim JG, Bosch Castells V, Augard C, Petit C, Bravo C, Delore V, Houillon G. One-week intramuscular or intradermal pre-exposure prophylaxis with human diploid cell vaccine or Vero cell rabies vaccine, followed by simulated post-exposure prophylaxis at one year: A phase III, open-label, randomized, controlled trial to assess immunogenicity and safety. Vaccine. 2022 Aug 26;40(36):5347-5355. doi: 10.1016/j.vaccine.2022.07.037. Epub 2022 Aug 3.

  PMID: 35933278 DERIVED

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: September 26, 2018
• Primary Completion: January 19, 2019
• Study Completion: April 8, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

PH (2)