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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 (VAJ00001)

Primary Purpose

Healthy Volunteers (Rabies Immunization)

Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
HDCV
HDCV
PVRV
PVRV
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Volunteers (Rabies Immunization)

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria :

  • Aged ≥ 2 years on the day of inclusion
  • 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

Exclusion criteria:

  • 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
  • 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 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 002
  • Investigational Site Number 001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Participant RVNA titer
Persistence of RVNA titer
Participant RVNA titer after simulated PEP vaccination
Seroconversion of participant
RVNA titer ≥ 0.5 IU/mL
Persistence of seroconversion
RVNA titer ≥ 0.5 IU/mL
Seroconversion of participant after simulated PEP vaccination -
RVNA titer ≥ 0.5 IU/mL
Seropositivity of participant
RVNA titer ≥ the lower limit of quantitation (LLOQ)
Persistence of seropositivity
RVNA titer ≥ the LLOQ
Seropositivity of participant after simulated PEP vaccination
RVNA titer ≥ the LLOQ
Participant RVNA titer ratios
Titer 14 days after the last PrEP vaccination / titer at D0
Participant RVNA titer ratios (persistence assessment)
RVNA titer ratios are assessed 6 months / 14 days after the last PrEP vaccination, and 1 year / 14 days after the last PrEP vaccination
Participant RVNA titer after simulated PEP vaccination
Ratio of titers measured 7 and 14 days after the first simulated PEP vaccination / 1 year after the last PrEP vaccination
Solicited injection site and systemic reactions after PrEP vaccination
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia.
Solicited injection site and systemic reactions after simulated PEP vaccination
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia. Solicited systemic reactions are collected between the first and second PEP injection and within 7 days after the second PEP injection.

Full Information

First Posted
October 5, 2018
Last Updated
April 22, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT03700242
Brief Title
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
Acronym
VAJ00001
Official Title
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 Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
January 19, 2019 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Study duration per participant is approximately 403 to 436 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers (Rabies Immunization)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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
Arm Title
Group 4
Arm Type
Experimental
Arm Description
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
Arm Title
Group 5
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
HDCV
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
HDCV
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Intradermal
Intervention Type
Biological
Intervention Name(s)
PVRV
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
PVRV
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Intradermal
Primary Outcome Measure Information:
Title
Seroconversion of participant
Description
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
Time Frame
14 days after the last PrEP vaccination
Secondary Outcome Measure Information:
Title
Participant RVNA titer
Time Frame
Day 0 and 14 days after the last PrEP vaccination
Title
Persistence of RVNA titer
Time Frame
6 months and 1 year after the last PrEP vaccination
Title
Participant RVNA titer after simulated PEP vaccination
Time Frame
7 and 14 days after the first simulated PEP vaccination
Title
Seroconversion of participant
Description
RVNA titer ≥ 0.5 IU/mL
Time Frame
Day 0 and 14 days after the last PrEP vaccination
Title
Persistence of seroconversion
Description
RVNA titer ≥ 0.5 IU/mL
Time Frame
6 months and 1 year after the last PrEP vaccination
Title
Seroconversion of participant after simulated PEP vaccination -
Description
RVNA titer ≥ 0.5 IU/mL
Time Frame
7 and 14 days after the first simulated PEPvaccination
Title
Seropositivity of participant
Description
RVNA titer ≥ the lower limit of quantitation (LLOQ)
Time Frame
Day 0 and 14 days after the last PrEP vaccination
Title
Persistence of seropositivity
Description
RVNA titer ≥ the LLOQ
Time Frame
6 months and 1 year after the last PrEP vaccination
Title
Seropositivity of participant after simulated PEP vaccination
Description
RVNA titer ≥ the LLOQ
Time Frame
7 and 14 days after the first simulated PEP vaccination
Title
Participant RVNA titer ratios
Description
Titer 14 days after the last PrEP vaccination / titer at D0
Time Frame
14 days after last PrEP vaccination
Title
Participant RVNA titer ratios (persistence assessment)
Description
RVNA titer ratios are assessed 6 months / 14 days after the last PrEP vaccination, and 1 year / 14 days after the last PrEP vaccination
Time Frame
6 months and 1 year after the last PrEP vaccination
Title
Participant RVNA titer after simulated PEP vaccination
Description
Ratio of titers measured 7 and 14 days after the first simulated PEP vaccination / 1 year after the last PrEP vaccination
Time Frame
1 year after the last PrEP vaccination
Title
Solicited injection site and systemic reactions after PrEP vaccination
Description
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia.
Time Frame
7 days after PrEP vaccination
Title
Solicited injection site and systemic reactions after simulated PEP vaccination
Description
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia. Solicited systemic reactions are collected between the first and second PEP injection and within 7 days after the second PEP injection.
Time Frame
7 days after simulated PEP vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria : Aged ≥ 2 years on the day of inclusion 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 Exclusion criteria: 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 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 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 002
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Investigational Site Number 001
City
Muntinlupa
ZIP/Postal Code
1770
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
35933278
Citation
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.
Results Reference
derived

Learn more about this trial

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

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