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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)

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ClinicalTrials.gov Identifier: NCT03700242
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers (Rabies Immunization) Biological: HDCV Biological: PVRV Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies
Drug Information available for: Imovax

Arm Intervention/treatment
Experimental: Group 1
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
Pharmaceutical form:Solution for injection Route of administration: Intramuscular

Active Comparator: Group 2
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
Pharmaceutical form:Solution for injection Route of administration: Intramuscular

Experimental: Group 3
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
Pharmaceutical form:Solution for injection Route of administration: Intradermal

Experimental: Group 4
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
Pharmaceutical form:Solution for injection Route of administration: Intramuscular

Experimental: Group 5
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
Pharmaceutical form:Solution for injection Route of administration: Intradermal




Primary Outcome Measures :
  1. Seroconversion of participant [ Time Frame: 14 days after the last PrEP vaccination ]
    Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL


Secondary Outcome Measures :
  1. Participant RVNA titer [ Time Frame: Day 0 and 14 days after the last PrEP vaccination ]
  2. Persistence of RVNA titer [ Time Frame: 6 months and 1 year after the last PrEP vaccination ]
  3. Participant RVNA titer after simulated PEP vaccination [ Time Frame: 7 and 14 days after the first simulated PEP vaccination ]
  4. Seroconversion of participant [ Time Frame: Day 0 and 14 days after the last PrEP vaccination ]
    RVNA titer ≥ 0.5 IU/mL

  5. Persistence of seroconversion [ Time Frame: 6 months and 1 year after the last PrEP vaccination ]
    RVNA titer ≥ 0.5 IU/mL

  6. Seroconversion of participant after simulated PEP vaccination - [ Time Frame: 7 and 14 days after the first simulated PEPvaccination ]
    RVNA titer ≥ 0.5 IU/mL

  7. Seropositivity of participant [ Time Frame: Day 0 and 14 days after the last PrEP vaccination ]
    RVNA titer ≥ the lower limit of quantitation (LLOQ)

  8. Persistence of seropositivity [ Time Frame: 6 months and 1 year after the last PrEP vaccination ]
    RVNA titer ≥ the LLOQ

  9. Seropositivity of participant after simulated PEP vaccination [ Time Frame: 7 and 14 days after the first simulated PEP vaccination ]
    RVNA titer ≥ the LLOQ

  10. Participant RVNA titer ratios [ Time Frame: 14 days after last PrEP vaccination ]
    Titer 14 days after the last PrEP vaccination / titer at D0

  11. Participant RVNA titer ratios (persistence assessment) [ Time Frame: 6 months and 1 year after the last PrEP vaccination ]
    RVNA titer ratios are assessed 6 months / 14 days after the last PrEP vaccination, and 1 year / 14 days after the last PrEP vaccination

  12. Participant RVNA titer after simulated PEP vaccination [ Time Frame: 1 year after the last PrEP vaccination ]
    Ratio of titers measured 7 and 14 days after the first simulated PEP vaccination / 1 year after the last PrEP vaccination

  13. Solicited injection site and systemic reactions after PrEP vaccination [ Time Frame: 7 days after PrEP vaccination ]
    Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia.

  14. Solicited injection site and systemic reactions after simulated PEP vaccination [ Time Frame: 7 days 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


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): NCT03700242


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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Philippines
Investigational Site Number 002 Recruiting
Cebu City, Philippines, 6000
Investigational Site Number 001 Recruiting
Muntinlupa, Philippines, 1770
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03700242     History of Changes
Other Study ID Numbers: VAJ00001
U1111-1216-6210 ( Other Identifier: UTN )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

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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

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases