Healthy Volunteers (Rabies Immunization)Phase 3VAJ00001NCT03700242
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
A Phase 3 study testing HDCV and PVRV in people with Healthy Volunteers (Rabies Immunization), run by Sanofi Pasteur, a Sanofi Company at 2 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (Rabies Immunization)
- What is being tested?
- HDCV and PVRV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 2 sitesPhilippines
- Study dates
- 26 Sep 2018to 8 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Investigational Site Number 002
Cebu City, 6000
Investigational Site Number 001
City of Muntinlupa, 1770
About this study
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
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
Read the detailed description
Study duration per participant is approximately 403 to 436 days
- Conditions
- Healthy Volunteers (Rabies Immunization)
- Being tested
- HDCV, PVRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDCVBiological
Pharmaceutical form:Solution for injection Route of administration: Intramuscular
HDCVBiological
Pharmaceutical form:Solution for injection Route of administration: Intradermal
PVRVBiological
Pharmaceutical form:Solution for injection Route of administration: Intramuscular
PVRVBiological
Pharmaceutical form:Solution for injection Route of administration: Intradermal
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: PVRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion of participant
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
Measured: 14 days after the last PrEP vaccination
Secondary outcomes (14)
Participant RVNA titer
Measured: Day 0 and 14 days after the last PrEP vaccination
Persistence of RVNA titer
Measured: 6 months and 1 year after the last PrEP vaccination
Participant RVNA titer after simulated PEP vaccination
Measured: 7 and 14 days after the first simulated PEP vaccination
Seroconversion of participant
RVNA titer ≥ 0.5 IU/mL
Measured: Day 0 and 14 days after the last PrEP vaccination
Persistence of seroconversion
RVNA titer ≥ 0.5 IU/mL
Measured: 6 months and 1 year after the last PrEP vaccination
Seroconversion of participant after simulated PEP vaccination -
RVNA titer ≥ 0.5 IU/mL
Measured: 7 and 14 days after the first simulated PEPvaccination
Seropositivity of participant
RVNA titer ≥ the lower limit of quantitation (LLOQ)
Measured: Day 0 and 14 days after the last PrEP vaccination
Persistence of seropositivity
RVNA titer ≥ the LLOQ
Measured: 6 months and 1 year after the last PrEP vaccination
Seropositivity of participant after simulated PEP vaccination
RVNA titer ≥ the LLOQ
Measured: 7 and 14 days after the first simulated PEP vaccination
Participant RVNA titer ratios
Titer 14 days after the last PrEP vaccination / titer at D0
Measured: 14 days after last PrEP vaccination
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
Measured: 6 months and 1 year 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
Measured: 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.
Measured: 7 days after PrEP vaccination
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.
Measured: 7 days after simulated PEP vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start26 Sep 2018
- Primary completion19 Jan 2019
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers (Rabies Immunization)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700242
- Sponsor's protocol ID
- VAJ00001
- Other IDs
- U1111-1216-6210
- Acronym
- VAJ00001
- Status last verified
- Apr 2022
- First submitted
- 5 Oct 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 35933278
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03700242
- Acronym / sponsor ID
- VAJ00001 / VAJ00001
- Conditions
- Healthy Volunteers (Rabies Immunization)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 19 Jan 2019 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: HDCV1 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 |
| Group 2 | Active comparator | Biological: HDCV1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days |
| Group 3 | Experimental | Biological: HDCV2 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 |
| Group 4 | Experimental | Biological: PVRV1 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 |
| Group 5 | Experimental | Biological: PVRV2 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDCVPharmaceutical form:Solution for injection Route of administration: Intramuscular | Biological | Group 1, Group 2 |
| HDCVPharmaceutical form:Solution for injection Route of administration: Intradermal | Biological | Group 3 |
| PVRVPharmaceutical form:Solution for injection Route of administration: Intramuscular | Biological | Group 4 |
| PVRVPharmaceutical form:Solution for injection Route of administration: Intradermal | Biological | Group 5 |
Primary outcome
Seroconversion of participant
Time frame: 14 days after the last PrEP vaccination
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
14 secondary outcomes
Participant RVNA titer
Time frame: Day 0 and 14 days after the last PrEP vaccination
Persistence of RVNA titer
Time frame: 6 months and 1 year after the last PrEP vaccination
Participant RVNA titer after simulated PEP vaccination
Time frame: 7 and 14 days after the first simulated PEP vaccination
Seroconversion of participant
Time frame: Day 0 and 14 days after the last PrEP vaccination
Persistence of seroconversion
Time frame: 6 months and 1 year after the last PrEP vaccination
Seroconversion of participant after simulated PEP vaccination -
Time frame: 7 and 14 days after the first simulated PEPvaccination
Seropositivity of participant
Time frame: Day 0 and 14 days after the last PrEP vaccination
Persistence of seropositivity
Time frame: 6 months and 1 year after the last PrEP vaccination
Seropositivity of participant after simulated PEP vaccination
Time frame: 7 and 14 days after the first simulated PEP vaccination
Participant RVNA titer ratios
Time frame: 14 days after last PrEP vaccination
Participant RVNA titer ratios (persistence assessment)
Time frame: 6 months and 1 year after the last PrEP vaccination
Participant RVNA titer after simulated PEP vaccination
Time frame: 1 year after the last PrEP vaccination
Solicited injection site and systemic reactions after PrEP vaccination
Time frame: 7 days after PrEP vaccination
Solicited injection site and systemic reactions after simulated PEP vaccination
Time frame: 7 days after simulated PEP vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 35933278Quiambao 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDCV and PVRV in people with Healthy Volunteers (Rabies Immunization), run by Sanofi Pasteur, a Sanofi Company at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion of participant (time frame: 14 days after the last PrEP vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.