RabiesPhase 3NCT01622062
Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen
A Phase 3 study testing PVRV and PVRV and pERIG Favirab® in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 1 site in Philippines.
Trial summary
The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Rabies
- What is being tested?
- PVRV and PVRV and pERIG Favirab®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePhilippines
- Study dates
- 29 Jun 2012to 14 Nov 2018
- 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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For all patients:
- Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site.
- For adults:
- Informed consent form has been signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For children:
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- For children under 18 years of age, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative.
- For children under 18 years, assent form or informed consent form has been signed and dated by the appropriate age-range patient, according to country specific institution requirement as detailed in each country specific assent form or informed consent form.
- Patient and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- For all patients:
- 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.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial immunization
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination and tetanus immunization (related only to current animal bite exposure
- Planned receipt of any vaccine in the 4 weeks following the trial primary and booster vaccination
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- Previous immunization against rabies at any time in the past with either the trial vaccine and immunoglobulin or another rabies immunobiological product (in pre-or post-exposure regimen)
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- 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)
- Self-reported seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
- Patient with clinical signs of encephalitis
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
- Prior history of mammal animal bite within the past 5 years.
- For infants or toddlers :
- Known personal or maternal seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus, as reported by the parent/guardian
- Prior history of seizures .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verorab® Immunogenicity and Safety After a One-week, 4-site, Intradermal (ID) Post-exposure Prophylaxis Regimen (4-4-4-0-0) Followed by a One-visit, 4-site, ID Booster at Five Years
The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.
Primary objective:
Read more
- To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen.
Secondary objectives:
- Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90.
- Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group.
- Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5.
- Safety: To describe the safety profile of each group after the primary and booster vaccinations.
Read the detailed description
Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen. Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®. All participants will receive a "single-visit, 4-site" booster vaccination five years later.
- Conditions
- Rabies
- Being tested
- PVRV, PVRV and pERIG Favirab®
- Keywords
- Rabies, Verorab®, Favirab®
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVRVBiological
Also called VERORAB®
0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally
PVRV and pERIG Favirab®Biological
Also called VERORAB®; pERIG Favirab®
0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
PVRV and pERIG Favirab®Biological
Also called VERORAB®; pERIG Favirab®
0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients with WHO Category II exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later Receives: Biological: PVRV |
| Group 2 | Experimental | Patients with WHO Category III exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later Receives: Biological: PVRV and pERIG Favirab® |
| Group 3 | Active comparator | Patients with WHO Category III exposure receive PEP with PVRV using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later Receives: Biological: PVRV and pERIG Favirab® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with seroconversion on Day 14
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Measured: Day 14 post vaccination
Secondary outcomes (8)
Percentage of participants with seroconversion before and after primary vaccination
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Measured: Day 0, Day 14, Day 90
Percentage of participants with seroconversion after primary vaccination (antibody persistence)
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Measured: Year 1 to Year 5
Percentage of participants with seroconversion after booster vaccination
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Measured: Year 5 + 11 days
Geometric mean titers (GMTs) before and after primary vaccination
Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
Measured: Day 0, Day 14, Day 90
GMTs after primary vaccination (antibody persistence)
Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
Measured: Year 1 to Year 5
GMTs after booster vaccination
Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
Measured: Year 5 + 11 days
Number of participants reporting solicited injection site reactions following primary and booster vaccination
Solicited injection site reactions are tenderness (for participants aged ≤ 23 months), pain (for participants aged ≥ 2 years), redness and swelling (for all participants)
Measured: 7 days after each and any injection
Number of participants reporting solicited systemic reactions following primary and booster vaccination
Solicited systemic reactions are Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability for participants aged ≤ 23 months and Fever (Temperature), Headache, Malaise, and Myalgia for participants aged ≥ 2 years
Measured: From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study start29 Jun 2012
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
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 RabiesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622062
- Sponsor's protocol ID
- RAB40
- Other IDs
- U1111-1122-2546
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2012
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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, Ambas C, Diego S, Bosch Castells V, Korejwo J, Petit C, Houillon G. Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines. Vaccine. 2019 Apr 10;37(16):2268-2277. doi: 10.1016/j.vaccine.2019.02.083. Epub 2019 Mar 16.
PubMed 30890382
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
- Verorab® Immunogenicity and Safety After a One-week, 4-site, Intradermal (ID) Post-exposure Prophylaxis Regimen (4-4-4-0-0) Followed by a One-visit, 4-site, ID Booster at Five Years
- ClinicalTrials.gov ID
- NCT01622062
- Acronym / sponsor ID
- RAB40
- Conditions
- Rabies
- Keywords
- Rabies, Verorab®, Favirab®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2012 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 18 Jun 2012 (estimated)
- 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 purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen.
Primary objective:
- To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen.
Secondary objectives:
- Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90.
- Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group.
- Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5.
- Safety: To describe the safety profile of each group after the primary and booster vaccinations.
Detailed description
Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen. Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®. All participants will receive a "single-visit, 4-site" booster vaccination five years later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: PVRVPatients with WHO Category II exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Group 2 | Experimental | Biological: PVRV and pERIG Favirab®Patients with WHO Category III exposure receive PEP with PVRV using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
| Group 3 | Active comparator | Biological: PVRV and pERIG Favirab®Patients with WHO Category III exposure receive PEP with PVRV using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®, and a "single-visit, 4-site" booster vaccination with PVRV 5 years later |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patient aged ≤50 years, with WHO category II or III contacts happened within 48 hours before appearance at site.
- Informed consent form has been signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For children under 18 years of age, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative.
- For children under 18 years, assent form or informed consent form has been signed and dated by the appropriate age-range patient, according to country specific institution requirement as detailed in each country specific assent form or informed consent form.
Key exclusion criteria (21 listed)
- 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.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial immunization
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination and tetanus immunization (related only to current animal bite exposure
- Planned receipt of any vaccine in the 4 weeks following the trial primary and booster vaccination
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 |
|---|---|---|
| PVRVAlso: VERORAB®0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally | Biological | Group 1 |
| PVRV and pERIG Favirab®Also: VERORAB®; pERIG Favirab®0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s) | Biological | Group 2 |
| PVRV and pERIG Favirab®Also: VERORAB®; pERIG Favirab®0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s) | Biological | Group 3 |
Primary outcome
Percentage of participants with seroconversion on Day 14
Time frame: Day 14 post vaccination
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
8 secondary outcomes
Percentage of participants with seroconversion before and after primary vaccination
Time frame: Day 0, Day 14, Day 90
Percentage of participants with seroconversion after primary vaccination (antibody persistence)
Time frame: Year 1 to Year 5
Percentage of participants with seroconversion after booster vaccination
Time frame: Year 5 + 11 days
Geometric mean titers (GMTs) before and after primary vaccination
Time frame: Day 0, Day 14, Day 90
GMTs after primary vaccination (antibody persistence)
Time frame: Year 1 to Year 5
GMTs after booster vaccination
Time frame: Year 5 + 11 days
Number of participants reporting solicited injection site reactions following primary and booster vaccination
Time frame: 7 days after each and any injection
Number of participants reporting solicited systemic reactions following primary and booster vaccination
Time frame: From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections
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 30890382Quiambao BP, Ambas C, Diego S, Bosch Castells V, Korejwo J, Petit C, Houillon G. Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines. Vaccine. 2019 Apr 10;37(16):2268-2277. doi: 10.1016/j.vaccine.2019.02.083. Epub 2019 Mar 16.
- Related InfoLink provided by the sponsor.
- 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.
Medical Director study director
Sanofi Pasteur SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PVRV and PVRV and pERIG Favirab® in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 1 site 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 9 inclusion and 21 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 1 site 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?
Percentage of participants with seroconversion on Day 14 (time frame: Day 14 post 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 NCT01622062, 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.