RabiesPhase 2NCT01877395
Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
A Phase 2 study testing Purified Vero Rabies Vaccine (VRVg) and Imovax® Rabies: inactivated rabies vaccine in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 5 sites in United States.
Trial summary
The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Purified Vero Rabies Vaccine (VRVg) and Imovax® Rabies: inactivated rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 2
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to < 65 years on the day of inclusion
- Informed consent form has been signed and dated - Able to attend all scheduled visits and comply with all trial procedures.
Who cannot join
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- Participation at the time of study enrollment 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 during the course of the trial
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- Receipt of immunoglobulins, 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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- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- At high risk of rabies infection during the trial
- Known systemic hypersensitivity to any of the components of either vaccine or HRIG, 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 intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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 ≥ 100.4°F). 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Boise, Idaho, 59802
Study site
Pembroke Pines, Florida, 33026
Study site
Raleigh, North Carolina, 27612
Study site
South Miami, Florida, 33143
Study site
West Jordan, Utah, 84088
About this study
Official title: Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Rabies Human Diploid Cell Vaccine (Imovax® Rabies) Administered in a Simulated Rabies Post-exposure Regimen in Healthy Adults
The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies).
Primary Objectives:
Read more
- To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at Day 14.
- To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI) of at least 97%.
Secondary Objectives:
- To assess the clinical safety of each vaccine after each vaccine injection when administered in a simulated post-exposure schedule.
- To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day 14.
Read the detailed description
All participants will receive five vaccine injections, i.e. one at Day 0, at Day 3, at Day 7, at Day 14 and at Day 28, respectively, (Essen regimen). In addition, human rabies immunoglobulins (HRIG) will be concomitantly administered to all subjects on Day 0.
Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to 6 months post-vaccination 5.
- Conditions
- Rabies
- Being tested
- Purified Vero Rabies Vaccine (VRVg), Imovax® Rabies: inactivated rabies vaccine
- Keywords
- Rabies, Purified Vero Rabies Vaccine - Serum Free, Human Diploid Cell Vaccine, Imovax® Rabies
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified Vero Rabies Vaccine (VRVg)Biological
0.5 mL, Intramuscular
Imovax® Rabies: inactivated rabies vaccineBiological
Also called Imovax® Rabies
1.0 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Purified Vero Rabies Vaccine Group | Experimental | Participants will receive the Purified Vero Rabies Vaccine (VRVg) Receives: Biological: Purified Vero Rabies Vaccine (VRVg) |
| Imovax® Rabies Vaccine Group | Experimental | Participants will receive the Imovax® Rabies vaccine Receives: Biological: Imovax® Rabies: inactivated rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series).
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
Measured: Day 14 post-vaccination
Secondary outcomes (2)
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia.
Measured: Day 0 up to 6 months post-vaccination
Geometric mean titer ratio (GMTR) following vaccination with either Purified Vero Rabies Vaccine, Serum Free or Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post exposure Regimen
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
Measured: Day 14 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 342 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
- NCT01877395
- Sponsor's protocol ID
- VRV04
- Other IDs
- U1111-1117-7447
- Status last verified
- Nov 2014
- First submitted
- 10 Jun 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Rabies Human Diploid Cell Vaccine (Imovax® Rabies) Administered in a Simulated Rabies Post-exposure Regimen in Healthy Adults
- ClinicalTrials.gov ID
- NCT01877395
- Acronym / sponsor ID
- VRV04
- Conditions
- Rabies
- Keywords
- Rabies, Purified Vero Rabies Vaccine - Serum Free, Human Diploid Cell Vaccine, Imovax® Rabies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Jun 2013 (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 aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies).
Primary Objectives:
- To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at Day 14.
- To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI) of at least 97%.
Secondary Objectives:
- To assess the clinical safety of each vaccine after each vaccine injection when administered in a simulated post-exposure schedule.
- To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day 14.
Detailed description
All participants will receive five vaccine injections, i.e. one at Day 0, at Day 3, at Day 7, at Day 14 and at Day 28, respectively, (Essen regimen). In addition, human rabies immunoglobulins (HRIG) will be concomitantly administered to all subjects on Day 0.
Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to 6 months post-vaccination 5.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purified Vero Rabies Vaccine Group | Experimental | Biological: Purified Vero Rabies Vaccine (VRVg)Participants will receive the Purified Vero Rabies Vaccine (VRVg) |
| Imovax® Rabies Vaccine Group | Experimental | Biological: Imovax® Rabies: inactivated rabies vaccineParticipants will receive the Imovax® Rabies vaccine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18 to < 65 years on the day of inclusion
- Informed consent form has been signed and dated - Able to attend all scheduled visits and comply with all trial procedures.
Key exclusion criteria (17 listed)
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- Participation at the time of study enrollment 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 during the course of the trial
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- Receipt of immunoglobulins, 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 |
|---|---|---|
| Purified Vero Rabies Vaccine (VRVg)0.5 mL, Intramuscular | Biological | Purified Vero Rabies Vaccine Group |
| Imovax® Rabies: inactivated rabies vaccineAlso: Imovax® Rabies1.0 mL, Intramuscular | Biological | Imovax® Rabies Vaccine Group |
Primary outcome
Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series).
Time frame: Day 14 post-vaccination
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
2 secondary outcomes
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Time frame: Day 0 up to 6 months post-vaccination
Geometric mean titer ratio (GMTR) following vaccination with either Purified Vero Rabies Vaccine, Serum Free or Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post exposure Regimen
Time frame: Day 14 post-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 3 Dec 2014.
- Related InfoLink provided by the sponsor.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Purified Vero Rabies Vaccine (VRVg) and Imovax® Rabies: inactivated rabies vaccine in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 5 sites in United States.
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 2 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series). (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?
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 3 Dec 2014.