RabiesPhase 2NCT01228383
Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
A Phase 2 study testing Rabies virus-specific monoclonal antibodies, human polyclonal rabies immune globulin (HRIG) and Human diploid cell vaccine (HDCV) in people with Rabies, run by Crucell Holland BV at 1 site in India.
Trial summary
Study design: Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Rabies virus-specific monoclonal antibodies, human polyclonal rabies immune globulin (HRIG) and Human diploid cell vaccine (HDCV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2011to Dec 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subject aged ≥18 to ≤55 years
- Subjects free of obvious health-problems or with stable conditions or medications
- Body mass index between ≥18 to ≤30 kg/m2
- Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90
- Male subjects must agree that they will not donate sperm from the first check-in until Day 90
- Subject signed written informed consent
Who cannot join
- Prior history of active or passive rabies immunization
- Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Planned immunization with live vaccines during the coming 3 months after first dosing
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind, Active-controlled, Mono-center Phase II Study to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Purified Vero Cell Rabies Vaccine vs. Human Rabies Immune Globulin or Placebo in Combination With Purified Vero Cell Rabies Vaccine vs. CL184 or Placebo in Combination With Human Diploid Cell Rabies Vaccine in Healthy Adult Subjects
Study design:
Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study
Read more
Study objectives:
Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.
Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).
Read the detailed description
This study was designed to explore and obtain further safety and RVNA data on CL184 in comparison to HRIG and placebo as part of a classical post-exposure prophylaxis (PEP) regimen. This regimen will be applied as simulated PEP regimen to healthy subjects (i.e. in a pre-exposure setting) in this study. A comparison with placebo combined with each rabies vaccine was included to differentiate between the contribution of immune globulin and vaccine and to investigate potential interactions between immune globulin and vaccine. RVNA provided by CL184 or HRIG, as well as vaccination response will be checked regularly during the study and booster doses can be applied after the study, if necessary. In addition pharmacokinetic data will be collected.
- Conditions
- Rabies
- Being tested
- Rabies virus-specific monoclonal antibodies, human polyclonal rabies immune globulin (HRIG), Placebo, Human diploid cell vaccine (HDCV), Purified verocell rabies vaccine (PVRV)
- Keywords
- Monoclonal antibody, Rabies, Post-exposure prophylaxis
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabies virus-specific monoclonal antibodiesBiological
Also called CL184
CL184 20 IU/kg intramuscularly on Day 0.
human polyclonal rabies immune globulin (HRIG)Biological
Also called Imogam® Rabies-HT
HRIG 20 IU/kg intramuscularly on Day 0.
PlaceboBiological
Placebo intramuscularly on Day 0.
Human diploid cell vaccine (HDCV)Biological
Also called Imovax®
Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.
Purified verocell rabies vaccine (PVRV)Biological
Also called Verorab™
Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
| Study group | Role | What they receive |
|---|---|---|
| CL184+PVRV | Experimental | CL184 with rabies vaccine (PVRV) Receives: Biological: Rabies virus-specific monoclonal antibodies; Biological: Purified verocell rabies vaccine (PVRV) |
| HRIG+PVRV | Active comparator | HRIG with rabies vaccine Receives: Biological: human polyclonal rabies immune globulin (HRIG); Biological: Purified verocell rabies vaccine (PVRV) |
| Placebo+PVRV | Placebo comparator | Placebo with rabies vaccine (PVRV) Receives: Biological: Placebo; Biological: Purified verocell rabies vaccine (PVRV) |
| CL184+HDCV | Experimental | CL184 with rabies vaccine (HDCV) Receives: Biological: Rabies virus-specific monoclonal antibodies; Biological: Human diploid cell vaccine (HDCV) |
| Placebo+HDCV | Placebo comparator | Placebo with rabies vaccine (HDCV) Receives: Biological: Placebo; Biological: Human diploid cell vaccine (HDCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety
Assessed by recording unsolicited adverse events, solicited local and systemic adverse events, and pain at the injection site (assessed on a Visual Analog Scale from Day 0 to Day 3); routine safety laboratory assessed on Days -1, 1, 3, 7, 42, and 90; ECG and vital signs assessed on Days -1, 7, and 90.
Measured: 90 days
Secondary outcomes (1)
Rabies virus neutralizing activity
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionDec 2012
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G Nagashayana, MD, Principal investigator, Lotus Labs Pvt. Ltd, Bangalore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228383
- Sponsor's protocol ID
- RAB-M-A008
- Other IDs
- U1111-1120-1647
- Status last verified
- Apr 2013
- First submitted
- 13 Oct 2010
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Active-controlled, Mono-center Phase II Study to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Purified Vero Cell Rabies Vaccine vs. Human Rabies Immune Globulin or Placebo in Combination With Purified Vero Cell Rabies Vaccine vs. CL184 or Placebo in Combination With Human Diploid Cell Rabies Vaccine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01228383
- Acronym / sponsor ID
- RAB-M-A008
- Conditions
- Rabies
- Keywords
- Monoclonal antibody, Rabies, Post-exposure prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Oct 2010 (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.
Study design:
Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study
Study objectives:
Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.
Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).
Detailed description
This study was designed to explore and obtain further safety and RVNA data on CL184 in comparison to HRIG and placebo as part of a classical post-exposure prophylaxis (PEP) regimen. This regimen will be applied as simulated PEP regimen to healthy subjects (i.e. in a pre-exposure setting) in this study. A comparison with placebo combined with each rabies vaccine was included to differentiate between the contribution of immune globulin and vaccine and to investigate potential interactions between immune globulin and vaccine. RVNA provided by CL184 or HRIG, as well as vaccination response will be checked regularly during the study and booster doses can be applied after the study, if necessary. In addition pharmacokinetic data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CL184+PVRV | Experimental | Biological: Rabies virus-specific monoclonal antibodies, Biological: Purified verocell rabies vaccine (PVRV)CL184 with rabies vaccine (PVRV) |
| HRIG+PVRV | Active comparator | Biological: human polyclonal rabies immune globulin (HRIG), Biological: Purified verocell rabies vaccine (PVRV)HRIG with rabies vaccine |
| Placebo+PVRV | Placebo comparator | Biological: Placebo, Biological: Purified verocell rabies vaccine (PVRV)Placebo with rabies vaccine (PVRV) |
| CL184+HDCV | Experimental | Biological: Rabies virus-specific monoclonal antibodies, Biological: Human diploid cell vaccine (HDCV)CL184 with rabies vaccine (HDCV) |
| Placebo+HDCV | Placebo comparator | Biological: Placebo, Biological: Human diploid cell vaccine (HDCV)Placebo with rabies vaccine (HDCV) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subject aged ≥18 to ≤55 years
- Subjects free of obvious health-problems or with stable conditions or medications
- Body mass index between ≥18 to ≤30 kg/m2
- Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90
- Male subjects must agree that they will not donate sperm from the first check-in until Day 90
Key exclusion criteria (5 listed)
- Prior history of active or passive rabies immunization
- Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Planned immunization with live vaccines during the coming 3 months after first dosing
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
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 |
|---|---|---|
| Rabies virus-specific monoclonal antibodiesAlso: CL184CL184 20 IU/kg intramuscularly on Day 0. | Biological | CL184+HDCV, CL184+PVRV |
| human polyclonal rabies immune globulin (HRIG)Also: Imogam® Rabies-HTHRIG 20 IU/kg intramuscularly on Day 0. | Biological | HRIG+PVRV |
| PlaceboPlacebo intramuscularly on Day 0. | Biological | Placebo+HDCV, Placebo+PVRV |
| Human diploid cell vaccine (HDCV)Also: Imovax®Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28. | Biological | CL184+HDCV, Placebo+HDCV |
| Purified verocell rabies vaccine (PVRV)Also: Verorab™Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28. | Biological | CL184+PVRV, HRIG+PVRV, Placebo+PVRV |
Primary outcome
Number of participants with adverse events as a measure of safety
Time frame: 90 days
Assessed by recording unsolicited adverse events, solicited local and systemic adverse events, and pain at the injection site (assessed on a Visual Analog Scale from Day 0 to Day 3); routine safety laboratory assessed on Days -1, 1, 3, 7, 42, and 90; ECG and vital signs assessed on Days -1, 7, and 90.
1 secondary outcome
Rabies virus neutralizing activity
Time frame: 90 days
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 10 Apr 2013.
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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.
G Nagashayana, MD principal investigator
Lotus Labs Pvt. Ltd, Bangalore, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rabies virus-specific monoclonal antibodies, human polyclonal rabies immune globulin (HRIG) and Human diploid cell vaccine (HDCV) in people with Rabies, run by Crucell Holland BV at 1 site in India.
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 6 inclusion and 5 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 10 Apr 2013. 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 India. 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. Some participants in this study may receive a placebo. 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 adverse events as a measure of safety (time frame: 90 days). 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 10 Apr 2013.