RabiesPhase 2NCT00708084
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents
A Phase 2 study testing CL184 and HRIG in people with Rabies, run by Crucell Holland BV at 1 site in Philippines.
Trial summary
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- CL184 and HRIG
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePhilippines
- Study dates
- May 2008to Oct 2008
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects free of obvious health-problems or with stable conditions
- Male or female subject aged ≥5 to ≤18 years
- Subject is living, studying, or working close to the study referral site
- Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form
Who cannot join
- Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin)
- Acute infection or disease within the last 2 weeks
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Any history of known or suspected anaphylaxis or hypersensitivity reaction
- Planned immunization with live vaccines during the next 3 months
- Chronic 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.
Philippines1 site
Research Institute for Tropical Medicine
Alabang, Muntinlupa, Metro Manila
About this study
Official title: A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.
- Conditions
- Rabies
- Being tested
- CL184, HRIG
- Keywords
- Rabies post-exposure prophylaxis, Monoclonal antibody
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL184Biological
CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
HRIGBiological
HRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | CL184 combined with rabies vaccination Receives: Biological: CL184 |
| B | Active comparator | HRIG combined with rabies vaccination Receives: Biological: HRIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 42 days
Secondary outcomes (1)
Rabies virus neutralizing activity
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2008
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beatriz P. Quiambao, MD, Principal investigator, Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708084
- Sponsor's protocol ID
- RAB-M-A004
- Status last verified
- Mar 2012
- First submitted
- 1 Jul 2008
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00708084
- Acronym / sponsor ID
- RAB-M-A004
- Conditions
- Rabies
- Keywords
- Rabies post-exposure prophylaxis, Monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Jul 2008 (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 this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: CL184CL184 combined with rabies vaccination |
| B | Active comparator | Biological: HRIGHRIG combined with rabies vaccination |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects free of obvious health-problems or with stable conditions
- Male or female subject aged ≥5 to ≤18 years
- Subject is living, studying, or working close to the study referral site
- Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form
Key exclusion criteria (6 listed)
- Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin)
- Acute infection or disease within the last 2 weeks
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Any history of known or suspected anaphylaxis or hypersensitivity reaction
- Planned immunization with live vaccines during the next 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 |
|---|---|---|
| CL184CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 | Biological | A |
| HRIGHRIG 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 | Biological | B |
Primary outcome
Safety and tolerability
Time frame: 42 days
1 secondary outcome
Rabies virus neutralizing activity
Time frame: 42 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 20 Mar 2012.
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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.
Beatriz P. Quiambao, MD principal investigator
Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
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 CL184 and HRIG in people with Rabies, run by Crucell Holland BV 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 4 inclusion and 6 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 20 Mar 2012. 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 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?
Safety and tolerability (time frame: 42 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 20 Mar 2012.