Primary ImmunodeficiencyPhase 4NCT02490956
Diagnostic Immunization With Rabies Vaccine in Patients With PID
A Phase 4 study testing Verorab® (PVRV; Purified Vero Cell Vaccine) in people with Primary Immunodeficiency, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders and study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency. Read more about this study
- Who is it for?
- Ages 12 months to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immunodeficiency
- What is being tested?
- Verorab® (PVRV; Purified Vero Cell Vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2015to Sep 2016
- Phase
- Phase 4
- 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 12 months to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Case group
- Patient with primary immunodeficiency diseases who follows up at Division of pediatric allergy and immunology unit, King Chulalongkorn Memorial Hospital
- Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.
- Subject is able to comply with the follow-up schedule of the protocol
- Control group
- Subject is healthy (from history and physical examination)
Show all 12Show fewer
- Subject do not has underlying diseases.
- Subject do not has primary and secondary immunodeficiency diseases
- Subject is not receiving immunosuppressive therapy or cytotoxic drugs
- Subject or father/mother/legally acceptable representative properly informed about the study and having signed the informed consent form.
- Subject is able to comply with the follow-up schedule of the protocol
- Age more than 12 month old to 60 years old
Who cannot join
- Reported history of previous rabies immunization or Rabies neutralizing antibody (Rabies Nab) > 0.5 IU/ml
- Subject is unable to comply with the follow-up schedule of the protocol
- Pregnancy
- Body temperature more than 38 degree celcius at screening visit
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Allergic and Immunology , Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
Narissara Suratannon, MD, +66812950190, mayzped@gmail.com
Suvanee Charoenlap, MD, +66814729600, suvanee171@gmail.com
About this study
Official title: Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders
The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders and study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency.
Read the detailed description
Objective Primary objective
: To study diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders. Secondary objective
- To study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency.
- To study anti-rabies immunization protocol in patients with primary immunodeficiency disorders.
Population Case group: Twenty primary immunodeficiency disease patients that are diagnosed, treated and followed at Allergy and Immunology unit, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University.
Control group: Twenty healthy subjects who have no underlying disease and age-matched with case patients. Inclusion and exclusion criteria
Vaccine :
- Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular
- Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363
Immunological evaluations :
- Humoral immune response : on 5 ml blood samples will be collected for antibody determination days 0, 14, 28, 90, 360, 367 and 374. Neutralizing antibodies will be determined blindly using the rapid fluorescent focus inhibition test (RFFIT) at Queen Saovabha Memorial Institute. Rabies neutralizing antibody will be reported in IU/ml The protective antibody level are defined rabies neutralizing antibody ≥ 0.5 IU/ml .
- Cellular mediated immune response :
On 5 ml blood samples will be collected for antibody determination days 14, 28, 90, 360, 367 and 374. Lymphocyte proliferation response to rabies antigen will be determined by using 3H-thymidine incorporation assay.
The responder criteria are defined as stimulation index (SI index) ≥ 2.0 was considered as evidence of antigen-induced lymphocyte proliferation.
- Conditions
- Primary Immunodeficiency
- Being tested
- Verorab® (PVRV; Purified Vero Cell Vaccine)
- Keywords
- Diagnostic immunization with rabies vaccine, Primary immunodeficiency
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verorab® (PVRV; Purified Vero Cell Vaccine)Biological
- Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular
- Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363
| Study group | Role | What they receive |
|---|---|---|
| Rabies vaccination | Experimental | * Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular
* Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363 Receives: Biological: Verorab® (PVRV; Purified Vero Cell Vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies neutralizing antibody titer (RFFIT test)
Measured: 1 year
Secondary outcomes (1)
Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narissara Suratannon, Chulalongkorn University
- Investigators
- Narissara - Suratannon, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490956
- Sponsor's protocol ID
- RabiesPID
- Status last verified
- Jul 2015
- First submitted
- 30 Mar 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency Disorders
- ClinicalTrials.gov ID
- NCT02490956
- Acronym / sponsor ID
- RabiesPID
- Conditions
- Primary Immunodeficiency
- Keywords
- Diagnostic immunization with rabies vaccine, Primary immunodeficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 7 Jul 2015 (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 evaluate diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders and study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency.
Detailed description
Objective Primary objective
: To study diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders. Secondary objective
- To study humoral and cellular immune response to rabies vaccine in patients with primary immunodeficiency.
- To study anti-rabies immunization protocol in patients with primary immunodeficiency disorders.
Population Case group: Twenty primary immunodeficiency disease patients that are diagnosed, treated and followed at Allergy and Immunology unit, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University.
Control group: Twenty healthy subjects who have no underlying disease and age-matched with case patients. Inclusion and exclusion criteria
Vaccine :
- Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular
- Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363
Immunological evaluations :
- Humoral immune response : on 5 ml blood samples will be collected for antibody determination days 0, 14, 28, 90, 360, 367 and 374. Neutralizing antibodies will be determined blindly using the rapid fluorescent focus inhibition test (RFFIT) at Queen Saovabha Memorial Institute. Rabies neutralizing antibody will be reported in IU/ml The protective antibody level are defined rabies neutralizing antibody ≥ 0.5 IU/ml .
- Cellular mediated immune response :
On 5 ml blood samples will be collected for antibody determination days 14, 28, 90, 360, 367 and 374. Lymphocyte proliferation response to rabies antigen will be determined by using 3H-thymidine incorporation assay.
The responder criteria are defined as stimulation index (SI index) ≥ 2.0 was considered as evidence of antigen-induced lymphocyte proliferation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rabies vaccination | Experimental | Biological: Verorab® (PVRV; Purified Vero Cell Vaccine)* Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular * Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363 |
Who may qualify
- Ages
- 12 months to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Case group
- Control group
Key exclusion criteria (4 listed)
- Reported history of previous rabies immunization or Rabies neutralizing antibody (Rabies Nab) > 0.5 IU/ml
- Subject is unable to comply with the follow-up schedule of the protocol
- Pregnancy
- Body temperature more than 38 degree celcius at screening visit
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 |
|---|---|---|
| Verorab® (PVRV; Purified Vero Cell Vaccine)* Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular * Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363 | Biological | Rabies vaccination |
Primary outcome
Rabies neutralizing antibody titer (RFFIT test)
Time frame: 1 year
1 secondary outcome
Lymphocyte proliferation response to rabies antigen (3H-Thymidine incorporation assay)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Related trials for Primary Immunodeficiency
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingObservational study
Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)
Infections, Pneumonia
RecruitingObservational study
Genetic Basis of Immunodeficiency
Severe Combined Immunodeficiency
RecruitingObservational study
Detection and Characterization of Infections and Infection Susceptibility
Immune Deficiencies
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.
Narissara - Suratannon, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Verorab® (PVRV; Purified Vero Cell Vaccine) in people with Primary Immunodeficiency, run by Chulalongkorn University at 1 site in Thailand.
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 12 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jul 2015. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narissara - Suratannon, MD (6622564455 ext. 14,15, mayzped@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rabies neutralizing antibody titer (RFFIT test) (time frame: 1 year). 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 7 Jul 2015.