RabiesNCT03093545
Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients
A study testing Equine Rabies Immunoglobulin and Purified chick-embryo cell rabies vaccine in people with Rabies, run by Mahidol University at 1 site in Thailand.
Trial summary
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rabies
- What is being tested?
- Equine Rabies Immunoglobulin and Purified chick-embryo cell rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2015to Nov 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ages of >= 18 years and older;
- Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s);
- Either a) obese with BMI >= 30 or b) normal weight and/or underweight with BMI < 25;
- Agree to independently consent to participate in all study procedures.
Who cannot join
- Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients;
- Co-enrolment with other studies or participated in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug;
- Female patients who are currently pregnant or breast feeding.
- Presenting with wound at eye(s) or eye lid(s);
- Receiving rabies vaccination more than 7 days for this exposure;
- History of complete pre-exposure or post-exposure regimen with at least 3 doses;
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- Known of allergic to egg or poultry meat;
- History of previous exposure to equine sera
- Significant illness that might harm or increase the risk to the patients;
- History of drug abuse or alcoholism.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
Read the detailed description
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
- Conditions
- Rabies
- Being tested
- Equine Rabies Immunoglobulin, Purified chick-embryo cell rabies vaccine
- Keywords
- rabies, obese, immunoglobulin, rabies vaccine, post-exposure, immunogenicity
- Medical subject headings
- Rabies, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine Rabies ImmunoglobulinBiological
Also called ERIG
40 IU per kg of body weight of ERIG at Day 0
Purified chick-embryo cell rabies vaccineBiological
Also called PCEC
1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.
| Study group | Role | What they receive |
|---|---|---|
| Normal BMI or underweight (< 24 Kg/m2) | Other | Not described Receives: Biological: Equine Rabies Immunoglobulin; Biological: Purified chick-embryo cell rabies vaccine |
| Obese (BMI > 30 Kg/m2) | Experimental | Not described Receives: Biological: Equine Rabies Immunoglobulin; Biological: Purified chick-embryo cell rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
To compare RVNA levels between obese and normal/underweight patients.
Measured: At day 7 prior to vaccination.
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
To compare RVNA levels between obese and normal/underweight patients.
Measured: At day 14 prior to vaccination.
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
To compare RVNA levels between obese and normal/underweight patients.
Measured: At day 28 prior to vaccination.
Secondary outcomes (1)
Incidence of adverse event
Number of participants with ERIG or PCEC-related adverse events as assessed by investigator as per CTCAE v4.03.
Measured: From day 0 to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startMar 2015
- Primary completionOct 2016
- Study completionNov 2016
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 Mahidol 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- VINS Bioproducts Ltd., Biogentech Co.,LTD
- Responsible party
- Principal investigator, Jatuporn Sirikun, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093545
- Sponsor's protocol ID
- Si178/2015
- Status last verified
- Mar 2017
- First submitted
- 24 Jan 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to provide individual participant data (IPD). However, other researcher could request IPD from principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients
- ClinicalTrials.gov ID
- NCT03093545
- Acronym / sponsor ID
- Si178/2015
- Conditions
- Rabies
- Keywords
- rabies, obese, immunoglobulin, rabies vaccine, post-exposure, immunogenicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- VINS Bioproducts Ltd., Biogentech Co.,LTD
- Study start
- Mar 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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.
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
Detailed description
A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal BMI or underweight (< 24 Kg/m2) | Other | Biological: Equine Rabies Immunoglobulin, Biological: Purified chick-embryo cell rabies vaccine |
| Obese (BMI > 30 Kg/m2) | Experimental | Biological: Equine Rabies Immunoglobulin, Biological: Purified chick-embryo cell rabies vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ages of >= 18 years and older;
- Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s);
- Either a) obese with BMI >= 30 or b) normal weight and/or underweight with BMI < 25;
- Agree to independently consent to participate in all study procedures.
Key exclusion criteria (10 listed)
- Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients;
- Co-enrolment with other studies or participated in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug;
- Female patients who are currently pregnant or breast feeding.
- Presenting with wound at eye(s) or eye lid(s);
- Receiving rabies vaccination more than 7 days for this exposure;
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 |
|---|---|---|
| Equine Rabies ImmunoglobulinAlso: ERIG40 IU per kg of body weight of ERIG at Day 0 | Biological | Normal BMI or underweight (< 24 Kg/m2), Obese (BMI > 30 Kg/m2) |
| Purified chick-embryo cell rabies vaccineAlso: PCEC1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28. | Biological | Normal BMI or underweight (< 24 Kg/m2), Obese (BMI > 30 Kg/m2) |
Primary outcome
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
Time frame: At day 7 prior to vaccination.
To compare RVNA levels between obese and normal/underweight patients.
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
Time frame: At day 14 prior to vaccination.
To compare RVNA levels between obese and normal/underweight patients.
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients.
Time frame: At day 28 prior to vaccination.
To compare RVNA levels between obese and normal/underweight patients.
1 secondary outcome
Incidence of adverse event
Time frame: From day 0 to day 60
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 4 Apr 2017.
- Individual participant dataSharing planned: No. No plan to provide individual participant data (IPD). However, other researcher could request IPD from principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine Rabies Immunoglobulin and Purified chick-embryo cell rabies vaccine in people with Rabies, run by Mahidol 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 4 inclusion and 10 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 4 Apr 2017. 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.
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?
The difference of rabies virus neutralizing antibody (RVNA) levels between obese and normal/underweight patients. (time frame: At day 7 prior to vaccination.). The study lists 3 primary outcomes in all. 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 4 Apr 2017.