RabiesNCT01610362
Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
A study testing Human Rabies Immune Globulin in people with Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Human Rabies Immune Globulin
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Apr 2018
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers age 18-60 years.
Who cannot join
- received prior rabies immunization
- pregnancy
- immunocompromised conditions
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, 10330
About this study
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.
Read the detailed description
- Controlled trial study.
- All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups. group 1 : 15 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 20 IU/kg of human rabies immune globulin (HRIG). group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
- Conditions
- Rabies
- Being tested
- Human Rabies Immune Globulin
- Keywords
- rabies, immunoglobulin, dosage
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Rabies Immune GlobulinBiological
Also called Human Rabies Immune Globulin produced by Thai Red Cross
HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
| Study group | Role | What they receive |
|---|---|---|
| 5-dose IM rabies vaccines, HRIG 20 IU/kg | Active comparator | Rabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg Receives: Biological: Human Rabies Immune Globulin |
| 5-dose IM rabies vaccines, HRIG 40 IU/kg | Experimental | Healthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg Receives: Biological: Human Rabies Immune Globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
Measured: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Secondary outcomes (1)
Number of participants who have Rabies Neutralizing antibody titers above protective levels.
Number of participants who have Rabies Neutralizing antibody titers above protective levels (> 0.5 IU/mL as recommended by WHO)at 3-month period.
Measured: Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2018
- Study completionApr 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Saovabha Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suda Sibunruang, Queen Saovabha Memorial Institute
- Investigators
- Suda Sibunruang, M.D., Principal investigator, Queen Saovabha Memorial Institute, Thai Red Cross Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610362
- Sponsor's protocol ID
- RC5504
- Status last verified
- Apr 2018
- First submitted
- 29 May 2012
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
- ClinicalTrials.gov ID
- NCT01610362
- Acronym / sponsor ID
- RC5504
- Conditions
- Rabies
- Keywords
- rabies, immunoglobulin, dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 4 Jun 2012 (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.
Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.
Detailed description
- Controlled trial study.
- All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups. group 1 : 15 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 20 IU/kg of human rabies immune globulin (HRIG). group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-dose IM rabies vaccines, HRIG 20 IU/kg | Active comparator | Biological: Human Rabies Immune GlobulinRabies exposed victims, 5-dose IM rabies vaccine, HRIG 20 IU/kg |
| 5-dose IM rabies vaccines, HRIG 40 IU/kg | Experimental | Biological: Human Rabies Immune GlobulinHealthy volunteers, 5-dose IM rabies vaccine, HRIG 40 IU/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers age 18-60 years.
Key exclusion criteria (3 listed)
- received prior rabies immunization
- pregnancy
- immunocompromised conditions
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 |
|---|---|---|
| Human Rabies Immune GlobulinAlso: Human Rabies Immune Globulin produced by Thai Red CrossHRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0 | Biological | 5-dose IM rabies vaccines, HRIG 20 IU/kg, 5-dose IM rabies vaccines, HRIG 40 IU/kg |
Primary outcome
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
Time frame: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg would be determined on day 0,14, 28 and 90. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
1 secondary outcome
Number of participants who have Rabies Neutralizing antibody titers above protective levels.
Time frame: Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..
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 9 Apr 2018.
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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.
Suda Sibunruang, M.D. principal investigator
Queen Saovabha Memorial Institute, Thai Red Cross Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Rabies Immune Globulin in people with Rabies, run by Queen Saovabha Memorial Institute 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 1 inclusion and 3 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 9 Apr 2018. 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?
Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg (time frame: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period). 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 9 Apr 2018.