RabiesNCT01641315
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
A study testing rabies vaccine in people with Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by… 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?
- rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2015to 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.
About this study
Official title: Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.
Read the detailed description
- Controlled trial study
- All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups. group 1 : 25 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 40 IU/kg of equine rabies immune globulin (ERIG). group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG). group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
- Conditions
- Rabies
- Being tested
- rabies vaccine
- Keywords
- rabies, rabies immunoglobulin
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabies vaccineBiological
Also called Equine rabies immunoglobulin produced by Thai Red Cross
Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Rabies vaccine, IM day 0,3,7,28 with RIG | Experimental | Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0. Receives: Biological: rabies vaccine |
| Rabies vaccine, IM day 0,3,7,14 with RIG | Experimental | Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0. Receives: Biological: rabies vaccine |
| Rabies vaccine, IM Day 0,3,7,14,28 with RIG | Active comparator | Rabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0 Receives: Biological: rabies vaccine |
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 rabies vaccination on day 0,3,7,14
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. 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 1 year period
Secondary outcomes (1)
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360. 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 1 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startSep 2015
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 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, MD, Principal investigator, Queen Saovabha Memorial Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641315
- Sponsor's protocol ID
- RC5502
- Status last verified
- Apr 2018
- First submitted
- 12 Jul 2012
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
- ClinicalTrials.gov ID
- NCT01641315
- Acronym / sponsor ID
- RC5502
- Conditions
- Rabies
- Keywords
- rabies, rabies immunoglobulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Jul 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.
Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.
Detailed description
- Controlled trial study
- All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups. group 1 : 25 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 40 IU/kg of equine rabies immune globulin (ERIG). group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG). group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rabies vaccine, IM day 0,3,7,28 with RIG | Experimental | Biological: rabies vaccineHealthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0. |
| Rabies vaccine, IM day 0,3,7,14 with RIG | Experimental | Biological: rabies vaccineHealthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0. |
| Rabies vaccine, IM Day 0,3,7,14,28 with RIG | Active comparator | Biological: rabies vaccineRabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0 |
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 |
|---|---|---|
| rabies vaccineAlso: Equine rabies immunoglobulin produced by Thai Red CrossGroup 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0. | Biological | Rabies vaccine, IM Day 0,3,7,14,28 with RIG, Rabies vaccine, IM day 0,3,7,14 with RIG, Rabies vaccine, IM day 0,3,7,28 with RIG |
Primary outcome
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14
Time frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
1 secondary outcome
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
Time frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year 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 6 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, MD principal investigator
Queen Saovabha Memorial Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rabies vaccine 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 6 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 rabies vaccination on day 0,3,7,14 (time frame: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year 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 6 Apr 2018.