RabiesNCT03524417
Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
A study testing Equine rabies immunoglobulin injection on day 7 in people with Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). 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?
- Equine rabies immunoglobulin injection on day 7
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 30 Apr 2018to 30 Dec 2023
- 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
- Age 18 - 60 years
- WHO category III rabies exposure
- Received rabies vaccination on day 0 and 3.
Who cannot join
- Received RIG
- Immunocompromised hosts or receiving immunosuppressive therapy
- Received blood or blood product within 3 months
- Received anti-malarial drugs
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, 10330
Suda Sibunruang, M.D., +66 81 7366076, sudapunrin@gmail.com
Terapong Tantawichien, M.D., +66 2 2520161 ext. 125, queensaovabha@hotmail.com
About this study
Official title: Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1).
Read the detailed description
Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7.
The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.
- Conditions
- Rabies
- Being tested
- Equine rabies immunoglobulin injection on day 7
- Keywords
- 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.
Equine rabies immunoglobulin injection on day 7Biological
The patients with WHO category III rabies exposure, who have received first dose of rabies vaccination a week before and have not received rabies immunoglobulin were enrolled. Blood for Rabies neutralizing antibody titers (RNab) would be examined on day 0. On the same day, Equine rabies immunoglobulin (ERIG) at the dosage of 40 IU/kg would be injected into and around the wound as much as possible and the rest would be injected intramuscularly at the site distance from rabies vaccine. Then blood for RNab would be serially examined on day 7, 14, 90, 365.
| Study group | Role | What they receive |
|---|---|---|
| RIG injection | Experimental | RIG injection on day 7 Receives: Biological: Equine rabies immunoglobulin injection on day 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies neutralizing antibody titers
Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)
Measured: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start30 Apr 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT03524417
- Sponsor's protocol ID
- 2/2017
- Status last verified
- Apr 2022
- First submitted
- 2 May 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Equine Rabies Immunoglobulin Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response
- ClinicalTrials.gov ID
- NCT03524417
- Acronym / sponsor ID
- 2/2017
- Conditions
- Rabies
- Keywords
- Rabies immunoglobulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 May 2018 (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.
No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1).
Detailed description
Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7.
The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIG injection | Experimental | Biological: Equine rabies immunoglobulin injection on day 7RIG injection on day 7 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 - 60 years
- WHO category III rabies exposure
- Received rabies vaccination on day 0 and 3.
Key exclusion criteria (4 listed)
- Received RIG
- Immunocompromised hosts or receiving immunosuppressive therapy
- Received blood or blood product within 3 months
- Received anti-malarial drugs
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 immunoglobulin injection on day 7The patients with WHO category III rabies exposure, who have received first dose of rabies vaccination a week before and have not received rabies immunoglobulin were enrolled. Blood for Rabies neutralizing antibody titers (RNab) would be examined on day 0. On the same day, Equine rabies immunoglobulin (ERIG) at the dosage of 40 IU/kg would be injected into and around the wound as much as possible and the rest would be injected intramuscularly at the site distance from rabies vaccine. Then blood for RNab would be serially examined on day 7, 14, 90, 365. | Biological | RIG injection |
Primary outcome
Rabies neutralizing antibody titers
Time frame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks
Rabies neutralizing antibody titers would be represented and compared by geometric mean titers (GMTs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Rabies
RecruitingPhase 4
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
Healthy Adult Participants, Age 65 and Older
Active, not recruitingPhase 3
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
Rabies
Active, not recruitingObservational study
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Rabies Post-exposure Prophylaxis, Rabies
RecruitingObservational study
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Rabies Post-exposure Prophylaxis
Enrolling by invitationPhase 3
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
Rabies Prevention
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 Equine rabies immunoglobulin injection on day 7 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 3 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 29 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suda Sibunruang, MD (+66 2 2520161 ext. 125, sudapunrin@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 titers (time frame: Change from baseline of geometric mean titres of rabies neutralizing antibody titres at 2 weeks). 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 29 Apr 2022.