RabiesNCT03729102
Immunological Tolerance After Frequent Rabies Booster Vaccinations
A study testing Blood drawn after rabies vaccine booster vaccination in people with Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
To study immunological tolerance effect after frequent rabies booster vaccination Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Blood drawn after rabies vaccine booster vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 4 Jun 2020to 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Previously received rabies vaccination
Who cannot join
- Had immunocompromised conditions
- 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
Pathum Wan, Bangkok, 10330
Suda Punrin, MD, +66 2 2520161 ext. 125, sudapunrin@gmail.com
Terapong Tantawichien, MD, +66 2 2520161 ext. 132, terapong_tantawichien@hotmail.com
About this study
To study immunological tolerance effect after frequent rabies booster vaccination
Read the detailed description
Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.
- Conditions
- Rabies
- Being tested
- Blood drawn after rabies vaccine booster vaccination
- Keywords
- rabies vaccination
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawn after rabies vaccine booster vaccinationBiological
All participants would be given one dose of rabies vaccine and monitor the immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cells, cytokines i.e., IL-10, TGF-Beta, and Rabies neutralizing antibody titers, before and after the booster injection
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Persons who had received primary immunization Receives: Biological: Blood drawn after rabies vaccine booster vaccination |
| Study group | Experimental | Persons who had received primary immunization and later received booster vaccination for at least 3 times Receives: Biological: Blood drawn after rabies vaccine booster vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies specific regulatory T cells
Rabies specific regulatory T cells are measured by flow cytometry method
Measured: Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Rabies specific regulatory B cells
Rabies specific regulatory B cells are measured by flow cytometry method
Measured: Change from baseline of numbers of Rabies specific regulatory B cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Rabies specific T follicular helper cells
Rabies specific T follicular helper cells are measured by flow cytometry method
Measured: Change from baseline of numbers of Rabies specific T follicular helper cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Secondary outcomes (1)
Rabies Neutralizing Antibody Titers (RNab)
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
Measured: before (baseline) and one month after receipt of rabies booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start4 Jun 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There would be two study groups. Those who had received primary immunization would be the control group. While persons who had received primary immunization and later received booster vaccination for at least 3 times would be the study group. All participants would be given one dose of rabies vaccine and monitored the immunological cells and cytokines before and after the rabies booster injection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT03729102
- Sponsor's protocol ID
- QSMI-IRB 2/2018
- Status last verified
- Apr 2022
- First submitted
- 30 Oct 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Immunological Tolerance After Frequent Rabies Booster Vaccinations
- ClinicalTrials.gov ID
- NCT03729102
- Acronym / sponsor ID
- QSMI-IRB 2/2018
- Conditions
- Rabies
- Keywords
- rabies vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Nov 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.
To study immunological tolerance effect after frequent rabies booster vaccination
Detailed description
Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There would be two study groups. Those who had received primary immunization would be the control group. While persons who had received primary immunization and later received booster vaccination for at least 3 times would be the study group. All participants would be given one dose of rabies vaccine and monitored the immunological cells and cytokines before and after the rabies booster injection.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Biological: Blood drawn after rabies vaccine booster vaccinationPersons who had received primary immunization |
| Study group | Experimental | Biological: Blood drawn after rabies vaccine booster vaccinationPersons who had received primary immunization and later received booster vaccination for at least 3 times |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults
- Previously received rabies vaccination
Key exclusion criteria (3 listed)
- Had immunocompromised conditions
- 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 |
|---|---|---|
| Blood drawn after rabies vaccine booster vaccinationAll participants would be given one dose of rabies vaccine and monitor the immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cells, cytokines i.e., IL-10, TGF-Beta, and Rabies neutralizing antibody titers, before and after the booster injection | Biological | Control group, Study group |
Primary outcome
Rabies specific regulatory T cells
Time frame: Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Rabies specific regulatory T cells are measured by flow cytometry method
Rabies specific regulatory B cells
Time frame: Change from baseline of numbers of Rabies specific regulatory B cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Rabies specific regulatory B cells are measured by flow cytometry method
Rabies specific T follicular helper cells
Time frame: Change from baseline of numbers of Rabies specific T follicular helper cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Rabies specific T follicular helper cells are measured by flow cytometry method
1 secondary outcome
Rabies Neutralizing Antibody Titers (RNab)
Time frame: before (baseline) and one month after receipt of rabies booster vaccination
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: No
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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 Blood drawn after rabies vaccine booster vaccination 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 2 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: 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 specific regulatory T cells (time frame: Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms). 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 29 Apr 2022.