RabiesNCT03228069
Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults
A study testing Blood drawn after rabies booster vaccination in people with Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rabies
- What is being tested?
- Blood drawn after rabies booster vaccination
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2017to 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy HIV-infected adults
- Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.
Who cannot join
- Have any active opportunistic infections
- Received blood or blood product within 3 months
- Received anti-malarial drugs
- Received rabies vaccination in a previous year.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Queen Saovabha Memorial Institute
Bangkok, 10330
Suda Sibunruang, MD, +66 2 2520161 ext. 125, sudapunrin@gmail.com
Terapong Tantawichien, MD, +66 2 2520161 ext. 132, terapong_tantawichien@hotmail.com
About this study
Official title: Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before
Read the detailed description
Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .
- Conditions
- Rabies
- Being tested
- Blood drawn after rabies 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 booster vaccinationProcedure or surgery
Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.
| Study group | Role | What they receive |
|---|---|---|
| single visit 4-site ID vaccination | Experimental | Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial. Receives: Procedure: Blood drawn after rabies booster vaccination |
| Conventional IM vaccination | Active comparator | Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial. Receives: Procedure: Blood drawn after rabies booster vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies Neutralizing Antibody Titers (RNab)
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
Measured: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Secondary outcomes (1)
Rabies specific T cell response
Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)
Measured: Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Aug 2017
- 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
- The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT03228069
- Sponsor's protocol ID
- 1/2017
- Status last verified
- Apr 2022
- First submitted
- 14 Jul 2017
- 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
- Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
- ClinicalTrials.gov ID
- NCT03228069
- Acronym / sponsor ID
- 1/2017
- Conditions
- Rabies
- Keywords
- rabies vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Jul 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.
To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before
Detailed description
Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.
| Arm | Type | Receives |
|---|---|---|
| single visit 4-site ID vaccination | Experimental | Procedure: Blood drawn after rabies booster vaccinationBlood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial. |
| Conventional IM vaccination | Active comparator | Procedure: Blood drawn after rabies booster vaccinationBlood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy HIV-infected adults
- Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.
Key exclusion criteria (4 listed)
- Have any active opportunistic infections
- Received blood or blood product within 3 months
- Received anti-malarial drugs
- Received rabies vaccination in a previous year.
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 booster vaccinationBlood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before. | Procedure or surgery | Conventional IM vaccination, single visit 4-site ID vaccination |
Primary outcome
Rabies Neutralizing Antibody Titers (RNab)
Time frame: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
1 secondary outcome
Rabies specific T cell response
Time frame: Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
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 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 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 (RNab) (time frame: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.). 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.