RabiesNCT02547727
Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults
A study testing rabies vaccine in people with Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rabies
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2016to 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
- No healthy volunteers
- Adult
Who may be able to join
- HIV infected patients
- Age 18 - 60 years
- Received primary rabies immunization
Who cannot join
- Have any active opportunistic infections
- Received blood or blood product within 3 months
- Allergy to vaccine or any vaccine components
- 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: Humoral and Cell-mediated Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.
Read the detailed description
A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.
- Conditions
- Rabies
- Being tested
- rabies vaccine
- 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.
rabies vaccineBiological
Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
| Study group | Role | What they receive |
|---|---|---|
| Four-site intradermal vaccination | Experimental | 0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. Receives: Biological: rabies vaccine |
| Intramuscular vaccination | Active comparator | 0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. 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
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
Secondary outcomes (2)
Specific T cell response
Specific T cell response is measured by OX-40 assay
Measured: Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
Cytokines assessment
A few cytokines levels are measured by multiplex bead array assay
Measured: Change from baseline of cytokines levels at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startFeb 2016
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Saovabha Memorial Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University
- Responsible party
- Principal investigator, Suda Sibunruang, Queen Saovabha Memorial Institute
- Investigators
- Suda Sibunruang, MD, Principal investigator, Queen Saovabha Memorial Institute. Faculty of Medicine, Chulalongkorn university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547727
- Sponsor's protocol ID
- 495/2015
- Status last verified
- Apr 2022
- First submitted
- 9 Sep 2015
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 After a Four-site Intradermal Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults
- ClinicalTrials.gov ID
- NCT02547727
- Acronym / sponsor ID
- 495/2015
- 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
- Collaborators
- Chulalongkorn University
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Sep 2015 (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.
A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.
Detailed description
A four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. So, the investigators hypothesized the same outcome in HIV - infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four-site intradermal vaccination | Experimental | Biological: rabies vaccine0.1 ml of rabies vaccine is distributed to 4 sites over both arms and thigh intradermally on day 0. Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. |
| Intramuscular vaccination | Active comparator | Biological: rabies vaccine0.5 ml of rabies vaccine is injected to one arm on day 0 and 3.Blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV infected patients
- Age 18 - 60 years
- Received primary rabies immunization
Key exclusion criteria (4 listed)
- Have any active opportunistic infections
- Received blood or blood product within 3 months
- Allergy to vaccine or any vaccine components
- 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 |
|---|---|---|
| rabies vaccineRabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14. | Biological | Four-site intradermal vaccination, Intramuscular vaccination |
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)
2 secondary outcomes
Specific T cell response
Time frame: Change from baseline of percentages of rabies-antigen specific CD4+ T cells at 2 weeks
Cytokines assessment
Time frame: Change from baseline of cytokines levels at 1 week
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.
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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. Faculty of Medicine, Chulalongkorn university
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 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 81 7366076, 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.