HIVNCT01286493
Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination
A study testing rabies vaccines on day 0 and 3 in people with HIV and Rabies, run by Queen Saovabha Memorial Institute at 1 site in Thailand.
Trial summary
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- rabies vaccines on day 0 and 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- HIV infected patients 18-60 years of age
- Ever received primary rabies immunization
Who cannot join
- currently have any active opportunistic infections
- have received blood or blood product within previous 3 months
- history of allergy to vaccine or any vaccine components
- currently received anti-malarial drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.
Read the detailed description
The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.
- Being tested
- rabies vaccines on day 0 and 3
- Keywords
- HIV, booster, rabies, immune response
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabies vaccines on day 0 and 3Biological
All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360
| Study group | Role | What they receive |
|---|---|---|
| Rabies vaccines on day 0 and 3 | Experimental | Cell culture Rabies vaccines on day 0 and 3 Receives: Biological: rabies vaccines on day 0 and 3 |
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(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.
for 7 times in 1 year.
Measured: Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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
- 33 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
- NCT01286493
- Sponsor's protocol ID
- RC5303
- Status last verified
- Oct 2015
- First submitted
- 26 Jan 2011
- Last updated
- 18 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination
- ClinicalTrials.gov ID
- NCT01286493
- Acronym / sponsor ID
- RC5303
- Keywords
- HIV, booster, rabies, immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.
Detailed description
The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rabies vaccines on day 0 and 3 | Experimental | Biological: rabies vaccines on day 0 and 3Cell culture Rabies vaccines on day 0 and 3 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HIV infected patients 18-60 years of age
- Ever received primary rabies immunization
Key exclusion criteria (4 listed)
- currently have any active opportunistic infections
- have received blood or blood product within previous 3 months
- history of allergy to vaccine or any vaccine components
- currently 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 vaccines on day 0 and 3All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360 | Biological | Rabies vaccines on day 0 and 3 |
Primary outcome
Rabies Neutralizing Antibody Titers
Time frame: Day 360
Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- http://www.saovabha.com/th/academic.aspLink provided by the sponsor.
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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 vaccines on day 0 and 3 in people with HIV and 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: finished, as of the sponsor's last update on 18 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: Day 360). 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 18 Nov 2015.