RabiesPhase 4NCT01137045
Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG
A Phase 4 study testing SPEEDA and TRCS SPEEDA in people with Rabies, run by Queen Saovabha Memorial Institute at 2 sites in Thailand.
Trial summary
A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- SPEEDA and TRCS SPEEDA
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesThailand
- Study dates
- Jun 2010to Apr 2018
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- subjects are healthy population older than 15 years.
- subjects are willing to give signed informed consents.
- subjects are willing to give blood samples on recommended days.
- subjects are available for follow up according to the table of administration
Who cannot join
- subjects who had received any type of rabies vaccination in the past
- subjects who had received rabies immunoglobulin in the past
- subjects who had known as immunocompromised hosts
- subjects on steroids or any other immunosuppressant
- subjects on concomitant antimalarials
- subjects who have received of any blood products within the previous 3 months
- subjects with history of allergy to any ingredient of the vaccine
- subjects who had known as pregnancy in first recruitment
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Suda Sibunruang
Bangkok, 10130
Queen Saovabha Memorial Institute
Bangkok, 10330
About this study
Official title: An Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine(SPEEDA/TRCS SPEEDA) and Rabies Immunoglobulin
A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Read the detailed description
Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
- Conditions
- Rabies
- Being tested
- SPEEDA and TRCS SPEEDA
- Keywords
- rabies vaccine, vero cells, serology, safety
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPEEDA and TRCS SPEEDABiological
Also called SPEEDA, TRCS SPEEDA
For modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28.
For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28.
For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI
| Study group | Role | What they receive |
|---|---|---|
| SPEEDA with modified TRC-ID regimen | Active comparator | 35 healthy volunteers Receives: Biological: SPEEDA and TRCS SPEEDA |
| VERORAB with modified TRC-ID regimen | Active comparator | 35 healthy volunteers Receives: Biological: SPEEDA and TRCS SPEEDA |
| SPEEDA with modified TRC-ID regimen plus ERIG | Active comparator | 35 healthy volunteers Receives: Biological: SPEEDA and TRCS SPEEDA |
| VERORAB with modified TRC-ID regimen plus ERIG | Active comparator | 35 WHO category III patients Receives: Biological: SPEEDA and TRCS SPEEDA |
| SPEEDA with ESSEN IM regimen plus ERIG | Active comparator | 35 healthy volunteers Receives: Biological: SPEEDA and TRCS SPEEDA |
| TRCS SPEEDA with modified TRC-ID regimen plus ERIG | Active comparator | 35 healthy volunteers Receives: Biological: SPEEDA and TRCS SPEEDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)
The immunogenicity (Rabies neutralizing antibodies) would be checked from the blood samples for 7 times (on days 0,7,14,28,90,180 and 360)for one year duration in each phase.
Measured: 32 months
Secondary outcomes (1)
safety
This would based on general examination, local examination and subjective evaluation of both solicited and unsolicited adverse events.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2018
- Study completionApr 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 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
- Terapong Tantawichien, MD.,Prof, Principal investigator, Queen Saovabha Memorial Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137045
- Sponsor's protocol ID
- RC5301
- Status last verified
- Apr 2018
- First submitted
- 3 Jun 2010
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine(SPEEDA/TRCS SPEEDA) and Rabies Immunoglobulin
- ClinicalTrials.gov ID
- NCT01137045
- Acronym / sponsor ID
- RC5301
- Conditions
- Rabies
- Keywords
- rabies vaccine, vero cells, serology, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 4 Jun 2010 (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 comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Detailed description
Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and proven to be immunogenic and effective. It represents a significant saving in vaccine cost and is now established in several developing countries. SPEEDA,chromatography purified vero cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SPEEDA with modified TRC-ID regimen | Active comparator | Biological: SPEEDA and TRCS SPEEDA35 healthy volunteers |
| VERORAB with modified TRC-ID regimen | Active comparator | Biological: SPEEDA and TRCS SPEEDA35 healthy volunteers |
| SPEEDA with modified TRC-ID regimen plus ERIG | Active comparator | Biological: SPEEDA and TRCS SPEEDA35 healthy volunteers |
| VERORAB with modified TRC-ID regimen plus ERIG | Active comparator | Biological: SPEEDA and TRCS SPEEDA35 WHO category III patients |
| SPEEDA with ESSEN IM regimen plus ERIG | Active comparator | Biological: SPEEDA and TRCS SPEEDA35 healthy volunteers |
| TRCS SPEEDA with modified TRC-ID regimen plus ERIG | Active comparator | Biological: SPEEDA and TRCS SPEEDA35 healthy volunteers |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- subjects are healthy population older than 15 years.
- subjects are willing to give signed informed consents.
- subjects are willing to give blood samples on recommended days.
- subjects are available for follow up according to the table of administration
Key exclusion criteria (8 listed)
- subjects who had received any type of rabies vaccination in the past
- subjects who had received rabies immunoglobulin in the past
- subjects who had known as immunocompromised hosts
- subjects on steroids or any other immunosuppressant
- subjects on concomitant antimalarials
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 |
|---|---|---|
| SPEEDA and TRCS SPEEDAAlso: SPEEDA, TRCS SPEEDAFor modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28. For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28. For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI | Biological | SPEEDA with ESSEN IM regimen plus ERIG, SPEEDA with modified TRC-ID regimen, SPEEDA with modified TRC-ID regimen plus ERIG, TRCS SPEEDA with modified TRC-ID regimen plus ERIG, VERORAB with modified TRC-ID regimen, VERORAB with modified TRC-ID regimen plus ERIG |
Primary outcome
immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)
Time frame: 32 months
The immunogenicity (Rabies neutralizing antibodies) would be checked from the blood samples for 7 times (on days 0,7,14,28,90,180 and 360)for one year duration in each phase.
1 secondary outcome
safety
Time frame: 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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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.
Terapong Tantawichien, MD.,Prof principal investigator
Queen Saovabha Memorial Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SPEEDA and TRCS SPEEDA in people with Rabies, run by Queen Saovabha Memorial Institute at 2 sites 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 4 inclusion and 8 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
immunogenicity (the level of rabies neutralizing antibodies by RFFIT test) (time frame: 32 months). 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 6 Apr 2018.