Non Inferiority TrialPhase 1NCT04715867
Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh
A Phase 1 study testing Rabix-VC in people with Non Inferiority Trial, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies include fever and tingling at the site of exposure, followed by one or more symptoms such as fear of water, violent movements, confusion, uncontrolled excitement, inability to move parts of the body, and loss of consciousness. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Inferiority Trial
- What is being tested?
- Rabix-VC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Males and females of age 18 years to 75 years. 2. Individuals who had given written consent. 3. Individuals in good health and available for all the visits scheduled in the study.
Who cannot join
- 1. Pregnancy or unwillingness to practice acceptable contraception. 2. A history of Rabies vaccination. 3. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
- 4. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
- 5. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination. 6. Individuals who received any other vaccines within 28 days prior to enrolment.
- 7. Clinically Significant abnormalities in screening hematology and serum bio-chemistry, as determined by the study physician.
- 8. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- 9. Any planned surgery during the study period. 10. Subjects who have cancer disorders excluding non-melatonin skin cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of New Rabies Vaccine 'Rabix-VC' on Bangladeshi Healthy Adults
Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies include fever and tingling at the site of exposure, followed by one or more symptoms such as fear of water, violent movements, confusion, uncontrolled excitement, inability to move parts of the body, and loss of consciousness. Once symptoms of the disease develop, rabies is invariably fatal. It is one of the oldest human diseases. It continues to be a major public health problem in developing countries. Rabies is the 10th biggest cause of death due to infectious diseases worldwide. Rabies is endemic in Bangladesh with high public health significance and ranked third highest among rabies-endemic countries for human rabies deaths. In Bangladesh, an estimated 200 000 animal bite cases with more than 2000 human rabies deaths are reported annually. Most importantly, most of the victims are children below 15 years old coming from poor rural communities.
Rabies is a vaccine-preventable viral disease and is highly effective when given pre- or post-exposure to a bite from a potentially rabid animal. Currently there is no locally manufactured Rabies vaccine available in Bangladesh. The results of this study will provide information regarding the immunogenicity and safety of the locally manufactured Rabies vaccine 'Rabix VC' as a test vaccine using 'Rabipur' as a comparator vaccine in a non inferiority study design.
Read the detailed description
This will be a randomized, controlled, double-blind, parallel design, comparative, non-inferiority study on a total of 440 healthy adult participants (18-75 years of age). Participants who will be eligible for the study, will be invited to participate in the study. The study will be conducted in four groups. In One Comparator group, 110 participants will receive Rabipur through Intramuscular Route, in Test group, 110 participants will receive Rabix VC through Intramuscular Route. In another Comparator group, 110 participants will receive Rabipur through Intradermal Route and Test group, 110 participants will receive Rabix VC through Intradermal Route. Total 220 participants will receive Rabix VC (Test Group) and 220 participants will receive Rabipur (Comparator Group), 1.0 ml through Intramuscular Route and 0.2 ml through Intradermal Route, (0.1 ml each arm) respectively.
Informed consent will be obtained from the participants. Only participants who give voluntary consent will be enrolled in the study. The potential risk and the procedures to be carried out are mentioned in the consent form. Compensation will include transportation costs for the participants. Participants only can decide whether they will participate in the study. They will also be able to withdraw their name from the study at any time, without giving any explanation, and will be able to refuse collection of any or all laboratory samples for the study.
Participants may not directly benefit from participating in the study; however, results obtained from this study will be useful in understanding of potential antigenic components for designing an effective Shigella vaccine and may thus benefit the society. The whole study period for each individual will be 90 days. Specimen collection and interview will be carried out 9-10 (maximum) times including enrollment and it will take around 30 minutes per visit.
After taking consent from participants, they will be asked to do the following: Blood (10-12 ml for adults) specimens will be collected at screening (day -7 to -2), day 14 and day 30 or day 44. For Intramuscular group vaccination schedule will be on day 0, day 7, day 21 and day 0, day 3, day 7, day 28 for intradermal group. Also, there will be additional follow up on day 60 and final visit on day 90.
- Conditions
- Non Inferiority Trial
- Being tested
- Rabix-VC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabix-VCDrug
Also called Rabipur
Rabix-VC will be locally manufactured by Incepta Vaccine Ltd
| Study group | Role | What they receive |
|---|---|---|
| Test Group for intramuscular route | Experimental | 110 adult participant will get Ravix-VC Receives: Drug: Rabix-VC |
| Comparator group for intramuscular route | Active comparator | 110 adult participant will get Rabipur Receives: Drug: Rabix-VC |
| Test Group for Intradermal Route | Experimental | 110 adult participant will get Ravix-VC Receives: Drug: Rabix-VC |
| Comparator Group for Intradermal Route | Active comparator | 110 adult participant will get Rabipur Receives: Drug: Rabix-VC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of immunogenicity by Seroconversion
The test vaccine will induce similar seroconversion rates in compare to reference vaccine. This will be done by calculating the responder rate through comparing the pre, day 14 and 30 days of initial post-vaccination Rabies Neutrializing Antibody titres among 'Rabix-VC' or 'Rabipur' vaccinated participants. The non-inferiority margin will be 10 percent. Rabies virus Neutralizing Antibody Titre ≥ 0.5 IU/ml will be logarithmically transformed prior to statistical analyses in order to better approximate normality. Student's t-test will be performed for continuous outcomes. Analysis of covariance may be used to adjust for imbalances in baseline titres. No interim analysis is planned.
Measured: One year
Secondary outcomes (1)
Safety data analysis
- Total number and percentage of immediate reactions (adverse events) reported within 30 minutes after vaccinations.
- Total number and percentage of solicited adverse events (prelisted in the participant's memory aid) occurring up to 7 days following vaccination.
- Total number and percentage of unsolicited AEs up to 90 days after initial vaccination.
- Occurrence of serious adverse events (SAEs) throughout the trial.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Inferiority TrialStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taufiqur Rahman, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715867
- Sponsor's protocol ID
- PR-20117
- Status last verified
- Dec 2021
- First submitted
- 13 Jan 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By publication in the journal
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of New Rabies Vaccine 'Rabix-VC' on Bangladeshi Healthy Adults
- ClinicalTrials.gov ID
- NCT04715867
- Acronym / sponsor ID
- PR-20117
- Conditions
- Non Inferiority Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jan 2021 (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.
Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies include fever and tingling at the site of exposure, followed by one or more symptoms such as fear of water, violent movements, confusion, uncontrolled excitement, inability to move parts of the body, and loss of consciousness. Once symptoms of the disease develop, rabies is invariably fatal. It is one of the oldest human diseases. It continues to be a major public health problem in developing countries. Rabies is the 10th biggest cause of death due to infectious diseases worldwide. Rabies is endemic in Bangladesh with high public health significance and ranked third highest among rabies-endemic countries for human rabies deaths. In Bangladesh, an estimated 200 000 animal bite cases with more than 2000 human rabies deaths are reported annually. Most importantly, most of the victims are children below 15 years old coming from poor rural communities.
Rabies is a vaccine-preventable viral disease and is highly effective when given pre- or post-exposure to a bite from a potentially rabid animal. Currently there is no locally manufactured Rabies vaccine available in Bangladesh. The results of this study will provide information regarding the immunogenicity and safety of the locally manufactured Rabies vaccine 'Rabix VC' as a test vaccine using 'Rabipur' as a comparator vaccine in a non inferiority study design.
Detailed description
This will be a randomized, controlled, double-blind, parallel design, comparative, non-inferiority study on a total of 440 healthy adult participants (18-75 years of age). Participants who will be eligible for the study, will be invited to participate in the study. The study will be conducted in four groups. In One Comparator group, 110 participants will receive Rabipur through Intramuscular Route, in Test group, 110 participants will receive Rabix VC through Intramuscular Route. In another Comparator group, 110 participants will receive Rabipur through Intradermal Route and Test group, 110 participants will receive Rabix VC through Intradermal Route. Total 220 participants will receive Rabix VC (Test Group) and 220 participants will receive Rabipur (Comparator Group), 1.0 ml through Intramuscular Route and 0.2 ml through Intradermal Route, (0.1 ml each arm) respectively.
Informed consent will be obtained from the participants. Only participants who give voluntary consent will be enrolled in the study. The potential risk and the procedures to be carried out are mentioned in the consent form. Compensation will include transportation costs for the participants. Participants only can decide whether they will participate in the study. They will also be able to withdraw their name from the study at any time, without giving any explanation, and will be able to refuse collection of any or all laboratory samples for the study.
Participants may not directly benefit from participating in the study; however, results obtained from this study will be useful in understanding of potential antigenic components for designing an effective Shigella vaccine and may thus benefit the society. The whole study period for each individual will be 90 days. Specimen collection and interview will be carried out 9-10 (maximum) times including enrollment and it will take around 30 minutes per visit.
After taking consent from participants, they will be asked to do the following: Blood (10-12 ml for adults) specimens will be collected at screening (day -7 to -2), day 14 and day 30 or day 44. For Intramuscular group vaccination schedule will be on day 0, day 7, day 21 and day 0, day 3, day 7, day 28 for intradermal group. Also, there will be additional follow up on day 60 and final visit on day 90.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group for intramuscular route | Experimental | Drug: Rabix-VC110 adult participant will get Ravix-VC |
| Comparator group for intramuscular route | Active comparator | Drug: Rabix-VC110 adult participant will get Rabipur |
| Test Group for Intradermal Route | Experimental | Drug: Rabix-VC110 adult participant will get Ravix-VC |
| Comparator Group for Intradermal Route | Active comparator | Drug: Rabix-VC110 adult participant will get Rabipur |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Males and females of age 18 years to 75 years. 2. Individuals who had given written consent. 3. Individuals in good health and available for all the visits scheduled in the study.
Key exclusion criteria (6 listed)
- 1. Pregnancy or unwillingness to practice acceptable contraception. 2. A history of Rabies vaccination. 3. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
- 4. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
- 5. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination. 6. Individuals who received any other vaccines within 28 days prior to enrolment.
- 7. Clinically Significant abnormalities in screening hematology and serum bio-chemistry, as determined by the study physician.
- 8. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
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 |
|---|---|---|
| Rabix-VCAlso: RabipurRabix-VC will be locally manufactured by Incepta Vaccine Ltd | Drug | Comparator Group for Intradermal Route, Comparator group for intramuscular route, Test Group for Intradermal Route, Test Group for intramuscular route |
Primary outcome
Analysis of immunogenicity by Seroconversion
Time frame: One year
The test vaccine will induce similar seroconversion rates in compare to reference vaccine. This will be done by calculating the responder rate through comparing the pre, day 14 and 30 days of initial post-vaccination Rabies Neutrializing Antibody titres among 'Rabix-VC' or 'Rabipur' vaccinated participants. The non-inferiority margin will be 10 percent. Rabies virus Neutralizing Antibody Titre ≥ 0.5 IU/ml will be logarithmically transformed prior to statistical analyses in order to better approximate normality. Student's t-test will be performed for continuous outcomes. Analysis of covariance may be used to adjust for imbalances in baseline titres. No interim analysis is planned.
1 secondary outcome
Safety data analysis
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Yes. By publication in the journal
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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.
Taufiqur Rahman, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rabix-VC in people with Non Inferiority Trial, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 1 inclusion and 6 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 Mar 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 Bangladesh. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Taufiqur Rahman, PhD (880-2-8860523-32 ext. 3444, taufiqur@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of immunogenicity by Seroconversion (time frame: One year). 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 Mar 2022.