Vaccine ReactionPhase 3NCT06066294
A Comparison of Safety and Immunogenicity of Rabies Pre Exposure Prophylaxis Regimen Between Gvt of India Approved and WHO Approved.
A Phase 3 study testing Regimen 1 and Regimen 2 in people with Vaccine Reaction, run by Kempegowda Institute of Medical Sciences, Bangalore at 1 site in India.
Trial summary
The goal of this clinical trial is to compare WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 and Government of India currently recommended PrEP Schedule, 0.1ml 3 doses on day 0, day 7 and day 28 in Healthy subjects above 18years of age, willing to volunteer and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- Regimen 1 and Regimen 2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIndia
- Study dates
- 3 Apr 2023to 9 Jan 2025
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects willing to volunteer and sign written informed consent for the study.
- Subjects should be available for the follow-up period.
Who cannot join
- Received Anti rabies vaccine or RIG or RMAb anytime in the past.
- Participation in any other clinical trial in the past three months.
- Severely immunocompromised subjects, pregnant and lactating women.
- Subjects with known history of allergy.
Trial locations and contacts
1 site in 1 country.
India1 site
Kempegowda Institute Of Medical Sciences Hospital and Research Center
Bengaluru, Karnataka, 560002
About this study
Official title: A Randomized Controlled Trial on Safety and Immunogenicity of Purified Verocell Rabies Vaccine as Pre-exposure Prophylaxis Via Intradermal Two Visits (2-0-2-0-0) Verses Three Visits (1-0-1-0-1) Regimen on Healthy Volunteers
The goal of this clinical trial is to compare WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 and Government of India currently recommended PrEP Schedule, 0.1ml 3 doses on day 0, day 7 and day 28 in Healthy subjects above 18years of age, willing to volunteer and sign written informed consent for the study. The main questions it aims to answer are:
- To assess the seroconversion (? 0.5 IU/mL) of the study subjects following primary \& boosting vaccination on Day 35 ,Day 365, Day 372/375.
- To assess the incidence of adverse events(immediate/delayed, local/systemic) among subjects.
Read more
Participants will be administerd with WHO Pre-qualified rabies vaccine (Rabivax-S) .
Researchers will compare the two regimens mentioned above.
Read the detailed description
The study will be conducted among healthy adult volunteers visiting the Anti Rabies Clinic, Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital\& Research Centre, Bangalore and visits to other institutes/places in bangalore.
Step-1: Selection of Volunteers: The healthy volunteers who agreed to participate in the study will be screened for the inclusion and exclusion criteria and subsequently explained regarding the vaccination regimen, benefits due to vaccine and informed consent will be taken. The selected volunteers will be randomized into two groups-study and control group.
Step-2: Collection of Data: A pre tested semi structured questionnaire will be used for collection of data about Socio demographic profile and other related variables.
Step-3: Vaccination of Volunteers: The volunteers will be given WHO Pre-qualified rabies vaccine (Rabivax-S, purchased from open market) 0.1ml each in 2 sites on Day 0 \& 7 intradermal for the study group and 0.1 ml of rabies vaccine at 1 site intradermal route on Day 0, 7 \& 28 for the control group. Later, in each group, 50% of the subjects will be provided a booster dose of vaccine i.e. 0.1 ml, one site on day 365(one visit); for another 50 % of the subjects, booster dose of vaccine i.e. 0.1 ml, one site on days 365 and 368(two visits).
Step 4: Safety evaluation: After each vaccination dose, subject will be observed for an hour, to find out any adverse drug reactions (ADRs) and then, a follow-up card will be given to enter any ADRs during the entire period of vaccination and one week after the last dose. All the reported ADRs will be recorded and analysed. The adverse events will be classified according to the revised adverse events following immunization (AEFI) guidelines.12 Step 5: Collection of Sample and immunogenicity analysis: 5ml of venous blood will be collected from the ante-cubital vein on day-0 (before vaccination), day-35 (after last dose of vaccination) and day 365. For subjects who have received 0.1 ml booster dose on day 365, 5ml blood sample will be collected on day 372 and for those subjects, who have received 0.1ml booster dose on day 365 and 368, 5ml blood sample will be collected on day 375 to estimate rabies virus neutralizing antibody(RVNA) titres. The samples collected from the volunteers are centrifuged, serum separated and stored in -200 Centigrade at the Anti Rabies Clinic, Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital\& Research Centre, Bangalore. The serum will be transported in cold chain to the Department of Neurovirology, National Institute of Mental Health and Neuro Sciences, Bangalore which is the WHO collaborating centre for reference and research on rabies, where the Rapid fluorescent focus inhibition test (RFFIT) is done to estimate RVNA titres. The results obtained from RFFIT will be shared to the volunteers. Information regarding next dose and sample collection will be given to the subjects.
- Conditions
- Vaccine Reaction
- Being tested
- Regimen 1, Regimen 2
- Keywords
- Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regimen 1Biological
WHO Pre-qualified rabies vaccine (Rabivax-S), WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7
Regimen 2Biological
WHO Pre-qualified rabies vaccine (Rabivax-S), Government of India approved vaccination schedule, 3 visits, 0.1ml 1 site on day 0, 7 and 28
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Experimental | WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 Receives: Biological: Regimen 1 |
| Regimen 2 | Active comparator | Government of India currently recommended PrEP Schedule, 0.1ml 3 visits, on day 0, day 7 and day 28 Receives: Biological: Regimen 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the seroconversion (>0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375.
5ml of venous blood will be collected from the ante-cubital vein on day-0 (before vaccination), day-35 and day 365. For subjects who have received 0.1 ml booster dose on day 365, 5ml blood sample will be collected on day 372 and for those subjects, who have received 0.1ml booster dose on day 365 and 368, 5ml blood sample will be collected on day 375 to estimate rabies virus neutralizing antibody(RVNA) titres. The Rapid fluorescent focus inhibition test (RFFIT) is done at the Department of Neurovirology, National Institute of Mental Health and Neuro Sciences, Bangalore which is the WHO collaborating centre for reference and research on rabies, to estimate RVNA titres. The results obtained from RFFIT will be shared to the volunteers.
Measured: Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start3 Apr 2023
- Primary completion24 Mar 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kempegowda Institute of Medical Sciences, Bangalore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. N.R. Ramesh Masthi, Kempegowda Institute of Medical Sciences, Bangalore
- Investigators
- Deekshith J Reddy, MBBS, Principal investigator, Kempegowda Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066294
- Sponsor's protocol ID
- KIMSCM01
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Safety and Immunogenicity of Purified Verocell Rabies Vaccine as Pre-exposure Prophylaxis Via Intradermal Two Visits (2-0-2-0-0) Verses Three Visits (1-0-1-0-1) Regimen on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06066294
- Acronym / sponsor ID
- KIMSCM01
- Conditions
- Vaccine Reaction
- Keywords
- Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Kempegowda Institute of Medical Sciences, BangaloreOther government
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 24 Mar 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 4 Oct 2023 (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.
The goal of this clinical trial is to compare WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 and Government of India currently recommended PrEP Schedule, 0.1ml 3 doses on day 0, day 7 and day 28 in Healthy subjects above 18years of age, willing to volunteer and sign written informed consent for the study. The main questions it aims to answer are:
- To assess the seroconversion (? 0.5 IU/mL) of the study subjects following primary \& boosting vaccination on Day 35 ,Day 365, Day 372/375.
- To assess the incidence of adverse events(immediate/delayed, local/systemic) among subjects.
Participants will be administerd with WHO Pre-qualified rabies vaccine (Rabivax-S) .
Researchers will compare the two regimens mentioned above.
Detailed description
The study will be conducted among healthy adult volunteers visiting the Anti Rabies Clinic, Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital\& Research Centre, Bangalore and visits to other institutes/places in bangalore.
Step-1: Selection of Volunteers: The healthy volunteers who agreed to participate in the study will be screened for the inclusion and exclusion criteria and subsequently explained regarding the vaccination regimen, benefits due to vaccine and informed consent will be taken. The selected volunteers will be randomized into two groups-study and control group.
Step-2: Collection of Data: A pre tested semi structured questionnaire will be used for collection of data about Socio demographic profile and other related variables.
Step-3: Vaccination of Volunteers: The volunteers will be given WHO Pre-qualified rabies vaccine (Rabivax-S, purchased from open market) 0.1ml each in 2 sites on Day 0 \& 7 intradermal for the study group and 0.1 ml of rabies vaccine at 1 site intradermal route on Day 0, 7 \& 28 for the control group. Later, in each group, 50% of the subjects will be provided a booster dose of vaccine i.e. 0.1 ml, one site on day 365(one visit); for another 50 % of the subjects, booster dose of vaccine i.e. 0.1 ml, one site on days 365 and 368(two visits).
Step 4: Safety evaluation: After each vaccination dose, subject will be observed for an hour, to find out any adverse drug reactions (ADRs) and then, a follow-up card will be given to enter any ADRs during the entire period of vaccination and one week after the last dose. All the reported ADRs will be recorded and analysed. The adverse events will be classified according to the revised adverse events following immunization (AEFI) guidelines.12 Step 5: Collection of Sample and immunogenicity analysis: 5ml of venous blood will be collected from the ante-cubital vein on day-0 (before vaccination), day-35 (after last dose of vaccination) and day 365. For subjects who have received 0.1 ml booster dose on day 365, 5ml blood sample will be collected on day 372 and for those subjects, who have received 0.1ml booster dose on day 365 and 368, 5ml blood sample will be collected on day 375 to estimate rabies virus neutralizing antibody(RVNA) titres. The samples collected from the volunteers are centrifuged, serum separated and stored in -200 Centigrade at the Anti Rabies Clinic, Preventive Medicine Unit, Kempegowda Institute of Medical Sciences Hospital\& Research Centre, Bangalore. The serum will be transported in cold chain to the Department of Neurovirology, National Institute of Mental Health and Neuro Sciences, Bangalore which is the WHO collaborating centre for reference and research on rabies, where the Rapid fluorescent focus inhibition test (RFFIT) is done to estimate RVNA titres. The results obtained from RFFIT will be shared to the volunteers. Information regarding next dose and sample collection will be given to the subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Experimental | Biological: Regimen 1WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 |
| Regimen 2 | Active comparator | Biological: Regimen 2Government of India currently recommended PrEP Schedule, 0.1ml 3 visits, on day 0, day 7 and day 28 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects willing to volunteer and sign written informed consent for the study.
- Subjects should be available for the follow-up period.
Key exclusion criteria (4 listed)
- Received Anti rabies vaccine or RIG or RMAb anytime in the past.
- Participation in any other clinical trial in the past three months.
- Severely immunocompromised subjects, pregnant and lactating women.
- Subjects with known history of allergy.
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 |
|---|---|---|
| Regimen 1WHO Pre-qualified rabies vaccine (Rabivax-S), WHO recommended PrEP Vaccination Schedule, 2 visits, 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 | Biological | Regimen 1 |
| Regimen 2WHO Pre-qualified rabies vaccine (Rabivax-S), Government of India approved vaccination schedule, 3 visits, 0.1ml 1 site on day 0, 7 and 28 | Biological | Regimen 2 |
Primary outcome
To assess the seroconversion (>0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375.
Time frame: Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375
5ml of venous blood will be collected from the ante-cubital vein on day-0 (before vaccination), day-35 and day 365. For subjects who have received 0.1 ml booster dose on day 365, 5ml blood sample will be collected on day 372 and for those subjects, who have received 0.1ml booster dose on day 365 and 368, 5ml blood sample will be collected on day 375 to estimate rabies virus neutralizing antibody(RVNA) titres. The Rapid fluorescent focus inhibition test (RFFIT) is done at the Department of Neurovirology, National Institute of Mental Health and Neuro Sciences, Bangalore which is the WHO collaborating centre for reference and research on rabies, to estimate RVNA titres. The results obtained from RFFIT will be shared to the volunteers.
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 7 Aug 2026.
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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.
Deekshith J Reddy, MBBS principal investigator
Kempegowda Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regimen 1 and Regimen 2 in people with Vaccine Reaction, run by Kempegowda Institute of Medical Sciences, Bangalore at 1 site in India.
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 7 Aug 2026. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the seroconversion (>0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375. (time frame: Blood samples will be collected on Day 0, Day 35, Day 365, Day 372 and Day 375). 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 7 Aug 2026.