RabiesPhase 2NCT07055880
Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)
A Phase 2 study testing Rabies Vaccine (Serum-free Vero Cell), Freeze-dried and Verorab® in people with Rabies, run by Sinovac Biotech Co., Ltd at 1 site in Pakistan.
Trial summary
To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Rabies Vaccine (Serum-free Vero Cell), Freeze-dried and Verorab®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jul 2025to 15 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Populations aged 18~59 years old;
- Participants are able to understand and sign the informed consent form (ICF) voluntarily;
- Participants are able to comply with the study procedures based on the investigator's assessment;
- In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);
- Participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);
- Female participants of childbearing potential were tested negative for urine pregnancy test pre-vaccination, and also need to have effective contraceptive measures in the previous 2 weeks pre-vaccination;
- Participants of childbearing potential and their partners are willing to take effective contraceptive measures and have no sperm or ovum donation plan from the time of signing ICF to 28 days after the last dose of vaccination;
- Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period.
Who cannot join
- Fever on vaccination day, with axillary temperature >37.0°C pre-vaccination;
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
- Previous administration with rabies immunoglobulins or monoclonal antibodies;
- Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
- Female participants who are currently lactating or pregnant;
- Known serious allergy to vaccines or vaccine ingredients, such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, or known other serious adverse reactions to vaccine;
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- With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;
- With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- With poor controlled chronic illnesses or history of severe diseases, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, a history of major organ transplantation, drug-uncontrolled hypertension (with systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), or any other disease or medical condition that the investigator believes could interfere with the trial results;
- With current or past history of severe neurological diseases (epilepsy, convulsions or seizures [excluding history of febrile seizures]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
- With coagulation disorders (eg. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
- Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment in this study;
- With long-term alcohol abuse [>14 drinks per week (1 drink =14 g 100% alcohol =360 mL beer, or 150 mL wine, or 45 mL distilled liquor/liquor)] or substance abuse (repeated and heavy use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.)
- Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the study;
- Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
- Currently participating in other vaccine or drug clinical trials, or plan to participate in other clinical trials during the study;
- Receipt of live-attenuated vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
- Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended vaccination site that may interfere with drug administration or observation of local reactions;
- Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
- Any other factors considered by the investigator to make the participant unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
The Aga Khan University
Karachi
Ali Faisal Saleem, +92 21 34864718, ali.saleem@aku.edu
Nosheen Nasir, +92 21 34864595, nosheen.nasir@aku.edu
About this study
Official title: Immunogenicity and Safety of Two Dosages of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Simulated Post-exposure Prophylaxis Regimen in Healthy Adults: A Randomized, Double-Blind, Active-controlled Phase Ⅱ Clinical Trial
To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.
Read the detailed description
This is a Phase Ⅱ, randomized, double-blind, active-controlled, dose-finding study. A total of 120 healthy participants aged 18~59 years old will be enrolled. All participants will be randomized at a 1:1:1 ratio to three armes, which receive low-dosage Sinovac rabies vaccine, high-dosage Sinovac rabies vaccine or Sanofi Pasteur Verorab®, in an Essen schedule of 5 doses at D0, 3, 7, 14, 28 through intramuscular route (IM) as a simulated rabies PEP.
Blood samples for immunogenicity assessment will be collected at D0, D14, D28, and D42. For safety assessment, the solicited local and systemic AEs within 7 days after each-dose vaccination (If the vaccination interval is less than 7 days, the actual interval shall prevail), as well as unsolicited AEs from the first-dose vaccination until 28 days after the last-dose vaccination will be actively monitored. SAEs will also be collected during the whole study period.
- Conditions
- Rabies
- Being tested
- Rabies Vaccine (Serum-free Vero Cell), Freeze-dried, Verorab®
- Keywords
- rabies vaccine, Serum-free
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabies Vaccine (Serum-free Vero Cell), Freeze-driedBiological
Receiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule
Verorab®Biological
Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule
| Study group | Role | What they receive |
|---|---|---|
| Sinovac rabies vaccine | Experimental | Participants will be randomly assigned to receive either low-dose or high-dose Sinovac rabies vaccine. Receives: Biological: Rabies Vaccine (Serum-free Vero Cell), Freeze-dried |
| Sanofi Pasteur Verorab® | Active comparator | Participants will be randomly assigned to receive the marketed rabies vaccine Verorab® Receives: Biological: Verorab® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Measured: Day 14, Day 28 and Day 42 after the first dose vaccination
Secondary outcomes (2)
GMCs of RVNA titers
Measured: Day 14, Day 28 and Day 42 after the first dose vaccination
Incidence of adverse reactions
Measured: Up to 28 days after the last-dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start28 Jul 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (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.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Faisal Saleem, Principal investigator, Vice Chair, Department of Pediatrics and Child Health, The Aga Khan University, Karachi, PakistanNosheen Nasir, Dr., Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055880
- Sponsor's protocol ID
- PRO-PVRV-sf-2001
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Two Dosages of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Simulated Post-exposure Prophylaxis Regimen in Healthy Adults: A Randomized, Double-Blind, Active-controlled Phase Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT07055880
- Acronym / sponsor ID
- PRO-PVRV-sf-2001
- Conditions
- Rabies
- Keywords
- rabies vaccine, Serum-free
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 9 Jul 2025 (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.
To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.
Detailed description
This is a Phase Ⅱ, randomized, double-blind, active-controlled, dose-finding study. A total of 120 healthy participants aged 18~59 years old will be enrolled. All participants will be randomized at a 1:1:1 ratio to three armes, which receive low-dosage Sinovac rabies vaccine, high-dosage Sinovac rabies vaccine or Sanofi Pasteur Verorab®, in an Essen schedule of 5 doses at D0, 3, 7, 14, 28 through intramuscular route (IM) as a simulated rabies PEP.
Blood samples for immunogenicity assessment will be collected at D0, D14, D28, and D42. For safety assessment, the solicited local and systemic AEs within 7 days after each-dose vaccination (If the vaccination interval is less than 7 days, the actual interval shall prevail), as well as unsolicited AEs from the first-dose vaccination until 28 days after the last-dose vaccination will be actively monitored. SAEs will also be collected during the whole study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinovac rabies vaccine | Experimental | Biological: Rabies Vaccine (Serum-free Vero Cell), Freeze-driedParticipants will be randomly assigned to receive either low-dose or high-dose Sinovac rabies vaccine. |
| Sanofi Pasteur Verorab® | Active comparator | Biological: Verorab®Participants will be randomly assigned to receive the marketed rabies vaccine Verorab® |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Populations aged 18~59 years old;
- Participants are able to understand and sign the informed consent form (ICF) voluntarily;
- Participants are able to comply with the study procedures based on the investigator's assessment;
- In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);
- Participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);
Key exclusion criteria (20 listed)
- Fever on vaccination day, with axillary temperature >37.0°C pre-vaccination;
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
- Previous administration with rabies immunoglobulins or monoclonal antibodies;
- Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
- Female participants who are currently lactating or pregnant;
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 Vaccine (Serum-free Vero Cell), Freeze-driedReceiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule | Biological | Sinovac rabies vaccine |
| Verorab®Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule | Biological | Sanofi Pasteur Verorab® |
Primary outcome
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Time frame: Day 14, Day 28 and Day 42 after the first dose vaccination
2 secondary outcomes
GMCs of RVNA titers
Time frame: Day 14, Day 28 and Day 42 after the first dose vaccination
Incidence of adverse reactions
Time frame: Up to 28 days after the last-dose vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Ali Faisal Saleem principal investigator
Vice Chair, Department of Pediatrics and Child Health, The Aga Khan University, Karachi, Pakistan
Nosheen Nasir, Dr. principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rabies Vaccine (Serum-free Vero Cell), Freeze-dried and Verorab® in people with Rabies, run by Sinovac Biotech Co., Ltd at 1 site in Pakistan.
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 8 inclusion and 20 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Faisal Saleem, Dr. (+92 21 34864718, ali.saleem@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL (time frame: Day 14, Day 28 and Day 42 after the first dose vaccination). 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 9 Jul 2025.