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Not yet recruitingNCT07055893Updated Jul 9, 2025

Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen

A Phase 3 interventional study of Rabies vaccine and Verorab® in Rabies (Healthy Volunteers), sponsored by Sinovac Biotech Co., Ltd. Not yet recruiting at 1 site in Pakistan. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
390
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study summary

To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after post-exposure prophylaxis (PEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PEP schedule

Read the detailed description

This is a Phase Ⅲ, randomized, double-blind, active-controlled study. A total of 390 healthy participants aged ≥1 years old will be enrolled. All participants will be randomized at a 2:1 ratio to receive Sinovac rabies vaccine (Trial group) or Sanofi Pasteur Verorab® (Control group), in an Essen schedule of 5 doses at Day 0, Day 3, Day 7, Day 14, Day 28 through intramuscular route (IM) as a simulated rabies PEP.

Blood samples for immunogenicity assessment will be collected at Day 0, Day 14, Day 28, and Day 42. For safety assessment, the solicited local and systemic adverse events (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. Serious adverse events (SAEs) will also be collected during the whole study period.

02

Conditions studied

  • Rabies (Healthy Volunteers)

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Keywords

  • rabies vaccine
  • Serum-free
  • post-exposure prophylaxis
03

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Populations aged ≥1 years old;
  2. Participants and/or participants' parents/legal guardians are able to understand and sign the informed consent form (ICF) voluntarily;
  3. Participants are able to comply with the study procedures based on the investigator's assessment;
  4. 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);
  5. Participants were tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);
  6. Female participants aged ≥15 years old with 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.
  7. 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;
  8. Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period

Exclusion criteria

Exclusion Criteria:

  1. Fever on vaccination day, with axillary temperature >37.0°C (aged ≥5 years old) or >37.3°C (aged 1\~4 years old) pre-vaccination;
  2. Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
  3. Previous administration with rabies immunoglobulins or monoclonal antibodies;
  4. Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
  5. Female participants who are currently lactating or pregnant;
  6. 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;
  7. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;
  8. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
  9. 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 (only for participants aged ≥18 years old: 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;
  10. 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;
  11. With coagulation disorders (eg. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
  12. 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;
  13. 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.)
  14. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the study;
  15. Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
  16. Currently participating in other vaccine or drug clinical trials, or plan to participate in other clinical trials during the study;
  17. Receipt of live-attenuated vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
  18. 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;
  19. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
  20. Any other factors considered by the investigator to make the participant unsuitable for participation in the study
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
390 participants (estimated)

Study arms

  • Experimental
    Sinovac rabies vaccine

    Participants will be randomly assigned to receive Sinovac rabies vaccine.

    Biological: Rabies vaccine

  • Active comparator
    Sanofi Pasteur Verorab®

    Participants will be randomly assigned to receive the marketed rabies vaccine Verorab®

    Biological: Verorab®

Interventions

  • BiologicalRabies vaccine

    Receiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule

  • BiologicalVerorab®

    Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule

05

What researchers measure

Primary outcomes

  1. Proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL

    Time frame: Day 14 and Day 28 after the first dose vaccination

Secondary outcomes

  1. Geometric mean concentrations (GMCs) of RVNA titers

    Time frame: Day 14, Day 28 and Day 42 after the first dose vaccination

  2. Proportion of participants achieving a RVNA titer ≥0.5 IU/mL

    Time frame: Day 42 after the first dose vaccination

  3. Incidence of adverse reactions

    Time frame: Up to 28 days after the last-dose vaccination

06

Study locations

1 site
  • Al-Shifa Trust Eye Hospital
    Rawalpindi, Pakistan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07055893
Lead sponsor
Sinovac Biotech Co., Ltd
Responsible party
Sponsor
First posted
Jul 9, 2025
Start date
Mar 1, 2026 (estimated)
Primary completion
Jan 30, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Jul 9, 2025

Study contacts

Ume Sughra, Dr.
Contact
dr_sughra@yahoo.com
+92 51 5487821-5
Ume Sughra, Dr.
principal investigator · Director Research, Al-Shifa Research Centre; Professor of Public Health, Al-Shifa Trust Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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