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

NCT07055295 | Not Yet Recruiting Phase 3

• 1 other identifier: PRO-PVRV-sf-3003
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rabies

Keywords

rabies vaccine; Serum-free; pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (2)

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

  Day 42 after the first dose of vaccination

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

  Day 28 after the first dose of vaccination

Secondary Outcomes (2)

• GMCs of RVNA titers

  Day 28 and Day 42 after the first dose of vaccination

• Incidence of adverse reactions

  Up to 28 days after the last-dose vaccination

Study Arms (2)

Sinovac rabies vaccine

EXPERIMENTAL

Participants will be randomly assigned to receive Sinovac rabies vaccine.

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®

Biological: Verorab®

Interventions

Rabies Vaccine (Serum-free Vero Cell), Freeze-dried BIOLOGICAL

Receiving three doses of rabies vaccine rabies vaccine manufactured by Sinovac using a three-dose PrEP schedule

Sinovac rabies vaccine

Verorab® BIOLOGICAL

Receiving three doses of marketed rabies vaccine manufactured by Sanofi using the three-dose PrEP schedule

Sanofi Pasteur Verorab®

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Populations aged ≥1 years old;
• Participants and/or participants' parents/legal guardians 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);
• Participants were tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided)
• 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;
• 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

You may not qualify if:

• Fever on vaccination day, with axillary temperature \>37.0°C (aged ≥5years old) or \>37.3°C (aged 1\~4 years old) 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;
• 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 (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;
• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Al-Shifa Trust Eye Hospital

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines; Freeze Drying

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Ume Sughra, Dr.

  Director Research, Al-Shifa Research Centre; Professor of Public Health, Al-Shifa Trust Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ume Sughra, Dr.

CONTACT

+92 51 5487821-5; dr_sughra@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

PA (1)