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Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)

ConditionRabies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorSinovac Biotech Co., Ltd

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Biological/Vaccine

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

  • Verorab®

    Biological/Vaccine

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Sinovac rabies vaccineExperimental treatment 1 intervention
Group B: Sanofi Pasteur Verorab®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

GMCs of RVNA titers

Time frame
Day 14, Day 28 and Day 42 after the first dose vaccination
2

Incidence of adverse reactions

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinovac Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: