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Not yet recruitingNCT07055295Updated Jul 8, 2025

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

A Phase 3 interventional study of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried and Verorab® in Rabies, 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 2025-07-08.

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 pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PrEP 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 a three doses of PrEP schedule at Day 0, Day 7 and Day 28 through intramuscular route (IM) that covers a two doses of IM PrEP schedule at Day 0, Day 7 as well.

Blood samples for immunogenicity assessment will be collected at Day 0, Day 28, and Day 42. For immunogenicity assessment, the blood sample at Day 28 will be used for the two-doses IM PrEP schedule, and the blood sample at Day 42 will be used for the three-doses IM PrEP schedule, in comparison with the active-control vaccine Verorab®.

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

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Keywords

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

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

This study's planned enrollment of 390 is above the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Populations aged ≥1 years old;
  2. Participants and/or participants' parents/legal guardians are able to understand and sign the 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 , Syphilis, , infection at the screening of this study (the test result should be provided)
  6. Female participants aged ≥15 years old with were tested negative for urine pregnancy test pre-vaccination, and also need to have effective 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 ≥5years 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 diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and 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, , 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, disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
  12. Receipt of ≥14 days of 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 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 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
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

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 (Serum-free Vero Cell), Freeze-dried

  • Active comparator
    Sanofi Pasteur Verorab®

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

    Biological: Verorab®

Interventions

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

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

  • BiologicalVerorab®

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

06

What researchers measure

Primary outcomes

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

    Time frame: Day 42 after the first dose of vaccination

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

    Time frame: Day 28 after the first dose of vaccination

Secondary outcomes

  1. GMCs of RVNA titers

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

  2. Incidence of adverse reactions

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

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07055295
Responsible party
Sponsor
First posted
Jul 8, 2025
Start date
Mar 1, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 8, 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 ↗

Not currently enrolling

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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