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CompletedNCT04644484Updated Apr 21, 2023Results posted

A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety

A Phase 3 interventional study of SYN023 and Human Rabies Immune Globulin (HRIG) in Rabies, Communicable Disease and Virus Diseases, sponsored by Synermore Biologics (Suzhou) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Synermore Biologics (Suzhou) Co., Ltd. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll the World Health Organization (WHO) Category III rabies exposure subjects. The subject's death and rabies data will be reviewed by Data and safety monitoring board (DSMB) to confirm the safety. Besides, rabies vaccine would be administered after Study Drug in each group.

This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in China.

Read the detailed description

This is a Phase 3, randomized, blinded, and active controlled study of SYN023 compared with a China licensed HRIG for PEP of patients who have been confirmed to have met all inclusion/exclusion criteria for their treatment group.

1000 patients aged 18 and above with the World Health Organization (WHO) Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3: 1 through on-site stratification as part of PEP.

All subjects should receive wound infiltration injection of SYN023 or HRIG on Study Day 1 (wound conditions should be described and recorded before injection, including diameter, depth, expansion treatment, etc.), and should also simultaneously receive intramuscular injection of one dose of the freeze-dried rabies vaccine for human use (Vero cells) into the deltoid muscle. In accordance with the Essen Scheme, each subject also needs to receive one dose of the freeze-dried rabies vaccine for human use (Vero cells) on Study Days 4, 8, 15, and 29 respectively.

3.0 mL of venous blood samples should be collected 8 times from each subject prior to administration and on Study Day 4, 8, 15, 43, 99, 183, and 365 post administration of study drug. Relevant information should be collected from the subjects through follow-up visits, such as occurrence of rabies and survival conditions.

RVNA should be assayed through rapid fluorescence focus inhibition test (RFFIT).

Local adverse events related to the SYN023 injection sites and injection sites of the first dose and second dose of rabies vaccine, and systemic adverse events (AE) other than injection sites should be collected within 7 days after administration; local adverse events related to the injection sites of the third dose, fourth dose and fifth dose of rabies vaccine, and systemic adverse events (AE) other than the injection sites should be collected 7 days after administration. In addition, all adverse events occurring within 43 days after administration should be collected, and pregnancy conditions in 6 months after administration and all serious adverse events (SAE) occurring during the study period should be collected.

02

Conditions studied

  • Rabies
  • Communicable Disease
  • Virus Diseases
  • Rhabdoviridae Infections
  • Mononegavirales Infections
  • RNA Virus Infections

Keywords

  • Post-exposure prophylaxis of Rabies
03

In context

Rabies

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

This study's enrollment of 1,000 is above the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Synermore Biologics (Suzhou) Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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. Is age ≥18 years, on Study Day 1 with legal identification documents, and plan to live in the local administration area during the study;
  2. Category III rabies exposure within 24 hours before Study Drug receipt ;
  3. Completed written process, and signed the informed consent forms;
  4. Subjects with the ability to understand the study procedure. And agreed to complete all follow-ups;
  5. Female subjects are not in pregnancy (with negative results of urine pregnancy tests before vaccination) and are not in the period of breast feeding, and agree to avoid pregnancy within 121 days after administration;
  6. Those who have an armpit temperature ≤ 37.0 °C.

Exclusion criteria

Exclusion Criteria:

  1. Previous receipt of equine or human (rabies) globulin or rabies vaccination prior to randomization;
  2. Clinical evidence of rabies infection;
  3. Category I and Category II rabies exposure;
  4. Had fever (armpit temperature ≥ 38.5 °C) within 3 days before Study Day 1, or in the acute episode of any chronic diseases;
  5. Received immunoglobulin or blood products (except for the anti-tetanus immunoglobulin) within 43 days before Study Day 1, or plan to use any such product (except for the anti-tetanus immunoglobulin) during the study;
  6. Received systemic medication such as systemic but not limited to systemic corticosteroids within 43 days before Study Day 1;
  7. History of any immunodeficiency disease (for example: AIDS, systemic lupus erythematosus, etc.); or Laboratory evidence of previous or current immunodeficiency disease, including, but not limited to, any laboratory evidence of infection;
  8. History of spleen function deficiency or function injury, such as no spleen caused by any cause (such as splenectomy);
  9. History of any severe allergy for vaccination, such as systemic urticaria, allergic laryngeal edema, anaphylactoid purpura, local allergic necrosis (Arthus reaction), angioedema, anaphylactic shock, etc., or allergic to any ingredient of the study drug/vaccine;
  10. Previous receipt of any study product (drug, vaccine, biological product or medical device) within 6 months before Study Day 1, or plan to participate in any other clinical study during this study period;
  11. History of or clinical evidence of any systemic disease, acute disease or chronic disease (such as convulsions, epilepsy, encephalopathy, nephrotic syndrome, etc.) that the investigator considers to be likely to interfere with safety or efficacy assessment of the study;
  12. Previous medical history that may compromise the safety of the subject in the study according to the opinion of the principal investigator.
Terms in these criteria, in plain language(4)

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (actual)

Study arms

  • Experimental
    Experimental Group: SYN023+Rabies Vaccine

    SYN023: Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible SYN023 is an equal mass mixture of CTB011 and CTB012, two monoclonal antibodies that exhibit a wide spectrum of activity against various wild-type rabies strains in vitro. Dosage form: 6mg/2mL, liquid; Dosage: 0.3 mg/kg of SYN023; Frequency/duration: at Day 1 Rabies vaccine : Interventions: should be administered in deltoid muscle Dosage form: \>=2.5 IU, freeze-dried vaccine, reconstitute into 0.5 mL before use Dosage: 0.5 mL after reconstitution Frequency/duration: at Day 1, 4, 8, 15, 29

    Biological: SYN023 · Biological: Rabies Vaccine

  • Active comparator
    Control Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine

    Human Rabies Immune Globulin (HRIG): Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible Dosage form: 100 IU/mL, liquid; Dosage: 20 IU/kg; Frequency/duration: at Day 1 Rabies vaccine : Interventions: should be administered in deltoid muscle Dosage form: \>=2.5 IU, freeze-dried vaccine, reconstitute into 0.5 mL before use; Dosage: 0.5 milliliters (mL) after reconstitution; Frequency/duration: at Day 1, 4, 8, 15, 29

    Biological: Human Rabies Immune Globulin (HRIG) · Biological: Rabies Vaccine

Interventions

  • BiologicalSYN023

    The finished product of SYN023 is a mixture of 3.0 mg/mL CTB011 and 3.0 mg/mL CTB012 at a ratio of 1:1. SYN023 is a sterile and preservative-free injection, and the excipient contains 25 mM histidine (3.879 mg/mL), 150 mM sodium chloride (8.766 mg/mL) and 0.02% polysorbate 80 (0.2 mg/mL) and pH of 6.0. Each vial contains 2.15 mL of SYN023, or 6.45 mg of monoclonal antibody. The glass bottle was closed with a 13 mm bromobutyl rubber stopper, a 13 mm aluminum crimping cap and a polypropylene flip-open lid.

    Also known as: A Humanized Anti-Rabies Molecular antibodies cocktails

  • BiologicalHuman Rabies Immune Globulin (HRIG)

    The HRIG is a Chinese licensed Human Rabies Immunoglobulin, which are derived from human plasma, and then purified and filled in the injectable vial form. The HRIG is indicated for the Post-exposure Prophylactic (PEP) of Rabies

  • BiologicalRabies Vaccine

    Interventions: The Chinese licensed rabies vaccine should be administered in deltoid muscle Dosage form: \>=2.5 IU, freeze-dried vaccine, reconstitute into 0.5 milliliters (mL) before use Dosage: 0.5 mL after reconstitution Frequency/duration: at Day 1, 4, 8, 15, 29

    Also known as: Freeze-dried Rabies Vaccine for Human Use (Vero Cells)

06

What researchers measure

Primary outcomes

  1. Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8

    Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).

    Time frame: Day 8

  2. Number of Probable or Confirmed Rabies Cases

    WHO's Classification of Rabies Cases: 1. Suspected case: refers to a case that satisfies the definition of clinical case; 2. Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; 3. Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.

    Time frame: Day 1 to Day 365

Secondary outcomes

  1. Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)

    Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).

    Time frame: Days 4, 15, 43, 99, 183 and 365

  2. Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL

    Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).

    Time frame: Days 4, 8, 15, 43, 99, 183 and 365

  3. Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)

    Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 1 to Day 15 after administration (AUEC1-15)

    Time frame: Day 1 to Day 15

07

Results

Posted Apr 21, 2023

Participant flow

Participant flow — Overall Study
MilestoneExperimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
Started750250
Completed750250
Not completed00

Outcome measures

PrimaryRabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8

Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).

Time frame:
Day 8
Reported as:
Geometric mean · IU/mL
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8
IU/mLExperimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 84.346 (4.111 to 4.595)0.232 (0.198 to 0.271)
PrimaryNumber of Probable or Confirmed Rabies Cases

WHO's Classification of Rabies Cases: 1. Suspected case: refers to a case that satisfies the definition of clinical case; 2. Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; 3. Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.

Time frame:
Day 1 to Day 365
Reported as:
Number · participants
Number of Probable or Confirmed Rabies Cases
participantsExperimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
Number of Probable or Confirmed Rabies Cases00
SecondaryRabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)

Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).

Time frame:
Days 4, 15, 43, 99, 183 and 365
Reported as:
Geometric mean · IU/mL
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
IU/mLExperimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
Day 44.212 (3.962 to 4.479)0.193 (0.172 to 0.216)
Day 1513.590 (12.624 to 14.630)7.651 (6.241 to 9.380)
Day 4313.084 (12.238 to 13.989)16.003 (13.650 to 18.762)
Day 992.023 (1.869 to 2.190)5.108 (4.109 to 6.351)
Day 1830.891 (0.812 to 0.978)3.319 (2.681 to 4.108)
Day 3650.520 (0.473 to 0.572)1.645 (1.343 to 2.014)
SecondaryPercentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL

Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).

Time frame:
Days 4, 8, 15, 43, 99, 183 and 365
Reported as:
Number · percentage of participants(%)
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
percentage of participants(%)Experimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
Day 499.8 (98.906 to 99.995)9.1 (5.178 to 14.551)
Day 899.6 (98.582 to 99.952)17.6 (12.098 to 24.256)
Day 15100 (99.275 to 100)96.4 (92.253 to 98.654)
Day 43100 (98.269 to 100)99.4 (96.670 to 99.985)
Day 9997.8 (96.059 to 98.886)97.5 (93.761 to 99.319)
Day 18372.8 (68.636 to 76.654)95.6 (91.194 to 98.223)
Day 36547.2 (42.678 to 51.766)81.9 (75.018 to 87.513)
SecondaryArea Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)

Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 1 to Day 15 after administration (AUEC1-15)

Time frame:
Day 1 to Day 15
Reported as:
Geometric mean · days *IU/mL
Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)
days *IU/mLExperimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie Vaccine
Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)96.972 (91.955 to 102.263)31.869 (26.563 to 38.233)

Adverse events

Collected over 365 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Group: SYN023+Rabies Vaccine0/750 (0%)41/750 (5.5%)315/750 (42%)
Control Group: HRIG+Rabie Vaccine0/250 (0%)14/250 (5.6%)138/250 (55.2%)
Most frequent serious events
Showing 10 of 83
Most frequent serious events
EventExperimental Group: SYN023+Rabies VaccineControl Group: HRIG+Rabie Vaccine
Infectious pneumonitisInfections and infestations4/7502/250
BronchitisInfections and infestations1/7502/250
Ureteral calculusRenal and urinary disorders4/7500/250
Herpes zosterInfections and infestations2/7501/250
Scrub typhusInfections and infestations0/7501/250
Chronic gastritisGastrointestinal disorders2/7501/250
HemorrhoidsGastrointestinal disorders2/7501/250
Gastric polypsGastrointestinal disorders0/7501/250
Craniocerebral TraumaInjury, poisoning and procedural complications0/7501/250
Skin lacerationInjury, poisoning and procedural complications0/7501/250
Most frequent other events
Showing 10 of 113
Most frequent other events
EventExperimental Group: SYN023+Rabies VaccineControl Group: HRIG+Rabie Vaccine
Administration site swellingGeneral disorders128/75087/250
Administration site painGeneral disorders36/75020/250
Administration site erythemaGeneral disorders32/75015/250
Vaccination site painGeneral disorders27/75012/250
HeadacheNervous system disorders30/75012/250
CoughRespiratory, thoracic and mediastinal disorders23/7508/250
FeverGeneral disorders17/7507/250
Administration site pruritusGeneral disorders7/7506/250
Oropharyngeal painRespiratory, thoracic and mediastinal disorders9/7506/250
Upper respiratory tract infectionInfections and infestations11/7506/250

Baseline characteristics

Age, Continuous
Age, Continuous(years)Experimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie VaccineTotal
Mean43.7 (18 to 79)44.6 (19 to 86)43.9 (18 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)Experimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie VaccineTotal
Female346117463
Male404133537
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie VaccineTotal
Hispanic or Latino000
Not Hispanic or Latino7502501000
Unknown or Not Reported000
BMI
BMI(kg/m^2)Experimental Group: SYN023+Rabies VaccineControl Group: Human Rabies Immune Globulin (HRIG)+Rabie VaccineTotal
Mean23.39 ± 3.48924.12 ± 3.78623.57 ± 3.578
08

Study locations

1 site
  • Yunnan Province Center for Disease Control and Prevention (CDC)
    Kunming, 650022, China
09

References and documents

Publications

  • McClain JB, Chuang A, Reid C, Moore SM, Tsao E. Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial. Vaccine. 2021 Sep 24;39(40):5822-5830. doi: 10.1016/j.vaccine.2021.08.066. Epub 2021 Sep 3. PubMed 34483020 ↗
  • Ding Y, Wu M, Zhang H, Zhu X, Hu Y, Li X, Liu J, Tsao E, Liu M, Li C. Safety, pharmacokinetics and pharmacodynamics of SYN023 alone or in combination with a rabies vaccine: An open, parallel, single dose, phase 1 bridging study in healthy Chinese subjects. Antiviral Res. 2020 Dec;184:104956. doi: 10.1016/j.antiviral.2020.104956. Epub 2020 Oct 19. PubMed 33091433 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Jun 2022, 21 months.

Results were first posted in Apr 2023, 9 months after primary completion.

Of 19 phase 3 interventional studies under Rabies, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's 21 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2020
First posted
Nov 25, 2020
StartActual
Sep 23, 2020
Primary completionActual
Jun 24, 2022
CompletionActual
Dec 16, 2022
Results first posted
Apr 21, 2023
Last update
Apr 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04644484
Lead sponsor
Synermore Biologics (Suzhou) Co., Ltd.
Collaborators
Simoon Record Pharma Information Consulting Co., Ltd.
Responsible party
Sponsor
First posted
Nov 25, 2020
Start date
Sep 23, 2020
Primary completion
Jun 24, 2022
Completion
Dec 16, 2022
Results posted
Apr 21, 2023
Last update
Apr 21, 2023

Study contacts

Xiaoqiang Liu, MD, PhD
principal investigator · Yunnan Province CDC

Oversight

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

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