Human RabiesPhase 1/2RabiesMabNCT02956746

A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines

A Phase 1/2 study testing SYN023, Imovax and RabAvert in people with Human Rabies, run by Synermore Biologics Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Human Rabies
What is being tested?: SYN023, Imovax and RabAvert
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Jan 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects between 18 and 50 years of age, inclusive
Body mass index between 18 and 30 kg/m², inclusive
Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:
Agree to avoid pregnancy from 28 days prior to Study Day 0 through the duration of the study.
If in a sexual relationship with a man, use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include: the use of at least two forms of contraception, including use by a partner of a barrier method (e.g., male condom with intravaginal spermicide) as one form of contraception.
Women of childbearing potential must have a negative serum pregnancy test within 24 hours preceding receipt of each dose.
Can understand and sign the informed consent document, can communicate with the investigator and provide updated contact information as needed for the duration of the study, has no current plans to move from the study area for the duration of the study, and can understand and comply with the requirements of the protocol.

Who cannot join

Oral temperature ≥37.5°C at screening
Complete blood count (CBC) and platelet count abnormal values (>5% above the upper limit of normal [ULN] or >5% below the lower limit of normal [LLN] per local laboratory parameters) at screening with exception of absolute lymphocyte count.
Abnormally elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase (ALP), or creatinine (Cr) values at screening (however a single test AST, ALT or ALP may be >10% above the ULN per local laboratory parameters)
Abnormal PT (INR) PTT
Abnormal screening urinalysis result that is, per the investigator, clinically significant, or a screening urine dipstick result of ≥2+ protein
Positive screening urine test for illicit drugs (opiates, cocaine, amphetamines methamphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, PCP, MDMA, and methadone)

Show all 18Show fewer

History or evidence of autoimmune disease
History or evidence of any past, present, or future possible immunodeficiency state, including laboratory evidence of human immunodeficiency virus (HIV) 1 or 2 infection
History or evidence of chronic hepatitis
History or evidence of rabies infection
History or evidence of any other acute or chronic disease that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject; for example a clinically relevant history of respiratory, thyroid, gastrointestinal, renal, hepatic, hematological, lymphatic, oncologic, cardiovascular, psychiatric, neurological, musculoskeletal, genitourinary, infective, inflammatory, immunological, dermatological or connective tissue disease
History or evidence of allergic disease or reaction, including adverse responses to therapeutic monoclonal antibodies that, in the opinion of the investigator, may compromise the safety of the subject
History of non-compliance that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol
Previous exposure to rabies vaccine
Receipt of an immunoglobulin or blood product within 90 days prior to Study Day 0
Receipt of immunosuppressive medications other than inhaled or topical immunosuppressant drugs within 45 days prior to Study Day 0
Body weight greater than 90 kg.
History or evidence of IgA deficiency

Trial locations and contacts

1 site in 1 country.

United States1 site

inVentiv Clinical Research Facility, 1951 NW 7th Ave. Suit 450
Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 2 Randomized Blinded Placebo Controlled Comparison of the Safety Pharmacokinetics and Pharmacodynamics of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines in Healthy Adult Subjects

This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi+RIG, RVa+SYN023 and RVa+RIG. The initial dose of RVi and RVa will be co-administered with either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given. The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies will also be measured.

Read the detailed description

Administered immunoglobulins directed against vaccine antigens have the potential to inhibit the immune response to a vaccine. Both vaccination and immune globulin are used together in the post exposure prophylaxis of rabies virus infection. SYN023 (a mixture of two monoclonal antibodies CTB011 and CTB012) may be used instead of human rabies immune globulin. Since there is a risk of antagonism of vaccine induced immunity by SYN023, as there is with rabies immune globulin, it is necessary to study possible interactions of these two agents that might be used concurrently. This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when administered concurrently with rabies immune globulin (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi + RIG, RVa+SYN023 and RVa + RIG. The initial dose of RVi and RVa will be co-administered with either RIG or SYN023). The remaining 4 doses of RVi and RVa will be administered intramuscularly as specified in the product labeling. Serum rabies virus neutralizing activity (RVNA) and serum concentrations of the components of of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given. Adverse events will be collected for the duration of the trial. The study will last 112 days. Anti-SYN023 antibodies will also be measured.

Conditions: Human Rabies
Being tested: SYN023, Imovax, RabAvert, HyperRAB ST (human rabies immune globulin)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYN023Biological
The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
ImovaxBiological
Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvertBiological
Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
HyperRAB ST (human rabies immune globulin)Biological
The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.

Study groups in NCT02956746
Study group	Role	What they receive
Imovax, SYN023	Experimental	Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine Receives: Biological: SYN023; Biological: Imovax
Imovax, human rabies immune globulin	Active comparator	Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine Receives: Biological: Imovax; Biological: HyperRAB ST (human rabies immune globulin)
RabAvert, SYN023	Experimental	Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine Receives: Biological: SYN023; Biological: RabAvert
RabAvert, human rabies immune globulin	Active comparator	Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine Receives: Biological: RabAvert; Biological: HyperRAB ST (human rabies immune globulin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Serum Rabies Virus Neutralizing Activity
Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA).
Measured: 112 days

Secondary outcomes (8)

Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients
Electrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events and serious adverse events will be analyzed. A comparison of adverse event incidence between the four treatment groups will be performed.
Measured: 42 days
Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive
Measurement of the development of anti-CTB012 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics.
Measured: 112 days
Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive
Measurement of the development of anti-CTB011 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics.
Measured: 112 days
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)
The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Measured: 84 days
Time to Maximum Concentration Tmax of CTB011 and CTB012
Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Measured: 84 days
Maximum Serum Concentration Cmax
Maximum concentration of of CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Measured: 84 days
Serum Clearance Rate (Clp) of CTB011 and CTB012
Calculated serum clearance rates for CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Measured: 84 days
Serum Half Lives of CTB011 and CTB012
The time in hours to reduce the serum concnetration of CTB011 and CTB012 to 50% of the maximum serum concentration at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Measured: 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Jan 2018

First posted7 Nov 2016 (estimated)
Study startAug 2016
Primary completionDec 2017
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human RabiesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02956746
Sponsor's protocol ID: SYN023-002
Acronym: RabiesMab
Status last verified: Feb 2019
First submitted: 1 Nov 2016
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Rabies trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized Blinded Placebo Controlled Comparison of the Safety Pharmacokinetics and Pharmacodynamics of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02956746
Acronym / sponsor ID: RabiesMab / SYN023-002
Conditions: Human Rabies
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Synermore Biologics Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: inVentiv Health Clinical
Study start: Aug 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Jan 2018 (actual)
First posted: 7 Nov 2016 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Imovax, SYN023	Experimental	Biological: SYN023, Biological: ImovaxSubjects will receive SYN023 and 5 doses of Imovax rabies vaccine
Imovax, human rabies immune globulin	Active comparator	Biological: Imovax, Biological: HyperRAB ST (human rabies immune globulin)Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, SYN023	Experimental	Biological: SYN023, Biological: RabAvertSubjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
RabAvert, human rabies immune globulin	Active comparator	Biological: RabAvert, Biological: HyperRAB ST (human rabies immune globulin)Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male or female subjects between 18 and 50 years of age, inclusive
Body mass index between 18 and 30 kg/m², inclusive
Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:
Women of childbearing potential must have a negative serum pregnancy test within 24 hours preceding receipt of each dose.
Can understand and sign the informed consent document, can communicate with the investigator and provide updated contact information as needed for the duration of the study, has no current plans to move from the study area for the duration of the study, and can understand and comply with the requirements of the protocol.

Key exclusion criteria (18 listed)

Oral temperature ≥37.5°C at screening
Complete blood count (CBC) and platelet count abnormal values (>5% above the upper limit of normal [ULN] or >5% below the lower limit of normal [LLN] per local laboratory parameters) at screening with exception of absolute lymphocyte count.
Abnormally elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase (ALP), or creatinine (Cr) values at screening (however a single test AST, ALT or ALP may be >10% above the ULN per local laboratory parameters)
Abnormal PT (INR) PTT
Abnormal screening urinalysis result that is, per the investigator, clinically significant, or a screening urine dipstick result of ≥2+ protein

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SYN023The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.	Biological	Imovax, SYN023, RabAvert, SYN023
ImovaxSubjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine	Biological	Imovax, SYN023, Imovax, human rabies immune globulin
RabAvertSubjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine	Biological	RabAvert, SYN023, RabAvert, human rabies immune globulin
HyperRAB ST (human rabies immune globulin)The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.	Biological	Imovax, human rabies immune globulin, RabAvert, human rabies immune globulin

Primary outcome

Percentage of Participants With Serum Rabies Virus Neutralizing Activity
Time frame: 112 days
Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA).

8 secondary outcomes

Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients
Time frame: 42 days
Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive
Time frame: 112 days
Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive
Time frame: 112 days
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)
Time frame: 84 days
Time to Maximum Concentration Tmax of CTB011 and CTB012
Time frame: 84 days
Maximum Serum Concentration Cmax
Time frame: 84 days
Serum Clearance Rate (Clp) of CTB011 and CTB012
Time frame: 84 days
Serum Half Lives of CTB011 and CTB012
Time frame: 84 days

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imovax, SYN023	40	38
Imovax, Human Rabies Immune Globulin	40	37
RabAvert, SYN023	42	36
RabAvert, Human Rabies Immune Globulin	42	38

Primary outcome: Percentage of Participants With Serum Rabies Virus Neutralizing Activity

Time frame: 112 days. Number. Unit: percentage of participants

Measure	Imovax, SYN023 n = 35	Imovax, Human Rabies Immune Globulin n = 35	RabAvert, SYN023 n = 34	RabAvert, Human Rabies Immune Globulin n = 36
Value	94.3	97.1	97.1	100

Imovax, SYN023 vs Imovax, Human Rabies Immune Globulin vs RabAvert, SYN023 vs RabAvert, Human Rabies Immune Globulin: p = 0.4187, ANOVA

Population analysed: Per-Protocol Population (subject with complete RVNA data).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 112 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Imovax, Human Rabies Immune Globulin	0 of 40 (0%)	20 of 40 (50%)	0 of 40
RabAvert, Human Rabies Immune Globulin	0 of 42 (0%)	25 of 42 (59.5%)	0 of 42
Imovax, SYN023	0 of 40 (0%)	24 of 40 (60%)	0 of 40
RabAvert, SYN023	1 of 42 (2.4%)	31 of 42 (73.8%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34483020McClain 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wyatt J David, PhD principal investigator

inVentiv Health Clinical Research Services LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYN023, Imovax and RabAvert in people with Human Rabies, run by Synermore Biologics Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Serum Rabies Virus Neutralizing Activity (time frame: 112 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02956746, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.