NCT02956746

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

November 1, 2016

Results QC Date

December 28, 2018

Last Update Submit

February 1, 2019

Conditions

Human Rabies

Outcome Measures

Primary Outcomes (1)

  • 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).

    112 days

Secondary Outcomes (8)

  • Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients

    42 days

  • Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive

    112 days

  • Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive

    112 days

  • SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)

    84 days

  • Time to Maximum Concentration Tmax of CTB011 and CTB012

    84 days

  • +3 more secondary outcomes

Study Arms (4)

Imovax, SYN023

EXPERIMENTAL

Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine

Biological: SYN023Biological: Imovax

Imovax, human rabies immune globulin

ACTIVE COMPARATOR

Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine

Biological: ImovaxBiological: HyperRAB ST (human rabies immune globulin)

RabAvert, SYN023

EXPERIMENTAL

Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine

Biological: SYN023Biological: RabAvert

RabAvert, human rabies immune globulin

ACTIVE COMPARATOR

Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine

Biological: RabAvertBiological: HyperRAB ST (human rabies immune globulin)

Interventions

SYN023BIOLOGICAL

The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.

Imovax, SYN023RabAvert, SYN023
ImovaxBIOLOGICAL

Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine

Imovax, SYN023Imovax, human rabies immune globulin
RabAvertBIOLOGICAL

Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine

RabAvert, SYN023RabAvert, human rabies immune globulin
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.

Imovax, human rabies immune globulinRabAvert, human rabies immune globulin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

    PMID: 34483020DERIVED

MeSH Terms

Interventions

Rabies Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Director of Clinical Trials
Organization
Synermore Biologics Co., Ltd.
achuang@synermore.com
+886 2 2659 0988

Study Officials

  • Wyatt J David, PhD

    inVentiv Health Clinical Research Services LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 7, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

February 27, 2019

Results First Posted

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)