NCT02559921

Brief Summary

This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

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

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

September 23, 2015

Last Update Submit

January 19, 2016

Conditions

Rabies

Keywords

Recombinant Human Rabies Immunoglobin (rhRIG)

Outcome Measures

Primary Outcomes (1)

  • Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects

    42 days

Secondary Outcomes (1)

  • Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects

    42 days

Study Arms (7)

rhRIG（20 IU/kg）only

EXPERIMENTAL

Subjects received rhRIG（20 IU/kg） on day 0

Biological: rhRIG（20 IU/kg）

rhRIG（40 IU/kg）only

EXPERIMENTAL

Subjects received rhRIG（40 IU/kg） on day 0

Biological: rhRIG（40 IU/kg）

HRIG（20 IU/kg）only

ACTIVE COMPARATOR

Subjects received HRIG（20 IU/kg）on day 0

Biological: HRIG（20 IU/kg）

rhRIG（20 IU/kg）+ vaccine

EXPERIMENTAL

Subjects received rhRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28

Biological: rhRIG（20 IU/kg） and vaccine

rhRIG（40 IU/kg）+ vaccine

EXPERIMENTAL

Subjects received rhRIG（40 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28

Biological: rhRIG（40 IU/kg） and vaccine

HRIG（20 IU/kg）+ vaccine

EXPERIMENTAL

Subjects received HRIG（20 IU/kg）in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28

Biological: HRIG（20 IU/kg） and vaccine

placebo + vaccine

PLACEBO COMPARATOR

Subjects received placebo in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28

Biological: placebo and vaccine

Interventions

rhRIG（20 IU/kg）BIOLOGICAL
rhRIG（20 IU/kg）only
rhRIG（40 IU/kg）BIOLOGICAL
rhRIG（40 IU/kg）only
HRIG（20 IU/kg）BIOLOGICAL
HRIG（20 IU/kg）only
rhRIG（20 IU/kg） and vaccineBIOLOGICAL
rhRIG（20 IU/kg）+ vaccine
rhRIG（40 IU/kg） and vaccineBIOLOGICAL
rhRIG（40 IU/kg）+ vaccine
HRIG（20 IU/kg） and vaccineBIOLOGICAL
HRIG（20 IU/kg）+ vaccine
placebo and vaccineBIOLOGICAL
placebo + vaccine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects aged at least 18 years but not more than 55 years;
  • According to medical history, physical examination and clinical judgment of investigator at enrollment, subjects should have no significant health problems, or their health status or medication treatment remain stable;
  • Subjects and their spouses should use adequate contraceptive methods from the screening day to Day 90;
  • Male subjects must agree not to donate sperm from the first day of enrollment to Day 90;
  • Subjects should sign a written Informed Consent Form;

You may not qualify if:

  • Previous exposure or immunization histories of rabies (rabies vaccine and/or immunoglobulin);
  • According to the clinical judgment of investigator, subjects had clinically significant acute disease or infection, including pyrexia (\>37.0℃) within 2 weeks before the initial dose;
  • After review of medical history or physical examination results, it is found that subjects have medical histories of abnormalities of heart, liver, kidney, blood, digestive tract, nervous system, spirit and metabolism;
  • Subjects are pregnant or plan to become pregnant or are breast-feeding during the study;
  • According to the judgment of investigator, subjects have clinically significant immunodeficiency or medical history and/or family history of autoimmune disease;
  • According to the judgment of investigator, subjects have known or suspected clinically significant anaphylaxis or hypersensitivity reactions;
  • Immunization has been arranged for the subjects within the next 3 months after the initial dose;
  • Subjects have used immunosuppressive preparations or other immunomodulating agents for more than 14 days within 6 months before the initial dose of study drug;
  • Subjects used hormone agents within 3 days before the initial dose;
  • Subjects donated blood or lost a lot of blood within 56 days before the initial dose;
  • Subjects donated plasma within 7 days before the initial dose;
  • Subjects received transfusion of blood or blood products within 6 months before the initial dose;
  • It is suspected that subjects do not follow study procedures;
  • Intake of alcohol within 12 hours before the initial dose;
  • Subjects smoke more than 20 cigarettes a day;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Li L, Li Y, Bai Y, Li G, Zhang J, Yang L, Zhao W, Zhao W, Luo F, Zhao Q, Zhang Z, Liu Y, Li S, Lu Q, Wang H, Zhang J, Zhang Y, Gao J, Shi N. Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase Ⅱb randomized, double-blind, parallel-controlled study. Vaccine. 2022 Oct 6;40(42):6153-6162. doi: 10.1016/j.vaccine.2022.09.022. Epub 2022 Sep 16.

    PMID: 36123259DERIVED

  • Zhang J, Shi N, Li G, Li L, Bai Y, Yang L, Zhao W, Gao J, Wei J, Zhao W, Zhai L, Huo P, Ren L, Yu L, Li Y. Population Pharmacodynamic Analyses of Human Anti-Rabies Virus Monoclonal Antibody (Ormutivimab) in Healthy Adult Subjects. Vaccines (Basel). 2022 Jul 29;10(8):1218. doi: 10.3390/vaccines10081218.

    PMID: 36016106DERIVED

MeSH Terms

Conditions

Rabies

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2015-09