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Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults

Primary Purpose

Rabies

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Rabies virus-specific monoclonal antibodies

human polyclonal rabies immune globulin (HRIG)

Placebo

Human diploid cell vaccine (HDCV)

Purified verocell rabies vaccine (PVRV)

About this trial

This is an interventional treatment trial for Rabies focused on measuring Monoclonal antibody, Rabies, Post-exposure prophylaxis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female subject aged ≥18 to ≤55 years
Subjects free of obvious health-problems or with stable conditions or medications
Body mass index between ≥18 to ≤30 kg/m2
Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90
Male subjects must agree that they will not donate sperm from the first check-in until Day 90
Subject signed written informed consent

Exclusion Criteria:

Prior history of active or passive rabies immunization
Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing
History and/or family history of clinically significant immunodeficiency or auto-immune disease
Planned immunization with live vaccines during the coming 3 months after first dosing
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Sites / Locations

Lotus House, Vasanth Nagar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

CL184+PVRV

HRIG+PVRV

Placebo+PVRV

CL184+HDCV

Placebo+HDCV

Arm Description

CL184 with rabies vaccine (PVRV)

HRIG with rabies vaccine

Placebo with rabies vaccine (PVRV)

CL184 with rabies vaccine (HDCV)

Placebo with rabies vaccine (HDCV)

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a measure of safety

Assessed by recording unsolicited adverse events, solicited local and systemic adverse events, and pain at the injection site (assessed on a Visual Analog Scale from Day 0 to Day 3); routine safety laboratory assessed on Days -1, 1, 3, 7, 42, and 90; ECG and vital signs assessed on Days -1, 7, and 90.

Secondary Outcome Measures

Rabies virus neutralizing activity

Full Information

NCT ID

NCT01228383

First Posted

October 13, 2010

Last Updated

April 3, 2013

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01228383

Brief Title

Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults

Official Title

A Randomized, Single-blind, Active-controlled, Mono-center Phase II Study to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Purified Vero Cell Rabies Vaccine vs. Human Rabies Immune Globulin or Placebo in Combination With Purified Vero Cell Rabies Vaccine vs. CL184 or Placebo in Combination With Human Diploid Cell Rabies Vaccine in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study design: Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study Study objectives: Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects. Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).

Detailed Description

This study was designed to explore and obtain further safety and RVNA data on CL184 in comparison to HRIG and placebo as part of a classical post-exposure prophylaxis (PEP) regimen. This regimen will be applied as simulated PEP regimen to healthy subjects (i.e. in a pre-exposure setting) in this study. A comparison with placebo combined with each rabies vaccine was included to differentiate between the contribution of immune globulin and vaccine and to investigate potential interactions between immune globulin and vaccine. RVNA provided by CL184 or HRIG, as well as vaccination response will be checked regularly during the study and booster doses can be applied after the study, if necessary. In addition pharmacokinetic data will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rabies

Keywords

Monoclonal antibody, Rabies, Post-exposure prophylaxis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CL184+PVRV

Arm Type

Experimental

Arm Description

CL184 with rabies vaccine (PVRV)

Arm Title

HRIG+PVRV

Arm Type

Active Comparator

Arm Description

HRIG with rabies vaccine

Arm Title

Placebo+PVRV

Arm Type

Placebo Comparator

Arm Description

Placebo with rabies vaccine (PVRV)

Arm Title

CL184+HDCV

Arm Type

Experimental

Arm Description

CL184 with rabies vaccine (HDCV)

Arm Title

Placebo+HDCV

Arm Type

Placebo Comparator

Arm Description

Placebo with rabies vaccine (HDCV)

Intervention Type

Biological

Intervention Name(s)

Rabies virus-specific monoclonal antibodies

Other Intervention Name(s)

CL184

Intervention Description

CL184 20 IU/kg intramuscularly on Day 0.

Intervention Type

Biological

Intervention Name(s)

human polyclonal rabies immune globulin (HRIG)

Other Intervention Name(s)

Imogam® Rabies-HT

Intervention Description

HRIG 20 IU/kg intramuscularly on Day 0.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo intramuscularly on Day 0.

Intervention Type

Biological

Intervention Name(s)

Human diploid cell vaccine (HDCV)

Other Intervention Name(s)

Imovax®

Intervention Description

Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.

Intervention Type

Biological

Intervention Name(s)

Purified verocell rabies vaccine (PVRV)

Other Intervention Name(s)

Verorab™

Intervention Description

Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.

Primary Outcome Measure Information:

Title

Number of participants with adverse events as a measure of safety

Description

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Rabies virus neutralizing activity

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subject aged ≥18 to ≤55 years Subjects free of obvious health-problems or with stable conditions or medications Body mass index between ≥18 to ≤30 kg/m2 Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90 Male subjects must agree that they will not donate sperm from the first check-in until Day 90 Subject signed written informed consent Exclusion Criteria: Prior history of active or passive rabies immunization Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing History and/or family history of clinically significant immunodeficiency or auto-immune disease Planned immunization with live vaccines during the coming 3 months after first dosing Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

G Nagashayana, MD

Organizational Affiliation

Lotus Labs Pvt. Ltd, Bangalore, India

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lotus House, Vasanth Nagar

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 052

Country

India

12. IPD Sharing Statement

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Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults

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