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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Rabies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CL184+PVRV

CL184 with rabies vaccine (PVRV)

Group Type EXPERIMENTAL

Rabies virus-specific monoclonal antibodies

Intervention Type BIOLOGICAL

CL184 20 IU/kg intramuscularly on Day 0.

Purified verocell rabies vaccine (PVRV)

Intervention Type BIOLOGICAL

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

HRIG+PVRV

HRIG with rabies vaccine

Group Type ACTIVE_COMPARATOR

human polyclonal rabies immune globulin (HRIG)

Intervention Type BIOLOGICAL

HRIG 20 IU/kg intramuscularly on Day 0.

Purified verocell rabies vaccine (PVRV)

Intervention Type BIOLOGICAL

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

Placebo+PVRV

Placebo with rabies vaccine (PVRV)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo intramuscularly on Day 0.

Purified verocell rabies vaccine (PVRV)

Intervention Type BIOLOGICAL

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

CL184+HDCV

CL184 with rabies vaccine (HDCV)

Group Type EXPERIMENTAL

Rabies virus-specific monoclonal antibodies

Intervention Type BIOLOGICAL

CL184 20 IU/kg intramuscularly on Day 0.

Human diploid cell vaccine (HDCV)

Intervention Type BIOLOGICAL

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

Placebo+HDCV

Placebo with rabies vaccine (HDCV)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo intramuscularly on Day 0.

Human diploid cell vaccine (HDCV)

Intervention Type BIOLOGICAL

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

Interventions

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Rabies virus-specific monoclonal antibodies

CL184 20 IU/kg intramuscularly on Day 0.

Intervention Type BIOLOGICAL

human polyclonal rabies immune globulin (HRIG)

HRIG 20 IU/kg intramuscularly on Day 0.

Intervention Type BIOLOGICAL

Placebo

Placebo intramuscularly on Day 0.

Intervention Type BIOLOGICAL

Human diploid cell vaccine (HDCV)

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

Intervention Type BIOLOGICAL

Purified verocell rabies vaccine (PVRV)

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

Intervention Type BIOLOGICAL

Other Intervention Names

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CL184 Imogam® Rabies-HT Imovax® Verorab™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes