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

NCT01228383 | Completed Phase 2 DMC

• 2 other identifiers: RAB-M-A008U1111-1120-1647
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Rabies

Keywords

Monoclonal antibody; Rabies; Post-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (1)

• Rabies virus neutralizing activity

  90 days

Study Arms (5)

CL184+PVRV

EXPERIMENTAL

CL184 with rabies vaccine (PVRV)

Biological: Rabies virus-specific monoclonal antibodies; Biological: Purified verocell rabies vaccine (PVRV)

HRIG+PVRV

ACTIVE COMPARATOR

HRIG with rabies vaccine

Biological: human polyclonal rabies immune globulin (HRIG); Biological: Purified verocell rabies vaccine (PVRV)

Placebo+PVRV

PLACEBO COMPARATOR

Placebo with rabies vaccine (PVRV)

Biological: Placebo; Biological: Purified verocell rabies vaccine (PVRV)

CL184+HDCV

EXPERIMENTAL

CL184 with rabies vaccine (HDCV)

Biological: Rabies virus-specific monoclonal antibodies; Biological: Human diploid cell vaccine (HDCV)

Placebo+HDCV

PLACEBO COMPARATOR

Placebo with rabies vaccine (HDCV)

Biological: Placebo; Biological: Human diploid cell vaccine (HDCV)

Interventions

Rabies virus-specific monoclonal antibodies BIOLOGICAL

CL184 20 IU/kg intramuscularly on Day 0.

Also known as: CL184

CL184+HDCV; CL184+PVRV

human polyclonal rabies immune globulin (HRIG) BIOLOGICAL

HRIG 20 IU/kg intramuscularly on Day 0.

Also known as: Imogam® Rabies-HT

HRIG+PVRV

Placebo BIOLOGICAL

Placebo intramuscularly on Day 0.

Placebo+HDCV; Placebo+PVRV

Human diploid cell vaccine (HDCV) BIOLOGICAL

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

Also known as: Imovax®

CL184+HDCV; Placebo+HDCV

Purified verocell rabies vaccine (PVRV) BIOLOGICAL

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

Also known as: Verorab™

CL184+PVRV; HRIG+PVRV; Placebo+PVRV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Lotus House, Vasanth Nagar

Bangalore, Karnataka, 560 052, India

Location

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• G Nagashayana, MD

  Lotus Labs Pvt. Ltd, Bangalore, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 26, 2010
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

IN (1)