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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

NCT01228383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-04-10

No results posted yet for this study

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

Interventions

BIOLOGICAL

Rabies virus-specific monoclonal antibodies

CL184 20 IU/kg intramuscularly on Day 0.

BIOLOGICAL

human polyclonal rabies immune globulin (HRIG)

HRIG 20 IU/kg intramuscularly on Day 0.

BIOLOGICAL

Placebo

Placebo intramuscularly on Day 0.

BIOLOGICAL

Human diploid cell vaccine (HDCV)

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

BIOLOGICAL

Purified verocell rabies vaccine (PVRV)

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

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • G Nagashayana, MD · Lotus Labs Pvt. Ltd, Bangalore, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228383 on ClinicalTrials.gov