A Phase 2 interventional study of Rabies virus-specific monoclonal antibodies and human polyclonal rabies immune globulin (HRIG) in Rabies, sponsored by Crucell Holland BV. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-10.
Sponsored by Crucell Holland BV (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
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).
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.
120 studies on the registry are indexed under Rabies; 14 are open to participants now.
This study's enrollment of 240 is above the median of 200 across 110 interventional studies indexed under Rabies.
Browse Rabies studies →Crucell Holland BV is the lead sponsor of 37 studies on the registry; none are open to participants now.
First submitted before Crucell Holland BV became part of Johnson & Johnson.
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Exclusion Criteria:
CL184 with rabies vaccine (PVRV)
Biological: Rabies virus-specific monoclonal antibodies · Biological: Purified verocell rabies vaccine (PVRV)
HRIG with rabies vaccine
Biological: human polyclonal rabies immune globulin (HRIG) · Biological: Purified verocell rabies vaccine (PVRV)
Placebo with rabies vaccine (PVRV)
Biological: Placebo · Biological: Purified verocell rabies vaccine (PVRV)
CL184 with rabies vaccine (HDCV)
Biological: Rabies virus-specific monoclonal antibodies · Biological: Human diploid cell vaccine (HDCV)
Placebo with rabies vaccine (HDCV)
Biological: Placebo · Biological: Human diploid cell vaccine (HDCV)
CL184 20 IU/kg intramuscularly on Day 0.
Also known as: CL184
HRIG 20 IU/kg intramuscularly on Day 0.
Also known as: Imogam® Rabies-HT
Placebo intramuscularly on Day 0.
Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.
Also known as: Imovax®
Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
Also known as: Verorab™
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.
Time frame: 90 days
Rabies virus neutralizing activity
Time frame: 90 days
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: CL184 · Rabies virus strain PM-1503-3M antigen (propiolactone inactivated)