Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
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|ClinicalTrials.gov Identifier: NCT01877395|
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : December 3, 2014
The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies).
- To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at Day 14.
- To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI) of at least 97%.
- To assess the clinical safety of each vaccine after each vaccine injection when administered in a simulated post-exposure schedule.
- To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day 14.
|Condition or disease||Intervention/treatment||Phase|
|Rabies||Biological: Purified Vero Rabies Vaccine (VRVg) Biological: Imovax® Rabies: inactivated rabies vaccine||Phase 2|
All participants will receive five vaccine injections, i.e. one at Day 0, at Day 3, at Day 7, at Day 14 and at Day 28, respectively, (Essen regimen). In addition, human rabies immunoglobulins (HRIG) will be concomitantly administered to all subjects on Day 0.
Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to 6 months post-vaccination 5.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||342 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Rabies Human Diploid Cell Vaccine (Imovax® Rabies) Administered in a Simulated Rabies Post-exposure Regimen in Healthy Adults|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Purified Vero Rabies Vaccine Group
Participants will receive the Purified Vero Rabies Vaccine (VRVg)
Biological: Purified Vero Rabies Vaccine (VRVg)
0.5 mL, Intramuscular
Experimental: Imovax® Rabies Vaccine Group
Participants will receive the Imovax® Rabies vaccine
Biological: Imovax® Rabies: inactivated rabies vaccine
1.0 mL, Intramuscular
Other Name: Imovax® Rabies
- Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series). [ Time Frame: Day 14 post-vaccination ]Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
- Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial [ Time Frame: Day 0 up to 6 months post-vaccination ]Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia.
- Geometric mean titer ratio (GMTR) following vaccination with either Purified Vero Rabies Vaccine, Serum Free or Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post exposure Regimen [ Time Frame: Day 14 post-vaccination ]Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877395
|United States, Florida|
|Pembroke Pines, Florida, United States, 33026|
|South Miami, Florida, United States, 33143|
|United States, Idaho|
|Boise, Idaho, United States, 59802|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27612|
|United States, Utah|
|West Jordan, Utah, United States, 84088|
|Study Director:||Medical Director||Sanofi Pasteur SA|