Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
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|ClinicalTrials.gov Identifier: NCT02956421|
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : November 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rabies||Biological: RABIPUR® Biological: PIKA rabies vaccine||Phase 2|
A multi-center, open labelled, randomized study in healthy naïve adult subjects. Subjects were randomly assigned to groups A (60) and B (60). Group A as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR®. Group B had received doses of the investigational PIKA rabies vaccine in an accelerated regimen.
Group A followed the vaccine regimen of (1-1-1-1),one injection on days 0, 3, 7 and 14 was administered respectively. Group B received the accelerated regimen (2-2-1), two injections on both days 0 and 3 were administered in different arms; and only one injection was administered on day 7.
Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and 1.0 ml of RABIPUR® for Group A after reconstitution. The route of administration is intramuscular injection, given in the deltoid region of the arm.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: RABIPUR®
Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Biological rabies vaccine
Experimental: PIKA Rabies vaccine
PIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose)
Biological: PIKA rabies vaccine
Biological rabies vaccine
Other Name: PIKA rabies vaccine with PIKA adjuvant
- Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen [ Time Frame: 42 days ]Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be better than a classic course with control commercialized vaccine.
- Identification of any adverse events for all the treatment groups [ Time Frame: 42 days ]Assessment of safety based on the identification of any adverse events for all the treatment groups, Group A, Group B and Group C through to the end of the study at day 42.
- Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course. [ Time Frame: Day 7 ]To analyze the titer level of RVNA from serum at day 7 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
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): NCT02956421
|SingHealth Investigational Medicine Unit|
|Singapore, Singapore, 169608|
|Clinical Trials & Research Unit|
|Singapore, Singapore, 529889|
|Principal Investigator:||Limin Wijaya||Singapore General Hospital|