Rabies Clinical Trial
Official title:
Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile of the vaccine composition in healthy adult volunteers under the accelerated regimen. The secondary objective is to achieve higher seroconversion of the vaccine under accelerated regimen at Day 7.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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