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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
126
Biological rabies vaccine
Biological rabies vaccine
SingHealth Investigational Medicine Unit
Singapore, Singapore, Singapore
Clinical Trials & Research Unit
Singapore, Singapore, Singapore
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen
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.
Time frame: 42 days
Identification of any adverse events for all the treatment groups
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.
Time frame: 42 days
Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
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
Time frame: Day 7
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