Phase I 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 was to assess the clinical safety of the vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the vaccine's efficacy based on an accelerated vaccine regimen.
A single-center, open label, randomized phase I study in healthy naïve adult subjects. There were three study groups; subjects were randomly assigned to groups A (12), B (12) and C (12). Group A, as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR® and Group B had received doses of the investigational PIKA rabies vaccine. Group C received an accelerated vaccine regimen with the investigational PIKA rabies vaccine. Group A and B followed the same vaccine regimen of (1-1-1-1), one injection on days 0, 3, 7 and 14 was administered respectively. Group C 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 Group C 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
37
Biological rabies vaccine
Biological rabies vaccine
Biological rabies vaccine
SingHealth Investigational Medicine Unit
Singapore, Singapore, Singapore
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
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at day 14 and 42 after the first injection
To analyze the titer level of RVNA from serum at day 14 and 42 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
Time frame: Day 14 and Day 42
Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Assessment of efficacy was determined by the observed immune response in subjects receiving the investigational vaccine where:Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Time frame: Day 7, Day 14 and Day 42
Number of subjects in Group C who has higher RVNA titre level on Day 7 or Day 14 when compared to classic course.
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be higher in day 7 or 14 than a classic course with control commercialized vaccine.
Time frame: Day 7 and Day 14
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