Rabies Clinical Trial
Official title:
Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03961555 -
Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
|
Phase 2 | |
| Completed |
NCT04644484 -
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
|
Phase 3 | |
| Active, not recruiting |
NCT05667974 -
A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried
|
Phase 3 | |
| Completed |
NCT01641315 -
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
|
N/A | |
| Completed |
NCT02238756 -
Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01930357 -
Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen
|
Phase 2 | |
| Completed |
NCT01680016 -
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
|
Phase 3 | |
| Completed |
NCT04019444 -
Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02729168 -
Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly
|
N/A | |
| Completed |
NCT02241135 -
RNActive® Rabies Vaccine (CV7201) in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01388985 -
Simplifying the Rabies Pre-exposure Vaccination
|
Phase 3 | |
| Completed |
NCT04829630 -
Immunity Persistence After Abridged Intradermal Rabies PEP
|
N/A | |
| Completed |
NCT03713086 -
A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT05350735 -
Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project
|
N/A | |
| Active, not recruiting |
NCT06132789 -
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10-60 Years
|
Phase 1 | |
| Completed |
NCT02281396 -
The Safety Research of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
|
Phase 1 | |
| Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
| Completed |
NCT00825305 -
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
|
Phase 3 | |
| Completed |
NCT05547815 -
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
|
Phase 4 | |
| Completed |
NCT02564471 -
Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
|
Phase 4 |