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Rabies vaccines+ Rabies immunoglobulins · 1 trial · 1 indication
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
| Arm | Type | Description |
|---|---|---|
| 4-sites, 1-week without HRIG | EXPERIMENTAL | PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen |
| 4-sites, 1-week with HRIG | EXPERIMENTAL | PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG |
| 2-sites, TRC without HRIG | ACTIVE_COMPARATOR | PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen |
| 2-sites, TRC with HRIG | ACTIVE_COMPARATOR | PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG |
| Name | Type | Description |
|---|---|---|
| Rabies vaccine | BIOLOGICAL | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). |
| Rabies vaccines + Rabies immunoglobulins | BIOLOGICAL | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle. |
Inclusion Criteria: 1. Healthy males and females ≥ 1 years of age 2. Individuals/ individual's parents or legal guardians who have given written consent 3. Individuals in good health 4. Individuals who can comply with study procedures Exclusion Criteria: 1. Behavioral or cognitive impairment or p...
Rabies vaccines plus rabies immunoglobulins are used for prevention and post-exposure protection against rabies infection. The combination pairs active immunization from the vaccine with passive immunity from rabies immunoglobulins. Novartis AG developed this combination, and it has been studied in a Phase 3 trial in subjects one year of age and older.
Novartis AG, which trades under the ticker NVS, is the developer of the rabies vaccines plus rabies immunoglobulins combination. The company sponsored the Phase 3 study evaluating these products together for rabies infection prevention.
Rabies vaccines plus rabies immunoglobulins have been evaluated in a completed Phase 3 clinical trial. The study enrolled 885 participants and assessed safety and immune response. No active trials are currently listed for this combination.
The Phase 3 trial NCT02177032 studied two intradermal rabies vaccine regimens given with and without human rabies immunoglobulin in subjects one year of age and older. It was an active-controlled, randomized study with 885 participants, conducted in the Philippines and Thailand, and it is now completed.