Immunogenicity

  1. Pre-exposure Prophylaxis1
  • All children achieved RVNA Geometric mean concentration (GMC) of ≥0.5 IU/mL with ChiroRab™ by Day 49.
  • After booster dose, RVNA concentrations rapidly increased within 7 days.
  1. Post-exposure Prophylaxis2
  • ChiroRab™ achieved a strong immune response by Day 7.

References:

  1. Pengsaa K. A three-year clinical study on immunogenicity, safety, and booster response of purified chick embryo cell rabies vaccine administered intramuscularly or intradermally to 12- to 18-month-old Thai children, concomitantly with Japanese encephalitis vaccine. Pediatr Infect Dis J. 2009;28(4):335-7.
  2. Mahendra BJ. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen). Hum Vaccin Immunother. 2015;11(2):428-34.
  1. Pre-exposure Prophylaxis1
  • All children achieved RVNA concentrations of ≥0.5 IU/mL with ChiroRab™ by Day 49.
  • After booster dose, RVNA concentrations rapidly increased within 7 days.
  1. Post-exposure Prophylaxis2
  • ChiroRab™ administered in a dose of 0.1 mL according to the Thai Red Cross ID PEP regimen is safe, immunogenic and non-inferior to Verorab.

References:

  1. Pengsaa K. A three-year clinical study on immunogenicity, safety, and booster response of purified chick embryo cell rabies vaccine administered intramuscularly or intradermally to 12- to 18-month-old Thai children, concomitantly with Japanese encephalitis vaccine. Pediatr Infect Dis J. 2009;28(4):335-7.
  2. Data on file. A phase IV, randomized, single-blind, single-center study to evaluate immunogenicity and safety of PCECV rabies vaccine (Rabipur) as compared to PVRV rabies vaccine (Verorab) when administered intradermally as a post-exposure Thai Red Cross (TRC) treatment regimen (2-2-2-0-1-1) to healthy adult volunteers in Sri Lanka. 2004.
  1. Pre-exposure Prophylaxis1 
  • ChiroRab™ is safe for pregnant women and did not interfere with the development of the fetuses or infants.
  • All of the infants exhibited normal development.
  • No miscarriages, stillbirths, or fetal malformations were reported.
  • No rabies cases were reported for any of the subjects or babies.
  1. Immunogenicity of ChiroRab™ in Immunocompromised Individuals2
  • 57% of individuals in the symptomatic HIV-infected group had RVNA titers >0.5 IU/mL by Day 37 (0.6 IU/mL).
  • Due to the possibility of a lower antibody response in individuals who are HIV-positive, it is important to note that when PEP is administered to HIV-positive individuals following exposure to rabies, the WHO recommends the administration of RIG in all cases.

3. Post-exposure Prophylaxis in Malnourished Children3

Protein energy malnutrition (PEM) as defined by the Indian Academy of Pediatrics:

  • Grade I: Children between 71 and 80% of the normal percent of standard weight for age.
  • Grade II: Children between 61 and 70% of the normal percent of standard weight for age.
  • Grade III: Children between 51 and 60% of the normal percent of standard weight for age.
  • Grade IV: Children below 50% of the normal percent of standard weight for age.

References:

  1. Huang G, Liu H, Cao Q, et. al., Safety of post-exposure rabies prophylaxis during pregnancy: a follow-up study from Guangzhou, China. Hum Vaccin Immunother. 2013 Jan;9(1):177-83.
  2. Data on file. Deshpande A, Briggs DJ. Rabies vaccination in immunosuppressed patients. In:Dodet E, Meslin FX, Heseltine E, eds. Rabies Control in Asia. Proceedings of the Fourth International Symposium on Rabies Control in Asia, Hanoi, Vietnam, 5–9 March 2001:John Libbey Eurotext,Paris:58–60.
  3. Sampath, G, et al. Rabies post-exposure prophylaxis in malnourished children exposed to suspect rabid animals. Vaccine. 2005;23(9), 1102–1105.
Intramuscular Route of Administration
  1. Pre-exposure Prophylaxis1
  • All children achieved RVNA Geometric mean concentration (GMC) of ≥0.5 IU/mL with ChiroRab™ by Day 49.
  • After booster dose, RVNA concentrations rapidly increased within 7 days.
  1. Post-exposure Prophylaxis2
  • ChiroRab™ achieved a strong immune response by Day 7.

References:

  1. Pengsaa K. A three-year clinical study on immunogenicity, safety, and booster response of purified chick embryo cell rabies vaccine administered intramuscularly or intradermally to 12- to 18-month-old Thai children, concomitantly with Japanese encephalitis vaccine. Pediatr Infect Dis J. 2009;28(4):335-7.
  2. Mahendra BJ. Comparative study on the immunogenicity and safety of a purified chick embryo cell rabies vaccine (PCECV) administered according to two different simulated post exposure intramuscular regimens (Zagreb versus Essen). Hum Vaccin Immunother. 2015;11(2):428-34.
Intradermal Route of Administration
  1. Pre-exposure Prophylaxis1
  • All children achieved RVNA concentrations of ≥0.5 IU/mL with ChiroRab™ by Day 49.
  • After booster dose, RVNA concentrations rapidly increased within 7 days.
  1. Post-exposure Prophylaxis2
  • ChiroRab™ administered in a dose of 0.1 mL according to the Thai Red Cross ID PEP regimen is safe, immunogenic and non-inferior to Verorab.

References:

  1. Pengsaa K. A three-year clinical study on immunogenicity, safety, and booster response of purified chick embryo cell rabies vaccine administered intramuscularly or intradermally to 12- to 18-month-old Thai children, concomitantly with Japanese encephalitis vaccine. Pediatr Infect Dis J. 2009;28(4):335-7.
  2. Data on file. A phase IV, randomized, single-blind, single-center study to evaluate immunogenicity and safety of PCECV rabies vaccine (Rabipur) as compared to PVRV rabies vaccine (Verorab) when administered intradermally as a post-exposure Thai Red Cross (TRC) treatment regimen (2-2-2-0-1-1) to healthy adult volunteers in Sri Lanka. 2004.
Special Populations
  1. Pre-exposure Prophylaxis1 
  • ChiroRab™ is safe for pregnant women and did not interfere with the development of the fetuses or infants.
  • All of the infants exhibited normal development.
  • No miscarriages, stillbirths, or fetal malformations were reported.
  • No rabies cases were reported for any of the subjects or babies.
  1. Immunogenicity of ChiroRab™ in Immunocompromised Individuals2
  • 57% of individuals in the symptomatic HIV-infected group had RVNA titers >0.5 IU/mL by Day 37 (0.6 IU/mL).
  • Due to the possibility of a lower antibody response in individuals who are HIV-positive, it is important to note that when PEP is administered to HIV-positive individuals following exposure to rabies, the WHO recommends the administration of RIG in all cases.

3. Post-exposure Prophylaxis in Malnourished Children3

Protein energy malnutrition (PEM) as defined by the Indian Academy of Pediatrics:

  • Grade I: Children between 71 and 80% of the normal percent of standard weight for age.
  • Grade II: Children between 61 and 70% of the normal percent of standard weight for age.
  • Grade III: Children between 51 and 60% of the normal percent of standard weight for age.
  • Grade IV: Children below 50% of the normal percent of standard weight for age.

References:

  1. Huang G, Liu H, Cao Q, et. al., Safety of post-exposure rabies prophylaxis during pregnancy: a follow-up study from Guangzhou, China. Hum Vaccin Immunother. 2013 Jan;9(1):177-83.
  2. Data on file. Deshpande A, Briggs DJ. Rabies vaccination in immunosuppressed patients. In:Dodet E, Meslin FX, Heseltine E, eds. Rabies Control in Asia. Proceedings of the Fourth International Symposium on Rabies Control in Asia, Hanoi, Vietnam, 5–9 March 2001:John Libbey Eurotext,Paris:58–60.
  3. Sampath, G, et al. Rabies post-exposure prophylaxis in malnourished children exposed to suspect rabid animals. Vaccine. 2005;23(9), 1102–1105.