OBJECTIVE: This study evaluated the safety and potency of a new highly purified equine rabies immunoglobulin (ERIG) through indirect measurement of suppression of vaccine-induced antibody production using rapid fluorescent focus inhibition test.
METHODOLOGY: This is a prospective, randomized open labeled clinical study on healthy volunteers. Forty-five subjects were randomly assigned to three groups of 15 subjects: All groups received the purified chick embryo cell culture (PCEC) rabies vaccine using the Zagreb regimen (2-1-1). Group A then received ERIG at the same site where the PCEC vaccine was administered; Group B received ERIG at a distant site from where the PCEC vaccine was administered; Group C received only the PCEC vaccine at the same regimen. Arithmetic mean (AM), standard deviation (SD) and range were used to describe the baseline characteristics. Geometric mean titer (GMT) was calculated on Days 0, 7, 14, 21 and 28. Wilcoxon rank-sum test and Kruskall-Wallis Analysis of Variance test were used to compare the means of two and three groups, respectively. Local and systemic adverse reactions were reported by subjects and monitored by investigators.
RESULTS: By day 14, 64% of the subjects in Group A, 20% in Group B and 7.0% in Group C failed to seroconvert. During that same period, comparative analysis of GMT of Group A (0.36, 95% CI: -17.92 to 18.64), Group B (1.09, 95% CI: 0.14 to 2.04) and Group C (3.90, 95% CI: -0.63 to 8.43) showed statistically significant differences (p = 0.0016). In terms of safety, neither serious adverse events nor anaphylactic reactions were reported.
CONCLUSION: ERIG is a potent and safe product that can be effectively used for passive immunization in category III rabies exposures. In resource-limited areas, this product is an excellent alternative to human rabies immunoglobulin (HRIG).

Human ; Male ; Female ; Adult ; Rabies Vaccines ; Rabies ; Anaphylaxis ; Healthy Volunteers ; Research Personnel ; Immunization, Passive ; Immune Sera ; Antibody Formation

OBJECTIVE: This is a prospective, randomized open-labeled clinical study to demonstrate the safety and immunogenicity of Purified Vero Cell Rabies Vaccine (PVRV) Freeze-Dried using pre-exposure and post- exposure regimen utilizing Modified Thai Red Cross schedule (Modified TRC) in comparison with Purified Chick Embryo Cell (PCEC) Rabies Vaccine among healthy volunteers in San Lazaro Hospital.
METHODOLOGY: A total of 189 healthy Filipino volunteers were randomized into three groups: Group A received PVRV 0.1 ml intradermally (ID) using the pre-exposure regimen (Day 0, 7, 28). Group B and Group C were given PVRV 0.1 ml ID and PCEC 0.1 ml ID, respectively, using the Modified TRC on days 0, 3, 7 and 30. The statistical tables and graphs were generated using Microsoft® Excel® 2010. SPSS® version 13 for Windows™ was used for descriptive statistics (geometric mean, arithmetic mean, standard deviation and percentages) and inferential statistics (?2 test, one-way ANOVA and two-way mixed factorial ANOVA).
RESULTS: The results revealed that the percentage seroconversion of both PRVR and PCEC post-exposure groups in this clinical study were 100% on days 14 and 90. The PRVR pre-exposure group achieved 96% seroconversion on Day 28 with Geometric Mean titers (GMT) of 1.96 IU/ml (95% CI: 1.45 - 2.65), which is comparable to other similar studies on pre-exposure rabies vaccination. There was no overall difference in all three groups for the whole duration of the study (p = 1.000). The geometic mean titers (GMT) for post-exposure PRVR and PCEC groups on days 14, 30 and 90 were all above 0.5 IU/ml. There was no significant difference between these two post-exposure groups (p = 0.052). The proportion of the subjects in the three groups who experienced local (pain and tenderness at the injection sites, erythema and itching) or systemic reactions (low grade fever, dizziness and headache) during follow-up period were not significantly different (p = 0.134). There were no serious adverse events (SAEs) reported during the follow-up period.
CONCLUSION: The Asian manufactured PVRV is safe, tolerable, immunogenic and comparable with PCEC and therefore, the Asian manufactured PVRV can be an economical alternative for rabies post-exposure treatment using the modified TRC regimen and for pre-exposure prophylaxis.

Human ; Male ; Female ; Aged ; Middle Aged ; Adult ; Rabies Vaccines ; Rabies ; Vero Cells ; Dizziness ; Pre-exposure Prophylaxis ; Seroconversion ; Pruritus ; Vertigo ; Vaccination ; Erythema

Background: Post-exposure prophylaxis (PEP) is the most important means of preventing rabies. Intradermal PEP was developed to improve compliance, still, many recipients fail to complete this regimen Objective: To determine the non-monetary factors contributing to non-compliance to PEP among patients in the Animal Bite Treatment Center (ABTC) of San Lazaro Hospital (SLH). Methods: This was an analytical, cross-sectional study. The authors randomly reviewed patient records of SLH-ABTC for one-year period. We characterized the cases according to World Health Organization (WHO) parameters. They determined the day intervals between exposure, first consultation, PEP initiation and follow-up visits. Statistical analyses used were descriptive statistics, χ2 test for independence and binary logistic regression. Results: The authors evaluated 667 records. Patients mostly had Category III exposures (76.91%, 95%CI: 73.92%80.62%). The chances of completing active immunization were more likely among patients exposed to unvaccinated animals (OR=1.85, 95%CI: 1.21-2.84, p=0.004). The chances of receiving passive immunization were higher for injuries on the head/neck regions (OR=8.18, 95%CI: 2.4-27.9, p=0.001). Overall, compliance to PEP was 70.21% and 40.70% for Categories II and III exposures, respectively. PEP compliance was moderately dependent on the exposure category (χ2=38.14, df=1, p<0.001, φ=0.25. Conclusion Category II exposure patients had better compliance than Category III, since rabies immunoglobulins are not required. The authors did not identify any factors that significantly affected Category II regimen compliance. Among Category III patients, compliance was better if the injuries were bite-inflicted while those who were exposed from “healthy”looking animals were less likely to comply.
Rabies ; Post-Exposure Prophylaxis