مقایسه تأثیر واکسنهای PCECVو PVRVدر بروز عوارض موضعی و منتشر « کارآزمایی بالینی دو سو کور »

Background: The World Health Organization (WHO) has recommended the cell culture based rabies vaccines have no significant side effects. PVRV is a type of cell culture based vaccine, which is used for human rabies vaccination in Iran. Because PVRV is produced by a single source provider; other cell-culture derived vaccines, PCECV, has recently been used for vaccination. Methods: In this double blind clinical trial study 1449 people bitten by animals (279 females) were recruited from 4 different cities of Iran and randomly assigned to receive PVRV and PCECV vaccine in 5-dose regimen. The local and systemic adverse reactions to both of two vaccines were reported by the patients and confirmed by a physician. Results: The most common local adverse reaction in both groups was pain at the injection site (4%). Most of the reported systemic adverse reaction was headache (2.5%) and fever (1.9%) in PCECV and PVRV group, respectively. The percentage of subjects had itching after vaccination was fewer In PCECV group than PVRV group (0.1% vs. 1%) (p<0.05). There was no significant difference between two groups in systemic adverse reaction. None of the subjects hospitalized due to vaccination. Conclusion: The result of the present study indicated that PCECV administered to people bitten by animals associated with fewer itching at the injection site. There was no significant difference between PCECV and PVRV vaccine considering local and systemic adverse reaction. Therefore, the PCECV vaccine can be administered instead of PVRV, when the country encounters serious challenges in PVRV vaccine supply.