Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects

• Published in: Human vaccines & immunotherapeutics 2017-06, Vol.13 (6), p.1338-1345
• Main Authors: Shi, Nianmin, Zhang, Yibin, Zheng, Huizhen, Zhu, Zhenggang, Wang, Dingming, Li, Sihai, Li, Yuhua, Yang, Liqing, Zhang, Junnan, Bai, Yunhua, Lu, Qiang, Zhang, Zheng, Luo, Fengji, Yu, Chun, Li, Li
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Animals; Antibodies, Viral - blood; Child; Child, Preschool; Dogs; Drug-Related Side Effects and Adverse Reactions - epidemiology; Female; Humans; Immunization Schedule; Immunogenicity; Infant; Infant, Newborn; Injections, Intramuscular; Male; Middle Aged; Post-exposure; Post-Exposure Prophylaxis - methods; Protective effect; Rabies - prevention & control; Rabies vaccine; Rabies Vaccines - administration & dosage; Rabies Vaccines - adverse effects; Rabies Vaccines - immunology; Research Papers; Safety; Technology, Pharmaceutical; Young Adult
• ISSN: 2164-5515; 2164-554X
• DOI: 10.1080/21645515.2017.1279770

Aim: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Methods: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). Results: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. Conclusions: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.