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Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.

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.

Author information

1
a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China.
2
b Liaoning Chengda biological Limited by Share Ltd , Shenyang , P.R. China.
3
c Guangdong Provincial Center for Disease Control and Prevention , Guangzhou , P.R. China.
4
d Wuhan City Center for Disease Control and Prevention , Wuhan , P.R. China.
5
e Guizhou Provincial Center for Disease Control and Prevention , Guiyang , P.R. China.
6
f Hunan Provincial Center for Disease Control and Prevention , Changsha , P.R. China.
7
g National Institutes for Food and Drug Control , Beijing , P.R. China.

Abstract

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.

KEYWORDS:

Immunogenicity; Post-exposure; Protective effect; Rabies vaccine; Safety

PMID:
28121231
PMCID:
PMC5489304
DOI:
10.1080/21645515.2017.1279770
[Indexed for MEDLINE]
Free PMC Article

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