Analysis on the risks of severe adverse events in rabies post-exposure prophylaxis and appropriate decision-making procedure

Figures & data

Figure 1. Vaccinations, AEs and treatments on this patient.

Table 1. Human rabies vaccine marketed in China.

Cell matrix	Dose (mL)	Form	Strain	Cultivation	Purification	Potency (IU/mL)	Excipient	Preservatives	Regimen
Vero	0.5	liquid	PV2061 from USA ATCC	microcarrier bioreactor	4-tandemed-columns chromatography	4.5	-	thiomersal	Zagreb/Essen
Vero	0.5	lyophilized					4.5	dextran	-
Vero	1.0	lyophilized	aG strain	fixed-bed bioreactor	chromatography	4.3	saccharose	gentamycin	Essen
Vero	0.5	lyophilized	aG strain	fixed-bed bioreactor	chromatography	4	lactose/dextran/gelatin	gentamycin	Essen
Vero	1.0	lyophilized	aG strain	roller bottle	chromatography	4	Dextran/gelatin		Essen
Vero	1.0	liquid	aG strain	bioreactor	chromatography	4	-	thiomersal	Essen
HDRV	1.0	lyophilized	PM strain	bioreactor	chromatography	4	maltose	kanamycin	Essen
PHKC	1.0	liquid	aG strain	roller bottle	chromatography	4	-	-	Essen
PHKC	1.0	liquid	aG strain	roller bottle	chromatography	4	-	-	Essen
CEF	1.0	lyophilized	Flury LEP strain	cell plant	gradient centrifugation	4	dextran	gentamycin	Zagreb/Essen

Figure 2. RVNA titers of this case and reference data from a previous study¹⁶ which used the same kind of vaccine with Essen regimen. The black dotted line (RVNA = 0.5 IU/mL) indicated minimum protective level of sero-conversion. Day 7 was actually 9 days post the first dose because of two-days delay on anaphylaxis treatment. It was the third dose in regimen and reflected the immune response of previous two doses, so in this figure, it was marked as day 7. It was comparative to the reference data. As for day 14, it reflected the immune response of previous three doses, though it was 16 days post the first dose, it was the fourth dose (Day 14) in regimen.

Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, et al. 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. Hum Vacc Immunother. 2017;13(6):1338–1345. doi:10.1080/21645515.2017.1279770.

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