The performance of licensed rotavirus vaccines and the development of a new generation of rotavirus vaccines: a review

Figures & data

Figure 1. The classification of rotavirus vaccines Rotavirus vaccines can be roughly divided into four categories according to origins or compositions: non-human, animal-human reassortant, human, and other rotavirus vaccines

Table 1. The table of the characteristics of licensed RV vaccines

Vaccine Name	Rotarix^TM	RotaTeq^TM	RotaShield^TM	Rotavac^TM	RotaSiil^TM	LLR	Rotavin-M1^TM
Status	Worldwide license	Worldwide license	Withdrawn	Worldwide license	Worldwide license	Restricted license	Restricted license
Category	Human RV	Animal-human reassortant RV	Animal-human reassortant RV	Animal-human reassortant RV	Animal-human reassortant RV	Nohuman RV	Human RV
Valent	1	5	4	1	5	1	1
Origin of antigen	Attenuated human G1P[8] strain	Human-bovine reassortant strain with G1, G2, G3, G4, P1[8] proteins	Human-simian reassortant strain with G1, G2, G4, G3P[5] proteins	Human G9P[11] strain	Human-bovine reassortant strain with G1-G4, G9 proteins	Lamb G10P[12] strain	Attenuated human G1P[8] strain
Storage Conditions	2 to 8°C, not frozen; avoid light	2 to 8°C, not frozen; avoid light	2 to 8°C	Frozen at －20±°C5°C	Stable at 37°C for 2 y and 40°C for six months	2 to 8°C	Frozen at －20±°C5°C
Intervention Route	Oral	Oral	Oral	Oral	Oral	Oral	Oral
schedule of administration	2 doses, given on same schedule as DPT vaccine	3 doses, given on same schedule as DPT vaccine	N/A	3 doses, four weeks apart, beginning at 6 weeks of age	3 doses, four weeks apart, beginning at 6–8 weeks of age	1 dose every year for 3 y between 2–35 months of age	The 1st dose from 6 weeks of age. The 2nd dose after 1–2 months before 6 months of age
Country	Belgium	USA	USA	India	India	China	Vietnam
Licensure Date	2008	2006	1998	2014	2016	2000	2014
WHO prequalification/ Date	✔ 2009	✔ 2008	❌ N/A	✔ 2018	✔ 2018	❌ N/A	❌ N/A
Manufacturer or sponsor	GlaxoSmithKline Biologicals	Merck	Wyeth-Ayerst Research, W-AR	Bharat Biotech International Limited	Serum Institute of India Limited	Lanzhou Institute of Biological Products	Center for Research and Production of Vaccines
Efficacy against severe RVGE	39.3%-96.9%	39.3%-100%	N/A	55.1%	66.7%	N/A	N/A
Price per vaccination course	From approximately US$0.50 in GAVI-eligible countries up to US$185–$226 in the USA		NA	US$ 2.50	US$ 6.00 maximim	US$ 24.00	US$ 17.60

Abbreviations: RV, rotavirus; N/A, not applicable; WHO, World Health Organization; DPT, diphtheria, pertussis and tetanus.

Table 2. Selected efficacy clinical trials* of four WHO prequalified live oral RV vaccines

Vaccines	Study Time/Reporting Time	Countries or Regions	Enrollments	Observation Duration (Year)	Doses	Efficacy on Conditions	Efficacy, %(95%CI)	Reference
Rotarix™	2001–2003	Singapore	2464	1	2	RVGE	82.0% (N/A)	^Citation231
	2003–2004	Latin American, Finland	63,225	1	2	severe RVGE	84.7% (71.7%-92.4%)	^Citation110
	2004–2005	Europe countries	3994	1	2	RVGE	78.9% (72.7%-83.8%)	^Citation106
						severe RVGE	90.4% (85.1%-94.1%)
	2003–2008	Hong Kong, Singapore, Taiwan	10,708	2	2	severe RVGE	96.1% (85.1%-99.5%)	^Citation113
				3	2	severe RVGE	96.9% (88.3%-99.6%)	^Citation114
	2003–2005	Singapore	6542	3	2	severe RVGE	95.2% (70.5%-99.9%)	^Citation232
	2003–2005	Hong Kong	3025	3	2	severe RVGE	96.1% (76.5%-99.9%)	^Citation233
	2005	South Africa, Malawi	4939	1	2/3	severe RVGE	61.2% (44.0%-73.2%)	^Citation25
	2006–2007	Malawi	1773	3	2/3	severe RVGE	38.1% (9.8%-57.3%)	^Citation118
RotaTeq™	2001–2004	Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Puerto Rico, Sweden, Taiwan, United States	70,301	First RV season	3	RVGE	74% (66.8%-79.9%)	^Citation84
						severe RVGE	98% (88.3%-100%)
				second RV season		RVGE	62.6% (44.3%-75.4%)
						severe RVGE	88% (49.4%-98.7%)
	2001–2004	Finland	23,422	3.1	3	RVGE hospitalizations and ED visits	93.8% (90.8%-95.9%)	^Citation88
	2007–2009	Ghana, Kenya, Mali	5560	2	3	severe RVGE	39.3% (19.1%-54.7%)	^Citation24
	2007–2009	Bangladesh, Vietnam	2119	2	3	severe RVGE	48.3% (22.3%-66.1%)	^Citation27
	2014–2015	China	4173	At least 14 d after the third dose	3	RVGE	69.3% (54.5%-79.7%)	^Citation95
						severe RVGE	78.9% (59.1%-90.1%)
Rotavac™	2011–2013	India	6799	1	3	severe RVGE	53.6% (35.0%-66.9%)	^Citation133
				2	3	severe RVGE	55.1% (39.9%-66.4%)	^Citation132
RotaSiil™	2014–2015	Niger	4137	28 d after the third dose	3	severe RVGE	66.7% (49.9%-77.9%)	^Citation144

Abbreviations: RV, rotavirus; RVGE, RV gastroenteritis; CI, confidence interval; ED, emergency department; N/A, not applicable.

*These selected clinical trials were chosen in terms of the representative researches and the number of participants more than 1500.

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