Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis

Figures & data

Figure 1. Number of samples selected and tested.

Table 1. Demographics of the subjects included in analysis.

	Pre-vaccination			Post-vaccination
Number of subjects	HRV group	Placebo group	Total	HRV group	Placebo group	Total
Planned, N	300	300	600	300	300	600
N	12	12	24	299	297	596
Females:Males	7:5	6:6	13:11	150:149	145:152	295:301
Mean Age, weeks (SD)^*	10.1 (2.6)	10.0 (2.1)	10.0 (2.3)	9.8 (2.4)	9.5 (2.3)	9.7 (2.4)
Median Age, weeks^* (minimum, maximum)	11 (6, 13)	11 (6, 12)	11 (6,13)	10 (6, 14)	9 (6, 16)	9 (6, 16)
White – Caucasian / European Heritage, n (%)	7 (58.3)	6 (50.0)	13 (54.2)	177 (59.2)	175 (58.9)	352 (59.1)
Hispanic, n (%)	2 (16.7)	3 (25.0)	5 (20.8)	70 (23.4)	69 (23.2)	139 (23.2)
Asian – East Asian Heritage, n (%)	0 (0)	1 (8.3)	1 (4.2)	25 (8.4)	23 (7.7)	48 (8.1)

HRV: Human Rotavirus Vaccine group; Placebo: Placebo group; N: Number of subjects tested for anti-PCV1 antibodies; n (%): number (percentage) of subjects in a given category.

* At first dose

Table 2. Seropositivity rates for anti-PCV1 antibody in sera collected before vaccination and 1–2 months after the second dose by study and overall.

			Seropositivity rates for anti-PCV1-antibody
						90% CI
Study	Group	Timing	N	n	%	LL	UL
Rota-005	HRV	Pre	7	0	0.0	0.0	34.8
		Post	7	0	0.0	0.0	34.8
	Placebo	Pre	4	0	0.0	0.0	52.7
		Post	4	0	0.0	0.0	52.7
Rota-023	HRV	Pre	105	1	1.0	0.0	4.4
		Post	105	1	1.0	0.0	4.4
	Placebo	Pre	105	0	0.0	0.0	2.8
		Post	105	1	1.0	0.0	4.4
Rota-028	HRV	Pre	1	0	0.0	0.0	95.0
		Post	1	0	0.0	0.0	95.0
	Placebo	Pre	1	0	0.0	0.0	95.0
		Post	1	0	0.0	0.0	95.0
Rota-029	HRV	Pre	24	0	0.0	0.0	11.7
		Post	24	0	0.0	0.0	11.7
	Placebo	Pre	25	0	0.0	0.0	11.3
		Post	25	0	0.0	0.0	11.3
Rota-036	HRV	Pre	121	0	0.0	0.0	2.4
		Post	121	1	0.8	0.0	3.9
	Placebo	Pre	121	0	0.0	0.0	2.4
		Post	121	0	0.0	0.0	2.4
Rota-054	HRV	Pre	41	0	0.0	0.0	7.0
		Post	41	1	2.4	0.1	11.1
	Placebo	Pre	41	0	0.0	0.0	7.0
		Post	41	0	0.0	0.0	7.0
Overall	HRV	Pre	299	1	0.3	0.0	1.6
		Post	299	3	1.0	0.3	2.6
	Placebo	Pre	297	0	0.0	0.0	1.0
		Post	297	1	0.3	0.0	1.6

HRV: Human Rotavirus Vaccine group; Placebo: Placebo group; N: total number of samples; n/%: number / percentage of samples in a given category; 90% CI: 90% confidence interval; LL: lower limit; UL: upper limit.

Table 3. Overview of clinical studies included in this retrospective analysis.

Study ID (NCT number)	Phase	Location	Population (Schedule)	Blood sample collection time points	Study groups	Reference
ROTA-005 (NCT00729001)	II	USA, Canada	Healthy infants (2, 4 months)	Pre-vaccination and 2 months post-dose 2	Lyophilized HRV 10^6.4 CCID50 Lyophilized HRV 10^5.2 CCID50 Placebo	Dennehy et al. 2005
ROTA-023 (NCT00140673)	III	Argentina, Brazil, Chile, Columbia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru, Venezuela, Finland	Healthy infants (2, 3–4 months)	Pre-vaccination and 1–2 months post-dose 2	Lyophilized HRV 10^6.5 CCID50 Placebo	Ruiz-Palacios et al. 2006
ROTA-028 (NCT00197210)	III	Singapore	Healthy infants (2, 3–4 months)	Pre-vaccination and 1–2 months post-dose 2	Lyophilized HRV 10^6.5 CCID50 Placebo	Phua et al. 2009
ROTA-029 (NCT00197210)	III	Hong Kong	Healthy infants (2, 3–4 months)	Pre-vaccination and 1–2 months post-dose 2	Lyophilized HRV 10^6.5 CCID50 Placebo	Phua et al. 2009
ROTA-036 (NCT00140686)	IIIb	Czech Republic, Finland, France, Germany, Italy, Spain	Healthy infants (2–3, 3–5 months)	Pre-vaccination and 2 months post-dose 2	Lyophilized HRV 10^6.5 CCID50 Placebo	Vesikari et al. 2007
ROTA-054 (NCT00420745)	IIIb	France, Portugal, Spain, Poland	Pre-term infants (6, 10/14 weeks)	Pre-vaccination and 1–2 months post-dose 2	Lyophilized HRV ≥10^6.0 CCID50 Placebo	Omenaca et al. 2012

HRV: Human Rotavirus Vaccine; CCID₅₀: median cell culture infective dose (quantity of virus causing infection in 50% of exposed cells)

Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH, Jr., Innis BL, Rathfon H, Schuind A, De Vos B. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J 2005; 24:481-8; PMID:15933555; http://dx.doi.org/10.1097/01.inf.0000164763.55558.71

 PubMed Web of Science ®Google Scholar

Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354:11-22; PMID:16394298; http://dx.doi.org/10.1056/NEJMoa052434

 PubMed Web of Science ®Google Scholar

Phua KB, Lim FS, Lau YL, Nelson EA, Huang LM, Quak SH, Lee BW, Teoh YL, Tang H, Boudville I, et al. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine 2009; 27:5936-41; PMID:19679216; http://dx.doi.org/10.1016/j.vaccine.2009.07.098

 PubMed Web of Science ®Google Scholar

Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet 2007; 370:1757-63; PMID:18037080; http://dx.doi.org/10.1016/S0140-6736(07)61744-9

 PubMed Web of Science ®Google Scholar

Omenaca F, Sarlangue J, Szenborn L, Nogueira M, Suryakiran PV, Smolenov IV, Han HH. Safety, reactogenicity and immunogenicity of the human rotavirus vaccine in preterm European Infants: a randomized phase IIIb study. Pediatr Infect Dis J 2012; 31:487-93; PMID:22228231; http://dx.doi.org/10.1097/INF.0b013e3182490a2c

 PubMed Web of Science ®Google Scholar