A review of epidemic preparedness for influenza through local vaccine production: national security for Thailand

Figures & data

Table 1. Baseline characteristics of screen-failed and enrolled participants in the phase II trial conducted in Thailand

	Enrolled fail	Enrolled participants
	(N = 104)	(N = 152)
Personal data	n (%)	n (%)	P-value
Sex
– Male	42(40.38%)	60(39.47%)	0.884
– Female	62(59.62%)	92(60.53%)
Age (years)
– Mean ± SD	31.20 ± 9.00	31.27 ± 8.54	0.948
Height (cm.)
– Mean ± SD	162.3 ± 8.46	162.1 ± 7.93	0.893
Weight (kg.)
– Mean ± SD	61.53 ± 13.69	58.98 ± 9.36	0.102

Figure 1. Adverse events by systemic organ classes (%by each group) either receiving H5N2 LAIV vaccine or placebo

Figure 2. Systemic reactions (%) after 1st and 2nd immunization with H5N2 LAIV vaccine or placebo

Table 2. Comparing seroconversion rates of 4 fold-rising between previously vaccinated with LAIV H5N2 and naïve subjects by hemagglutinin-inhibition assay (HAI) at day 1, 7, 28 and 90 (Test Virus: A/17turkey/05/133 (H5N2))

Day	Group		4-fold rising N (%)
Day 1	Vaccinated (N = 40)		0(0.00)
	Naïve (N = 20)		0(0.00)
		p- vale = -[3]
Day 7	Vaccinated (N = 40)		39(97.50)
	Naïve (N = 20)		3(15.00)
		p- vale = <0.0001 [2]α
Day 28	Vaccinated (N = 40)		40(100.00)
	Naïve (N = 20)		14(70.00)
		p- vale = <0.0008 [1]α
Day 90	Vaccinated (N = 40), (n = 39)		39(97.50)
	Naïve (N = 20)		15(75.00)
		p- vale = <0.0031 [1]α

SID 93014 in previously vaccinated with LAIV H5N2 group got missing data at day 90 both in HIA and micro NT.

[1] Overall p-value (2-sided) based on Fisher’s exact test.

[2] Overall p-value (2-sided) based on Chi-square test.

[3] No statistic was considered.

- Intention to Treat (ITT)

α – significant difference

Table 3. Comparing seroconversion rates of 4 fold rising between previously vaccinated with LAIV H5N2 and naïve subjects by hemagglutinin-inhibition assay (HAI) at day 1, 7, 28 and 90 (Test virus: rg-H5N1-KAN-1)

Day	Group		4-fold rising N (%)
Day 1	Vaccinated (N = 40)		0(0.00)
	Naïve (N = 20)		0(0.00)
		p- vale = -[3]
Day 7	Vaccinated (N = 40)		35(87.50)
	Naïve (N = 20)		0(0.00)
		p- vale = <0.0001 [2]
Day 28	Vaccinated (N = 40)		40(100.00)
	Naïve (N = 20)		3(15.00)
		p- vale = <0.0001 [2]
Day 90	Vaccinated (N = 40), (n = 39)		38(95.00)
	Naïve (N = 20)		4(20.00)
		p- vale = <0.0001 [1]

SID 93014 in previously vaccinated with LAIV H5N2 group got missing data at day 90 both in HIA and micro NT.

[1] Overall p-value (2-sided) based on Fisher’s exact test.

[2] Overall p-value (2-sided) based on Chi-square test.

[3] No statistic was considered.

- Intention to Treat (ITT)

Table 4. Geometric mean of immune response by previously vaccinated with LAIV H5N2 and naïve subjects

Antibody assay	Test virus	Study group	Day 1 GMT (95% CI)	Day 7 GMT (95% CI)	Day 28 GMT (95% CI)
HAI Assay	A17/turkey/Turkey/05/133	Previously vaccinated	3.92 (3.24, 4.75)	211.12 (134.45, 331.52)	566.89 (436.97, 735.44)
		Naïve	2.59 (2.41, 2.78)	3.66 (2.60, 5.15)	25.49 (11.82, 54.96)
		P – value = 0.0011^[5]α		< 0.0001^[5]α	< 0.0001^[5]α
	A/Thailand/1(KAN-1)/04	Previously vaccinated	2.59 (2.46, 2.72)	32.49 (22.01, 47.96)	98.49 (75.44, 128.58)
		Naïve	2.5 (-)	2.77 (2.46, 3.12)	5.18 (2.90, 9.25)
		P – value = 0.3254^[5]		< 0.0001^[5]α	< 0.0001^[5]α
Micro NT	A17/turkey/Turkey/05/133	Previously vaccinated	8.56 (6.48, 11.29)	528.93 (333.88, 837.91)	1,395.8 (1,040.8, 1,872.0)
		Naïve	2.68 (2.42, 2.96)	3.42 (2.47, 4.72)	17.41 (9.05, 33.48)
		P – value = < 0.0001^[5]α		< 0.0001^[5]α	< 0.0001^[5]α
	A/Thailand/1 (KAN-1)/04	Previously vaccinated	2.5 (-)	25.49 (17.90, 36.30)	52.78 (38.92, 71.57)
		Naïve	2.5 (-)	2.5 (-)	3.19 (2.50, 4.06)
		P – value = 1.0000^[5]		<0.0001^[5]α	<0.0001^[5]α

SID 93014 in previously vaccinated with LAIV H5N2 group got missing data at day 90 both in HIA and micro NT.

[4] Overall p-value (2-sided) based on Independence T-test.

[5] Overall p-value (2-sided) based on Wilcoxon rank sum test.

- Antibody titers were compared between study groups.

- Intention to Treat (ITT)

α – significant difference