Side effects and antibody response of an inactive severe acute respiratory syndrome coronavirus 2 vaccine among health care workers

Gümüş, Hatice Hale; Ödemiş, İlker; Alışka, Hikmet Eda; Karslı, Aslı; Kara, Sibel; Özkale, Murat; Gül, Eylem

doi:10.1590/1806-9282.20210755

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Original Article • Rev. Assoc. Med. Bras. 67 (12) • Dec 2021 • https://doi.org/10.1590/1806-9282.20210755 copy

Side effects and antibody response of an inactive severe acute respiratory syndrome coronavirus 2 vaccine among health care workers

Authorship SCIMAGO INSTITUTIONS RANKINGS

SUMMARY

OBJECTIVE:

This study aims to investigate the antibody response and the side effects of the two-dose inactive SARS-CoV-2 vaccine (CoronaVac, Sinovac, China) among a health care worker population in Turkey.

METHODS:

This study was a prospective, cross-sectional, single-center study conducted between December 16, 2020, and March 15, 2021. We evaluated the side effects from a questionnaire, and anti-spike immunoglobulin G response to the vaccine (0- and 28-day schedule) using an enzyme-linked immunosorbent assay.

RESULTS:

A total of 94 of 184 health care workers completed this study. The percentages of participants who were seronegative at baseline and achieved to the seropositivity were 21.3 and 97.9%, respectively, on day 21 after vaccinations. The seropositivity was predominantly detected in 31–45 years of the age group (55.4%, p=0.636), normal body mass index (47.8%, p=0.999), nonsmokers (64.1%, p=0.999), those without any comorbidities (73.9%, p=0.463), and those without any side effects (70.2%, p=0.256). The frequencies of overall side effects within seven days after the first and second doses of CoronaVac were 37.2 and 28.7%, respectively. The most common side effects was localized pain at the injection site (15.7 and 11.6%, respectively).

CONCLUSIONS:

We found that vaccination by two-dose CoronaVac could elicit a specific humoral response, and it was well tolerated in health care workers. The high seropositivity developed after the second dose attracted attention. Our study will be useful in terms of showing short-term immunity and side effects.

KEYWORDS:
COVID-19; Pandemics; Vaccine; Adverse events; Health personnel

Items		Results (n=94)
Age (years), mean values±SD (min–max)		41.0±7.74 (22–54)
Sex (F/M), n (%)		43/51 (45.7/54.3)
Weight (kg), mean values±SD		72.86±12.74
Height (cm), mean values (min–max)		170 (155–190)
BMI (kg/m²), mean values±SD		24.95±3.25
BMI groups, n (%)
	18.5–24.9 (Normal)	45 (47.9)
	25–29.9 (Preobesity)	42 (44.7)
	30–34.9 (Obesity)	7 (7.4)
Age groups, n (%)
	18–30	11 (11.7)
	31–45	53 (56.4)
	45–60	30 (31.9)
Comorbidities
	None	69 (68.3)
	Cardiovascular diseases	11 (10.9)
	Rheumatic diseases	2 (2.0)
	Endocrine diseases	9 (8.9)
	Autoimmune diseases	3 (3.0)
	Malignancy	3 (3.0)
	Other diseases^* * Other diseases include uveitis, seborrheic dermatitis, endometriosis, asthma, and migraine.	4 (4.0)
Smoking status, n (%)
	Non-smoker	60 (63.8)
	Smoker	34 (36.2)

		After the first dose of vaccine				After the second dose of vaccine				Ratio of antibody index value increase
		Negative	Borderline	Positive	p-value	Negative	Borderline	Positive	p-value	<4-fold	≥4-fold	p-value
Age groups (years), n (%)
	18–30	6 (9.0)	2 (28.6)	3 (15.0)	0.166^a a Fisher–Freeman–Halton test;	–	–	11 (12.0)	0.636^a a Fisher–Freeman–Halton test;	2 (11.8)	9 (11.7)	0.356^b b Pearson's χ² test.
	31–45	36 (53.7)	3 (42.9)	14 (70.0)		–	2 (100.0)	51 (55.4)		12 (70.6)	41 (53.2)
	45–60	25 (37.3)	2 (28.6)	3 (15.0)		–	–	30 (32.6)		3 (17.6)	27 (35.1)
Sex, n (%)
	Female	27 (40.3)	3 (42.9)	13 (65.0)	0.158^a a Fisher–Freeman–Halton test;	–	–	43 (46.7)	0.498^a a Fisher–Freeman–Halton test;	11 (64.7)	32 (41.6)	0.083^b b Pearson's χ² test.
	Male	40 (59.7)	4 (57.1)	7 (35.0)		–	2 (100.0)	49 (53.3)		6 (35.3)	45 (58.4)
BMI groups (kg/m²), n (%)
	18.5–24.9	31 (46.3)	4 (57.1)	10 (50.0)	0.932^a a Fisher–Freeman–Halton test;	–	1 (50.0)	44 (47.8)	0.999^a a Fisher–Freeman–Halton test;	9 (52.9)	36 (46.8)	0.128^b b Pearson's χ² test.
	25–29.9	30 (44.8)	3 (42.9)	9 (45.0)		–	1 (50.0)	41 (44.6)		5 (29.4)	37 (48.0)
	30–34.9	6 (8.9)	–	1 (5.0)		–	–	7 (7.6)		3 (17.6)	4 (5.2)
Smoking status, n (%)
	Non-smoker	41 (61.2)	4 (57.1)	15 (75.0)	0.555^a a Fisher–Freeman–Halton test;	–	1 (50.0)	59 (64.1)	0.999	13 (76.5)	47 (61.0)	0.276^b b Pearson's χ² test.
	Smoker	26 (38.8)	3 (42.9)	5 (25.0)			1 (50.0)	33 (35.9)		4 (23.5)	30 (39.0)
Comorbidities
	Negative	53 (79.1)	4 (57.1)	12 (60.0)	0.142^a a Fisher–Freeman–Halton test;	–	1 (50.0)	68 (73.9)	0.463	13 (76.5)	56 (72.7)	0.752^b b Pearson's χ² test.
	Positive	14 (20.9)	3 (42.9)	8 (40.0)		–	1 (50.0)	24 (26.1)		4 (23.5)	21 (27.3)
	Total	67 (100.0)	7 (100.0)	20 (100.0)		–	2 (100.0)	92 (100.0)		17 (100.0)	77 (100.0)
Comorbidities^* * Multiple response variables. Among the participants, 69 had none, 18 had only one, and seven had more than one coexisting condition. , n (%)
	Cardiovascular disease	6 (8.1)	3 (30.0)	2 (8.0)	0.007^a a Fisher–Freeman–Halton test;	–	1 (33.3)	10 (9.4)	0.015^a a Fisher–Freeman–Halton test;	1 (5.3)	10 (11.1)	0.680^b b Pearson's χ² test.
	Rheumatic disease	2 (2.7)	–	–		–	–	2 (1.9)		–	2 (2.2)
	Endocrine disease	7 (9.5)	–	2 (8.0)		–	1 (33.3)	8 (7.5)		1 (5.3)	8 (8.9)
	Autoimmune disease	1 (1.4)	–	2 (8.0)		–	–	3 (2.8)		1 (5.3)	2 (2.2)
	Malignancy		–	3 (12.0)		–	–	3 (2.8)		1 (5.3)	2 (2.2)
	Other diseases^ Other diseases include uveitis, seborrheic dermatitis, endometriosis, asthma, and migraine.	58 (78.4)	7 (70.0)	16 (64.0)		–	1 (33.3)	80 (75.5)		15 (78.9)	66 (73.3)
Side effects, n (%)
	None	45 (67.2)	4 (57.1)	10 (50.0)	0.381^a a Fisher–Freeman–Halton test;	–	1 (33.3)	66 (70.2)	0.256^a a Fisher–Freeman–Halton test;	14 (82.4)	53 (66.3)	0.222^b b Pearson's χ² test.
	Any local SEs	12 (17.9)	2 (28.6)	6 (30.0)		–	1 (33.3)	12 (12.8)		–	13 (16.3)
	Any systemic SEs	12 (17.9)	2 (28.6)	7 (35.0)		–	1 (33.3)	16 (17.0)		3 (17.6)	14 (17.5)

Side effects within seven days	After the first dose of vaccine n (%)	After the second dose of vaccine n (%)
None	59 (48.8)	67 (59.8)
Localized pain	19 (15.7)	13 (11.6)
Localized redness	–	1 (0.9)
Localized swelling	2 (1.7)	1 (0.9)
Weakness	10 (8.2)	4 (3.6)
Headache	13 (10.7)	12 (10.7)
Fever	–	1 (0.9)
Myalgia	5 (4.1)	5 (4.4)
Dyspnea	1 (0.8)	–
Nausea–vomiting	3 (2.5)	1 (0.9)
Arthralgia	3 (2.5)	3 (2.7)
Hypertension	2 (1.7)	2 (1.8)
Runny nose	2 (1.7)	1 (0.9)
Asthenia	1 (0.8)	1 (0.9)
Numbness, tingling in the left arm	1 (0.8)	–

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[1] *Corresponding author: hhaleag01@hotmail.com