Inactivated Severe Acute Respiratory Syndrome Research Articles

Comprehensive evaluation of inactivated SARS-CoV-2 vaccination on sperm parameters and sex hormones.

The inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has made significant contributions to fighting the epidemic in the past three years. However, the rapid development and application raised concerns about its safety in reproductive health, especially after several studies had observed a decrease in semen parameters following two doses of mRNA SARS-CoV-2 vaccination. Thus, it is necessary to comprehensively evaluate the effect of inactivated SARS-CoV-2 vaccine on male fertility. A retrospective cohort study was conducted in the Center for Reproductive Medicine of the Affiliated Hospital of Jining Medical University between July 2021 and March 2023.A total of 409 men with different vaccination status and no history of SARS-CoV-2 infection were included in this study. Their sex hormone levels and semen parameters were evaluated and compared separately. The levels of FSH and PRL in one-dose vaccinated group were higher than other groups, while there were no significant changes in other sex hormone levels between the control and inactivated SARS-CoV-2 vaccinated groups. Most semen parameters such as volume, sperm concentration, total sperm count, progressive motility and normal forms were similar before and after vaccination with any single dose or combination of doses (all P > 0.05). Nevertheless, the total motility was significantly decreased after receiving the 1+2 doses of vaccine compared to before vaccination (46.90 ± 2.40% vs. 58.62 ± 2.51%; P = 0.001). Fortunately, this parameter was still within the normal range. Our study demonstrated that any single dose or different combined doses of inactivated SARS-CoV-2 vaccination was not detrimental to male fertility. This information could reassure men who want to conceive after vaccination and be incorporated into future fertility recommendations.

Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Patients with Rheumatic Diseases and Serum Antibody Changes Post-Omicron Variant Infection.

The purpose of this study was to investigate whether the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has a similar effectiveness and safety profile in patients with rheumatic and musculoskeletal diseases (RMDs) and healthy controls (HCs). Between August 10, 2021 and September 30, 2021, 134 HCs and 269 patients with RMDs were recruited. All participants who tested negative for COVID-19 were vaccinated with SARS-CoV-2 inactivated vaccine. Next, 150 patients with RMDs and 30 HCs infected with the SARS-CoV-2 Omicron variant within the previous 12weeks were recruited between February 20, 2023 and March 1, 2023. Serum samples were collected from each participant, and the serum immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody titers against SARS-CoV-2 were determined using a chemiluminescence assay. No statistically significant difference was found in the titer of anti-SARS-CoV-2 IgG and IgM antibodies, or in the incidence of vaccination-related adverse events between the RMD and HC groups (P = 0.183, P = 0.903, and P = 0.27, respectively). Serum IgG titers of SARS-CoV-2 neutralizing antibodies were significantly higher in patients who received two or more doses of inactivated vaccine than in patients who were unvaccinated or had received one dose of vaccine (244.36 ± 109.79 vs. 66.20 ± 82.50; P < 0.001). SARS-CoV-2 inactivated vaccines have similar protective effects in HCs and patients with RMDs, with an appreciable safety profile. Fully vaccinated patients with RMDs infected with the Omicron variant were able to produce effective neutralizing antibody concentrations.

A third (booster) dose of the inactivated SARS-CoV-2 vaccine elicits immunogenicity and T follicular helper cell responses in people living with HIV.

This study sought to explore the immunogenicity of a booster dose of an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in people living with human immunodeficiency virus (HIV) and identify the factors affecting the magnitude of anti-SARS-CoV-2 antibody levels. A total of 34 people living with HIV (PLWH) and 34 healthy donors (HD) were administered a booster dose of the same SARS-CoV-2 vaccine. Anti-SARS-CoV-2 antibody and immunoglobulin G (IgG) levels were measured using the SARS-CoV-2 S protein neutralizing antibody Enzyme-Linked Immunosorbent Assay (ELISA) and 2019-nCov IgG Chemiluminescent Immunoassay Microparticles, respectively. Spearman correlation analysis was used to measure the correlation between laboratory markers and neutralizing antibody and IgG levels. Peripheral blood mononuclear cells (PBMCs) were extracted from each subject using density gradient centrifugation and the numbers of memory T and T follicular helper (Tfh) cells were determined using flow cytometry. PLWH had a marked reduction in CD4 and B cell levels that was accompanied by a lower CD4/CD8 T cell ratio. However, those who received a supplementary dose of inactivated SARS-CoV-2 vaccines exhibited antibody positivity rates that were analogous to levels previously observed. The booster vaccine led to a reduction in IgG and neutralizing antibody levels and the amplitude of this decline was substantially higher in the PLWH than HD group. Correlation analyses revealed a strong correlation between neutralizing antibody levels and the count and proportion of CD4 cells. Anti-SARS-CoV-2 IgG antibody levels followed a similar trend. The expression of memory T and Tfh cells was considerably lower in the PLWH than in the HD group. PLWH had an attenuated immune response to a third (booster) administration of an inactivated SARS-CoV-2 vaccine, as shown by lower neutralizing antibody and IgG levels. This could be attributed to the reduced responsiveness of CD4 cells, particularly memory T and cTfh subsets. CD4 and cTfh cells may serve as pivotal markers of enduring and protective antibody levels. Vaccination dose recalibration may be critical for HIV-positive individuals, particularly those with a lower proportion of CD4 and Tfh cells.

Comprehensive evaluation of the effect of inactivated SARS-CoV-2 vaccination on female fertility: A retrospective cohort study.

Fear of possible negative effects of coronavirus disease 2019 (COVID-19) vaccine on fertility is the main reason for vaccine hesitancy among the public especially women of childbearing age. Despite the high coverage of COVID-19 vaccination in China, more scientific evidence is still needed to address their concerns and guide fertility counseling and management in the future. Herein, we performed a retrospective cohort study at a single large center for reproductive medicine in China between August 2020 and May 2023. Patients aged 20-42 years with no history of laboratory-confirmed COVID-19 were included and categorized into different groups according to their vaccination status. The serum sex hormone levels, anti-Müllerian hormone concentrations, embryo quality, and pregnancy outcomes were evaluated and compared among them. We found there were no significant differences in the concentrations of follicle-stimulating hormone, luteinizing hormone and progesterone between the unvaccinated, first-dose, second-dose, and booster vaccinated groups. However, the estradiol showed a highly significant increase in the one-dose vaccinated group compared with its levels in other groups. Among unvaccinated and either vaccinated patients, anti-Müllerian hormone levels were comparable (p = 0.139). The number of oocytes retrieved, fertilization rate and good-quality embryo rate were all similar between each group of in vitro fertilization and intracytoplasmic sperm injection. No significant differences were observed regarding other laboratory parameters. Moreover, the vaccination status of infertile couples did not exert any adverse effect on the pregnancy outcomes in all assisted reproductive technologies cycles. In short, we comprehensively evaluated the reproductive safety of inactivated severe acute respiratory syndrome coronavirus 2 vaccine and found any dose of vaccination wouldn't negatively affect female fertility parameters such as sex hormone levels and ovarian reserve. Moreover, this is the first study to complete the live birth follow-up of the cohort after receiving inactivated severe acute respiratory syndrome coronavirus 2 vaccine, further dispelling the misconception and providing reassurance for decision-making by clinicians.

Short-term safety of inactivated SARS-Cov-2 vaccines in Chinese patients with central nervous system inflammatory demyelinating diseases

ObjectiveThis study aims to evaluate the short-term safety of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in Chinese patients with central nervous system inflammatory demyelinating diseases (CNS IDDs). MethodsA web-based survey was conducted among patients with CNS IDDs from April 15 to 19, 2022 in China. In total, 645 patients with CNS IDDs were identified, including 425 patients with multiple sclerosis (MS), 194 with neuromyelitis optica spectrum disorder (NMOSD), and 26 with other CNS IDDs. The questionnaire consisted of demographic data, clinical records, history of SARS-CoV-2 vaccination, and vaccination-related symptoms within one month after vaccination. The demographic data, clinical information, and relapse rates between vaccinated and non-vaccinated patients were compared. ResultsAmong 645 patients with CNS IDDs, 78 were vaccinated and 567 were non-vaccinated with the vaccination rate of 12.1 %. Compared to non-vaccinated group, a lower percentage of patients on DMDs therapy (41.0 % vs. 71.8 %, P < 0.001) and an increased proportion of patients with other vaccination in past 3 years (17.9 % vs. 4.8 %, P < 0.001) were observed in vaccinated group. Six patients experienced a relapse within 30 days of a vaccination. Additionally, vaccine-associated relapse rates in vaccinated patients did not significantly differ from these in non-vaccinated patients among 2020, 2021, and from January 1 to October 1, 2022. ConclusionsNo increased risk of vaccination-associated relapses among Chinese patients with CNS IDDs indicated that inactivated SARS-CoV-2 vaccines appear to be safe for this population.

Study of efficacy and antibody duration to fourth-dose booster of Ad5-nCoV or inactivated SARS-CoV-2 vaccine in Chinese adults: a prospective cohort study.

China experienced a record surge of coronavirus disease 2019 cases in December 2022, during the pandemic. We conducted a randomized, parallel-controlled prospective cohort study to evaluate efficacy and antibody duration after a fourth-dose booster with Ad5-nCoV or inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. A total of 191 participants aged ≥18 years who had completed a three-dose regimen of the inactivated SARS-CoV-2 vaccine 6 months earlier were recruited to receive the intramuscular Ad5-nCoV booster or the inactivated SARS-CoV-2 vaccine. TheAd5-nCoV group had significantly higher antibody levels compared with the inactivated vaccine group at 6 months after the fourth vaccination dose. After the pandemic, the breakthrough infection rate for the Ad5-nCoV and the inactivated vaccine groups was 77.89% and 78.13%, respectively. Survival curve analysis (p = 0.872) and multivariable logistic regression analysis (p = 0.956) showed no statistically significant differences in breakthrough infection between the two groups. Compared with a homologous fourth dose, a heterologous fourth dose of Ad5-nCoV elicited a higher immunogenic response in healthy adults who had been immunized with three doses of inactivated vaccine. Nevertheless, the efficacy of the two vaccine types was equivalent after the pandemic.

Nanoadjuvants Produced by Advanced Nanochelating Technology in the Inactivated-Severe Acute Respiratory Syndrome Coronavirus-2 Vaccine Formulation: Preliminary Results on Cytokines and IgG Responses.

Despite the great success of vaccines in various infectious diseases, most current vaccines are not effective enough, and on the contrary, clinically approved alum adjuvants cannot induce sufficient immune responses, including a potent cellular immune response to confer protection. In this study, we used Nanochelating Technology to develop novel nanoadjuvants to boost the potency of the alum-adjuvanted inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine. BALB/c mice were immunized twice over 2 weeks with different doses of adjuvanted-vaccine formulations and immune responses were assessed. The analysis results of IFN-γ and IL-17 cytokines demonstrated the effectiveness of the nanoadjuvants produced by the Nanochelating Technology in shifting the alum-based vaccine toward a stronger Th1 pattern. In addition, these nanoadjuvants improved IL-2 cytokine response, which shows the efficacy of these novel formulations in inducing specific T lymphocyte proliferation. Using these nanoadjuvants increased IL-10 cytokine secretion that may be representative of a better immunoregulatory impact and may also potentially prevent immunopathology responses. Moreover, specific IgG titer analysis revealed the potency of these nanoadjuvants in improving humoral immune responses. The enzyme-linked immunosorbent assay of receptor-binding domain (RBD)-specific IgG response showed that the developed novel formulations induced strong IgG responses against this protein. This study shows that the nanostructures produced by the Advanced Nanochelating Technology have potent adjuvant effects on alum-based SARS-CoV-2 vaccines to not only compensate for alum weakness in inducing the cellular immune responses by smart regulation of the immune system but also significantly improve the humoral and cellular immune responses simultaneously.

Vaccination against coronavirus disease 2019 in patients with pulmonary hypertension: A national prospective cohort study.

Coronavirus disease 2019 (COVID-19) has potential risks for both clinically worsening pulmonary hypertension (PH) and increasing mortality. However, the data regarding the protective role of vaccination in this population are still lacking. This study aimed to assess the safety of approved vaccination for patients with PH. In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) were enrolled from October 2021 to April 2022. The primary outcome was the composite of PH-related major adverse events. We used an inverse probability weighting (IPW) approach to control for possible confounding factors in the baseline characteristics of patients. In total, 706 patients with PH participated in this study (mean age, 40.3 years; mean duration after diagnosis of PH, 8.2 years). All patients received standardized treatment for PH in accordance with guidelines for the diagnosis and treatment of PH in China. Among them, 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. None of the participants were infected with COVID-19 during our study period. Overall, 398 patients received inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine, whereas 30 received recombinant protein subunit vaccine. After adjusting for baseline covariates using the IPW approach, the odds of any adverse events due to PH in the vaccinated group did not statistically significantly increase (27/428 [6.3%] vs. 24/278 [8.6%], odds ratio = 0.72, P = 0.302). Approximately half of the vaccinated patients reported at least one post-vaccination side effects, most of which were mild, including pain at the injection site (159/428, 37.1%), fever (11/428, 2.6%), and fatigue (26/428, 6.1%). COVID-19 vaccination did not significantly augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.

P-518 The effect of inactivated SARS-CoV-2 vaccination on the outcome of the first frozen-thawed embryo transfer cycle

Abstract Study question Is there an effect of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination on the outcome of the first frozen-thawed embryo transfer(FET) cycle. Summary answer Inactivated SARS-CoV-2 vaccination did not affect the outcome of the first FET cycle, including clinical pregnancy rate, early miscarriage rate and newborns’ birth weight. What is known already SARS-CoV-2 vaccination can significantly reduce the risk of severe disease and death after SARS-CoV-2 infection. However, due to the lack of vaccine safety data, the infertile population who plan to undergo ART treatment have high concerns about the safety of vaccine vaccination. To date, there are merely few researches aimed to determine the impact of inactivated SARS-CoV-2 vaccination on reproductive and neonatal outcomes of women attempting FET. Study design, size, duration This was a retrospective cohort study of patients who underwent the first FET cycle in the Reproductive Center of Ningbo Women and Children Hospital from November 1st 2021 to December 19th 2022. All patients were followed up until January 19th 2023. Patients whose age was &amp;gt;40 years old were excluded. The patients were organized into groups based on age, anti-Müllerian hormone (AMH) levels, antral follicle count (AFC), body mass index (BMI), and vaccination or not. Participants/materials, setting, methods Patients fully vaccinated with two doses of Sinopharm or Sinovac inactivated vaccines(Group A, n = 452) were compared with unvaccinated patients(Group B, n = 452) who were matched by age, AMH, AFC and BMI. The baseline characteristics and clinical outcomes of each group were compared.SPSS version 26.0 (SPSS Inc., USA) was used for all data analyses. Main results and the role of chance There were no statistically significant differences in age, AMH, AFC, BMI, infertility duration, infertility type, infertility causes, fertilization type, ovarian stimulation protocol, number of oocytes retrieved(9.24 vs 9.92, p = 0.102), endometrial preparation protocol, endometrial thickness(9.40 vs 9.29mm, p = 0.344), embryo stage, number of embryos for transfer(1.4 vs 1.42, p = 0.589) between two groups. No difference was found between vaccinated and unvaccinated patients in clinical pregnancy rate(55.31% vs 57.52%, p = 0.502), early miscarriage rate(10.4% vs 11.54%, p = 0.681). The newborns’ birth weight were comparable between two groups(2971.44 vs 3156.83g, p = 0.66). Limitations, reasons for caution This is a single-center retrospective study and further accumulated data is warranted to validate the findings. Because of the short follow-up time, some patients are still pregnant, hence we await live birth outcomes. Wider implications of the findings These findings contribute to the evidence regarding the reproductive safety of inactivated SARS-CoV-2 vaccination for fertility-seeking women, and it can provide further theoretical reassurance for doctors and patients to vaccinate before pregnancy. Trial registration number not applicable

Antibody response and safety of inactivated SARS-CoV-2 vaccines in chronic hepatitis B patients with and without cirrhosis.

The immune response and safety of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines among patients with chronic hepatitis B (CHB), especially those with cirrhosis, are not clear. Therefore, this study was conducted to evaluate the efficacy and safety of inactivated SARS-CoV-2 vaccines among CHB patients with and without cirrhosis. A total of 643 CHB patients who received two doses of inactivated SARS-CoV-2 vaccines (BBIBP-CorV and CoronaVac) were enrolled. Serum samples were collected and tested for SARS-CoV-2 S-receptor-binding domain (S-RBD) immunoglobulin G (IgG) at enrollment. Data on adverse events (AEs) within 7days after the second dose were obtained using a questionnaire. A total of 416 non-cirrhotic and 227 cirrhotic patients were included in the analysis. Cirrhotic patients had lower antibody titers than non-cirrhotic patients after adjusting for age, sex, and time interval (2.45 vs. 2.60ng/ml, p=0.034). Furthermore, the study revealed that cirrhotic patients demonstrated a slower rate of seropositivity increase, with the highest rate being recorded at week4 and reaching 94.7%. On the other hand, among non-cirrhotic patients, the seropositivity rate peak was observed at week2 and reached 96.0%. In addition, cirrhotic patients displayed a more rapid decline in the seropositivity rate, dropping to 54.5% after ≥16weeks, while non-cirrhotic patients exhibited a decrease to 67.2% after the same time period. The overall incidence of AEs was low (18.4%), and all AEs were mild and self-limiting. In addition, 16.0% of participants had mild liver function abnormalities, and half of them returned to normality within the next 6months without additional therapy. The participants who experienced liver function abnormalities showed a higher seropositivity rate and antibody titer than those who did not (91.6% vs. 79.5%, p=0.005; 2.73 vs. 2.41ng/ml, p<0.001). Cirrhotic CHB patients had lower antibody titers to inactivated SARS-CoV-2 vaccines than non-cirrhotic patients. The vaccines were generally well tolerated in both non-cirrhotic and cirrhotic CHB patient groups. Patients with abnormal liver function may have a better antibody response than those without.

Immunodominant SARS-CoV-2-specific CD4+ and CD8+ T-cell responses elicited by inactivated vaccines in healthy adults.

Safety profiles and humoral responses to inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines have been previously assessed, but cellular immune responses to inactivated SARS-CoV-2 vaccines remain understudied. Here, we report the comprehensive characteristics of SARS-CoV-2-specific CD4+ and CD8+ T-cell responses elicited by the BBIBP-CorV vaccine. A total of 295 healthy adults were recruited, and SARS-CoV-2-specific T-cell responses were detected after stimulation with overlapping peptide pools spanning the entire length of the envelope (E), membrane (M), nucleocapsid (N), and spike (S) proteins. Robust and durable CD4+ (p < 0.0001) and CD8+ (p < 0.0001) T-cell responses specific to SARS-CoV-2 were detected following the third vaccination, with an increase in specific CD8+ T-cells, compared to CD4+ T-cells. Cytokine profiles showed that interferon gamma and tumor necrosis factor-α were predominantly expressed with the negligible expression of interleukin (IL)-4 and IL-10, indicating a Th1- or Tc1-biased response. Compared to E and M proteins, N and S activated a higher proportion of specific T-cells with broader functions. The predominant frequency of the N antigen (49/89) was highest for CD4+ T-cell immunity. Furthermore, N19-36 and N391-408 were identified to contain dominant CD8+ and CD4+ T-cell epitopes, respectively. In addition, N19-36 -specific CD8+ T-cells were mainly effector memory CD45RA cells, whereas N391-408 -specific CD4+ T-cells were mainly effector memory cells. Therefore, this study reports comprehensive features of T-cell immunity induced by the inactivated SARS-CoV-2 vaccine BBIBP-CorV and proposes highly conserved candidate peptides which may be beneficial in vaccine optimization.

Efficacy, Immunogenicity, and Safety of the Two-Dose Schedules of TURKOVAC versus CoronaVac in Healthy Subjects: A Randomized, Observer-Blinded, Non-Inferiority Phase III Trial.

We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18-55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or CoronaVac at Day 0 and Day 28, both of which are 3 μg/0.5 mL of inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) adsorbed to aluminum hydroxide. The primary efficacy outcome was the prevention of polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) at least 14 days after the second dose in the modified per-protocol (mPP) group. Safety analyses were performed in the modified intention-to-treat (mITT) group. Between 22 June 2021 and 7 January 2022, 1290 participants were randomized. The mITT group consisted of 915 participants, and the mPP group consisted of 732 participants. During a median follow-up of 90 (IQR 86-90) days, the relative risk reduction with TURKOVAC compared to CoronaVac was 41.03% (95% CI 12.95-60.06) for preventing PCR-confirmed symptomatic COVID-19. The incidences of adverse events (AEs) overall were 58.8% in TURKOVAC and 49.7% in CoronaVac arms (<i>p</i> = 0.006), with no fatalities or grade four AEs. TURKOVAC was non-inferior to CoronaVac in terms of efficacy and demonstrated a good safety and tolerability profile.

Bullous Pemphigoid After Vaccination With the Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine: Two Cases in China

BACKGROUND: Coronavirus disease-2019 (COVID-19) led to a global pandemic in March 2020 that has involved tens of millions of people. To date, prophylactic vaccines have been found to be the most effective method to contain the pandemic. Bullous pemphigoid (BP) is an autoimmune skin disease that mainly affects older individuals. CASE REPORTS: The authors report 2 confirmed cases of BP in patients with history of cerebral infarction who received the inactivated severe acute respiratory syndrome coronavirus 2 vaccine. A 67-year-old woman was hospitalized for a generalized rash that appeared 7 days after the first dose of inactivated COVID-19 vaccine. The rash was aggravated after the second dose. The second patient was a 66-year-old woman who was hospitalized for a generalized rash that appeared 10 days after the first dose of inactivated COVID-19 vaccine. There were no abnormalities in the baseline blood tests. Laboratory and histologic examinations confirmed the diagnosis of BP. The patients were treated with systemic glucocorticoids, antibiotics, topical corticosteroids, and emollients, which resulted in a significant reduction in pruritus and regression of lesions after 2 weeks. CONCLUSION: Two patients with a genetic background of HLA-DQB1*0302 had BP after vaccination in China. However, there is not enough evidence to indicate a requirement for genetic screening before receiving inactivated severe acute respiratory syndrome coronavirus 2 vaccines.

Characterization of the Intestinal Microbiome in Healthy Adults over Sars-Cov-2 Vaccination.

In response to the outbreak of coronavirus disease 2019 (COVID-19) worldwide, inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are implemented. Dysbiosic gut microbiota is implicated in the COVID-19 patients. Whereas, how intestinal microbiota are affected by vaccination remains elusive, and it is important to investigate the microbial shifts during vaccines treatment. In the present study, we assessed the gut microbial composition in healthy adults, and performed comparison before and post an inactivated SARS-CoV-2 vaccine candidate, BBIBP-CorV vaccination. Microbial diversity in shannon, pielou evenness, simpson and invsimpson index was remarkably suppressed by vaccination. Ruminococcus and Actinomyces were observed to be strikingly deficient, and Faecalibacterium was dramatically augmented after BBIBP-CorV treatment. Potential functional profiles of gut microbiome in amino acid metabolism, lipid biosynthesis proteins and steroid biosynthesis were remarkably increased, while the capacity in renin-angiotensin system was remarkably decreased following vaccines. Our study suggests that inactivated BBIBP-CorV against SARS-CoV-2 could elicit modulations on gut microbial composition and functions, which might favor host immune response and protect from COVID-19.

Safety and Adverse Effects of Inactive SARS-Cov-2 Vaccine (CoronaVac) in Health Care Professionals.

To assess adverse effects post-vaccination in healthcare professionals in the first vaccinated group against coronavirus disease-2019. The retrospective study was conducted at the Indus Hospital, Badin, The prospective study was conducted at the vaccination unit of a university hospital in Tekirdag, Turkey, from January to February 2021, and comprised healthcare professionals who came for receiving the second dose of the coronavirus disease-2019 inactivated severe acute respiratory syndrome coronavirus 2 vaccine 28 days after the first dose. Data was analysed using SPSS 18. Of the 1088 subjects, 714(65.6%) were female with mean age 29.85±9.2 years and 374(34.4%) were male with mean age 29.57±9.85 years. Overall, local pain in the vaccinated area 495(45.5%), fatigue 266(24.4%), headache 261(23.9%) and muscle pain 197(18.1%) were very common adverse effects. Inactivated severe acute respiratory syndrome coronavirus 2 vaccine was found to be safe.

Immunogenicity and immune-persistence of the CoronaVac or Covilo inactivated COVID-19 Vaccine: a 6-month population-based cohort study.

BackgroundOwing to the coronavirus disease 2019 (COVID-19) pandemic and the emergency use of different types of COVID-19 vaccines, there is an urgent need to consider the effectiveness and persistence of different COVID-19 vaccines.MethodsWe investigated the immunogenicity of CoronaVac and Covilo, two inactivated vaccines against COVID-19 that each contain inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The levels of neutralizing antibodies to live SARS-CoV-2 and the inhibition rates of neutralizing antibodies to pseudovirus, as well as the immunoglobulin (Ig)G and IgM responses towards the spike (S) and nucleocapsid (N) protein of SARS-CoV-2 at 180 days after two-dose vaccination were detected.ResultsThe CoronaVac and Covilo vaccines induced similar antibody responses. Regarding neutralizing antibodies to live SARS-CoV-2, 77.9% of the CoronaVac vaccine recipients and 78.3% of the Covilo vaccine recipients (aged 18–59 years) seroconverted by 28 days after the second vaccine dose. Regarding SARS-CoV-2-specific antibodies, 97.1% of the CoronaVac vaccine recipients and 95.7% of the Covilo vaccine recipients seroconverted by 28 days after the second vaccine dose. The inhibition rates of neutralizing antibody against a pseudovirus of the SARS-CoV-2 Delta variant were significantly lower compared with those against a pseudovirus of wildtype SARS-CoV-2. Associated with participant characteristics and antibody levels, persons in the older age group and with basic disease, especially a chronic respiratory disease, tended to have lower anti-SARS-CoV-2 antibody seroconversion rates.ConclusionAntibodies that were elicited by these two inactivated COVID-19 vaccines appeared to wane following their peak after the second vaccine dose, but they persisted at detectable levels through 6 months after the second vaccine dose, and the effectiveness of these antibodies against the Delta variant of SARS-CoV-2 was lower than their effectiveness against wildtype SARS-CoV-2, which suggests that attention must be paid to the protective effectiveness, and its persistence, of COVID-19 vaccines on SARS-CoV-2 variants.

COVID-19 vaccine affects neither prothrombotic antibody profile nor thrombosis in primary anti-phospholipid syndrome: a prospective study.

ObjectiveTo explore whether inactivated coronavirus disease 2019 vaccine influences the profile of prothrombotic autoantibodies and induces thrombotic events in primary APS patients.MethodsWe enrolled 39 primary APS patients who received two doses of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (BBIBPCorV, Sinopharm, Beijing, China) voluntarily in this prospective cohort. Prothrombotic autoantibodies were determined before vaccination and 4 weeks after the second dose of vaccination. Thrombotic disorders were evaluated via hospital site visits and assessments.ResultsThere was no significant difference in the presence of all 11 autoantibodies detected before and 4 weeks after vaccination: for aCL, IgG (14 vs 16, P = 0.64), IgM (13 vs 19, P = 0.34), IgA (2 vs 3, P = 0.64); anti-β2GP1, IgG (12 vs 12, P = 1.00), IgM (5 vs 8, P = 0.36), IgA (4 vs 3, P = 0.69); anti-PS/PT IgG (13 vs 16, P = 0.48), IgM (17 vs 22, P = 0.26); LAC (22 vs 28, P = 0.16); aPF4-heparin (0 vs 0, P = 1.00) and ANA (23 vs 26, P = 0.48). Notably, the distribution of the aPL profile in the pre- and post-vaccination cohorts was not affected by SARS-CoV-2 vaccination: for patients with a low-risk aPL profile (11 vs 10, P = 0.799) and patients with a high-risk aPL profile (28 vs 29, P = 0.799), respectively. Furthermore, no case exhibited symptoms of the thrombotic disorder during a minimum follow-up period of 12 weeks. There was no adjustment to the ongoing treatment regimens following SARS-CoV-2 vaccination.ConclusionInactivated SARS-CoV-2 vaccine does not influence the profile of anti-phospholipid antibodies and anti-PF4-heparin antibodies nor induces thrombotic events in primary APS patients.

Clinical features of children with coronavirus disease 2019 Delta variant infection after vaccination with inactivated SARS-CoV-2 vaccine

To study the clinical features of children with coronavirus disease 2019 (COVID-19) Delta variant infection vaccinated or not vaccinated with inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. A total of 11 children with COVID-19 Delta variant infection who were vaccinated with inactivated SARS-CoV-2 vaccine and were hospitalized in the designated hospital in Henan Province, China, from November 3 to December 17, 2021 were enrolled as the vaccinated group. Thirty-one children with COVID-19 Delta variant infection who were not vaccinated and were hospitalized during the same period were enrolled as the unvaccinated group. A retrospective analysis was performed on their epidemiological data, clinical features, and laboratory examination results. There was no significant difference in gender composition and disease classification between the two groups (P>0.05), and there was also no significant difference in the incidence rates of the clinical symptoms such as cough, expectoration, and fever between the two groups (P>0.05). No significant difference was found between the two groups in leukocyte count, lymphocyte percentage, alanine aminotransferase, and serum creatinine (P>0.05). Compared with the unvaccinated group, the vaccinated group had significantly lower levels of aspartate aminotransferase, lactate dehydrogenase, and creatine kinase-MB (P<0.05). There was no significant difference between the two groups in the proportion of children with elevated C-reactive protein or procalcitonin and the levels of peripheral blood cytokines (P>0.05). The vaccinated group had significantly lower counts of B lymphocytes and total T lymphocytes (CD3+) than the unvaccinated group (P<0.05). Compared with the unvaccinated group, the vaccinated group had a significantly higher positive rate of IgG on admission and at week 2 of the course of disease (P<0.05), as well as a significantly higher Ct value of nucleic acid at weeks 1 and 2 of the course of disease (P<0.05). Vaccination with inactivated SARS-CoV-2 vaccine may reduce myocardial injury caused by SARS-CoV-2 Delta variant. For children with SARS-CoV-2 Delta variant infection after the vaccination, more attention should be paid to their immune function.

The Role of Vitamin D for Modulating the T Helper 1 Immune Response After the Coronavac Vaccination

The purpose of this study was to observe the role of vitamin D levels with T helper 1 (Th1)-type cytokines, such as interferon γ (IFN-γ) and interleukin-12 (IL-12) efficacy, in those who had already received 2 injections of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccines (CoronaVac). We also observed if these cytokines played any significance in the CoronaVac effectiveness for preventing coronavirus disease 2019 (Covid-19) infection. One hundred ninety-four volunteers were monitored for 8 months upon receiving 2 inactivated SARS-CoV2 vaccination injections (CoronaVac, Sinovac Life Sciences). The rate of confirmed Covid-19 infections was the primary outcome. Six to 7 weeks after the second vaccine injection, and blood samples were obtained to measure the serum vitamin D, IFN-γ, and IL-12 levels. Low vitamin D level was defined if vitamin D level <30 ng/mL. Subjects with low vitamin D had lower IFN-γ and IL-12 levels (P = 0.04 and P = 0.04, respectively). The receiver operating characteristics curve analysis revealed that the area under curve for IFN-γ was 0.59, whereas IL-12 was 0.59 for predicting the low vitamin D levels. During follow-up, a higher incidence of Covid-19 infections was observed in subjects with low IFN-γ levels (P = 0.03). Kaplan-Meier survival analysis revealed that the cumulative hazard of confirmed Covid-19 cases was increased in subjects with low IFN-γ levels (log-rank test, P = 0.03). We concluded that lower vitamin D level was correlated with a lower Th1 immune response, whereas the adequate IFN-γ level was required to obtain better CoronaVac effectiveness.

Effectiveness of the CoronaVac Vaccine on Symptomatic COVID-19 Infection, Severe Disease, ICU/semi-ICU Admission, and Mortality in Samut Sakhon Province: a Test-Negative Case-Control Study

A mass vaccination campaign with the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine, CoronaVac, was implemented in Thailand during the early months of the COVID-19 pandemic. As the Delta variant became the dominant strain in the country, we aimed to evaluate the real-world effectiveness of this particular vaccine among adults in Samut Sakhon Province, Thailand. A test-negative case-control study was conducted from 1 Jun to 31 Jul 2021 to evaluate the effectiveness of CoronaVac against symptomatic COVID-19 infection, severe disease, admission to intensive care unit (ICU)/semi-ICU and mortality. We estimated odds ratios using multiple logistic regression. Among 11,371 participants included in the study, 3,116 (27.4%) tested positive for COVID-19 and 3,333 (29.3%) completed two doses of vaccine. The adjusted vaccine effectiveness of two-dose CoronaVac was 65.8% (95% confidence interval (CI) 61.9 – 69.3) for the prevention of symptomatic infection, 71.8% (95% CI 58.5 – 81.6) for severe disease, 72.7% (95% CI 56.6 – 83.9) for ICU/semi-ICU admission and 86.7% (95% CI 34.8 – 99.3) for mortality. Results of this study demonstrate that CoronaVac had moderate effectiveness against symptomatic COVID-19 infection, while it was effective in preventing severe disease, ICU/semi-ICU admission and COVID-19 related deaths in a setting where the two variants were circulating.