A real-world study of BBIBP-CorV vaccine effectiveness in a Sri Lanka rural province.

Objective: Real-world studies assessing the effectiveness of the BBIBP-CorV vaccine in low and middle-income countries are limited. We evaluated the BBIBP-CorV vaccine's effectiveness in reducing COVID-19 symptomatic disease, hospitalisation, severe disease, and mortality during the third wave of the pandemic in Sri Lanka. Methods: We conducted a test-negative case-control study in North Central Province from May 2021 to February 2022. Evidence of vaccination was obtained from the national registry. The PCR-positive patients were cases, while negative individuals were controls. Adjusted vaccine effectiveness (aVE) was computed for fully, partially, and non-vaccinated groups in reducing symptomatic disease, hospitalisation, severe disease, and mortality. Results: Our study involved 3305 cases and 3418 controls. The overall aVE for preventing PCR-positive infection in fully vaccinated was 30·8 % (95 % CI:17·9-41·6). In fully vaccinated over 60 years, the overall aVE was 72·3 % (95 % CI: 49·7-84·8). Full vaccination with BBIBP-CorV is effective in reducing hospitalisation, severe COVID-19 disease, and death, with aVE rates of 70·3 % (95 % CI: 57·9-79·0), 88·9 % (95 % CI: 81·8-93·2), and 92·3 % (95 % CI: 84·8-96·1) respectively. Conclusion: Individuals who have received two doses of the BBIBP-CorV vaccine are protected against hospitalisation, severe COVID-19 disease, and death. Duration of protection against hospitalisation, severe COVID-19, and fatal COVID-19 sustained at least 121 days, with no sign of waning during that time.

Comparing the immunogenicity of COVID-19 infection and vaccination in pregnant women as measured by anti-S IgG.

BACKGROUND: Pregnancy is a critical time for women, making them more susceptible to infectious diseases like COVID-19. This study aims to determine the immunogenicity of COVID-19 in pregnant women who have been infected compared to those who have received the inactive COVID-19 vaccine. MATERIALS AND METHODS: In this retrospective cohort study, pregnant women who received the inactivated COVID-19 vaccine (Sinopharm) and those with a history of COVID-19 infection during pregnancy were studied. Participants who had experienced stillbirth, received different COVID-19 vaccines, or had intrauterine fetal death were excluded from the study. Overall, the study included 140 participants. The participants were divided into two groups of 70 participants - pregnant women who received the Sinopharm vaccine and pregnant women who had COVID-19 infection during pregnancy. Before delivery, blood samples were collected from all mothers to evaluate the maternal immunoglobulin G (IgG) level. Blood samples were also taken from the baby's umbilical cord during delivery to measure the newborn's IgG level. Additionally, blood samples were collected from babies whose mothers showed signs of acute infection to measure their IgM levels and evaluate vertical transmission. FINDINGS: The study found a significant relationship between the mean level of maternal IgG and umbilical cord IgG within the groups (P < 0.001). The highest levels of maternal IgG (2.50 ± 2.17) and umbilical cord IgG (2.43 ± 2.09) were observed in pregnant women with a previous COVID-19 infection and no history of vaccination (P < 0.001). Only one baby was born with a positive IgM, and this baby was born to a mother who showed signs of COVID-19 infection in the last five days of pregnancy. The mother was 28 years old, with a BMI of 33; it was her first pregnancy, and she gave birth to a male newborn at term. CONCLUSION: Administering an inactivated vaccine during pregnancy can generate immunity in both the mother and the child. However, the vaccine's immunity level may not be as potent as that conferred by COVID-19 infection during pregnancy. Nonetheless, the risk of vertical transmission of COVID-19 is considered minimal and can be classified as negligible.

BBIBP-CorV vaccine effectiveness against COVID-19 in patients aged 60 years and older during the Delta-dominant period in the Federation of Bosnia and Herzegovina, a test-negative case-control study.

COVID-19 vaccine uptake in the Federation of Bosnia and Herzegovina (FBiH) accelerated in the second half of 2021, with greater vaccine availability. In this study, we estimated the vaccine effectiveness (VE) of complete primary series BBIBP-CorV vaccine against COVID-19 in patients aged 60 years and older, during the Delta-dominant period, using a test-negative case-control design. Surveillance sites were 11 primary health care centers (PHC) collecting patient data from October 1, 2021, to January 4, 2022, retrospectively according to a common protocol. In total, we included 1711 participants in the analysis: 933 cases and 778 controls. Of the 933 cases, 508 (54.4 %) had mild and 425 (45.6 %) had moderate to severe disease presentation. We observed no effectiveness against mild COVID-19. Overall vaccine effectiveness was 65.0 % (95 %CI: 40.1-79.5) against moderate to severe COVID-19. In time since vaccination analysis, VE was 78.7 % (95 % CI: 54.8-89.9) in patients who received their last dose < 90 days before onset; 66.0 % (95 % CI: -0.5-88.5) in those 90-119 days before onset; 42.1 % (95 % CI: -88.6-82.3) in those 120-149 days before onset and 45.0 % (95 % CI: -94.0-84.4) in those ≥ 150 days before onset. In our study, two doses of BBIBP-CorV provided considerable protection against moderate to severe COVID-19 in older adults, highest within 3 months after second dose, during the Delta-dominant period. Point estimates declined thereafter, suggesting a need for additional doses.

Evaluating long-term antibody responses to booster doses of COVID-19 vaccines in the Pakistani population.

Background & Objective: Nearly 80 million of the Pakistani population received two doses of the BBIBP-CorV vaccine, against SARS-CoV-2, and 2.6 million people received heterologous booster doses up to February 2022. Our objective was to measure the long-term change of antibody titers in persons vaccinated with Pfizer-BioNTech COVID-19 following two doses of BBIBP-CorV. Methods: Serum specimens from forty-three participants were collected 4-8 weeks following two doses of BBIBP-CorV at the Indus Hospital & Health Network, Karachi. A second set of serum specimens were collected 2-12 months after Pfizer-BioNTech COVID-19 booster dose administration. Chemiluminescent Microparticle Immunoassay (CMIA, Abbott Alinity Quant), and the pseudotyped lentivirus antibody neutralization assay were performed on all specimens. The latter assay was reported as log half-maximal inhibitory concentrations (IC50), calculated using a nonlinear regression algorithm (log [inhibitor] versus normalized response variable slope) in Graph Pad Prism 9. Paired sample t-test was used to ascertain the statistical significance of the difference in means of antibody titers obtained before and after the booster vaccine doses. Results: Mean log10 values obtained with CMIA before and after the booster dose were 2.90 AU/mL and 3.87 AU/mL respectively, while the corresponding log10 IC50 values obtained through pseudotyped lentivirus antibody neutralization assay were 2.45 and 2.80. These differences were statistically significant with CMIA (p = <0.00001), but not with pseudotyped lentivirus antibody neutralization assay (p = 0.06318.). Conclusion: A heterologous booster dose with Pfizer-BioNTech COVID-19 vaccine following two doses of BBIBP results in increased total antibody titers, though neutralizing antibody titers may start to wane a few months after the booster dose.

SARS-CoV-2 specific antibody response after an mRNA vaccine as the third dose: Homologous versus heterologous boost.

The aim of this study was to evaluate immunogenicity and longevity of the humoral immune response within six months after the homologous (BNT162b2/BNT162b2) or heterologous (BBIBP-CorV/BNT162b2) third dose, and to assess breakthrough infections among vaccinees during the Omicron wave in Serbia. Serum samples were analyzed at four timepoints: five months after the primary series; three weeks, three months, and six months after the boost. IgG antibodies against the receptor-binding domain of the spike protein were detected using enzyme-linked fluorescence assay. Both homologous (n = 55) and heterologous group (n = 36) showed a highly significant increase in antibody concentrations (p < 0.001) three weeks after the boost. A moderate inverse correlation between the age of recipients and the antibody levels at three weeks post-boost was observed in the homologous group (p = 0.02, r = -0.37), while the same correlation was not significant for heterologous group (p = 0.55, r = -0.15). Heterologous group had significantly higher antibody concentrations than homologous group at three weeks (Median 851.4(IQR 766.6-894.1); 784.3(676.9-847.4); p = 0.03) and three months post-boost (766.6(534.8-798.9); 496.8(361.6-664.0); p < 0.001). However, a significant decline in antibody response over time was noted for both strategies. The overall incidence of breakthrough cases was estimated at 36.36% (20/55) for homologous, and 16.67% (6/36) for heterologous group, but none of them required hospitalization. Although observed incidence in the homologous group was more than double when compared to the heterologous group, this difference was not statistically significant, most likely due to the small sample size. In conclusion, waning immunity after inactivated vaccine can be recovered by BNT162b2 heterologous boost regardless of the age of recipients, and both boost strategies induced potent humoral immune response and protection against severe COVID-19 during the Omicron wave. However, as the observed incidence of breakthrough infections was higher in the homologous group, although non-significant, this finding could indicate an advantage of heterologous approach.

Safety and immunogenicity of the NVX-CoV2373 vaccine as a booster in adults previously vaccinated with the BBIBP-CorV vaccine.

This phase 3 observer-blind, randomized, controlled study was conducted in adults ≥18 years of age to assess the safety and immunogenicity of NVX-CoV2373 as a heterologous booster compared to BBIBP-CorV when utilized as a homologous booster. Approximately 1000 participants were randomly assigned in a 1:1 ratio to receive a single dose of NVX-CoV2373 or BBIBP-CorV after prior vaccination with 2 or 3 doses of BBIBP-CorV. Solicited adverse events (AEs) were collected for 7 days after vaccination. Unsolicited AEs were collected for 28 days following the booster dose and serious adverse and adverse events of special interest (AESI) were collected throughout the study. Anti-spike IgG and neutralizing antibodies against SARS-CoV-2 were measured at baseline, day 14, day 28, and day 180. The study achieved its primary non-inferiority endpoint and also demonstrated statistically higher neutralization responses when NVX-CoV2373 was utilized as a heterologous booster compared with BBIBP-CorV as a homologous booster. Both vaccines had an acceptably low reactogenicity profile, and no new safety concerns were found. Heterologous boosting with NVX-CoV2373 was a highly immunogenic and safe vaccine regimen in those previously vaccinated with BBIBP-CorV.

Immunogenicity Persistence of a Third-Dose Homologous BBIBP-CorV/CoronaVac Boosting Vaccination: A Prospective Open-Label Study.

The inactivated whole-virion severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has been widely used in a two-dose schedule, but with insufficient data on the immunogenicity of homologous BBIBP-CorV/CoronaVac boosting vaccination and too little follow-up to assess the duration of the immunogenic response. We prospectively evaluated the immunogenicity of a third-dose BBIBP-CorV/CoronaVac boosting vaccination, with neutralizing titers against wild type and Omicron assessed at the baseline (immediately before the booster dose), and days 14, 28, 98, and 174 post the third-booster. Of 182 volunteers screened, 165 were assessed eligible for enrolment. No moderate/severe adverse events were observed during the term of the study. From the baseline to day 174 post the third booster, neutralizing titers against wild type and Omicron peaked by approximately sixfold increase (up to 811.83 and 33.40, respectively) at day 14 and slowly decreased over time. The geometric mean titers against Omicron were lower than against type with a 19.8-39. Sixfold reduction at all time points. The seropositivity against Omicron at the baseline, days 14, 28, 98, and 174 after the booster dose was 12.6%, 50.0%, 37.8%, 38.6%, and 22.8%, respectively. Data presented herein indicated that the BBIBP-CorV/CoronaVac booster significantly enhances the neutralizing potency against wild-type strain but elicited weaker neutralizing activity to Omicron. Our findings suggest that individuals receiving booster inactivated vaccine remain at risk for Omicron infection, which is crucial to inform ongoing and future vaccination strategies to combat coronavirus disease 2019.

Clinical characteristics, outcomes, and risk factors of SARS-CoV-2 breakthrough infections among 572 fully vaccinated (BBIBP-CorV) hospitalized patients.

Background: Breakthrough infections have been widely reported in vaccinated individuals. However, the clinical characteristics, outcomes, and risk factors of SARS-CoV-2 breakthrough infections among fully vaccinated (BBIBP-CorV) hospitalized patients have not yet been fully elucidated. Methods: In the single-center cohort study conducted at Xiangya Hospital of Central South University, we enrolled the hospitalized COVID-19 patients who had received full (2 doses) vaccination with the BBIBP-CorV vaccine between December 5, 2022, and January 31, 2023. We collected and analyzed information related to clinical characteristics, laboratory results, treatments, outcomes and prognostic data. Univariate and multivariable Cox regression were performed to assess the impact of clinical characteristics and laboratory results on the composite outcome (including the initiation of endotracheal intubation, non-invasive respiratory support, intensive care unit admission, and all-cause death). Results: A total of 572 COVID-19 hospitalized patients with fully vaccinated (BBIBP-CorV) were included. The median age of the patients was 66 years (IQR 53, 74). The most common symptoms included fever (347 [60.7 %]), dry cough (401 [70.1 %]), and expectoration (333 [58.2 %]). Among those with pre-existing chronic comorbidities, 44.2 % had hypertension and 20.5 % had diabetes. Laboratory tests revealed that the majority of patients (425/549 [77.4 %]) had normal white blood cell counts. Composite outcome occurred in 11.9 % of patients, with 96.7 % of patients discharged and 3.3 % of patients died. Multivariate Cox regression analyses suggested that the NLR >4 (adjusted HR, 5.50 [95%CI: 1.56-19.47]; P = 0.008), D-dimer >0.5 mg/ml (adjusted HR, 2.17 [95%CI: 1.03-4.59]; P = 0.042) and procalcitonin >0.1 ng/ml (adjusted HR, 3.22 [95%CI: 1.38-7.52]; P = 0.007) were independently associated with the composite outcome. Conclusion: Breakthrough infection after being fully vaccinated (BBIBP-CorV) is more likely to occur in older patients and patients with pre-existing chronic comorbidities. NLR >4, D-dimer >0.5 mg/ml and procalcitonin >0.1 ng/ml were independent risk factors for composite outcome.

Evaluation of SARS-CoV-2 infection risks after primary vaccination with BNT162b2, BBIBP-CorV, or ChAdOx1-nCOV-19 and after homologous and heterologous booster vaccinations with these vaccines and evaluation of SARS-CoV-2 reinfection profiles.

Background: The emergence of SARS-CoV-2 variants has significantly increased the number of cases of COVID-19 among vaccinated individuals, raising concerns about the effectiveness of current vaccines. The aim of this study was to analyze the SARS-CoV-2 infection risks after primary vaccination with BNT162b2, BBIBP-CorV, or ChAdOx1-nCOV-19 and after homologues and heterologous booster vaccinations with these vaccines, as well as the profiles of reinfected patients. Methods: We analyzed retrospectively 1082 patients vaccinated or unvaccinated with BNT162b2, BBIBP-CorV, and/or ChAdOx1nCoV-19 vaccines to determine their SARS-CoV2 infection statuses using the reverse transcription-polymerase chain reaction (RT-PCR) in addition to their clinical features. The infection risks of patients receiving the different vaccine regimens were compared using multivariate logistic regression analysis, comparing the adjusted OR of a positive COVID-19 test result. Results: Among 596 vaccinated patients, 53%(n = 286) tested positive for SARS-CoV-2 and 57%(n = 310) tested negative. Among positive cases, 10 were reinfection cases. The risk of SARS-CoV-2 infection was 1.6 (adj. OR) for patients who received one dose compared with those who received two doses (95% CI = 1.3-1.8; p < 0.01).The risk was 2.6 (adj. OR) for patients who received one dose compared with those who received three doses (95%CI = 2.1-3.3; p < 0.01), and 1.6 (adj. OR) for patients who received two doses compared with those who received three doses (95% CI = 1.3-2; p < 0.01). The patients who received two doses that were heterologous to that of the primary vaccine had the lowest risk of infection. Booster vaccinations (third dose) significantly reduced the number of positive cases with an acceptable safety profile. Higher cycle-threshold (Ct) values (indicative of viral load) were observed in vaccinated patients, whereas low Ct values were observed in unvaccinated patients. Conclusion: A complete cycle of vaccination with homologous vaccines or heterologous vaccines resulted in an acceptable reduction in SARS-CoV-2 infection. Further, vaccination was associated with a reduction in viral load.

COVID-19 Antibody Seroconversion in Cancer Patients: Impact of Therapy Cessation-A Single-Center Study.

BACKGROUND: The effective development of COVID-19 vaccination has mitigated its harm. Using two laboratory methods, we investigated the efficacy of the BNT162b2 mRNA and BBIBP-CorV COVID-19 vaccines on seroconversion rates in cancer patients undergoing active cancer treatment. METHODS: SARS-CoV-2 vaccines were scheduled for 134 individuals. The consenting participants submitted three venous blood samples. Three samples: T0, T1, and T2. The ABBOTT-SARS-CoV-2 IgG II Quant and Elecsys® Anti-SARS-CoV-2 assays were used to evaluate the samples and convert the antibody titers to WHO (BAU)/mL units. RESULTS: Cancer patients exhibited a higher seroconversion rate at T2, regardless of vaccination type, and the mean antibody titers at T1 and T2 were higher than those at T0. BBIBP-CorV patients required a booster because BNT162b2 showed a higher seroconversion rate between T0 and T1. Statistics indicate that comparing Abbott and Roche quantitative antibody results without considering the sample collection time is inaccurate. CONCLUSIONS: COVID-19 vaccines can still induce a humoral immune response in patients undergoing cancer-targeted therapy. The strength of this study is the long-term monitoring of antibody levels after vaccination in cancer patients on active therapy using two different immunoassays. Further multicenter studies with a larger number of patients are required to validate these findings.