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26 protocols using bbibp corv

1

COVID-19 Vaccination Effectiveness Against Hospitalization and Death

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The primary endpoint was defined as a binary variable capturing COVID-19-related hospitalisation and/or death. The primary exposure of interest was vaccination status at time of COVID-19 infection. Individuals were defined as being partially vaccinated at diagnosis if they tested COVID-19 positive 14 or more days after their first vaccination dose and less than 7 days after their second vaccination dose, as fully vaccinated at diagnosis if they tested COVID-19 positive 7 or more days after their second vaccination dose and as unvaccinated at diagnosis otherwise. Repeat infections that occurred within 3 months of each other were assumed to be the same infection and the earliest positive test date was used as the infection date. Re-infections were included in the analysis although there were few. Vaccination status was also split by vaccine type resulting in the vaccination exposure variable having 5 categories: (i) unvaccinated, (ii) partially vaccinated with BBIBP-CorV (Sinopharm), (iii) fully vaccinated with BBIBP-CorV (Sinopharm), (iv) partially vaccinated with ChAdOx1 nCoV-19 (SII Covishield) and (v) fully vaccinated with ChAdOx1 nCoV-19 (SII Covishield).
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2

Effectiveness of Inactivated and Vector Vaccines Against COVID-19 Hospitalization and Death in Seychelles

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This nationwide, retrospective cohort study assessed the effectiveness of the inactivated vaccine, BBIBP-CorV (Sinopharm) and the viral vector vaccine, ChAdOx1 nCoV-19 (SII Covishield) against COVID-19-related hospitalization and/or death post-COVID-19 diagnosis. The study population included all Seychelles residents aged 18 or older that tested positive by RT-PCR or rapid antigen test, for COVID-19 between 25 January 2021 and 30 June 2021.
The start date of the study was set to start on 25th January 2021, 14 days after the first COVID-19 vaccination was administered in Seychelles. BBIBP-CorV (Sinopharm) was first administered on 10 January 2021 and ChAdOx1 nCoV-19 (SII Covishield) on 28 January 2021.
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3

Inactivated SARS-CoV-2 Vaccine Booster Trial

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In this study, we conducted a nonrandomized trial and recruited participants from a prospective cohort at the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, Guangdong, China. As we described previously11 (link), 63 HCWs received the inactivated SARS-CoV-2 vaccine BBIBP-CorV (BBIBP-CorV, Sinopharm, Beijing) in the morning (9 am–11 am) or afternoon (3 pm–5 pm) on d0 and d28, respectively. Fifty of the 63 HCWs were volunteered to receive a third booster shot of the inactivated vaccine 6 months after the prime vaccination (d180). They were assigned to the morning or afternoon group as to their previous vaccinating time accordingly. Demographic characteristics of the HCWs were summarized in Supplementary Table S1. Blood samples were collected on d180 before the booster dose and d187, d194, and d208 after the booster dose. Convalescent patients who had recovered from SARS-CoV-2 infection were recruited as the positive control (Supplementary Table S2). All studies were approved by the Institutional Review Board of the First Affiliated Hospital of Sun Yat-sen University and written consent was obtained from all participants. The prospective cohort and the trial were registered to the Chinese Clinical Trial Registry (ChiCTR2100042222 and ChiCTR2100048665).
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4

Longitudinal Antibody Dynamics in COVID-19

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Venous blood was collected in dry tubes and centrifuged at 900g for 10 minutes. Serum supernatants were stored at -20°C. Serum samples were collected from COVID-19 patients at various time points after symptom onset, including 2–5 days (D00), 9–12 days (D07), 17–20 days (D15), 32–37 days (D30), 62–67 days (D60), 92–98 days (D90), 182–188 days (D180), and 363–367 days (D360). Participants were separated into two groups: one group consisted of infected and unvaccinated patients over a 12-month period, while the other group consisted of patients who had been vaccinated with ChAdOx1 nCoV-19 (AstraZeneca) before infection. Patients who received mRNA or vector vaccines (Pfizer, AstraZeneca, Johnson) during follow-up were excluded from the anti-RBD IgG antibody analysis, and patients who received BBIBP-CorV (Sinopharm) were excluded from all analyses. Furthermore, throughout the study, some patients were excluded for other reasons, such as relocation from the city, hospitalization and unavailability due to work. Samples from patients reinfected with SARS-CoV-2 between study visits were not included.
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5

Comparative COVID-19 Vaccine Trials

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Individuals were randomized in a 1:1:1 ratio to receive the Gam-COVID-Vac (SPUTNIK-V) second component (rAd5) vaccine, ChAdOx1 nCoV-19 (Oxford-Astra Zeneca) or BBIBP-CorV (Sinopharm). For allocation of the participants, an ad-hoc software was used. After consent was obtained, the participant was randomised and immediately notified of the treatment allocation. Both participant and health-care personnel were aware of group allocation; however, the investigators who performed the full blood count and antibody measurements were blinded to the vaccine allocation.
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6

Evaluating SARS-CoV-2 Variant Vaccines

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Eight-week-old female BALB/c or C57BL/6 mice were obtained from IIB-UNSAM animal facility. For immunogenicity studies, animals were intramuscularly (i.m) inoculated at day 0 and 14 with (i) Gamma RBD (10 µg) + Alum (100 µg), (ii) Ancestral RBD (10 µg) + Alum (100 µg) or (iii) placebo (Alum alone). In other experiments, BALB/c mice were vaccinated with: (i) Gamma RBD (10 µg) + Alum (100 µg) or (ii) placebo. A group containing ancestral spike 2 P (5 µg, BPS Biosciences) and Alum (100 µg) was used as control in some experiments. Blood samples were collected weekly to measure total and neutralizing antibody titers and at day 42 post prime immunization animals were sacrificed and spleens harvested.
In booster experiments, eight-week-old female BALB/c mice were i.m inoculated on days 0 and 21 with (i) Gamma RBD (10 µg/dose) + Alum (100 µg/dose, n = 5 mice), (ii) Comirnaty (1 µg/dose) (Pfizer-BioNTech, n = 10 mice), (iii) BBIBP-CorV (1.3 U/dose containing 45 µg of Alum) (Sinopharm, n = 10 mice), (iv) and ChAdOx1 nCoV-19 (3 × 109 particles/dose) (Oxford-AstraZeneca, n = 10 mice). At day 99, 5 animals per group were boosted with the Gamma RBD (10 µg) + Alum (100 µg) while the other 5 animals received the homologous vaccine. Blood samples were collected weekly to measure total and neutralizing antibody titers.
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7

COVID-19 Vaccine Comparison Study

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The study vaccines were as follows: inactivated: BBIBP-CorV (Sinopharm, Beijing, China), viral vector: AZD1222 (AstraZeneca, Oxford, UK), mRNA (original monovalent): 30 μg BNT162b2 (full-dose group) and 15 μg (half-dose group) (Pfizer-BioNTech Inc., New York City, NY, USA), mRNA (original monovalent): 100 μg mRNA-1273 (full-dose group) (Moderna Inc., Cambridge, MA, USA), and 50 μg mRNA-1273 (half-dose group).
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8

Postvaccine Side Effects and Antibody Response

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An online survey was designed to detect the postvaccine side effects. Healthy subjects who received two doses of BBIBP-CorV (Sinopharm), ChAdOx1 (AstraZeneca), or BNT162 (Pfizer BioNTech) vaccines participated in the study. A total of 168 participants participated in the study. The sample size was determined according to the previous report [14 (link)].
From the total participants, 78 participants recalled and agreed to undergo IgG anti-spike-protein antibodies tests after three days and three weeks after the first dose of vaccination with the BBIBP-CorV or ChAdOx1 vaccines, and three weeks after the second dose of vaccination with the BBIBP-CorV or ChAdOx1 vaccines.
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9

Three-Dose COVID-19 Vaccine Boosting Trial

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The study was conducted in two parts. First, an online survey using the WeChat Questionnaire Star software were conducted. 424 healthy adults aged 18-70 years and healthy teenagers aged 12-18 years completed the survey. Second, we recruited 60 volunteers for the trial. They received three doses of the BBIBP-CorV (Sinopharm) or CoronaVac (Sinovac Biotech) COVID-19 inactivated vaccine. The boosting effect of the three vaccine doses was evaluated for safety, reactogenicity, and immunogenicity at 7, 14, 21, 28, and 56 days after vaccination. The study was conducted accordance with the guidelines of the Declaration of Helsinki and was approved by the Institutional Review Board of the Ethics Committee of Jinan Central Hospital (Ethical code No. D202111Ab). All participants provided written informed consents. Questionnaire and informed consent forms are available upon request.
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10

Assessing Booster Vaccine Immune Responses

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Prior approval had been granted by institutional review boards (IRBs) under the Agency for Science Technology and Research (A*STAR) to Singapore Immunology Network for the conduct of this study. Healthy donors who were above the age of 21 and due for their COVID-19 vaccine booster were recruited under a Singapore Immunology Network study entitled, “Study of B cell immune responses to SARS-CoV2 vaccine”. These donors either received the mRNA (BNT162b2, Pfizer-BioNTech/COMIRNATY or mRNA-1273, Moderna) or an inactivated virus (CoronaVac, Sinovac or BBIBP-CorV, Sinopharm) vaccine as their third dose booster. These individuals were not infected with SARS-CoV2 before or during the study. Peripheral blood was collected before the booster dose and on day 28 (±5) after the booster. A total of 66 subjects were recruited for this study, 29 males and 37 females. Written informed consent was obtained from all donors in accordance with the Declaration of Helsinki for Human Research.
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