key: cord-0795956-drw9haii
authors: Stoma, I.; Korsak, K.; Voropaev, E.; Osipkina, O.; Kovalev, A.
title: Comparative study of immunogenicity and safety of Gam-COVID-Vac and Sinopharm BBIBP-CorV vaccines in Belarus
date: 2022-02-06
journal: nan
DOI: 10.1101/2022.02.05.22270499
sha: 0de6db82f16d6f09cb43cb75b11dff671a501627
doc_id: 795956
cord_uid: drw9haii

Introduction: Lack of comparative studies on efficiency of a broad range of COVID19 vaccines leads to lower levels of adoption and subsequent lower total immunity in several regions, including Republic of Belarus. This clinical study captures and transparently demonstrates varying immunogenic responses to Sputnik V and Sinopharm vaccines. Aim of this study was: to compare the immunogenicity and reactogenicity of Sputnik V (Gam-COVID-Vac), RF and Sinopharm (BBIBP-CorV), PRC vaccines in vaccinated individuals. Materials and Methods: A total of 60 adults participated the study. The immune response after vaccination was assessed using enzyme immunoassay. IgG levels measured in all participants at three time points: before the vaccination, 42 days after the first vaccine dose, and 6 months after the first vaccine dose. The results of the SARS-CoV-2 antibody test is quantified according to the WHO First International Standard (NIBSC code:20/136) and expressed in international units (BAU/ml). Results: The study participants were divided into two groups, where 30 people (50%) were vaccinated with Sputnik V (Gam-COVID-Vac), and 30 people were vaccinated with Sinopharm (BBIBP-CorV), with no gender differences in the groups. The IgG levels at 42 days after the first vaccine dose were: Sputnik V (Gam-COVID-Vac)(42 days): Me=650.4 (642.2-669.4); Sinopharm (BBIBP-CorV)(42 days): Me=376.5 (290.9-526.4); p<0,001). The IgG levels at 6 months after the first vaccine dose were: Sputnik V (Gam-COVID-Vac)(6 months) Me=608.7 (574.6-647.1); Sinopharm (BBIBP-CorV)(6 months): Me=106.3 (78.21-332.4); p<0,001). Reactions after vaccination appeared in 27 vaccinated individuals (45%). Conclusion: The study showed that Sputnik V (Gam-COVID-Vac) vaccine was more immunogenic than Sinopharm (BBIBP-CorV) vaccine. IgG levels in vaccinated individuals who previously recovered from SARS-CoV-2 infection ("hybrid immunity") were higher than in SARS-CoV-2 naive individuals. Reactions after vaccines administration were mild to moderate.

package and the ggpubr package). Normality of the distribution was assessed using the Shapiro- PRC) were performed using the Friedman test, followed by pairwise comparison of groups by 1 1 5 the Wilcoxon test with Bonferroni multiple comparison adjustment. Mann-Whitney test was 1 1 6 used for unrelated samples (comparison of the dynamics of IgG levels in the group in which 1 1 7 participants were vaccinated with Sputnik V (Gam-COVID-Vac), RF with the group vaccinated 1 1 8 with Sinopharm (BBIBP-CorV), China). A qualitative comparison of the groups (achievement of 1 1 9 one of the IgG values: up to 150 BAU/ml, 150-500 BAU/ml, >500 BAU/ml after administration . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. participants were divided into two groups, where 30 people (50%) were vaccinated with Sputnik with Sinopharm (BBIBP-CorV) vaccine, PRC (7 men (23.33%), 23 women (76.67%)).

According to the questionnaire, 43 people (71.67%) reported having no chronic diseases. The diseases were 17.65% (3 individuals), 4) respiratory diseases were 11.76% (2 individuals), 5) 1 3 6 endocrine diseases were 5.88% (1 individual), 6) female reproductive system diseases were difference was found (p=1.0). The characteristics of the study participants are presented in Table   1 4 0 1. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)

The copyright holder for this preprint this version posted February 6, 2022. The main surrogate marker for a vaccine efficacy is its immunogenicity. In this study, IgG levels to SARS-CoV-2 S-protein were tested in all participants at three stages: before

CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint vaccination, 42 days after the first dose of vaccine and 6 months after the first dose of vaccine. As shown in Figure 1 , quantitative IgG levels at the three measurement points have 1 5 5 significant differences (Friedman chi-squared = 47.267, df = 2, p-value < 0,001). IgG levels 1 5 6 42 days after the first vaccine dose were significantly higher compared to the "Before vaccine the IgG level has a significant decrease (p < 0,001), however, compared to the "before vaccination" point, the IgG level remains at a higher level (p < 0,001). IgG at 42 days after the first dose of vaccine were significantly higher than prior to 1 6 8 vaccination (р < 0,001). At 6 months after the first dose, there was a significant decrease in IgG values (p < 0,001), but they remained at a higher level compared to the "before At the pre-vaccination point there is no significant difference between the Sputnik V According to a questionnaire survey answers of study participants, 51.67% of . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint 1 9 0 Sinopharm (BBIBP-CorV)) by IgG levels (proportion reaching <150 BAU/ml, 150-500 1 9 2 BAU/ml, >500 BAU/ml) at study sites: "42 days" -42 days after the first dose, "6 months" -6 1 9 3 months after the first vaccine dose. Vac) vaccine group most individuals had IgG levels above 500 BAU/ml, while most patients the IgG value declined among those who had not previously been ill (p=0.003) and those who 2 1 4 had had COVID-19 before vaccination (p < 0,001). There are a number of publications suggesting that those with "hybrid immunity" are 2 1 6 most protected against COVID-19. Figure 5 also shows this trend. However, the "hybrid immunity" generated by the Sputnik V vaccine has greater strength and duration (p < 0,001). vaccines is worth considering separately, as this is a frequent topic of discussion. The 2 2 0 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint incidence of post-vaccine reactions in this study was 45% (27 individuals). All of the 2 2 1 observed reactions were mild to moderate in severity. The most frequent ones were: injection 2 2 2 site soreness (16.67% of 10 people) and redness around the site of injection (5% -3 people), 2 2 3 fever (6.67% of 4 people), and a combination of these reactions (Fig. 8) . Participants also Post-vaccination reactions were observed in both vaccinated groups (p=0.119).

However, significant statistical differences were found only for the increase in body be concluded that the Sputnik V (Gam-COVID-Vac) vaccine is more immunogenic, but the 2 3 6 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint Sinopharm (BBIBP-CorV) vaccine is less reactogenic. For a better understanding of the 2 3 7 properties of the above mentioned vaccines, a comparative evaluation should be carried out. instructions are, in most cases, mild to moderate in severity, which resolve within a few days site. Less frequent, but quite common (≥1/100 to <1/10): fever, muscle and joint pain, fatigue, have several features that make them ideal candidates: a high immunogenic profile and the 2 5 7 ability, using a smaller amount of antigen, to induce both cellular and humoral immune CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint

COVID-19 vaccines and herd immunity: Perspectives

previous immunity. Vectors of a rare serotype (human adenoviruses Ad26, Ad5) are used for 2 6 3 this purpose [12] . Advantages include: 1) high immunogenicity (without adding adjuvant); 2) 2 6 4 stability (vectors used have a protein envelope that protects the genetic material inside it, 2 6 5 hence the vaccine can be stored at +2 -+8 for at least 6 months; 3) possibility of large-scale nasal congestion, rhinorrhoea, sore and stuffy throat, enlargement of regional lymph nodes, declared by the manufacturer, is more than 91% (16).

Therefore, there is still a lack of international publications comparing the CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. Only few international publications reflect the results of a study of the reactogenicity 2 9 0 of Sputnik V (Gam-COVID-Vac) and Sinopharm (BBIBP-CorV) vaccines. A study based on 2 9 1 a survey of vaccinees conducted in Iran found that reactions in response to Sputnik V (Gam-2 9 2 COVID-Vac) vaccine were longer (up to 3 days) than reactions in response to Sinopharm However, a subsequent association between vaccination and conditions related to clotting contradict international studies and the study is conducted in a similar way, which in ourCC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint opinion allows a comparative assessment of postvaccination reactions and immunogenicity of The study has a number of limitations: sample size (60 people), age of participants 3 1 5 (the study represents individuals whose age ranges from 29 to 73 years). According to the results of the study, the Sputnik V (Gam-COVID-Vac) vaccine The study confirmed that antibodies developed as a result of prior infection with Me=376.5 (290.9-526.4); p<0,001), which persist for a longer time (for Sputnik V (Gam- The main reactions after vaccination were fever, redness and soreness at the injection CorV, p=0.006). is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint Authors report no relevant conflict of interest regarding this study. Vaccine-associated complications: a comparative multicenter evaluation among dental 4 0 5 practitioners and dental students-which candidate vaccine is more safe in SARS COV . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)The copyright holder for this preprint this version posted February 6, 2022. ; https://doi.org/10.1101/2022.02.05.22270499 doi: medRxiv preprint