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Objectives: Widespread vaccination is considered as one of the best methods in combating any pandemic including COVID-19. Gam-COVID-Vac also known as Sputnik V, is one of the first vaccines that was registered in 74 countries and received an emergency approval for immunization. Monitoring anti-SARS-CoV-2 antibodies over time is essential for evaluation of post-vaccination humoral immune response.To date, there are only a limited number of clinical studies regarding the analysis of immune response after Sputnik V administration. It is of crucial importance to report independently on safety and efficiency of this vaccine with the aim to speed up the process of its final approval by the WHO. Methods: Humoral immune response was monitored by seven immunoassays to analyze different classes of anti-SARS-CoV-2 Ig in five health workers after receiving the combined vector vaccination. This vaccine is based on two replication-deficient rAd26 and rAd5 viral vectors that carry the gene SARS-CoV-2 full-length glycoprotein S(rAd26-S and rAd5-S). Sputnik V was administered with a 21-day interval between the first and second dose. Venous blood was collected two hours before vaccination as a baseline, and then followed by 18 series up to 170-day post-vaccination. Results: The participants in this study used a self-report form in which they noted their observations on safety at 72 h post-immunization. One participant reported mild side effects, such as muscle pain and fever, while the other four individuals had no noticeable complications. Seroconversion was detected in all individuals at 28 days of post-vaccination. Plateau of seropositivity has been achieved by 50th day of vaccination, while titer values decreased after 6 months. Conclusion: This study provides some clinical data regarding the kinetics of antibody levels elicited after administration of heterologous rAd26-S and rAd5-S vaccine. Based on the preliminary data from this pilot study, it appears that Sputnik V vaccine generates a solid humoral immune response lasting at least 6 months after immunization.
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BACKGROUND: A variety of recent evidence exists about the clinical implication of low level of Pregnancy-associated plasma protein A (PAPP-A) in pregnancy. This glycoprotein is a protease, which releases the Insulin-like growth factor from IGFBP 4. Its role is a trophoblastic invasion of decidua, stimulation of cell mitosis and differentiation. It has an immunosuppressive effect in the placenta, inhibition of coagulation and complex role for integration of all these processes in the placenta. Level of PAPP-A (under 0.4 MoM-Multiple of Medians) in first-trimester screening in chromosomally and morphologically normal fetuses, could influence fetal weight, preeclampsia, premature birth and stillbirth. As a result of the complications mentioned above, there is implication on timing, mode of delivery and condition of the newborn. AIM: The study aims to evaluate the influence of low PAPP-A, measured in the first trimester on the outcome of pregnancy, with accent disorders which are the result of placental insufficiency. Also, gestational week, mode of delivery and condition of newborn secondary underlying conditions will be evaluated. MATERIAL AND METHODS: After given information and consultation about the expectation from the screening, pregnant women with a singleton pregnancy were tested for First Trimester Screening to estimate the risk for Trisomy 21, 13, 18- the most frequent chromosomopathies. After exclusion of chromosomopathies and congenital malformations, one hundred and fourteen patients enrolled in the study. The target group (n = 64) with PAPP-A below 0.4 MoM and control group (n = 50) with PAPP-A equal and above 0.4 MoM. An assessment of mode and time of delivery and presence of small for gestational age newborns, preeclampsia, premature birth and newborn condition at delivery was made. RESULTS: The percentage of the patients delivered in term was similar between the target group (n = 64) and the control group (n = 50), 82.81% vs 82.0% respectively. The rate of cesarean section was 29.7 % in the target group vs 32% in the control group. A significant difference was found about elective vs urgent cesarean section in favour of the target group. The difference was present about the complication in pregnancy before delivery, 56% vs 22%, p = 0.023, which were the main indication for cesarean section. The difference in newborn outcome was not significant. CONCLUSION: There is a difference in frequency of complications, in the cases with PAPP-A under 0.4 MoM, such as premature birth, preeclampsia compound with SGA fetuses versus the control group. The difference for SGA newborn and premature birth among the groups has statistical significance. The patients delivered with cesarean section were with the main indications SGA or elevated blood pressure, often occurred combined with prematurity. Apgar score and birth weight were similar in target and control group, but the newborns with a birth weight under 2500 g. were more frequent in the target group. Because these results did not show another significance among two groups, probably lower cut-off is needed, combining with another test (Doppler of uterine arteries in the first trimester, biochemical test). Presence of other diseases which could hurt placental function should be emphasised.
