1st Booster Research Articles

SARS-COV-2 breakthrough infection and its covariates among healthcare providers of a hospital in Bangladesh during the omicron wave

IntroductionBreakthrough infection by SARS-COV-2 virus among vaccinated individuals has been reported from all over the world and it has created a substantial challenge in designing strategies to live with the virus in the post-pandemic era. Factors affecting the extent and nature of breakthrough infection are still not fully understood and those are known to vary depending on host and agent factors. Health Care Workers (HCWs), especially in hospital settings, are front-liners in combating the epidemic and, consequently, they are more vulnerable to breakthrough infection by SARS-COV-2. Like most of the countries of the world, Bangladesh went through several waves of COVID-19 and the last (3rd wave) was the widespread Omicron wave during the winter of 2022. HCWs in Bangladesh have been disproportionately affected by the virus. Under this context, the aim of the present study was to explore breakthrough infection (BTI) and its host-related covariates among HCWs of a COVID-dedicated city-based hospital during the Omicron wave in Bangladesh. Materials and methodsAn observational cross-sectional study was conducted on 267 HCWs of the Narayanganj Tertiary (300-bed) hospital during February–March 2022 which coincided with the terminal part of the 3rd wave. Data were collected by trained Field Assistants using Interviewer-administered Data Collection Forms with Questionnaires as instruments. Previous COVID-19 status (any time after the onset of the pandemic and within last 3 months) was explored by the history of specific symptoms as well as by the confirmatory rtPCR test reports from DGHS approved laboratories Anti-nucleocapsid antibody (Anti-N-Ab) in venous blood samples, assayed by a chemiluminescent ELISA technique, was used as a seroprevalence-based marker of breakthrough infection during the preceding few months. Data were analyzed by bivariate as well as multivariate statistics using the IBM-SPSS software. ResultsThe median age (range) of the HCWs was 38 (21–65) years; Body Mass Index (BMI, kg/m2) 25 (15–49); and Waist-Hip Ratio (WHR) was 0.92 (0.46–1.21). The male subjects had significantly higher median age (p = 0.01) and higher WHR (p = 0.001) as compared to the female subjects. As per the BMI category, subjects with overweight and obesity constituted 83.3 % of the male subjects as compared to 61.6 % of the female subjects (p = 0.001). The time lapse between receiving of 3rd dose and blood sampling was significantly higher among females compared to males (median days 60 vs 49, p < 0.02) indicating earlier vaccination with 1st booster dose among females. A proportion of 51.85 % male and 49.68 % female subjects showed Anti-N-Ab positivity; there was no significant difference between the gender groups. Also, there was no significant difference among male and female subjects regarding the Ab levels. On Spearman correlation analysis, a tendency of association of WHR with Ab level was observed among the male subjects; however, the association did not show statistical significance (p = 0.09). On binary logistic regression Ab positivity was found to be independently associated with WHR (p = 0.03), and prior SARS-COV-2 infection within the last 3 months (p = 0.02) among males. When all the subjects were considered together, COVID symptom positivity during the last 3 months (p = 0.067) and receiving the 1st booster dose (p = 0.07) showed a tendency of association with Ab positivity. On multiple regression analysis, Ab levels showed a negative association with WHR (p = 0.035) among males. ConclusionsMore than 50 % of the vaccinated hospital-based HCWs in Bangladesh suffered from BTI during the winter of 2022 when the Omicron wave (the 3rd wave) of COVID-19 was at its peak. The data also indicate that overweight and obesity are major host-related risk factors underlying BTI. Inadequate coverage by a booster dose seems to be another determinant of BTI and the level of immune response in this population.

Avidity maturation of humoral response following primary and booster doses of BNT162b2 mRNA vaccine among nursing home residents and healthcare workers

Infections, despite vaccination, can be clinically consequential for frail nursing home residents (NHR). Poor vaccine-induced antibody quality may add risk for such subsequent infections and more severe disease. We assessed antibody binding avidity, as a surrogate for antibody quality, among NHR and healthcare workers (HCW). We longitudinally sampled 112 NHR and 52 HCWs who received the BNT162b2 mRNA vaccine after each dose up to the Wuhan-BA.4/5-based Omicron bivalent boosters. We quantified anti-spike, anti-receptor binding domain (RBD), and avidity levels to the ancestral Wuhan, Delta, and Omicron BA.1 & 4/5 strains. The primary vaccination series produced substantial anti-spike and RBD levels which were low in avidity against all strains tested. Antibody avidity progressively increased in the 6–8 months that followed. Avidity significantly increased after the 1st booster but not for subsequent boosters. This study underscores the importance of booster vaccination among NHR and HCWs. The 1st booster dose increases avidity, increasing vaccine-induced functional antibody. The higher cross-reactivity of higher avidity antibodies to other SARS-CoV-2 strains should translate to better protection from ever-evolving strains. Higher avidities may help explain how the vaccine’s protective effects persist despite waning antibody titers after each vaccine dose.

Effectiveness of Sinopharm's BBIBP-CorV Booster Vaccination against COVID-19-Related Severe and Critical Cases and Deaths in Morocco during the Omicron Wave.

This study investigates the effectiveness of the 1st booster dose against COVID-19 severe and critical hospitalizations and deaths occurring due to the Omicron wave in Morocco. This study uses nationally representative data on COVID-19 from 15 December 2021 to 31 January 2022. The aim is to investigate the effectiveness of the inactivated COVID-19 vaccine BBIBP-CorV (Sinopharm) 1st booster dose against the Omicron wave in Morocco using real-world data established from nationally representative statistics on COVID-19 cases, deaths and vaccinations. The screening method was used to estimate vaccine effectiveness against COVID-19 severe or critical hospitalization and COVID-19-related deaths. The data were grouped by, age subgroup, sex, week, and geographical area and were analyzed using binary logistic regression with an offset for vaccine coverage. The overall BBIBP-CorV VE estimate is 89% (95% CI 85 to 92) effective in curbing COVID-19 deaths, and 81% (95% CI 78 to 84 in curbing COVID-19 severe/critical hospitalizations. Death-related VE estimate was 86% (95% CI 81 to 90) for patients aged ≥65 years, 96% (95% CI 90 to 98) for those aged <65 years, 95% (95% CI 88 to 98) in no-risk factor patients, 91% (95% CI 85 to 94) with 1 risk factor, 90% (95% CI 83 to 95) with 2 risk factors, and 72% (95% CI 52 to 84) in patients with 3 risk factors and more. Severe/critical hospitalization VE estimate was 78% (95% CI 74 to 82) for patients aged ≥65 years, 87% (95% CI 82 to 90) for those aged <65 years, 86% (95% CI 80 to 90) in no-risk factor patients, 80% (95% CI 73 to 84) with 1 risk factor, 80% (95% CI 70 to 85) with 2 risk factors, and 80% (95% CI 68 to 86) in patients with 3 risk factors and more. BBIBP-CorV boosters are effective in increasing protection against the Omicron variant-related COVID-19 deaths and severe/critical hospitalizations. The protection is reduced with older age and higher risk factors. These findings emphasize the importance of targeted vaccination strategies for different demographic groups and underscore the protective benefits of the first booster BBIBP-CorV vaccine.

Objectively measured peri-vaccination sleep does not predict COVID-19 breakthrough infection

Prior studies have shown that sleep duration peri-vaccination influences an individual’s antibody response. However, whether peri-vaccination sleep affects real-world vaccine effectiveness is unknown. Here, we tested whether objectively measured sleep around COVID-19 vaccination affected breakthrough infection rates. DETECT is a study of digitally recruited participants who report COVID-19-related information, including vaccination and illness data. Objective sleep data are also recorded through activity trackers. We compared the impact of sleep duration, sleep efficiency, and frequency of awakenings on reported breakthrough infection after the 2nd vaccination and 1st COVID-19 booster. Logistic regression models were created to examine if sleep metrics predicted COVID-19 breakthrough infection independent of age and gender. Self-reported breakthrough COVID-19 infection following 2nd COVID-19 vaccination and 1st booster. 256 out of 5265 individuals reported a breakthrough infection after the 2nd vaccine, and 581 out of 2583 individuals reported a breakthrough after the 1st booster. There was no difference in sleep duration between those with and without breakthrough infection. Increased awakening frequency was associated with breakthrough infection after the 1st booster with 3.01 ± 0.65 awakenings/hour in the breakthrough group compared to 2.82 ± 0.65 awakenings/hour in those without breakthrough (P < 0.001). Cox proportional hazards modeling showed that age < 60 years (hazard ratio 2.15, P < 0.001) and frequency of awakenings (hazard ratio 1.17, P = 0.019) were associated with breakthrough infection after the 1st booster. Sleep duration was not associated with breakthrough infection after COVID vaccination. While increased awakening frequency during sleep was associated with breakthrough infection beyond traditional risk factors, the clinical implications of this finding are unclear.

Community-based COVID vaccination center ready for the switch towards a broad community-based prevention center: In Jan'21 the Flemish Region started the COVID vaccination in a public health mode, at 60 primary health care units.

Framework: Each local “unit of care” has an average population of 100.000 people and is managed by local caregivers. Within two months (Jan-Feb'21), 80 vaccination centers were set up and launched. A central strategic center and logistic/financial support were created. A local team of municipal representatives and caregivers was composed. It resulted in a management team which launched the operational vaccination sessions.&#x0D; All citizens were invited by email, letter or SMS. An individual appointment was booked in the vaccination center matching the zip code of the citizen’s residence. Specific software enabled vaccination agenda management and its registration in Flanders’ central vaccination database.&#x0D; The initial goal was to cover at least 70% of the target population, but in the primary care unit “Voorkempen”, a coverage of 95,45% was reached.&#x0D; Vaccination center “Voorkempen” ‘s results: The health unit “Voorkempen” is a defined area, situated in the province of Antwerp and is composed of 6 municipalities which give home to 111.102 inhabitants.&#x0D; The campaign consisted of four periods :&#x0D; - Feb-Sep'21 : basic vaccination (97.763 citizens)&#x0D; - Oct'21-Feb'22 : 1st booster campaign for all 12+ ( 93.316 citizens).&#x0D; - May-June'22: extra booster exclusively for 80+ (7.153 citizens)&#x0D; - Sept-Oct'22 : 2nd booster for all 18+, (90.473 citizens)&#x0D; Lessons learned: &#x0D; 1.Flexible management by a limited number of managers (4) with daily meetings and quick decision making is essential and covers :&#x0D; A.The infrastructure in time and space.&#x0D; B.The IT environment including call center, vaccination agenda and HR management.&#x0D; C.Vaccination sessions planning : stock control and ordering, session planning and unfolding of a mobile team.&#x0D; D.HR management : staff recruitment &amp; selection, training, coaching, contracting, team composition, insurance, payroll.&#x0D; E.Operational vaccination sessions: reception and flow inside the vaccination center, problem solving, administrative check-in, vaccination, registration, surveillance.&#x0D; F.Vaccination registration : group registration in Vaccinnet as a base for COVID certification&#x0D; 2.The support of the municipalities was crucial : accountancy, logistic support, mass communication.&#x0D; 3.The primary healthcare providers’ trust and cooperation was established by constant communication, information and feedback.&#x0D; 4.The mobilization of local volunteers was overwhelming - it became a flexible group coping with unforeseen circumstances and unexpected events.&#x0D; 5.Population management: the data collection concerns local infection rates, hospitalizations and vaccination rates. Its analysis allowed quick reactions.&#x0D; Future: The broad experiences of the central management, people management and population management in this vaccination center can be used to improve preventive actions and early detection programs in different domains:&#x0D; -Infectious diseases including influenza: testing and vaccinations in a similar center as the COVID vaccination center, - new vaccines will be on the market soon.&#x0D; -Chronic diseases: early risk detection and risk management: lifestyle, healthy diet, exercising,…&#x0D; -Improvement of oncological screening programs (breast cancer, cervix cancer and colorectal cancer).&#x0D; -Geriatric stratification and early support&#x0D; -Mental health&#x0D; For the permanent switch to a local “prevention center”, political decisions, a legal framework and structural support is absolutely necessary.&#x0D;

2373. "Longitudinal Investigation of Avidity Maturation following Multiple Doses of BNT162b2 mRNA Vaccine Including Bivalent Boosters among Nursing Home Residents and Healthcare Workers"

Abstract Background Increased breakthrough infections among nursing home residents (NHR) are clinically consequential despite good vaccine coverage and substantial antibody titers. While vaccination blunted severe outcomes, breakthrough infections may arise from lower vaccine-induced antibody quality. We aimed to assess vaccine-induced antibody quality among NHR and younger healthcare workers (HCW) using antibody avidity. Methods We longitudinally sampled 50 NHR and 30 HCWs, with or without prior history of COVID-19, who received the BNT162b2 mRNA vaccine at 0-14 days before, 2 weeks, and 4-6 months after each vaccine dose up to the bivalent (BV) boosters. Primary outcomes included anti-spike, anti-Receptor Binding Domain (RBD), and avidity levels to the ancestral Wuhan, Delta, and Omicron BA.1 strains determined by bead-multiplex immunoassay and ability to bind after 6M urea vs. saline incubation. Results After the primary series, anti-spike and RBD titers increased significantly to all 3 strains in both NHR and HCW. Avidity levels progressively increased across all time points up to the 3rd dose. Interestingly, this increase continued 6-8 months after vaccination suggesting that affinity maturation continues to occur for many months after the primary vaccination series. NHRs without prior infection have the poorest avidity levels to Delta and Omicron, especially before the 3rd dose. The 3rd dose raised avidity levels substantially in all groups and for all strains. Avidity levels after boosting, across the 3rd and 4th doses, demonstrate evidence of durability. Preliminary findings after BV boost show a continuation of avidity maturation with a larger impact on prior infected individuals. Wuhan Spike Avidity Avidity index of the Wuhan spike antibody across different time points among naive and prior infected individuals. Prevax- before primary series; Postvax- 2 weeks after primary series; M6- 6 months after primary series; Postboost- 2 weeks after 1st monovalent booster; M3M6postboost- 3-6months post booster; Postboost 2- 2 weeks after 2nd monovalent booster. NH- Nursing home; HCW- Healthcare Workers Omicron BA.1 spike Avidity Avidity index of the BA.1 spike antibody across different time points among naive and prior infected individuals. Prevax- before primary series; Postvax- 2 weeks after primary series; M6- 6 months after primary series; Postboost- 2 weeks after 1st monovalent booster; M3M6postboost- 3-6months post booster; Postboost 2- 2 weeks after 2nd monovalent booster. NH- Nursing home; HCW- Healthcare Workers Conclusion This study underscores the importance of booster vaccination among NHR and HCWs. The booster dose increases avidity, adding to vaccine-induced antibody functional ability. Higher avidity antibodies have higher cross-reactivity to other SARS-CoV-2 strains, as Wuhan boosting improves Delta and Omicron avidity, and should improve protection from ever-evolving strains. Higher avidities may help explain how the vaccine’s protective effects persist even while antibody titers fade between vaccine doses. Disclosures Stefan Gravenstein, MD, MPH, CDC: Grant/Research Support|Genentech: Advisor/Consultant|Genentech: Grant/Research Support|GSK: Advisor/Consultant|GSK: Honoraria|Janssen: Advisor/Consultant|Janssen: Honoraria|NIH: Grant/Research Support|Pfizer: Grant/Research Support|Pfizer: Honoraria|Sanofi: Advisor/Consultant|Sanofi: Grant/Research Support|Sanofi: Honoraria|Seqirus: Grant/Research Support|Seqirus: Honoraria David Canaday, MD, Pfizer: Grant/Research Support

Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: A randomised VACCELERATE trial in adults ≥75 years (EU-COVAT-1)

BackgroundVaccination remains crucial for protection against severe SARS-CoV-2 infection, especially for people of advanced age, however, optimal dosing regimens are as yet lacking. MethodsEU-COVAT-1-AGED Part A is a randomised controlled, adaptive, multicentre phase II trial evaluating safety and immunogenicity of a 3rd vaccination (1st booster) in individuals ≥75 years. Fifty-three participants were randomised to full-doses of either mRNA-1273 (Spikevax®, 100 µg) or BNT162b2 (Comirnaty®, 30 µg). The primary endpoint was the rate of 2-fold circulating antibody titre increase 14 days post-vaccination measured by quantitative electrochemiluminescence (ECL) immunoassay, targeting RBD region of Wuhan wild-type SARS-CoV-2. Secondary endpoints included the changes in neutralising capacity against wild-type and 25 variants of concern at 14 days and up to 12 months. Safety was assessed by monitoring of solicited adverse events (AEs) for seven days after on-study vaccination. Unsolicited AEs were collected until the end of follow-up at 12 months, SAEs were pursued for a further 30 days. ResultsBetween 08th of November 2021 and 04th of January 2022, 53 participants ≥75 years received a COVID-19 vaccine as 1st booster. Fifty subjects (BNT162b2 n = 25/mRNA-1273 n = 25) were included in the analyses for immunogenicity at day 14.The primary endpoint of a 2-fold anti-RBD IgG titre increase 14 days after vaccination was reached for all subjects. A 3rd vaccination of full-dose mRNA-1273 provided higher anti-RBD IgG titres (Geometric mean titre) D14 mRNA-127310711 IU/mL (95 %-CI: 8003;14336) vs. BNT162b2: 7090 IU/mL (95 %-CI: 5688;8837). We detected a pattern showing higher neutralising capacity of full-dose mRNA-1273 against wild-type as well as for 23 out of 25 tested variants. InterpretationThird doses of either BNT162b2 or mRNA-1273 provide substantial circulating antibody increase 14 days after vaccination. Full-dose mRNA-1273 provides higher antibody levels with an overall similar safety profile for people ≥75 years. FundingThis trial was funded by the European Commission (Framework Program HORIZON 2020).

The Effects of Bifidobacterium animalis Subsp. Lactis and Vitamin D on Immunological Response Following Vaccination in Puppies

Abstract This study aimed to determine the effects of oral application of Bifidobacterium animalis subsp. lactis and vitamin D on the immune response after vaccination in puppies. Crossbred dogs at the age of 55–65 days (n=21) of both sexes were grouped according to the application as follows: Group 1 - commercial polyvalent vaccine only (Vanguard 5L4, Zoetis); Group 2 -polyvalent vaccine and vitamin D; and Group 3 - polyvalent vaccine, B. animalis subsp. lactis, and vitamin D. The antibody titers, measured 3 weeks after the vaccination and after the 1st booster, demonstrated sufficient protective levels against the canine distemper virus but without significant difference between the groups when compare both values. No significant differences either, were observed in antibody titers against canine parvovirus after the initial vaccination. However, after the 1st booster, Group 2 samples showed significantly higher antibody titer value compared to the other groups (p&lt;0.05). In conclusion, the dogs included in this study had an adequate antibody response to canine parvovirus and distemper viruses following the vaccination and 1st booster in all three groups of animals, and significant increasing of protective antibody titers against canine parvovirus virus the after the 1st booster in the group where B. animalis subsp. lactis was included.

Evaluation of Different Cell Components of &lt;i&gt;Aeromonas hydrophila&lt;/i&gt; on the Immune Response of Rohu (&lt;i&gt;Labeo rohita&lt;/i&gt;)

The humoral immune response of rohu (Labeo rohita) against different cell components of Aeromonas hydrophila was studied. Heat-killed cells (HKC), formalin killed cells (FKC) and crude lipopolysaccharides (LPS) were prepared from a virulent strain (G-49) of A. hydrophila. Three methods of vaccination were followed, viz., intraperitoneal injection, direct immersion and oral administration through feed. A primary immunization of three vaccines was given on day 0, followed by a 1st booster on day 28 after priming and a 2nd booster on day 28 after 1st booster both for injection and immersion groups. A group of fishes were fed with vaccine-incorporated feed for a period of 14 days during priming, 1st booster and 2nd booster immunization. Antibodies against different immunogens of A. hydrophila were detected using standard method of agglutination on day 0, 7, 14 and 28 following priming and booster immunizations. The degree of protection of all the immunization groups of fish was assessed by challenging the fishes with a LD50 dose of 1.5 x 107 cfu/ml of A. hydrophila on a low titre day after priming and on a peak titre day after 2nd booster. The results showed that the vaccines prepared from FKC yielded higher antibody than HKC and LPS. Vaccines prepared from HKC and LPS offered absolute (100%) protection against challenge. Vaccination with LPS resulted in lower antibody production but better immune protection against challenge in rohu.

Comparison of COVID-19 epidemic among Czech dentists and the Czech general population

Dentists are one of the professional groups most at risk for COVID-19 infection. Enhanced protective measures in dentistry have been adopted worldwide; however, it is unclear to what extent they were sufficient. To assess whether the protective measures outweighed the high infection risk, we compared COVID-19-related data between Czech dentists and the general Czech population. The data was obtained through a survey study attended by 15.8% of Czech Dental Chamber members. Data of the general population were acquired from the Czech Ministry of Health database. By the end of May 2022, COVID-19 full vaccination and 1st booster dose rates among study participants were 85.8% and 70.1%, respectively, which is significantly higher (p < 0.0001) compared to the Czech general population aged over 24 years (74.9% and 49.4%, respectively). To the same date, PCR/Antigen test verified COVID-19 prevalence among participants was 41.7%, and 49.9% among the general population (p < 0.0001). Prevalence and reinfection rates among individuals who received the 1st booster were significantly lower than among individuals without the booster or full vaccination (p < 0.0001). Persons who received the booster showed a faster return to work, shorter and different types of complications. Willingness to future vaccination was positive among 79.7% of respondents. Mandatory vaccination for healthcare workers and the general population was supported by 62.0% and 49.0%, respectively. The results showed that the high risk of COVID-19 infection associated with dentistry did not lead to higher COVID-19 prevalence among respondents compared to the general population.

Lack of seroresponse to SARS-CoV-2 booster vaccines given early post-transplant in patients primed pre-transplantation.

SARS-CoV-2 vaccines are recommended pre-transplantation, however, waning immunity and evolving variants mandate booster doses. Currently there no data to inform the optimal timing of booster doses post-transplant, in patients primed pre-transplant. We investigated serial serological samples in 204 transplant recipients who received 2 or 3 SARS-CoV-2 vaccines pre-transplant. Spike protein antibody concentrations, [anti-S], were measured on the day of transplantation and following booster doses post-transplant. In infection-naïve patients, post-booster [anti-S] did not change when V3 (1st booster) was given at 116(78-150) days post-transplant, falling from 122(32-574) to 111(34-682) BAU/ml, p=0.78. Similarly, in infection-experienced patients, [anti-S] on Day-0 and post-V3 were 1090(133-3667) and 2207(650-5618) BAU/ml respectively, p=0.26. In patients remaining infection-naïve, [anti-S] increased post-V4 (as 2nd booster) when given at 226(208-295) days post-transplant, rising from 97(34-1074) to 5134(229-5680) BAU/ml, p=0.0016. Whilst in patients who had 3 vaccines pre-transplant, who received V4 (as 1st booster) at 82(49-101) days post-transplant, [anti-S] did not change, falling from 981(396-2666) to 871(242-2092) BAU/ml, p=0.62. Overall, infection pre-transplant and [anti-S] at the time of transplantation predicted post-transplant infection risk. As [Anti-S] fail to respond to SARS-CoV-2 booster vaccines given early post-transplant, passive immunity may be beneficial to protect patients during this period.

Impact of COVID-19 Pandemic on Routine Children Immunisation: Experience from a Tertiary Care Centre, in New Delhi, India

Introduction: Coronavirus Disease-2019 (COVID-19) pandemic was a global emergency in 2019 with multiphasic national lockdowns in most countries. Poor accessibility to travel and disease scare led to major fall in routine children vaccination. Aim: To study the impact of COVID-19 pandemic on routine children immunisation at a tertiary care centre in New Delhi, India. Materials and Methods: This retrospective cross-sectional study was carried out in May and June 2022, by collecting retrospective data from Immunisation Clinic of Paediatric Department of Dr. Ram Manohar Lohia hospital, a tertiary care public hospital from January 2018 to December 2021. The data of routine immunisation was further analysed to know the impact of the COVID-19 pandemic in children from birth to 5 years of age in 2019 i.e., before the lockdown versus the first and second major waves of COVID-19 in 2020 and 2021, respectively. The data was entered in an excel chart and statistical testing was conducted with Statistical Package for the Social Sciences (SPSS) version 27.0. Unpaired t-test of equal variance was used for data analysis and p &lt;0.05 was considered as statistically significant. Results: There was a sharp fall in children receiving routine immunisation during COVID-19 pandemic in 2020(30.5%) and 2021 (24.9%) as compared to PreCOVID-19 period (2019). The overall vaccination coverage was significantly lower (p&lt;0.001) in postlockdown-1 phase (July/Aug 2020; n=521) and postlockdown-2 phase (July/Aug 2021; n=735) in comparison to pre COVID-19 period (July/Aug 2019; n=899). Significant fall in vaccination (p&lt;0.05) was seen in postlockdown phase 1 for birth dose vaccines, primary doses of combination vaccines, Measles-Rubella (MR-1) vaccine 1st dose, MR-2 and booster doses of Diphtheria, Pertussis, Tetanus (DPT) and for primary doses of combination vaccines, MR-1 vaccine 1st dose, MR-2 for postlockdown phase 2 (p&lt;0.05). Conclusion: Routine immunisation for all vaccines had a major setback during unlockdown period in 2020 and 2021. There is an urge for national drive for routine Vaccine Preventable Diseases (VPD) to prevent their re-surgence.

Role of the 1st booster dose of COVID-19 vaccine in the protection against the infection: A fundamental public health tool.

The COVID-19 pandemic is having a huge impact on human health with high morbidity and mortality rates worldwide. Healthcare Workers (HCWs) are one of the most at risk categories to contract the infection. Effective anti-COVID-19 vaccines were approved in a very short time. Making the 1st booster dose is essential to induce a good protection against the infection. We conducted a retrospective sero-epidemiological survey of already existing data concerning the antibody response of a HCWs sample vaccinated with the primary cycle and the 1st booster dose of the Pfizer-BioNTech COVID-19 mRNA vaccine and, specifically, after three weeks from the third dose of vaccination. In our analysis, after the primary cycle, a 95.15% efficacy was detected. Among the non-responders, women were significantly more frequent (69.56%). Moreover, we found a significant reverse correlation between the immune response and the age of the sample, especially in women. However, the 1st booster dose completely cancelled these differences. Our data are perfectly in line with what has been declared by the conducted studies in terms of efficacy. However, it is important to highlight that people with only the primary cycle are at high risk to contract the COVID-19 infection. Therefore, it is necessary to not consider people vaccinated with the primary cycle completely risk-free and to stress the importance to perform the 1st booster dose.

Relative effectiveness of a 2nd booster dose of COVID-19 mRNA vaccine up to four months post administration in individuals aged 80 years or more in Italy: A retrospective matched cohort study

Several countries started a 2nd booster COVID-19 vaccination campaign targeting the elderly population, but evidence around its effectiveness is still scarce. This study aims to estimate the relative effectiveness of a 2nd booster dose of COVID-19 mRNA vaccine in the population aged ≥ 80 years in Italy, during predominant circulation of the Omicron BA.2 and BA.5 subvariants.We linked routine data from the national vaccination registry and the COVID-19 surveillance system. On each day between 11 April and 6 August 2022, we matched 1:1, according to several demographic and clinical characteristics, individuals who received the 2nd booster vaccine dose with individuals who received the 1st booster vaccine dose at least 120 days earlier. We used the Kaplan-Meier method to compare the risks of SARS-CoV-2 infection and severe COVID-19 (hospitalisation or death) between the two groups, calculating the relative vaccine effectiveness (RVE) as (1 – risk ratio)X100.Based on the analysis of 831,555 matched pairs, we found that a 2nd booster dose of mRNA vaccine, 14–118 days post administration, was moderately effective in preventing SARS-CoV-2 infection compared to a 1st booster dose administered at least 120 days earlier [14.3 %, 95 % confidence interval (CI): 2.2–20.2]. RVE decreased from 28.5 % (95 % CI: 24.7–32.1) in the time-interval 14–28 days to 7.6 % (95 % CI: −14.1 to 18.3) in the time-interval 56–118 days. However, RVE against severe COVID-19 was higher (34.0 %, 95 % CI: 23.4–42.7), decreasing from 43.2 % (95 % CI: 30.6–54.9) to 27.2 % (95 % CI: 8.3–42.9) over the same time span.Although RVE against SARS-CoV-2 infection was much reduced 2–4 months after a 2nd booster dose, RVE against severe COVID-19 was about 30 %, even during prevalent circulation of the Omicron BA.5 subvariant. The cost-benefit of a 3rd booster dose for the elderly people who received the 2nd booster dose at least four months earlier should be carefully evaluated.

COVID-19 among Czech Dentistry Students: Higher Vaccination and Lower Prevalence Compared to General Population Counterparts.

The restrictions on medical students' clinical education during the COVID-19 pandemic has affected their professional readiness and often lengthened their training. These negative impacts are often considered a necessary price as clinical education is hypothesized to be associated with a high risk of pandemic spread. This work assesses this hypothesis based on COVID-19 epidemiological data among Czech dentistry students and their comparison to data of the Czech general population of similar age. We addressed two of the five Czech medical faculties (Charles University, Faculty of Medicine in Hradec Kralove and in Pilsen) providing dentistry study program with a survey. A total of 240 students participated, representing a 66.9% response rate. Over 75% of respondents participated in clinical education during the pandemic. The school environment was identified as a place of infection by only 9.8% of respondents who were aware of where they were infected. Overall, 100% of students used FFP2 respirators, and 75.3% used face shields or protective glasses while working with patients. By the end of May 2022, COVID-19 full vaccination and 1st booster rates among students were 93.8% and 54.6%, respectively, which is significantly higher (p &lt; 0.0001, OR 7.3, 95% CI 4.4-12; p &lt; 0.0001, OR 3.7, 95% CI 2.9-4.8, respectively) compared to their peers from the general population (67.1% and 24.4%, respectively). A total of 75.4% of respondents supported mandatory COVID-19 vaccination for healthcare professionals. To the same date, PCR and/or antigen test verified COVID-19 prevalence among students was 37.1%, while among peers from the general population, it was 45.1% (p = 0.015, OR 1.2, 95% CI 1.0-1.5). The combination of extensive protective measures and high vaccination against COVID-19 led to significantly lower COVID-19 prevalence among the students compared to their general population counterparts.

A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network

BackgroundIn the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and research should focus on optimal vaccination schedules. In addition to each individual’s medical history, immunosenescence warrants further research in this population. This study investigates vaccine-induced immune response over 1 year.Methods/designEU-COVAT-1-AGED is a randomised controlled, adaptive, multicentre phase II protocol evaluating different booster strategies in individuals aged ≥75 years (n=600) already vaccinated against SARS-CoV-2. The initial protocol foresaw a 3rd vaccination (1st booster) as study intervention. The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants. The primary endpoint of the trial is to assess the rate of 2-fold antibody titre increase 14 days after vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus. Secondary endpoints include the changes in neutralising antibody titres (Virus Neutralisation Assay) against wild-type as well as against Variants of Concern (VOC) at 14 days and up to 12 months. T cell response measured by qPCR will be performed in subgroups at 14 days as exploratory endpoint. Biobanking samples are being collected for neutralising antibody titres against potential future VOC. Furthermore, potential correlates between humoral immune response, T cell response and neutralising capacity will be assessed.The primary endpoint analysis will be triggered as soon as for all patients the primary endpoint (14 days after the 4th vaccination dose) has been observed.DiscussionThe EU-COVAT-1-AGED trial Part B compares immunogenicity and safety of mRNA-1273 (Spikevax®) and BNT162b2 (Comirnaty®) as 4th SARS-CoV-2 vaccine dose in adults ≥75 years of age. The findings of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population.Trial registrationClinicalTrials.govNCT05160766. Registered on 16 December 2021.Protocol version: V06_0: 27 July 2022

Systematic review of immunogenicity and duration of immunity of currently licensed pertussis wP vaccines in children

Background: Currently recommended whole cell pertussis (wP) vaccination schedule for children includes a 3-dose primary schedule, and at least one booster dose. When estimating the impact of additional strategies to reduce pertussis burden through modelling, duration of immunity conferred by childhood immunization is among the parameters models are most sensitive to. We aim to assess the duration of immunity of currently available wP vaccines in children and the additional protection conferred by booster doses. Methods: We conducted a systematic review of published studies of current commercially available vaccines indexed in Medline, Embase, Web of Science, Lilacs, SciELO and Central until September 2021. We included clinical trials, observational longitudinal, and cross-sectional studies. Citation screening, data extraction, and risk of bias and methodological quality assessment were done in duplicate by independent reviewers, following the study protocol registered in PROSPERO. Studies were included if they reported primary data on the protection, immunity, or duration of immunity conferred by ≥3 doses of wP vaccine in healthy children, without restriction to time or location of the study. Outcomes included clinical events or serological evidence of protection. Results: We included 12 studies conducted from 2007-2020 with heterogeneous methodological quality. Studies report on 5 of the 18 currently available wP vaccines in use. After primary immunization, geometric mean concentration (GMC) of anti-pertussis toxin ranged from 9.1 EU/mL (95% confidence intervals [CI]: 8.1-10.2) to 50.9 (95%CI: 45.9-56.4). Prior to the 1st booster, GMC titers were low ranging from 4.7 to 10 EU/mL, and after the 1st booster averaged around 42 EU/mL. Conclusions: The limited available evidence on immunogenicity of currently available wP vaccines reinforces the need for booster doses and suggests that the duration of wP immunity is short, probably &lt;5 years. This is important information for vaccination policy makers, investigators and modelers. PROSPERO registration: CRD42018107309

Development of monospecific polyclonal antibodies against hypervirulent Klebsiella pneumoniae

Abstract. Darniati, Setiyaningsih S, Agungpriyono DR, Handharyani E. 2021. Development of monospecific polyclonal antibodies against hypervirulent Klebsiella pneumoniae. Biodiversitas 22: 99-105. The aim of the research was to produce monospecific antibodies against Klebsiella pneumoniae serotype K1 and K2. Klebsiella pneumonia isolates were recovered from pneumonic lungs of Aceh cattle. The bacteria were identified by rpoB (RNA polymerase β subunit) PCR amplification specific for K. pneumoniae. The presence of capsule cluster gene magA and k2A was used to characterize capsular serotype K1 and K2, respectively. Antisera were produced using serial immunization of New Zealand White rabbits with K. pneumoniae serotypes K1 and K2. The presence of antibodies was determined by using immunodiffusion test and purification was performed by immunoaffinity purification method. K. pneumoniae antibodies began to appear on the 14th day after the first injection and progressively intensified after the 1st and 2nd booster. The cross-reactivity between the antigen was eliminated by absorbing the antisera with the opposite antigen and several serotypes of non-K1/K2. After purification, serum protein concentrations were substantially decreased from 58.48 µg/µL and 53.99 µg/µL to 2.38 µg / µL and 3.72 µg / µL for K1 and K2, respectively). The SDS-PAGE analysis showed two bands with molecular weight at 54 kDa and 25 kDa representing the heavy and light chains of immunoglobulin G, respectively. Purified polyclonal antiseras against K. pneumoniae serotypes K1 and K2 showed high affinity and specificity for homologous antigens in immunodiffusion and direct agglutination tests, and immunohistochemical staining.

Transversal sero-epidemiological study of Bordetella pertussis in Tehran, Iran.

Pertussis remains endemic despite high vaccine coverage in infants and toddlers. Pertussis vaccines confer protection but immunity wanes overtime and boosters are needed in a lifetime. Iran, eligible for the Expanded Program on Immunization that includes the primary immunization, implemented two additional booster doses using a whole-cell vaccine (wPV) at 18 months-old and about 6 years-old. Duration of protection induced by the wPVs currently in use and their impact as pre-school booster are not well documented. This study aimed at assessing vaccination compliance and at estimating the duration of protection conferred by vaccination with wPV in children aged < 15 years in Tehran, Iran. Detailed information on vaccination history and capillary blood samples were obtained from 1047 children aged 3-15 years who completed the 3 doses-primary pertussis immunization, in Tehran. Anti-pertussis toxin IgG levels were quantified by ELISA. Compliance was very high with 93.3% of children who received the three primary and 1st booster doses in a timely manner. Timeliness of the 2nd booster was lower (63.3%). Rate of seropositive samples continuously and significantly increased from 1-2 to 5-6 years after 1st booster attaining 30.4% of children exhibiting serological sign of recent contact with B. pertussis. Second booster dating back 1 or 2 years was associated with high antibody titers, which significantly decreased within 3 years from injection. Among children who received 2nd booster injection more than 2 years before serum analysis, seroprevalence of pertussis infection was 8.4% and seropositivity rate was higher from the 10 years-old group. Seropositivity in children aged 6-7 years with no 2nd booster supports the need for a vaccination at that age. Adolescent booster may also be considered.

A cross sectional study of contraceptive use and reasons for unmet needs among mothers attending immunisation clinic at tertiary care centre of central India

Background: Unmet need of contraception remains a national problem. The study was conducted among the mothers attending immuno-prophylaxis clinic (IPC) at tertiary care centre of central India to determine the use of different types of contraception and assess the unmet need for contraception along with the reasons associated with the unmet needs of contraception. Aim and objective was to study the contraceptive use, reasons for unmet needs amongst the mothers attending IPC and some related factors.Methods: This was a cross-sectional study conducted during the period from February-April 2016 at IPC in tertiary care setting. In this study 280 mothers attending IPC for Measles and DPT 1st booster of their child were enrolled. The sample population was selected by simple random sampling method. A pre-tested structured questionnaire was used to collect data from the respondents with written informed consent.Results: This study shows that, 65% of mother told they were practicing any type of family planning method. Unmet need for contraception was 37.14 per cent. Among those having unmet need (n=104), fear of side effects (41.35%), infrequent sex (25%) were the common reasons for unmet need. Religion, age of marriage, age at 1st pregnancy, education, socioeconomic status, occupation of husband, counselling about contraceptives during ANC/PNC visits and resumption of menses were significantly associated with the use of contraceptives.Conclusions: The unmet need for contraception was quite high. Most of the study subjects were not using contraception due to fear of side effects and lack of knowledge.