Prevalence and predictors of anti-SARS-CoV-2 serology in a highly vulnerable population of Rio de Janeiro: A population-based serosurvey

Coelho, Lara E.; Luz, Paula M.; Castanheira, Débora; Jalil, Emilia Moreira; Perazzo, Hugo; Torres, Thiago Silva; Cardoso, Sandra Wagner; Peixoto, Eduardo Mesquita; Nazer, Sandro; Massad, Eduardo; Silveira, Mariângela Freitas da; Barros, Fernando C.; Vasconcelos, Ana Tereza Ribeiro de; Costa, Carlos; Amâncio, Rodrigo Teixeira; Villela, Daniel A. M.; Pereira, Tiago; Goedert, Guilherme Tegoni; Santos, Cléber Vinícius Brito dos; Rodrigues, Nádia Cristina Pinheiro; Grinsztejn, Beatriz; Veloso, Valdiléa G.; Struchiner, Cláudio J.

doi:10.1016/j.lana.2022.100338

Cited by 9 publications

(10 citation statements)

References 61 publications

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“… 9 In a Brazilian study with more than 4.000 vulnerable individuals, the identification of female gender was higher among the population tested positive for Anti-SARS-CoV (59.9 %), in relation to age, the highest seroprevalence of anti-SARS-CoV-2 IgG was found in the 20‒29 age group (17.3 %), while in the 40‒49 age group the prevalence was 14.3 %. 10 In a Thai study, carried out with more than 4.000 samples and over a timeframe similar to our study (May 14, 2020, and May 21, 2021), a similar average age was found when evaluating the prevalence of anti-SARS-CoV-2 among adults. However, there was a low prevalence of anti-SARS-CoV-2 detection, with 0.44 %.…”

Section: Introductionsupporting

confidence: 83%

“…This is consistent with studies revealing the housing situation and vulnerability of populations living in impoverished slum communities in Brazil, with high seroprevalence of anti-SARS-CoV-2, reaching an overall prevalence of 49 %, which varied across different slums (from 3‒68 % to 4‒31 %) and the highest percentages of years of education in this population were in primary school (38 %) and in high school (37 %), reinforcing the vulnerability of these groups. 10 …”

Section: Introductionmentioning

confidence: 99%

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Seroprevalence of anti-SARS-CoV-2 in patients with hepatitis B and C: a pre-vaccination study

da Silva,

Lewis-Ximenez,

Magalhães

et al. 2024

The Brazilian Journal of Infectious Diseases

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Section: Introductionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Seroprevalence of anti-SARS-CoV-2 in patients with hepatitis B and C: a pre-vaccination study

da Silva,

Lewis-Ximenez,

Magalhães

et al. 2024

The Brazilian Journal of Infectious Diseases

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“…While this study measured total antibodies against S-RBD SARS-CoV-2 virus, our study measured anti-N IgG antibodies. Disparities in prevalence estimate obtained using different serological assays are known [34].…”

Section: Safety Resultsmentioning

confidence: 99%

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Gunale

Kapse

Kar

et al. 2023

Preprint

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Background: A recombinant, adjuvanted COVID-19 vaccine, SII-NVX-CoV2373 was manufactured in India and evaluated in Indian children and adolescents to assess safety and immunogenicity. Methods: This was a Phase 2/3 observer-blind, randomized, controlled study in children and adolescents aged 2 to 17 years. Participants were randomly assigned in 3:1 ratio to receive two doses of SII-NVX-CoV2373 or placebo on day 1 and day 22. Solicited adverse events (AEs) were collected for 7 days after each vaccination. Unsolicited AEs were collected for 35 days following first dose and serious AEs (SAEs) and adverse events of special interest (AESI) were collected throughout the study. Anti S IgG and neutralizing antibodies against the SARS-CoV-2 were measured at baseline, day 22, day 36 and day 180. Variant immune responses were assessed in a subset of participants at baseline, day 36 and day 180. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 in each pediatric age group (12 to 17 years and 2 to 11 years, separately) to that in adults in terms of ratio of titers of both anti-S IgG and neutralizing antibodies 14 days after the second dose (day 36). Non-inferiority was to be concluded if the lower bound of 95% CI of the ratio was >0.67. Results: A total of 920 children and adolescents (460 in each age cohort; 12 to 17 years and 2 to 11 years) were randomized and vaccinated. The demographic and baseline characteristics between the two groups were comparable in both age groups. After the second dose, there were more than 100-fold rise in anti-S IgG GMEUs and more than 84-fold rise in neutralizing antibodies GMTs from baseline in the participants who received SII-NVX-CoV2373. The GMTs in both age groups were non-inferior to those observed in Indian adults. The seroconversion rate was ≥ 98% (anti-S IgG) and ≥ 97.9% (neutralizing antibodies) in both age groups, respectively. Similar findings were seen in the baseline seronegative participants. SII-NVX-CoV2373 also showed robust responses against various variants of concern. Injection site pain, tenderness, swelling, erythema and fever, headache, malaise, fatigue, myalgia, arthralgia, nausea and vomiting were the common solicited adverse events which were transient and resolved without any sequelae. Throughout the study, only two causally unrelated SAEs and no AESI were reported. Conclusion: SII-NVX-CoV2373 has been found safe and well tolerated in children and adolescents of 2 to 17 years. The vaccine was highly immunogenic and the immune response was non-inferior to that in adults.

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“…While this study measured total antibodies against the spike protein receptor-binding domain, our study measured anti-nucleocapsid IgG antibodies. Disparities in prevalence estimates obtained using different assays are known …”

Section: Discussionmentioning

confidence: 99%

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India

Gunale,

Kapse,

Kar

et al. 2023

JAMA Pediatr

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ImportanceThe recombinant COVID-19 vaccine NVX-CoV2373 has demonstrated efficacy of approximately 90% in adults; however, its safety and efficacy in children is unknown.ObjectiveTo assess the noninferiority of SII-NVX-CoV2373 in children and adolescents compared to adults and to evaluate its safety in comparison with placebo.Design, Setting, and ParticipantsThis phase 2-3 observer-blind randomized clinical trial was conducted in 2 cohorts, children (aged 2 to 11 years) and adolescents (aged 12 to 17 years) between August 2021 and August 2022. Participants were randomized 3:1 to SII-NVX-CoV2373 or placebo and monitored for 179 days. The participants, study team, and laboratory staff were blinded. This was a multicenter study conducted across 10 tertiary care hospitals in India. Exclusion criteria included previous COVID-19 infection or vaccination, immunocompromised condition, and immunosuppressive medications.InterventionsTwo doses of 0.5-mL SII-NVX-CoV2373 or placebo were administered intramuscularly on days 1 and 22.Main Outcomes and MeasuresPrimary outcomes were geometric mean titer ratio of both anti-spike (anti-S) IgG and neutralizing antibodies (NAbs) between both pediatric age groups to that of adults on day 36. Noninferiority was concluded if the lower bound of 95% CI of this ratio was greater than 0.67 for each age group. Both the antibodies were assessed for the index strain and for selected variants at various time points. Solicited adverse events (AEs) were recorded for 7 days after each vaccination, unsolicited AEs were recorded for 35 days, and serious AEs and AEs of special interest were recorded for 179 days.ResultsA total of 460 children in each age cohort were randomized to receive vaccine or placebo. The mean (SD) age was 6.7 (2.7) years in the child cohort and 14.3 (1.6) years in the adolescent cohort; 231 participants (50.2%) in the child cohort and 218 in the adolescent cohort (47.4%) were female. Both anti-S IgG and NAb titers were markedly higher in the SII-NVX-CoV2373 group than in the placebo group on both day 36 and day 180. The geometric mean titer ratios compared to those in adults were 1.20 (95% CI, 1.08-1.34) and 1.52 (95% CI, 1.38-1.67) for anti-S IgG in adolescents and children, respectively; while for NAbs, they were 1.33 (95% CI, 1.17-1.50) and 1.93 (95% CI, 1.70-2.18) in adolescents and children, respectively, indicating noninferiority. SII-NVX-CoV2373 also showed immune responses against variants studied. Injection site reactions, fever, headache, malaise, and fatigue were common solicited AEs. There were no AEs of special interest and no causally related serious AEs.Conclusions and RelevanceSII-NVX-CoV2373 was safe and well tolerated in children and adolescents in this study. The vaccine was highly immunogenic and may be used in pediatric vaccination against COVID-19.Trial RegistrationClinical Trials Registry of India Identifier: CTRI/2021/02/031554

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Prevalence and predictors of anti-SARS-CoV-2 serology in a highly vulnerable population of Rio de Janeiro: A population-based serosurvey

Cited by 9 publications

References 61 publications

Seroprevalence of anti-SARS-CoV-2 in patients with hepatitis B and C: a pre-vaccination study

Seroprevalence of anti-SARS-CoV-2 in patients with hepatitis B and C: a pre-vaccination study

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India

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