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Homologous equivalence study of immunogenicity after third dose of Covid-19 vaccine (recombinant) with an interval of six months after the second dose, comparing the interval of eight and 12 weeks between the first two doses.
Vianna, Clarice Monteiro; da Silva E Sá, Gloria Regina; Seid, Maria Vitória Hadland; Camacho, Luiz Antonio Bastos; Xavier, Janaína Reis; da Gama, Vitor Cardoso; de Castro, Thalita da Matta; Dos Santos, Ewerton Alves Portela; de Almeida, Camila Dias; Cruz, Robson Leite de Souza; Siqueira, Marilda; Maia, Maria de Lourdes de Sousa; Ferroco, Clara Lucy de Vasconcellos; de Araújo, Mia Ferreira; Tort, Luis Fernando López; Caetano, Braulia Costa.
Affiliation
  • Vianna CM; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • da Silva E Sá GR; Universidade Federal do Estado do Rio de Janeiro, Instituto de Saúde Coletiva, Rio de Janeiro, RJ, Brasil.
  • Seid MVH; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • Camacho LAB; Fundação Oswaldo Cruz-Fiocruz, Escola Nacional de Saúde Pública, Rio de Janeiro, RJ, Brasil.
  • Xavier JR; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • da Gama VC; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • de Castro TDM; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • Dos Santos EAP; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • de Almeida CD; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • Cruz RLS; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • Siqueira M; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Laboratório de Vírus Respiratórios, Exantemáticos, Enterovírus e Emergências Virais, Rio de Janeiro, RJ, Brasil.
  • Maia MLS; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • Ferroco CLV; Fundação Oswaldo Cruz-Fiocruz, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos, Rio de Janeiro, RJ, Brasil.
  • de Araújo MF; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Laboratório de Vírus Respiratórios, Exantemáticos, Enterovírus e Emergências Virais, Rio de Janeiro, RJ, Brasil.
  • Tort LFL; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Laboratório de Vírus Respiratórios, Exantemáticos, Enterovírus e Emergências Virais, Rio de Janeiro, RJ, Brasil.
  • Caetano BC; Universidad de la República, Centro Universitario Regional Litoral Norte, Laboratório de Virologia Molecular, Salto, Uruguay.
Mem Inst Oswaldo Cruz ; 119: e240094, 2024.
Article in En | MEDLINE | ID: mdl-39258623
ABSTRACT

BACKGROUND:

In response to the coronavirus disease 2019 (Covid-19) pandemic, Brazil authorised the Astra Zeneca/Fiocruz vaccine in January 2021. As the Delta variant emerged in May 2021, interval between vaccine doses was adjusted. By September 2021, the Brazilian National Immunisation Program recommended a booster dose for individuals over 70, and later expanded the recommendation to all adults.

OBJECTIVES:

Assess the equivalence of IgG antibody response against the Covid-19 S protein before and approximately 28 days after the third dose of a Covid-19 recombinant vaccine. Two groups received initial two doses with intervals of eight and 12 weeks.

METHODS:

This is a phase IV clinical study, uncontrolled, non-randomised. The study proposes calculating the ratio of geometric means titres (GMT) 28 days after the third dose, with a target ratio of confidence interval (CI) between 0.77 and 1.3.

FINDINGS:

In the primary endpoint, there was no equivalence between the eight- and 12-week intervals with a slight variation favouring the eight-week group. Post-third dose, both groups showed increases titres at 28 days, three months, six months and 12 months. Both groups responded similarly to Delta and Omicron BA.1, with a more significant increase for Delta. MAIN

CONCLUSIONS:

The study showed strong and consistent immune response in all age groups receiving the Covid-19 recombinant vaccine. Third dose elicited an increase in GMT by at least three times aligned with Ministry of Health strategies emphasising Bio-Manguinhos crucial role in pandemic control in the country.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Immunoglobulin G / Vaccines, Synthetic / Immunization Schedule / Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / Antibodies, Viral Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do sul / Brasil Language: En Journal: Mem Inst Oswaldo Cruz Year: 2024 Document type: Article Affiliation country: Brazil Country of publication: Brazil

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Immunoglobulin G / Vaccines, Synthetic / Immunization Schedule / Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / Antibodies, Viral Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do sul / Brasil Language: En Journal: Mem Inst Oswaldo Cruz Year: 2024 Document type: Article Affiliation country: Brazil Country of publication: Brazil