A phase I COVID-19 vaccine trial among SARS-CoV-2 seronegative and seropositive individuals in Uganda utilizing a self-amplifying RNA vaccine platform: Screening and enrollment experiences

Kitonsa, Jonathan; Kamacooko, Onesmus; Ruzagira, Eugene; Nambaziira, Florence; Abaasa, Andrew; Serwanga, Jennifer; Gombe, Ben; Lunkuse, Jane; Naluyinda, Hadijah; Tukamwesiga, Naboth; Namata, Tamara; Kigozi, Antony; Kafeero, Paddy; Basajja, Vincent; Joseph, Sarah; Pierce, Benjamin F.; Shattock, Robin; Kaleebu, Pontiano

doi:10.1080/21645515.2023.2240690

Cited by 2 publications

(1 citation statement)

References 21 publications

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“…Since the seroconversion rate in both studies was lower compared to other SARS-CoV-2 vaccines, a second-generation vaccine (LNP-nCoV saRNA-02) was developed to address these limitations. This new vaccine, with an undisclosed redesigned saRNA backbone to dampen IFN responses, will be used in a phase I trial in Uganda (NCT04934111) [ 99 ].…”

Section: Sarna-based Covid-19 Vaccines In Clinical Trialsmentioning

confidence: 99%

Self-Amplifying RNA: A Second Revolution of mRNA Vaccines against COVID-19

Silva-Pilipich,

Beloki,

Salaberry

et al. 2024

Vaccines

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SARS-CoV-2 virus, the causative agent of COVID-19, has produced the largest pandemic in the 21st century, becoming a very serious health problem worldwide. To prevent COVID-19 disease and infection, a large number of vaccines have been developed and approved in record time, including new vaccines based on mRNA encapsulated in lipid nanoparticles. While mRNA-based vaccines have proven to be safe and effective, they are more expensive to produce compared to conventional vaccines. A special type of mRNA vaccine is based on self-amplifying RNA (saRNA) derived from the genome of RNA viruses, mainly alphaviruses. These saRNAs encode a viral replicase in addition to the antigen, usually the SARS-CoV-2 spike protein. The replicase can amplify the saRNA in transfected cells, potentially reducing the amount of RNA needed for vaccination and promoting interferon I responses that can enhance adaptive immunity. Preclinical studies with saRNA-based COVID-19 vaccines in diverse animal models have demonstrated the induction of robust protective immune responses, similar to conventional mRNA but at lower doses. Initial clinical trials have confirmed the safety and immunogenicity of saRNA-based vaccines in individuals that had previously received authorized COVID-19 vaccines. These findings have led to the recent approval of two of these vaccines by the national drug agencies of India and Japan, underscoring the promising potential of this technology.

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Section: Sarna-based Covid-19 Vaccines In Clinical Trialsmentioning

confidence: 99%

Self-Amplifying RNA: A Second Revolution of mRNA Vaccines against COVID-19

Silva-Pilipich,

Beloki,

Salaberry

et al. 2024

Vaccines

View full text Add to dashboard Cite

show abstract

An Optimised Indirect ELISA Protocol for Detection and Quantification of Anti-viral Antibodies in Human Plasma or Serum: A Case Study Using SARS-CoV-2

Baine,

Sembera,

Oluka

et al. 2023

BIO-PROTOCOL

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Advanced immunoassays are crucial in assessing antibody responses, serving immune surveillance goals, characterising immunological responses to evolving viral variants, and guiding subsequent vaccination initiatives. This protocol outlines an indirect ELISA protocol to detect and quantify virus-specific antibodies in plasma or serum after exposure to viral antigens. The assay enables the measurement of IgG, IgA, and IgM antibodies specific to the virus of interest, providing qualitative and quantitative optical densities and concentration data. Although this protocol refers to SARS-CoV-2, its methodology is versatile and can be modified to assess antibody responses for various viral infections and to evaluate vaccine trial outcomes. Key features • This protocol builds upon previously described methodology [1] explicitly tailored for SARS-CoV-2 and broadens its applicability to other viral infections. • The protocol outlines establishing antibody responses to SARS-CoV-2 infections by determining optical densities and concentrations from blood plasma or serum.

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A phase I COVID-19 vaccine trial among SARS-CoV-2 seronegative and seropositive individuals in Uganda utilizing a self-amplifying RNA vaccine platform: Screening and enrollment experiences

Cited by 2 publications

References 21 publications

Self-Amplifying RNA: A Second Revolution of mRNA Vaccines against COVID-19

Self-Amplifying RNA: A Second Revolution of mRNA Vaccines against COVID-19

An Optimised Indirect ELISA Protocol for Detection and Quantification of Anti-viral Antibodies in Human Plasma or Serum: A Case Study Using SARS-CoV-2

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