3- Wednesday Research News – 24th November

 1 – Immunogenicity and safety of the homogenous booster shot of a recombinant fusion protein vaccine (V-01) against COVID-19 in healthy adult participants primed with a two-dose regimen

• Rising concerns over waning immunity and reduction in neutralizing activity against variants of concern (VOCs) have contributed to deploying booster doses by different strategies to tackle the COVID-19 pandemic.
• Preliminary findings from Phase I and II have shown that V-01, a recombinant fusion protein vaccine against COVID-19, exhibited favorable safety and immunogenicity profiles in 1060 adult participants of both younger and senior age.
• Herein, they aimed to assess the immunogenicity and safety for a booster dose in participants previously primed with a two-dose 10μg V-01 regimen (day 0, 21) from phase I trial, providing reassuring data for necessity and feasibility of a homogenous booster dose.
• A homogenous booster immunization in participants receiving a primary series of two-dose V-01 elicited a substantial humoral immune response against wild-type SARS-CoV-2 and emerging VOCs, along with a favorable safety and reactogenicity profile.

Source: MedRxiv

2- Interventions to prevent or delay the onset of type 2 diabetes in women with prior gestational diabetes mellitus: protocol for a living systematic review and prospective meta-analysis

• Gestational diabetes mellitus (GDM), once considered a transient condition during pregnancy, is now a firmly established risk factor for type 2 diabetes mellitus (T2DM).
• Women whose blood glucose levels do not return to normal soon after giving birth are particularly at high risk of developing established diabetes and consequent heart and blood vessel disease.
• Lifestyle interventions are recommended for women with GDM to prevent or delay the subsequent development of T2DM.
• Recent systematic reviews and meta-analyses have suggested postpartum lifestyle interventions may be beneficial in reducing the risk of developing diabetes in women with GDM, however, included studies were generally small.
• In addition, formal systematic review and meta-analysis of other approaches to preventing diabetes in this population (e.g. pharmacotherapy) has not been attempted.
• Therefore, an updated systematic review is needed and will be formulated as a living systematic review to ensure the inclusion of emerging studies.

Source: MedRxiv

3- Humoral immune response to Covid-19 vaccination in diabetes: age-dependent but independent of type of diabetes and glycaemic control – the prospective COVAC-DM cohort study

• Immune response to COVID-19 vaccination and a potential impact of glycaemia on antibody levels in people with diabetes remains unclear.
• They investigated the seroconversion following first and second COVID-19 vaccination in people with type 1 and type 2 diabetes in relation to glycaemic control prior to vaccination and analysed the response in comparison to individuals without diabetes.
• Anti-SARS-CoV-2 S antibody levels after the second vaccination were comparable in healthy controls, people with type 1 and type 2 diabetes, irrespective of glycaemic control. Age and renal function correlated significantly with the extent of antibody levels.

Source: MedRxiv

4- SARS-CoV-2 anti-spike IgG antibody responses after second dose of ChAdOx1 or BNT162b2 and correlates of protection in the UK general population

• They investigated anti-spike IgG antibody responses and correlates of protection following second doses of ChAdOx1 or BNT162b2 SARS-CoV-2 vaccines in the UK general population.
• In 222,493 individuals, they found significant boosting of anti-spike IgG by second doses of both vaccines in all ages and using different dosing intervals, including the 3-week interval for BNT162b2.
• After second vaccination, BNT162b2 generated higher peak levels than ChAdOX1.
• Antibody levels declined faster at older ages and in males with BNT162b2, but declines were similar across ages and sexes with ChAdOX1.
• Prior infection significantly increased antibody half-life with both vaccines.
• Anti-spike IgG levels were associated with protection from infection after vaccination and, to an even greater degree, after prior infection.
• At least 67% protection against infection was estimated to last for 2-3 months after two ChAdOx1 doses and 6-15 months after two BNT162b2 doses in those without prior infection, and 1-2 years for those unvaccinated after natural infection.

Source: MedRxiv

5- Curating, collecting, and cataloguing global COVID-19 datasets for the aim of predicting personalized risk

• The COVID-19 data catalogue is a repository that provides a landscape view of COVID-19 studies and datasets as a putative source to enable researchers to develop personalized COVID-19 predictive risk models.
• The COVID-19 data catalogue currently contains over 400 studies and their relevant information collected from a wide range of global sources such as global initiatives, clinical trial repositories, publications and data repositories.
• Further, the curated content stored in this data catalogue is complemented by a web application, providing visualizations of these studies, including their references, relevant information such as measured variables, and the geographical locations of where these studies were performed.
• This resource is one of the first to capture, organize and store studies, datasets and metadata in the area of COVID-19 in a comprehensive repository.

Source: MedRxiv

6- Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme

• SOBERANA 02 is a COVID-19 conjugate vaccine candidate based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid.
• SOBERANA Plus antigen is dimeric-RBD.
• Here they report safety, reactogenicity and immunogenicity from phase I and IIa clinical trials using two-doses SOBERANA 02 (homologous protocol) and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols.
• SOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T cell response. Highest immune responses were obtained in the heterologous three doses protocol.

Source: MedRxiv

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