Safety and Immunogenicity of mRNA-LNP COVID-19 Vaccine CVnCoV in Latin American Adults; A Phase 2 Randomized Study

Sáez-Llorens, Xavier; Lanata, Claudio F.; Aranguren, Elaine; Celis, Carlos R.; Cornejo, Rubelio; DeAntonio, Rodrigo; Ecker, Lucie; Garrido, Diegi; Gil, Ana I.; Gonzales, Marina; Hess‐Holtz, Morgan; Leroux‐Roels, Geert; Junker, Helga; Kays, Sarah-Katharina; Koch, Sven D.; Lazzaro, Sandra; Mann, Philipp; Quintini, Gianluca; Srivastava, Barkha; Vahrenhorst, Dominik; Eisenhart-Rothe, Philipp von; Wolz, Olaf‐Oliver; Oostvogels, Lidia

doi:10.2139/ssrn.3982187

Cited by 2 publications

(10 citation statements)

References 12 publications

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“…We previously reported that two doses of CVnCoV induced seroconversion in more than 60% of those who were immunologically naïve for SARS-CoV-2 although GMTs waned to baseline levels on D180 in our phase 1 and 2a studies [7,11]. Here we observed that SARS-CoV-2 pre-exposed individuals still had measurable neutralizing antibodies against both wild-type and Delta up to six months after the first two doses.…”

Section: Discussionsupporting

confidence: 53%

“…The methods for this randomized phase 2a clinical trial assessing the safety and immunogenicity of the first generation CVnCoV vaccine have been described previously [11]. In this trial, open-label subsets of participants who had received 12 µg of CVnCoV on Day (D) 1 and D29, received a third dose (12 µg) on D57 (n=30, aged >60 years old) or on D180 (n=30, aged 18-60 years and n=15, aged >60 years).…”

Section: Methodsmentioning

confidence: 99%

“…Here we report the neutralizing antibody response against the SARS-CoV-2 wild-type and Delta sub-type B.1.617.2 variant after the administration of a third (e.g. booster) dose of CVnCoV vaccine in a subset of the phase 2a trial participants [11].…”

Section: Introductionmentioning

confidence: 99%

“…The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19) is responsible for the current pandemic declared by World Health Organization (WHO) on 11 March 2020 [1]. As of 1 February 2022, there have been nearly 377 million confirmed cases of COVID-19, including more than 5.7 million deaths, reported to WHO and nearly 9.9 billion vaccine doses have been administered worldwide [2].…”

mentioning

confidence: 99%

“…Recently we reported the results from three clinical trials assessing the safety, efficacy and immunogenicity of a first-generation COVID-19 vaccine candidate: CVnCoV [9][10][11]. CVnCoV was developed as a sequence-optimized unmodified mRNA vaccine using the proprietary RNActive ® technology platform.…”

mentioning

confidence: 99%

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Third dose of COVID-19 vaccine, CVnCoV, increased neutralizing activity against SARS-CoV-2 wild-type and Delta variant

Wolz

Kays

Junker

et al. 2022

Preprint

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A third dose of CVnCoV, a former candidate mRNA vaccine against SARS-CoV-2, was previously shown to boost neutralizing antibody responses against SARS-CoV-2 wild-type in adults aged 18-60 and >60 years in a phase 2a clinical study. Here we report neutralizing antibody responses to wild-type and a variant of concern, Delta, after a third dose on day (D) 57 and D180. Neutralization activity was assessed using a microneutralization assay. Comparable levels of neutralizing antibodies against wild-type and Delta were induced. These were higher than those observed after the first two doses, irrespective of age or pre- SARS-CoV-2-exposure status, indicating that the first two doses induced immune memory. Four weeks after the third dose on D180, neutralizing titers for wild-type and Delta were two-fold higher in younger participants than in older participants; seroconversion rates were 100% for wild-type and Delta in the younger group and for Delta in the older group. A third CVnCoV dose induced similar levels of neutralizing responses against wild-type virus and the Delta variant in both naive and pre-exposed participants, aligning with current knowledge from licensed COVID-19 vaccines that a third dose is beneficial against SARS-CoV-2 variants.

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Section: Discussionsupporting

confidence: 53%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Third dose of COVID-19 vaccine, CVnCoV, increased neutralizing activity against SARS-CoV-2 wild-type and Delta variant

Wolz

Kays

Junker

et al. 2022

Preprint

Self Cite

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A Third Dose of the COVID-19 Vaccine, CVnCoV, Increased the Neutralizing Activity against the SARS-CoV-2 Wild-Type and Delta Variant

et al. 2022

Self Cite

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A third dose of CVnCoV, a former candidate mRNA vaccine against SARS-CoV-2, was previously shown to boost neutralizing antibody responses against SARS-CoV-2 wild-type in adults aged 18–60 and >60 years in a phase 2a clinical study. In the present study, we report the neutralizing antibody responses to a wild-type and a variant of concern, Delta, after a third dose of the vaccine on day (D)57 and D180. Neutralization activity was assessed using a microneutralization assay. Comparable levels of neutralizing antibodies against the wild-type and Delta were induced. These were higher than those observed after the first two doses, irrespective of age or pre-SARS-CoV-2-exposure status, indicating that the first two doses induced immune memory. Four weeks after the third dose on D180, the neutralizing titers for wild-type and Delta were two-fold higher in younger participants than in older participants; seroconversion rates were 100% for wild-type and Delta in the younger group and for Delta in the older group. A third CVnCoV dose induced similar levels of neutralizing responses against wild-type virus and the Delta variant in both naïve and pre-exposed participants, aligning with current knowledge from licensed COVID-19 vaccines that a third dose is beneficial against SARS-CoV-2 variants.

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Safety and Immunogenicity of mRNA-LNP COVID-19 Vaccine CVnCoV in Latin American Adults; A Phase 2 Randomized Study

Cited by 2 publications

References 12 publications

Third dose of COVID-19 vaccine, CVnCoV, increased neutralizing activity against SARS-CoV-2 wild-type and Delta variant

Third dose of COVID-19 vaccine, CVnCoV, increased neutralizing activity against SARS-CoV-2 wild-type and Delta variant

A Third Dose of the COVID-19 Vaccine, CVnCoV, Increased the Neutralizing Activity against the SARS-CoV-2 Wild-Type and Delta Variant

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