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23 mei 2020: Bron: The Lancet

Een vaccin dat werd ontwikkeld en toegepast in China bij tot nu toe 108 deelnemers blijkt na een eerste evaluatie veilig te zijn en mensen te beschermen tegen het coronavirus, zo schrijft o.a. The New York Times. De studie is inmiddels ook ter inzage in The Lancet.

Het vaccin is getest op 108 mensen tussen de 18 en 60 jaar. De studie was een veiligheidsstudie met drie verschillende doses. Bijna alle deelnemers die het vaccin kregen ongeacht de hoogte van de dosis, bleken binnen twee weken T-lymfocyten aan te maken. T-cellen zijn een bepaald soort witte bloedcellen die nodig zijn voor de specifieke afweer tegen het virus. De meerderheid van de deelnemers, maar niet allemaal, maakten binnen vier weken (28 dagen) antistoffen aan die ervoor moeten zorgen dat er immuniteit ontstaat tegen het virus.

In het volledige studierapport: Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial staat heel veel meeer te lezen. Met gedetailleerd verslag hoe het vaccin is ontwikkeld en toegepast.

Het abstract:

Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

Summary

Background

A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.

Methods

We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.govNCT04313127.

Findings

Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.

Interpretation

The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.

Funding

National Key R&D Program of China, National Science and Technology Major Project, and CanSino Biologics.

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