Evidence map›Paper›PMID 35963274›Full record

Trial reportThe Lancet. Infectious diseases2022

Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial.

Raburn M Mallory, Neil Formica, Susan Pfeiffer, Bethanie Wilkinson, Alex Marcheschi, Gary Albert, Heather McFall, Michelle Robinson, Joyce S Plested, Mingzhu Zhu and 13 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 80 citations in OpenAlex.

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  9. Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 2 institutions in 1 country.

Raburn M MalloryNovavax, Gaithersburg, MD, USA. Electronic address: rmallory@novavax.com.
Neil FormicaNovavax, Gaithersburg, MD, USA.
Susan PfeifferNovavax, Gaithersburg, MD, USA.
Bethanie WilkinsonNovavax, Gaithersburg, MD, USA.
Alex MarcheschiNovavax, Gaithersburg, MD, USA.
Gary AlbertNovavax, Gaithersburg, MD, USA.
Heather McFallNovavax, Gaithersburg, MD, USA.
Michelle RobinsonNovavax, Gaithersburg, MD, USA.
Joyce S PlestedNovavax, Gaithersburg, MD, USA.
Mingzhu ZhuNovavax, Gaithersburg, MD, USA.
Shane Cloney-ClarkNovavax, Gaithersburg, MD, USA.
Bin ZhouNovavax, Gaithersburg, MD, USA.
Gordon ChauNovavax, Gaithersburg, MD, USA.
Andreana RobertsonNovavax, Gaithersburg, MD, USA.
Sonia MaciejewskiNovavax, Gaithersburg, MD, USA.
Holly L HammondUniversity of Maryland School of Medicine, University of Maryland, Baltimore, MD, USA.
Lauren BaraccoUniversity of Maryland School of Medicine, University of Maryland, Baltimore, MD, USA.
James LogueUniversity of Maryland School of Medicine, University of Maryland, Baltimore, MD, USA.
Matthew B FriemanUniversity of Maryland School of Medicine, University of Maryland, Baltimore, MD, USA.
Gale SmithNovavax, Gaithersburg, MD, USA.
Nita PatelNovavax, Gaithersburg, MD, USA.
Gregory M GlennNovavax, Gaithersburg, MD, USA.
Novavax 2019nCoV101 Study Group
Novavax (United States) · USUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEmerging SARS-CoV-2 variants and evidence of waning vaccine efficacy present substantial obstacles towards controlling the COVID-19 pandemic. Booster doses of SARS-CoV-2 vaccines might address these concerns by amplifying and broadening the immune responses seen with initial vaccination regimens. We aimed to assess the immunogenicity and safety of a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373).

methodsThis secondary analysis of a phase 2, randomised study assessed a single booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-M adjuvant (NVX-CoV2373) in healthy adults aged 18-84 years, recruited from 17 clinical centres in the USA and Australia. Eligible participants had a BMI of 17-35 kg/m

findings1610 participants were screened from Aug 24, 2020, to Sept 25, 2020. 1282 participants were enrolled, of whom 173 were assigned again to placebo (group A), 106 were re-randomised to NVX-CoV2373-placebo (group B1), and 104 were re-randomised to NVX-CoV2373-NVX-CoV2373 (group B2); after accounting for exclusions and incorrect administration, 172 participants in group A, 102 in group B1, and 105 in group B2 were analysed for safety. Following the active booster, the proportion of participants with available data reporting local (80 [82%] of 97 participants had any adverse event; 13 [13%] had a grade ≥3 event) and systemic (75 [77%] of 98 participants had any adverse event; 15 [15%] had a grade ≥3 event) reactions was higher than after primary vaccination (175 [70%] of 250 participants had any local adverse event, 13 [5%] had a grade ≥3 event; 132 [53%] of 250 had any systemic adverse event, 14 [6%] had a grade ≥3 event). Local and systemic events were transient in nature (median duration 1·0-2·5 days). In the per-protocol immunogenicity population at day 217 (167 participants in group A, 101 participants in group B1, 101 participants in group B2), IgG geometric mean titres (GMT) had increased by 4·7-fold and MN

interpretationAdministration of a booster dose of NVX-CoV2373 resulted in an incremental increase in reactogenicity. For both the prototype strain and all variants evaluated, immune responses following the booster were similar to or higher than those associated with high levels of efficacy in phase 3 studies of the vaccine. These data support the use of NVX-CoV2373 in booster programmes.

fundingNovavax and the Coalition for Epidemic Preparedness Innovations.

Indexed as

COVID-19VaccinesAdjuvants, ImmunologicAdultAntibodies, ViralCOVID-19 VaccinesDouble-Blind MethodFemaleHumansImmunogenicity, VaccinePandemicsSARS-CoV-2Spike Glycoprotein, CoronavirusAdjuvants, ImmunologicAntibodies, ViralCOVID-19 VaccinesNVX-CoV2373 adjuvated lipid nanoparticleSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines

Identifiers

PMID35963274
PMCPMC9365313
OpenAlexW4290987220

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.