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

Emerging 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...

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Published in:The Lancet infectious diseases 2022-11, Vol.22 (11), p.1565-1576
Main Authors: Mallory, Raburn M, Formica, Neil, Pfeiffer, Susan, Wilkinson, Bethanie, Marcheschi, Alex, Albert, Gary, McFall, Heather, Robinson, Michelle, Plested, Joyce S, Zhu, Mingzhu, Cloney-Clark, Shane, Zhou, Bin, Chau, Gordon, Robertson, Andreana, Maciejewski, Sonia, Hammond, Holly L, Baracco, Lauren, Logue, James, Frieman, Matthew B, Smith, Gale, Patel, Nita, Glenn, Gregory M, Adams, Mark, Arya, Mark, Athan, Eugene, Berger, Ira, Bradley, Paul, Briskin, Toby, Glover II, Richard, Griffin, Paul, Kim, Joshua, Kitchener, Scott, Klein, Terry, Leah, Amber, Leelasena, Indika, Lemech, Charlotte, Lickliter, Jason, Manning, Mary Beth, Napier-Flood, Fiona, Nugent, Paul, Thackwray, Susan, Turner, Mark
Format: Article
Language:English
Subjects:
Adjuvants, Immunologic
Adult
Adverse events
Antibodies, Viral
Antigens
Breast feeding
Clinical trials
Contraception
Coronaviruses
COVID-19
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Disease transmission
Double-Blind Method
Effectiveness
Epidemics
Female
Health services
Homology
Humans
IgG antibody
Immune response
Immunogenicity
Immunogenicity, Vaccine
Immunoglobulin G
Infections
Infectious diseases
Interactive systems
Nanoparticles
Pandemics
Pandemics - prevention & control
Personnel
Placebos
Proteins
Randomization
Safety
SARS-CoV-2 - genetics
Secondary analysis
Severe acute respiratory syndrome coronavirus 2
Spike Glycoprotein, Coronavirus - genetics
Spike protein
Vaccine efficacy
Vaccines
Viral diseases
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Summary:Emerging 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). This 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/m2 and, for women, were heterosexually inactive or using contraception. Participants who had a history of SARS-CoV or SARS-CoV-2, confirmed diagnosis of COVID-19, serious chronic medical conditions, or were pregnant or breastfeeding were excluded. Approximately 6 months following their primary two-dose vaccination series (administered day 0 and day 21), participants who received placebo for their primary vaccination series received a placebo booster (group A) and participants who received NVX-CoV2373 for their primary vaccination series (group B) were randomly assigned (1:1) again, via centralised interactive response technology system, to receive either placebo (group B1) or a single booster dose of NVX-CoV2373 (5 μg SARS-CoV-2 rS with 50 μg Matrix-M adjuvant; group B2) via intramuscular injection; randomisation was stratified by age and study site. Vaccinations were administered by designated site personnel who were masked to treatment assignment, and participants and other site staff were also masked. Administration personnel also assessed the outcome. The primary endpoints are safety (unsolicited adverse events) and reactogenicity (solicited local and systemic) events and immunogenicity (serum IgG antibody concentrations for the SARS-CoV-2 rS protein antigen) assessed 14 days after the primary vaccination series (day 35) and 28 days following booster (day 217). Safety was analysed in all participants in groups A, B1, and B2, according to the treatment received; immunogenicity was analysed in the per-protocol population (ie, participants in groups A, B1, and B2) who received all assigned doses and who did not test SARS-CoV-2-positive or received an authorised vaccine, analysed according to treatment assignment).
ISSN:1473-3099
1474-4457
DOI:10.1016/S1473-3099(22)00420-0