Evidence map›Paper›PMID 39666396›Full record

Trial reportHuman vaccines & immunotherapeutics2024

Immunogenicity and safety following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine with Matrix-M

Vivek Shinde, Anthonet Lombard Koen, Zaheer Hoosain, Moherndran Archary, Qasim Bhorat, Lee Fairlie, Umesh Lalloo, Mduduzi S L Masilela, Dhayendre Moodley, Sherika Hanley and 36 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04533399 (A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04533399 phase2completednot on this map

A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

TypeinterventionalSponsorNovavaxRan2020 to 2022Enrolled4,422ConditionsSARS-CoV-2 Infection, COVID-19ArmsSARS-CoV-2 rS/Matrix-M1 Adjuvant, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors.

Vivek ShindeResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Anthonet Lombard KoenSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Zaheer HoosainResearch and Development, Josha Research Centre, Bloemfontein, Free State, South Africa.
Moherndran ArcharyPaediatric Infectious Diseases Unit, University of KwaZulu-Natal, Durban, South Africa.
Qasim BhoratResearch and Development, Soweto Clinical Trials Centre, Johannesburg, South Africa.
Lee FairlieWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Umesh LallooRespiratory and Critical Care Unit, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
Mduduzi S L MasilelaResearch and Development, Setshaba Research Centre, Tshwane, South Africa.
Dhayendre MoodleyDepartment of Obstetrics and Gynaecology, University of KwaZulu-Natal, Durban, South Africa.
Sherika HanleyCentre for the AIDS Programme of Research in South Africa (CAPRISA), and Department of Family Medicine, University of KwaZulu-Natal, Durban, South Africa.
Leon Frederik FoucheResearch and Development, Limpopo Clinical Research Initiative, Thabazimbi, South Africa.
Cheryl LouwResearch and Development, Madibeng Centre for Research, Brits, South Africa.
Michele TamerisSouth African TB Vaccine Initiative, University of Cape Town, Cape Town, South Africa.
Nishanta SinghSouth African Medical Research Council, HIV and other Infectious Diseases Research Unit (HIDRU) and, Health Systems Research Unit, Durban, South Africa.
Ameena GogaSouth African Medical Research Council, HIV and other Infectious Diseases Research Unit (HIDRU) and, Health Systems Research Unit, Durban, South Africa.
Keertan DhedaCentre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.
Coert GrobbelaarAurum Institute, University of Pretoria, Pretoria, South Africa.
Natasha JosephResearch and Development, PEERMED Clinical Trial Centre, Kempton Park, South Africa.
Johan J LombaardResearch and Development, Josha Research Centre, Bloemfontein, Free State, South Africa.
Rosie MngqibisaPaediatric Infectious Diseases Unit, University of KwaZulu-Natal, Durban, South Africa.
As'ad Ebrahim BhoratResearch and Development, Soweto Clinical Trials Centre, Johannesburg, South Africa.
Gabriella BenadéWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Natasha LallooRespiratory and Critical Care Unit, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
Anna PitsiResearch and Development, Setshaba Research Centre, Tshwane, South Africa.
Pieter-Louis VollgraaffResearch and Development, Limpopo Clinical Research Initiative, Thabazimbi, South Africa.
Angelique LuabeyaSouth African TB Vaccine Initiative, University of Cape Town, Cape Town, South Africa.
Aliasgar EsmailCentre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.
Friedrich G PetrickResearch and Development, MERC Research, Middelburg, South Africa.
Aylin Oommen JoseSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Sharne FoulkesResearch and Development, Josha Research Centre, Bloemfontein, Free State, South Africa.
Khatija AhmedResearch and Development, Setshaba Research Centre, Tshwane, South Africa.
Asha ThombrayilSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Dishiki KalonjiSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Shane Cloney-ClarkResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Mingzhu ZhuResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Chijioke BennettResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Gary AlbertResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Alex MarcheschiResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Joyce S PlestedResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Susan NealResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Gordon ChauResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Iksung ChoResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Louis FriesResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Greg M GlennResearch and Development, Novavax, Inc, Gaithersburg, MD, USA.
Shabir A MadhiSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
2019nCoV-501 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

COVID-19 remains a global public health issue and an improved understanding of vaccine performance in immunocompromised individuals, including people living with HIV (PLWH), is needed. Initial data from the present study's pre-crossover/booster phase were previously reported. This phase 2a/b clinical trial in South Africa (2019nCoV-501/NCT04533399) revisits 1:1 randomly assigned HIV-negative adults (18-84 years) and medically stable PLWH (18-64 years) who previously received two NVX-CoV2373 doses (5 μg recombinant Spike protein with 50 μg Matrix-M™ adjuvant) or placebo. During the 6-month blinded crossover/booster phase, NVX-CoV2373 recipients could receive a single NVX-CoV2373 booster dose and placebo recipients a 2-dose NVX-CoV2373 primary series. NVX-CoV2373 safety and immunogenicity were assessed according to prior SARS-CoV-2 infection and HIV status. Post-crossover, 1900/3793 NVX-CoV2373 recipients were assigned another dose, and 1893/3793 placebo recipients were assigned NVX-CoV2373 primary series. Approximately 56% of the participants were SARS-CoV-2-seropositive ("seropositive") at crossover (6% PLWH). In seropositive participants (HIV-negative and PLWH), booster-dose anti-spike IgG, MN

Indexed as

COVID-19 VaccinesHIV InfectionsSpike Glycoprotein, CoronavirusAdjuvants, ImmunologicAdolescentAdultAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralCOVID-19Cross-Over StudiesFemaleHumansImmunization, SecondaryImmunogenicity, VaccineAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesNVX-CoV2373 adjuvated lipid nanoparticleSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, Syntheticand the Coalition for Epidemic Preparedness InnovationsNovavax, Inc.the Bill & Melinda Gates Foundation

Identifiers

PMID39666396
PMCPMC11789733

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Registered trials

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.