Evidence map›Paper›PMID 35380448›Full record

ArticleScience translational medicine2022

SARS-CoV-2 BA.1 variant is neutralized by vaccine booster-elicited serum but evades most convalescent serum and therapeutic antibodies.

Sabrina Lusvarghi, Simon D Pollett, Sabari Nath Neerukonda, Wei Wang, Richard Wang, Russell Vassell, Nusrat J Epsi, Anthony C Fries, Brian K Agan, David A Lindholm and 20 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Science translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05648110 (A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study), which is not on this map. Cited by 74 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 3 pooled it
9.4field-weighted citation impact, top 1% 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.

NCT05648110 phase2 / phase3completednot on this map

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

TypeinterventionalSponsorAstraZenecaRan2022 to 2025Enrolled3,882ConditionsCOVID-19, SARS-CoV-2ArmsAZD5156 (Parent study Sentinel Safety Cohort), Placebo (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort), Placebo (Parent study Main Cohort)
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.

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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 11 institutions in 1 country.

Sabrina LusvarghiDivision of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.ORCID 0000-0003-1793-0450
Simon D PollettInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
Sabari Nath NeerukondaDivision of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.ORCID 0000-0002-1049-1929
Wei WangDivision of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.ORCID 0000-0003-2935-6388
Richard WangDivision of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.ORCID 0000-0003-2726-3161
Russell VassellDivision of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.ORCID 0000-0002-2295-5890
Nusrat J EpsiInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0001-5363-075X
Anthony C FriesU.S. Air Force School of Aerospace Medicine, Wright-Patterson Air Force Base, Fairborn, OH 45433, USA.ORCID 0000-0001-7556-1353
Brian K AganInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0002-5114-1669
David A LindholmBrooke Army Medical Center, Joint Base San Antonio-Fort Sam Houston, San Antonio, TX 78234, USA.ORCID 0000-0001-5428-7404
Christopher J ColomboDepartment of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0001-5499-3368
Rupal ModyWilliam Beaumont Army Medical Center, El Paso, TX 799218, USA.ORCID 0000-0003-3862-4495
Evan C EwersFort Belvoir Community Hospital, Fort Belvoir, Fairfax county, VA 22060, USA, 22060.ORCID 0000-0002-1384-9973
Tahaniyat LalaniInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
Anuradha GanesanInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
Emilie GoguetHenry M. Jackson Foundation for the Advancement of Military Medicine Inc., Bethesda, MD 20817, USA.ORCID 0000-0001-6284-4346
Monique Hollis-PerryClinical Trials Center, Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, MD 20910, USA.ORCID 0000-0002-7130-9772
Si'Ana A CogginsHenry M. Jackson Foundation for the Advancement of Military Medicine Inc., Bethesda, MD 20817, USA.
Mark P SimonsInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
Leah C KatzelnickViral Epidemiology and Immunity Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.ORCID 0000-0003-1033-6758
Gregory WangClinical Trials Center, Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, MD 20910, USA.ORCID 0000-0002-3454-7392
David R TribbleInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0003-3077-9505
Lisa BentleyOffice of the Assistant Secretary for Preparedness and Response, U.S. Department of Human Health and Services, Washington, D.C. 20201, USA.
Ann E EakinDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Disease, National Institutes of Health, Rockville, MD 20892, USA.
Christopher C BroderDepartment of Microbiology and Immunology, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0001-5382-0510
Karl J ErlandsonInfluenza and Emerging Infectious Diseases Division, Biomedical Advanced Research and Development Authority, U.S. Department of Health and Human Services, Washington, D.C. 20024, USA.ORCID 0000-0002-2333-4391
Eric D LaingDepartment of Microbiology and Immunology, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0002-5574-2584
Timothy H BurgessInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0003-1247-8370
Edward MitreDepartment of Microbiology and Immunology, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.ORCID 0000-0001-7506-3266
Carol D WeissDivision of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.ORCID 0000-0002-9965-1289
Henry M. Jackson Foundation · USUniformed Services University of the Health Sciences · USCenter for Biologics Evaluation and Research · USNational Institutes of Health · USNaval Medical Research Command · USAlexander T. Augusta Military Medical Center · USBiomedical Advanced Research and Development Authority · USMadigan Army Medical Center · USOffice of Readiness and Response · USWilliam Beaumont Army Medical Center · USWright-Patterson Air Force Base · US

Funding

Epidemiology, immunology, and evolution of SARS-CoV-2 and other coronaviruses before and during the COVID-19 pandemicZIAAI001347 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KATZELNICK, LEAH · 2021 to 2025
$223k
DATA CENTER FOR EPIDEMIOLOGIC INVESTIGATIONS OF HIVN01AI005072 · NIAID · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MCKINLAY, SONJA M · 1990 to 1994
–
NIAID NIH HHS Y01 AI005072
6 · The paper itself

Abstract

The rapid spread of the highly contagious Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) along with its high number of mutations in the spike gene has raised alarms about the effectiveness of current medical countermeasures. To address this concern, we measured the neutralization of the Omicron BA.1 variant pseudovirus by postvaccination serum samples after two and three immunizations with the Pfizer/BioNTech162b2 SARS-CoV-2 mRNA (Pfizer/BNT162b2) vaccine, convalescent serum samples from unvaccinated individuals infected by different variants, and clinical-stage therapeutic antibodies. We found that titers against the Omicron variant were low or undetectable after two immunizations and in many convalescent serum samples, regardless of the infecting variant. A booster vaccination increased titers more than 30-fold against Omicron to values comparable to those seen against the D614G variant after two immunizations. Neither age nor sex was associated with the differences in postvaccination antibody responses. We also evaluated 18 clinical-stage therapeutic antibody products and an antibody mimetic protein product obtained directly from the manufacturers. Five monoclonal antibodies, the antibody mimetic protein, three antibody cocktails, and two polyclonal antibody preparations retained measurable neutralization activity against Omicron with a varying degree of potency. Of these, only three retained potencies comparable to the D614G variant. Two therapeutic antibody cocktails in the tested panel that are authorized for emergency use in the United States did not neutralize Omicron. These findings underscore the potential benefit of mRNA vaccine boosters for protection against Omicron and the need for rapid development of antibody therapeutics that maintain potency against emerging variants.

Indexed as

COVID-19SARS-CoV-2Antibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 SerotherapyCOVID-19 VaccinesHumansImmunization, PassivemRNA VaccinesVaccinationVaccines, SyntheticAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesmRNA VaccinesVaccines, Synthetic

Identifiers

PMID35380448
PMCPMC8995032
OpenAlexW4223499046

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.