Evidence map›Paper›PMID 36921715›Full record

Trial reportClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2023

Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up.

Noam Barda, Yaniv Lustig, Victoria Indenbaum, Daniel Zibly, Gili Joseph, Keren Asraf, Yael Weiss-Ottolenghi, Sharon Amit, Limor Kliker, Bayan Abd Elkader and 11 more

Erratum issuedOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
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  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 4 institutions in 1 country.

Noam BardaARC Innovation Center, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Software and Information Systems Engineering, Ben-Gurion University of the Negev, Be'er Sheva, Israel; Epidemiology, Biostatistics and Community Health Services, Ben-Gurion University of the Negev, Be'er Sheva, Israel.
Yaniv LustigSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Victoria IndenbaumSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Daniel ZiblyThe Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Gili JosephThe Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Keren AsrafSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; The Dworman Automated-Mega Laboratory, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Yael Weiss-OttolenghiSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Sharon AmitSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Clinical Microbiology, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Limor KlikerSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Bayan Abd ElkaderSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Eytan Ben-AmiPhase 1 Clinical Trials Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Michal CanettiSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Ravit KorenCentral Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Shiri Katz-LikvornikCentral Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Osnat HalpernCentral Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Ella MendelsonSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Ram DoolmanThe Dworman Automated-Mega Laboratory, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Dror HaratsSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; General Management, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Yitshak KreissSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; General Management, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Michal MandelboimSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Central Virology Laboratory, Public Health Services, Ministry of Health, Tel Hashomer, Ramat Gan, Israel.
Gili Regev-YochaySackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; The Infection Prevention & Control Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel. Electronic address: gili.regev@sheba.health.gov.il.
Tel Aviv University · ILSheba Medical Center · ILIsrael Ministry of Health · ILBen-Gurion University of the Negev · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine.

methodsThis is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 μg and 60 μg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases.

resultsOverall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3-1.32) and 0.54 (0.24-1.2) for monovalent/60 μg, 0.9 (0.42-1.92) and 2.69 (1.17-6.17) times for monovalent-Omi.BA.1/30 μg, 1.28 (0.6-2.75) and 2.79 (1.21-6.41) times for monovalent-Omi.BA.1/60 μg, 0.96 (0.46-1.97) and 2.07 (0.93-4.58) times for bivalent-Omi.BA.1/30 μg, and 0.79 (0.38-1.63) and 1.95 (0.88-4.32) times for bivalent-Omi.BA.1/60 μg when compared with BNT162b2/30 μg against the ancestral strain and BA.1 variant, respectively. DISCUSSION: BA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.

Indexed as

COVID-19VaccinesAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineFollow-Up StudiesHumansmRNA VaccinesSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralBNT162 VaccinemRNA VaccinesVaccinesCOVID-19ImmunogenicityOmicronVaccine

Identifiers

PMID36921715
PMCPMC10010049
OpenAlexW4324044556

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.