Evidence map›Paper›PMID 34078915›Full record

ArticleNPJ vaccines2021

A conditionally replication-defective cytomegalovirus vaccine elicits potent and diverse functional monoclonal antibodies in a phase I clinical trial.

Leike Li, Daniel C Freed, Yaping Liu, Fengsheng Li, Diane F Barrett, Wei Xiong, Xiaohua Ye, Stuart P Adler, Richard E Rupp, Dai Wang and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ vaccines, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01986010 (A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT01986010 phase1completednot on this map

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2017Enrolled190ConditionsCytomegalovirus InfectionsArmsV160 Low Dose IM, V160 Medium Dose IM, V160 High Dose IM, V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM, V160 High Dose plus MAPA 225 µg /dose IM
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
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  8. Structure-based design of a soluble human cytomegalovirus glycoprotein B antigen stabilized in a prefusion-like conformation.Proceedings of the National Academy of Sciences of the United States of America · 2024
    Article
  9. Article
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  11. Article
  12. Article
  13. Navigating paediatric virology through the COVID‑19 era (Review).International journal of molecular medicine · 2023
    Review
  14. Article
  15. Article
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  17. Review
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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

13 authors at 3 institutions in 1 country.

Leike LiTexas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.ORCID http://orcid.org/0000-0002-1379-1396
Daniel C FreedDepartment of Infectious Diseases and Vaccines Research, Merck Research Laboratories, Merck and Co. Inc., Kenilworth, NJ, USA.
Yaping LiuDepartment of Infectious Diseases and Vaccines Research, Merck Research Laboratories, Merck and Co. Inc., Kenilworth, NJ, USA.ORCID http://orcid.org/0000-0001-7293-9701
Fengsheng LiDepartment of Infectious Diseases and Vaccines Research, Merck Research Laboratories, Merck and Co. Inc., Kenilworth, NJ, USA.
Diane F BarrettSealy Institute for Vaccine Sciences, The University of Texas Medical Branch, Galveston, TX, USA.
Wei XiongTexas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.
Xiaohua YeTexas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.
Stuart P AdlerDepartment of Microbiology and Immunology, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.
Richard E RuppSealy Institute for Vaccine Sciences, The University of Texas Medical Branch, Galveston, TX, USA.
Dai WangDepartment of Infectious Diseases and Vaccines Research, Merck Research Laboratories, Merck and Co. Inc., Kenilworth, NJ, USA.ORCID http://orcid.org/0000-0001-5666-8622
Ningyan ZhangTexas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA. ningyan.zhang@uth.tmc.edu.ORCID http://orcid.org/0000-0002-4348-2180
Tong-Ming FuTexas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA. tong-ming.fu@uth.tmc.edu.
Zhiqiang AnTexas Therapeutics Institute, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA. zhiqiang.an@uth.tmc.edu.ORCID http://orcid.org/0000-0001-9309-2335
Brown Foundation · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USVirginia Commonwealth University · US

Funding

Welch Foundation AU-0042-20030616
6 · The paper itself

Abstract

A conditionally replication-defective human cytomegalovirus (HCMV) vaccine, V160, was shown to be safe and immunogenic in a two-part, double-blind, randomized, placebo-controlled phase I clinical trial (NCT01986010). However, the specificities and functional properties of V160-elicited antibodies remain undefined. Here, we characterized 272 monoclonal antibodies (mAbs) isolated from single memory B cells of six V160-vaccinated subjects. The mAbs bind to diverse HCMV antigens, including multiple components of the pentamer, gB, and tegument proteins. The most-potent neutralizing antibodies target the pentamer-UL subunits. The binding sites of the antibodies overlap with those of antibodies responding to natural HCMV infection. The majority of the neutralizing antibodies target the gHgL subunit. The non-neutralizing antibodies predominantly target the gB and pp65 proteins. Sequence analysis indicated that V160 induced a class of gHgL antibodies expressing the HV1-18/KV1-5 germline genes in multiple subjects. This study provides valuable insights into primary targets for anti-HCMV antibodies induced by V160 vaccination.

Identifiers

PMID34078915
PMCPMC8172929
OpenAlexW3164120648

What OpenQuestion holds

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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.