Evidence map›Paper›PMID 32313928›Full record

Trial reportThe Journal of infectious diseases2022

A Randomized Dose-Escalating Phase I Trial of a Replication-Deficient Lymphocytic Choriomeningitis Virus Vector-Based Vaccine Against Human Cytomegalovirus.

Michael Schwendinger, Georges Thiry, Beatrice De Vos, Geert Leroux-Roels, Jacques Bruhwyler, Ariane Huygens, Corinne Ganeff, Heidemarie Buchinger, Klaus K Orlinger, Daniel D Pinschewer and 2 more

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
2.6field-weighted citation impact, top 9% 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

27 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Review
  3. Cytomegalovirus Vaccines in Transplantation: History, Hurdles, and Hope.Transplant infectious disease : an official journal of the Transplantation Society · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. A vaccine against cytomegalovirus: how close are we?The Journal of clinical investigation · 2025
    Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. A replicating LCMV-based vaccine for the treatment of solid tumors.Molecular therapy : the journal of the American Society of Gene Therapy · 2024
    Article
  17. Article
  18. Review
  19. Article
  20. Review
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

12 authors at 3 institutions in 3 countries.

Michael SchwendingerHookipa Pharma Inc., New York, New York, USA.
Georges ThiryHookipa Pharma Inc., New York, New York, USA.
Beatrice De VosBejamad bvba, Consultancy Office Pharmaceutical Sciences, Dworp, Belgium.
Geert Leroux-RoelsCenter for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium.
Jacques BruhwylerECSOR, Brussels, Belgium.
Ariane HuygensCaprion Biosciences, Gosselies, Belgium.
Corinne GaneffCaprion Biosciences, Gosselies, Belgium.
Heidemarie BuchingerHookipa Pharma Inc., New York, New York, USA.
Klaus K OrlingerHookipa Pharma Inc., New York, New York, USA.
Daniel D PinschewerHookipa Pharma Inc., New York, New York, USA.
Thomas P MonathHookipa Pharma Inc., New York, New York, USA.
Anders E LiljaHookipa Pharma Inc., New York, New York, USA.
Crozet BioPharma (United States) · USGhent University Hospital · BEUniversity of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA vaccine (HB-101) consisting of 2 nonreplicating lymphocytic choriomeningitis virus (LCMV) vectors expressing the human cytomegalovirus antigens glycoprotein B (gB) and the 65-kD phosphoprotein (pp65), respectively, is in development to prevent cytomegalovirus infection.

methodsHB-101 was tested in cytomegalovirus-naive, healthy adults in a randomized, double-blind, placebo-controlled, dose-escalation Phase I trial. Fifty-four subjects received low, medium, or high dose of HB-101 or placebo by intramuscular administration at Month 0, 1, and 3. Safety and immunogenicity were the respective primary and secondary endpoints. Subjects were followed for 12 months after the initial immunization.

resultsVaccination was associated with transient mild to moderate adverse events. HB-101 administration induced dose-dependent gB- and pp65-specific cellular responses, dominated by pp65-specific CD8 T cells, a high fraction of which were polyfunctional. Two administrations were sufficient to elicit dose-dependent gB-binding and cytomegalovirus-neutralizing antibodies (Abs). Cytomegalovirus-specific immune responses were boosted after each administration. Only 1 of 42 vaccine recipients mounted a transient LCMV vector-neutralizing Ab response.

conclusionsHB-101 was well tolerated and induced cytomegalovirus-specific polyfunctional CD8 T-cell and neutralizing Ab responses in the majority of subjects. Lack of vector-neutralizing Ab responses should facilitate booster vaccinations. These results justify further clinical evaluation of this vaccine candidate.

Indexed as

Cytomegalovirus VaccinesVaccinesAdultAntibodies, NeutralizingAntibodies, ViralCytomegalovirusHumansImmunization, SecondaryLymphocytic choriomeningitis virusAntibodies, NeutralizingAntibodies, ViralCytomegalovirus VaccinesVaccinescytomegalovirushealthy volunteersPhase Ivaccineviral vector

Identifiers

PMID32313928
PMCPMC9016443
OpenAlexW3016644798

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.