Evidence map›Paper›PMID 11895966›Full record

Trial reportInfection and immunity2002

Phase I evaluation of delta virG Shigella sonnei live, attenuated, oral vaccine strain WRSS1 in healthy adults.

Karen L Kotloff, David N Taylor, Marcelo B Sztein, Steven S Wasserman, Genevieve A Losonsky, James P Nataro, Malabi Venkatesan, Antoinette Hartman, William D Picking, David E Katz and 3 more

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

Trial report in Infection and immunity, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
5.3field-weighted citation impact, top 4% 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

48 citing papers in PubMed, 111 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. A phase I trial of WRSS1, aHuman vaccines & immunotherapeutics · 2019
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  10. Article
  11. Article
  12. BECC-engineered live-attenuatedResearch square · 2024
    Article
  13. International journal of molecular sciences · 2024
    Review
  14. Oral immunization withmSphere · 2024
    Article
  15. Article
  16. Toward aInternational journal of molecular sciences · 2023
    Review
  17. TheVaccines · 2022
    Review
  18. Incidence of AsymptomaticLife (Basel, Switzerland) · 2022
    Article
  19. Review
  20. Article
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 5 institutions in 3 countries.

Karen L KotloffDivision of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. kkotloff@medicine.umaryland.edu
David N Taylor
Marcelo B Sztein
Steven S Wasserman
Genevieve A Losonsky
James P Nataro
Malabi Venkatesan
Antoinette Hartman
William D Picking
David E Katz
James D Campbell
Myron M Levine
Thomas L Hale
Walter Reed Army Institute of Research · USHospital for Tropical Diseases · VNUniversity of Maryland, Baltimore · USInstitut de Recherche Vaccinale · FRUniversity of Kansas · US

Funding

CONTROL MESURES IN AGING AND INFECTIOUS DISEASEN01AI045251 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI LEVINE, MYRON MAX · 1994 to 2000
–
MUCOSAL AND SYSTEMIC IMMUNITY IN HUMAN SHIGELLA VACCINESR21AI042802 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI SZTEIN, MARCELO B. · 1999 to 1999
–
NIAID NIH HHS N01-AI-45251NIAID NIH HHS R21-AI-42802
6 · The paper itself

Abstract

We conducted a phase I trial with healthy adults to evaluate WRSS1, a live, oral Delta virG Shigella sonnei vaccine candidate. In a double-blind, randomized, dose-escalating fashion, inpatient volunteers received a single dose of either placebo (n = 7) or vaccine (n = 27) at 3 x 10(3) CFU (group 1), 3 x 10(4) CFU (group 2), 3 x 10(5) CFU (group 3), or 3 x 10(6) CFU (group 4). The vaccine was generally well tolerated, although a low-grade fever or mild diarrhea occurred in six (22%) of the vaccine recipients. WRSS1 was recovered from the stools of 50 to 100% of the vaccinees in each group. The geometric mean peak anti-lipopolysaccharide responses in groups 1 to 4, respectively, were 99, 39, 278, and 233 for immunoglobulin (IgA) antibody-secreting cell counts; 401, 201, 533, and 284 for serum reciprocal IgG titers; and 25, 3, 489, and 1,092 for fecal IgA reciprocal titers. Postvaccination increases in gamma interferon production in response to Shigella antigens occurred in some volunteers. We conclude that WRSS1 vaccine is remarkably immunogenic in doses ranging from 10(3) to 10(6) CFU but elicits clinical reactions that must be assessed in further volunteer trials.

Indexed as

Administration, OralAdolescentAdultAntibodies, BacterialDouble-Blind MethodHumansImmunoglobulin AInterferon-gammaLactoferrinLipopolysaccharidesMiddle AgedShigella sonneiShigella VaccinesVaccines, AttenuatedAntibodies, BacterialImmunoglobulin AInterferon-gammaLactoferrinLipopolysaccharidesShigella VaccinesVaccines, Attenuated

Identifiers

PMID11895966
PMCPMC127867
OpenAlexW2164381068

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.