NCT02126384

Brief Summary

The purpose of this study is to determine which B lymphocytes subsets are responsible for the production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after vaccination with a 23-valent pneumococcal polysaccharide vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 18, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2016

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

April 15, 2014

Last Update Submit

August 22, 2025

Conditions

Pneumococcal Diseases

Keywords

ImmunologyhumanB-lymphocytes subsetsAntibody-Producing Cells23 valent pneumococcal capsular polysaccharide vaccine

Outcome Measures

Primary Outcomes (1)

  • Identification of the precursor of B lymphocytes

    On vitro measure of blood mononuclear cell populations by cell sorting at day 7 to identify the clonal progeny of the secreting B lymphocyte precursor

    day 7

Secondary Outcomes (1)

  • measure of serum anti-capsular polysaccharide antibody titers

    day 0, day 28

Study Arms (1)

pneumovax

EXPERIMENTAL

Single arm, open label pneumovax vaccination of healthy subjects

Drug: pneumovax vaccination

Interventions

pneumovax vaccinationDRUG

vaccination

Also known as: pneumovax
pneumovax

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • aged 18 to 40 y

You may not qualify if:

  • no documented primary immunodeficiency
  • no splenectomy
  • no functional/congenital asplenia,
  • no pneumococcal infections within the last 5 years before enrolment into the research protocol
  • no vaccinations with the 23-valent pneumococcal polysaccharide vaccine or the 7- or 13-valent conjugate-polysaccharide vaccines within the last 5 years before enrolment into the research protocol
  • no other vaccination within 1 month before enrolment into the research protocol
  • fever, current antibiotic treatment
  • any chronic or inflammatory disease
  • any immunosuppressive treatment
  • hyper-responsiveness to one component of the Pneumovax vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique, hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • Weller S, Sterlin D, Fadeev T, Coignard E, Verge de Los Aires A, Goetz C, Fritzen R, Bahuaud M, Batteux F, Gorochov G, Weill JC, Reynaud CA. T-independent responses to polysaccharides in humans mobilize marginal zone B cells prediversified against gut bacterial antigens. Sci Immunol. 2023 Jan 27;8(79):eade1413. doi: 10.1126/sciimmunol.ade1413. Epub 2023 Jan 27.

    PMID: 36706172BACKGROUND

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Sandra WELLER, PhD

    Institut National de la santé et de la recherché Médicale (INSERM)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 30, 2014

Study Start

November 18, 2014

Primary Completion

April 1, 2016

Study Completion

April 5, 2016

Last Updated

August 29, 2025

Record last verified: 2021-08

Locations

FR(1)