Skip to main content
OpenTrials
Completed

NCT Number: NCT01847781

PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency

The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13) in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the antibody response will be impaired in patients as compared with controls. In contrast, we postulate that the cellular immune response will be intact.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Immunedeficiency Unit, Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

About this study

Ten patients with Immunoglobulin G1 and/or Immunoglobulin G2 deficiency will be enrolled together with 10 age and sex- matched controls. Blood-samples will be drawn at base-line and after 1, 2 and 4 weeks post-vaccination. Serum will be analyzed for opsonophagocytic antibodies. Peripheral blood monocytic cells (PBMCs) will be isolated, frozen and later analyzed for all time-points simultaneously. PBMCs will be stimulated with vaccine-antigens for 3-5 days and cellular activation markers will be measured together with cytokines (Interferon-gamma, Interleukin (IL)-5, IL-13, IL-10, IL-17, IL-22). In addition, levels of antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks post-vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Immunoglobulin gamma-deficiency: Immunoglobulin gamma 1-deficiency < 2,8 g/L and/or Immunoglobulin gamma 2-deficiency < 1,15 g/L
  • Age 18-65

Exclusion criteria

  • Immunoglobulin gamma-substitution for 6 months prior to study inclusion
  • Prevenar7 or Prevenar13 given prior to study inclusion.
  • Pneumovax given during a 2 year period prior to study inclusion
  • Pregnancy or planning to become pregnant during the study period (4 weeks)
  • Taking part in another clinical study involving drugs or vaccinations during the study period (4 weeks).
  • Taking systemic steroids, Non steroidal anti inflammatory drugs (NSAID) or immunosuppressive drugs.
  • Being allergic to any substance in the vaccine.
  • Acute and ongoing disease with high fever.
  • Thrombocytopenia (< 100x109/L).
  • Coagulopathy
  • Breastfeeding a baby
  • The healthy controls should not have any disease with effects on the immune-system

Treatment and study plan

Prevenar13

Biological

Primary outcomes

  1. Change in opsonophagocytic antibodies

    Time frame: 4 weeks post-vaccination, change from baseline

    Titers of opsonophagocytic antibodies will be measured at baseline and 4 weeks post-vaccination. Titers from 4 weeks post-vaccination will be compared with baseline-levels.

Secondary outcomes

  1. Change in cellular immunity

    Time frame: 4 weeks post-vaccination, change from baseline

    PBMCs will be collected and stimulated with vaccine-antigens. Cellular activation markers and cytokine release will be measured and results from 4 weeks post-vaccination will be compared with baseline-levels.

  2. Change in antimicrobial peptides

    Time frame: 4 weeks post-vaccination, change from baseline

    Levels of AMPs in nasal fluid will be measured at 0 and 4 weeks post-vaccination. Results from 4 weeks will be compared with base-line levels.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Pfizer

Registry information

Acronym: PNEUMOCELL

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 7, 2013
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.