NCT02114255

Brief Summary

In the present study, the investigators want to investigate whether prior BCG-vaccination improves the efficacy of influenza ("the flu") vaccination in young and/or old healthy volunteers and consequently could protect against influenza virus infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

March 10, 2014

Last Update Submit

November 9, 2015

Conditions

Influenza Virus InfectionTrained Immunity

Keywords

InfluenzaTrained immunityBCG

Outcome Measures

Primary Outcomes (2)

  • Difference in influenza antibody titres between BCG-vaccinated subjects and subjects in the control group

    Day 14, day 21, day 28, day 42 (±2 days)

  • Difference in Thrombocyte function between BCG-vaccinated subjects and subjects in the control group

    Day 0, day 14, day 21, day 28, day 42 (±2 days)

Secondary Outcomes (7)

  • Proportion of participants in each group who achieved seroprotection (defined by antibody titre ≥1:40).

    day 21, day 28, day 42 (±2 days)

  • Proportion of participants in each group who achieved seroconversion (defined by a ≥4-fold rise in antibody titre).

    day 21, day 28, day 42 (±2 days)

  • IFN-gamma/IL-10 production of leukocytes ex vivo stimulated with inactivated/live influenza virus (0.1ug HA/ml).

    Day 0, day 14, day 28, day 42 (±2 days)

  • Production of Type 1 IFNs, IL-17 and IL-22 by leukocytes ex vivo stimulated with inactivated/live influenza virus (0.1ug HA/ml).

    Day 0, day 14, day 28, day 42 (±2 days)

  • Production of other inflammatory mediators (including TNFα, IL-1β, IFN-gamma, IL-10, IL-17, IL-22) by leukocytes ex vivo stimulated with different not-related stimuli (including m. tuberculosis, s. aureus, c. albicans, and inactivated influenza).

    Day 0, day 21, day 28, day 42 (±2 days)

  • +2 more secondary outcomes

Study Arms (2)

BCG vaccination

EXPERIMENTAL

BCG vaccination

Biological: BCG

NaCl 0.9%

PLACEBO COMPARATOR

administration of NaCl 0.9%.

Other: Placebo

Interventions

PlaceboOTHER

Administration of 0.9% NaCl.

NaCl 0.9%
BCGBIOLOGICAL

Vaccination with the live attenuated BCG vaccine.

BCG vaccination

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥18 and ≤35 yrs
  • Male
  • Healthy

You may not qualify if:

  • History of influenza vaccination within the year prior to study entry
  • History of BCG vaccination within 5 years prior to study entry
  • History of Mantoux testing within the year prior to study entry
  • Vaccination other than BCG or influenza, within 3 months prior to study or within study period
  • Medical history of any disease associated with immune deficiency
  • Clinically significant acute illness, including infections, within 4 weeks before vaccination
  • Participation in a drug trial or donation of blood 3 months prior to study entry
  • Use of recreational drugs within 21 days prior to experiment day
  • Recent hospital admission or surgery with general anaesthesia (\<3 months)
  • Known chronic kidney or liver disease
  • Latent or active tuberculosis infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Mihai Netea, PhD

    Radboud University Nijmegen Medical Centre, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

April 15, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

NL(1)