Influence of BCG on TDaP-IPV Vaccination
The Influence of BCG Vaccine as a Booster TDaP-IPV Vaccination: an Explorative Study
1 other identifier
interventional
75
1 country
1
Brief Summary
This study has three purposes: To investigate whether the immune response to pertussis is increased when TDaP-IPV is given together with BCG vaccine, compared to when it is given alone. To investigate whether BCG vaccination modulates the immune response to non vaccine target antigens (i.e., antigens/pathogens not used in the vaccine itself). To investigate whether TDaP-IPV vaccination modulates the immune response to non vaccine target antigens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2015
Typical duration for phase_4
1 active site
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
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedOctober 13, 2016
April 1, 2016
1.5 years
February 22, 2016
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Antibody response to TDaP-IPV
antibody titers to antigens in the TDaP-IPV (PT, FHA, Prn, DT, TT) will be measured.
2 weeks
Antibody response to TDaP-IPV
antibody titers to antigens in the TDaP-IPV (PT, FHA, Prn, DT, TT) will be measured.
3 months
Antibody response to TDaP-IPV
antibody titers to antigens in the TDaP-IPV (PT, FHA, Prn, DT, TT) will be measured.
1 year
T-cell response to TDaP-IPV
T-cell responses will be measured by FACS
2 weeks
T-cell response to TDaP-IPV
T-cell responses will be measured by FACS
3 months
T-cell response to TDaP-IPV
T-cell responses will be measured by FACS
1 year
PBMC cytokine response to pertussis related antigens
IL-6, TNF, IL-1b, IL-10, IL-17, IL-22, IFN-g
2 weeks
PBMC cytokine response to pertussis related antigens
IL-6, TNF, IL-1b, IL-10, IL-17, IL-22, IFN-g
3 months
PBMC cytokine response to pertussis related antigens
IL-6, TNF, IL-1b, IL-10, IL-17, IL-22, IFN-g
1 year
B-cell phenotype analysis
pertussis specific B-cells will be analyzed by FACS
2 weeks
B-cell phenotype analysis
pertussis specific B-cells will be analyzed by FACS
3 months
B-cell phenotype analysis
pertussis specific B-cells will be analyzed by FACS
1 year
Secondary Outcomes (13)
PBMC responses to heterologous antigens
1 day
PBMC responses to heterologous antigens
4 days
PBMC responses to heterologous antigens
2 weeks
PBMC responses to heterologous antigens
3 months
PBMC responses to heterologous antigens
1 year
- +8 more secondary outcomes
Other Outcomes (11)
Leukocyte differential count
1 day,
Leukocyte differential count
4 days
Leukocyte differential count
2 weeks
- +8 more other outcomes
Study Arms (3)
BCG
EXPERIMENTALSubjects are vaccinated with BCG vaccine (SSI) alone, 0,1ml intradermal
TDaP-IPV
EXPERIMENTALSubjects are vaccinated with TDaP-IPV vaccine (Boostrix Polio) vaccine alone, 0,5ml intramuscular
BCG+TDaP-IPV
EXPERIMENTALSubjects are vaccinated with BCG vaccine (SSI) (0.1ml intradermal) and TDaP-IPV vaccine Boostrix Polio (0.5ml intramuscular) simultaneously
Interventions
Eligibility Criteria
You may qualify if:
- healthy females
You may not qualify if:
- systemic medication use other than oral contraceptive drugs
- history of disease resulting in immunodeficiency
- previous vaccination with BCG
- pregnancy
- allergy to neomycin or polymyxin
- known previous allergic reaction to vaccination with diphteria, tetanus, pertussis or polio vaccines
- One of following phenomena after previous vaccination with pertussis containing antigens: Fever \>40 °C within 48 hours after vaccination, hypotonous-hyporesponsiveness episode within 48 hours after vaccination, convulsions with or without fever within 3 days after vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- University of Southern Denmarkcollaborator
Study Sites (1)
Radbdoudumc
Nijmegen, 6500HB, Netherlands
Related Publications (1)
Blok BA, de Bree LCJ, Diavatopoulos DA, Langereis JD, Joosten LAB, Aaby P, van Crevel R, Benn CS, Netea MG. Interacting, Nonspecific, Immunological Effects of Bacille Calmette-Guerin and Tetanus-diphtheria-pertussis Inactivated Polio Vaccinations: An Explorative, Randomized Trial. Clin Infect Dis. 2020 Jan 16;70(3):455-463. doi: 10.1093/cid/ciz246.
PMID: 30919883DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mihai Netea, Prof. Dr.
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
May 13, 2016
Study Start
January 1, 2015
Primary Completion
July 1, 2016
Study Completion
April 1, 2017
Last Updated
October 13, 2016
Record last verified: 2016-04