BCG VaccinationNCT02175420
Role of BCG as Booster Vaccination
A study testing BCG and TFV in people with BCG Vaccination, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis. Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- BCG Vaccination
- What is being tested?
- BCG and TFV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2012to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Born in Salmonella typhi endemic country
- Pregnancy
- Oral medication except anticonceptive drugs
- Previous vaccination with BCG and/or TFV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.
Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious diseases.
Read more
Several studies have shown that BCG can boost the effect of other vaccines. The present study aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.
The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better vaccination result in terms of antibody production will be accomplished against typhoid fever due to the effects of BCG on the innate immune system.
- Conditions
- BCG Vaccination
- Being tested
- BCG, TFV
- Keywords
- BCG, Salmonella, Trained immunity, Non-specific effect vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
Also called BCG vaccine (SSI, Denmark)
TFVBiological
Also called Typhim Vi
| Study group | Role | What they receive |
|---|---|---|
| TFV alone | Active comparator | Typhim Vi Receives: Biological: TFV |
| BCG+TFV | Experimental | BCG (SSI, Denmark) followed after 14 days by Typhim Vi Receives: Biological: BCG; Biological: TFV |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV
anti-salmonella typhi Vi antigen antibody titers at 2 weeks after TFV will be compared between TFV only and TFV after BCG groups.
Measured: 2 weeks
anti-salmonella typhi Vi antigen antibody titer 3 months post TFV
anti-salmonella typhi Vi antigen antibody titers at 3 months after TFV will be compared between TFV only and TFV after BCG groups.
Measured: 3 months
Secondary outcomes (1)
Change in ex vivo cytokine responses
Ex vivo cytokine response to unrelated antigens
Measured: 0, 1 and 4 days; 2 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BCG VaccinationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihai Netea, Prof. Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175420
- Sponsor's protocol ID
- BCG-TFV1
- Status last verified
- Feb 2016
- First submitted
- 20 Jun 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Blok BA, Arts RJW, van Crevel R, Aaby P, Joosten LAB, Benn CS, Netea MG. Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1177-1184. doi: 10.1007/s10096-020-03813-y. Epub 2020 Feb 17.
PubMed 32065303
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
- ClinicalTrials.gov ID
- NCT02175420
- Acronym / sponsor ID
- BCG-TFV1
- Conditions
- BCG Vaccination
- Keywords
- BCG, Salmonella, Trained immunity, Non-specific effect vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.
Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious diseases.
Several studies have shown that BCG can boost the effect of other vaccines. The present study aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.
The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better vaccination result in terms of antibody production will be accomplished against typhoid fever due to the effects of BCG on the innate immune system.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFV alone | Active comparator | Biological: TFVTyphim Vi |
| BCG+TFV | Experimental | Biological: BCG, Biological: TFVBCG (SSI, Denmark) followed after 14 days by Typhim Vi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (4 listed)
- Born in Salmonella typhi endemic country
- Pregnancy
- Oral medication except anticonceptive drugs
- Previous vaccination with BCG and/or TFV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCGAlso: BCG vaccine (SSI, Denmark) | Biological | BCG+TFV |
| TFVAlso: Typhim Vi | Biological | BCG+TFV, TFV alone |
Primary outcome
anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV
Time frame: 2 weeks
anti-salmonella typhi Vi antigen antibody titers at 2 weeks after TFV will be compared between TFV only and TFV after BCG groups.
anti-salmonella typhi Vi antigen antibody titer 3 months post TFV
Time frame: 3 months
anti-salmonella typhi Vi antigen antibody titers at 3 months after TFV will be compared between TFV only and TFV after BCG groups.
1 secondary outcome
Change in ex vivo cytokine responses
Time frame: 0, 1 and 4 days; 2 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Derived from this study: PubMed 32065303Blok BA, Arts RJW, van Crevel R, Aaby P, Joosten LAB, Benn CS, Netea MG. Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1177-1184. doi: 10.1007/s10096-020-03813-y. Epub 2020 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihai Netea, Prof. Dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG and TFV in people with BCG Vaccination, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.