InfectionMOSAIC-2NCT02924246
Effect of Milk on the Vaccination Response
A study testing cholera vaccination, raw milk and pasteurized milk in people with Infection, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
Rationale: Oral vaccination is known to induce a systemic immune response as well as an immune response in mucosal tissues, and can therefore serve as a model to study systemic and mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- cholera vaccination, raw milk and pasteurized milk
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Dec 2017
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 yr
- Signed informed consent
- Availability of internet connection
- Male or female
- Willing to stop blood donation at the blood bank during the study period
Who cannot join
- Currently participating in another clinical trial
- Previous Cholera, Salmonella, or E. coli vaccination
- Tonsillectomy
- Acute gastroenteritis in the past 2 months
- Use of antibiotics in the past 2 months
- Hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts)
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- Pregnancy or lactating
- Not willing to drink raw milk
- Allergic to milk or lactose-intolerant
- Disease of GI tract, liver, gall bladder, kidneys, thyroid gland
- Immune-compromised
- Use of immunosuppressive drugs
- Drug abuse, and not willing/able to stop this during the study
- Excessive alcohol usage (men: >4 consumptions/day or >20 consumptions/week; women: >3 consumptions/day or >15 consumptions/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MOSAIC-2: Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
Rationale: Oral vaccination is known to induce a systemic immune response as well as an immune response in mucosal tissues, and can therefore serve as a model to study systemic and mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this pilot, in this study oral cholera vaccination will be applied to study the support of immunity by raw milk, compared to heat-treated milk. The study design has been optimised based on previous results: study duration is extended and sample size is based on relevant change and known variation in the primary outcome parameters.
Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. In a previous study, this model was developed using oral cholera vaccination in human adult volunteers. In that study, raw milk was shown to support the immune response to vaccination. In this follow-up study, the effect of raw milk will be compared with pasteurized and ultra-heat treated (UHT) milk.
Read more
Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the immune response as induced by oral cholera vaccination, in comparison to raw milk and to regular vaccination.
Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.
Study population: Healthy subjects of 18-50 years of age.
Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat pasteurized milk.
- Conditions
- Infection
- Being tested
- cholera vaccination, raw milk, pasteurized milk, UHT milk
- Keywords
- immunity, vaccination, milk
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholera vaccinationBiological
Also called Dukoral
Oral cholera vaccination on day 0 and day 14
raw milkOther
raw milk
pasteurized milkOther
pasteurized milk
UHT milkOther
UHT milk
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Regular cholera vaccination Receives: Biological: cholera vaccination |
| Raw milk | Active comparator | Cholera vaccination - raw milk Receives: Biological: cholera vaccination; Other: raw milk |
| Pasteurized milk | Active comparator | Cholera vaccination - pasteurized milk Receives: Biological: cholera vaccination; Other: pasteurized milk |
| UHT milk | Active comparator | Cholera vaccination - UHT milk Receives: Biological: cholera vaccination; Other: UHT milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response
Measured: baseline and day 14, 28, 42
Secondary outcomes (3)
Change in the cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response
Measured: baseline and day 14, 28, 42
Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response
Measured: baseline and day 14, 28, 42
Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response
Measured: baseline and day 14, 28, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
- Investigators
- Els van Hoffen, PhD, Principal investigator, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924246
- Sponsor's protocol ID
- NL56906.081.16
- Acronym
- MOSAIC-2
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOSAIC-2: Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
- ClinicalTrials.gov ID
- NCT02924246
- Acronym / sponsor ID
- MOSAIC-2 / NL56906.081.16
- Conditions
- Infection
- Keywords
- immunity, vaccination, milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Oct 2016 (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.
Rationale: Oral vaccination is known to induce a systemic immune response as well as an immune response in mucosal tissues, and can therefore serve as a model to study systemic and mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this pilot, in this study oral cholera vaccination will be applied to study the support of immunity by raw milk, compared to heat-treated milk. The study design has been optimised based on previous results: study duration is extended and sample size is based on relevant change and known variation in the primary outcome parameters.
Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. In a previous study, this model was developed using oral cholera vaccination in human adult volunteers. In that study, raw milk was shown to support the immune response to vaccination. In this follow-up study, the effect of raw milk will be compared with pasteurized and ultra-heat treated (UHT) milk.
Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the immune response as induced by oral cholera vaccination, in comparison to raw milk and to regular vaccination.
Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.
Study population: Healthy subjects of 18-50 years of age.
Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat pasteurized milk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Biological: cholera vaccinationRegular cholera vaccination |
| Raw milk | Active comparator | Biological: cholera vaccination, Other: raw milkCholera vaccination - raw milk |
| Pasteurized milk | Active comparator | Biological: cholera vaccination, Other: pasteurized milkCholera vaccination - pasteurized milk |
| UHT milk | Active comparator | Biological: cholera vaccination, Other: UHT milkCholera vaccination - UHT milk |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50 yr
- Signed informed consent
- Availability of internet connection
- Male or female
- Willing to stop blood donation at the blood bank during the study period
Key exclusion criteria (14 listed)
- Currently participating in another clinical trial
- Previous Cholera, Salmonella, or E. coli vaccination
- Tonsillectomy
- Acute gastroenteritis in the past 2 months
- Use of antibiotics in the past 2 months
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 |
|---|---|---|
| cholera vaccinationAlso: DukoralOral cholera vaccination on day 0 and day 14 | Biological | Control group, Pasteurized milk, Raw milk, UHT milk |
| raw milkraw milk | Other | Raw milk |
| pasteurized milkpasteurized milk | Other | Pasteurized milk |
| UHT milkUHT milk | Other | UHT milk |
Primary outcome
Change in cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response
Time frame: baseline and day 14, 28, 42
3 secondary outcomes
Change in the cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response
Time frame: baseline and day 14, 28, 42
Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response
Time frame: baseline and day 14, 28, 42
Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response
Time frame: baseline and day 14, 28, 42
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 5 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Els van Hoffen, PhD principal investigator
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholera vaccination, raw milk and pasteurized milk in people with Infection, run by NIZO Food Research 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 5 inclusion and 14 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 5 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Change in cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response (time frame: baseline and day 14, 28, 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2018.