Iron Deficiency AnemiaNCT06027801
Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity
A study testing Iron-fortified cookies, Japanese encephalitis (JE) vaccine and Typhoid Vi polysaccharide (Vi-PS) vaccine in people with Iron Deficiency Anemia, run by University of Oxford at 1 site in Thailand.
Trial summary
Iron deficiency (ID) anaemia (IDA) is a global public health problem, with the highest prevalence in Africa and in South-East Asia. While immunization programs have achieved high global coverage, vaccines often underperform in low- and middle-income countries (LMIC). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron-fortified cookies, Japanese encephalitis (JE) vaccine and Typhoid Vi polysaccharide (Vi-PS) vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 6 Sep 2023to 30 Dec 2024
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial.
- Female aged 18-49 years.
- Diagnosed with anaemia (i.e. hemoglobin (Hb) concentration <12 g/dl), but no severe anaemia (Hb <8 g/dl), and iron deficiency (ZnPP >40 µmol/mol)
- Anticipated residence in the area for the study duration
Who cannot join
- Pregnant (confirmed by rapid test during screening and at time of vaccination), lactating or planning pregnancy during the trial.
- Blood transfusion or intravenous iron treatment within 4 months of study start
- Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
- Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
- Treatment with supplemental iron two weeks prior to enrolment
- JE or typhoid vaccine within the past two years
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Mahidol University
Roi Et
Sueppong Gowachirapant, PhD
About this study
Official title: Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity: a Randomized Controlled Trial in Iron Deficient Thai Women
Iron deficiency (ID) anaemia (IDA) is a global public health problem, with the highest prevalence in Africa and in South-East Asia. While immunization programs have achieved high global coverage, vaccines often underperform in low- and middle-income countries (LMIC). The cause remains uncertain, but undernutrition, including ID, likely plays a role. Our recent in vitro and in vivo studies have shown the importance of iron status in adaptive immunity and vaccine response. Hypoferremia blunted T cell, B cell, and neutralizing antibody responses to influenza virus infection in mice, allowing the virus to persist. Iron deficient anaemic Kenyan women receiving intravenous iron at time of vaccination had a better immune response to the first dose of the ChAdOx Coronavirus 19 (COVID-19) vaccine and yellow fever vaccine. Japanese encephalitis and typhoid fever are endemic in Thailand. Vaccines are available but show variable efficacy. Whether ID impairs adult vaccine response to the live attenuated Japanese encephalitis (JE) and the Typhoid Vi polysaccharide (Vi-PS) vaccine and whether iron repletion via iron fortification improves vaccine response is uncertain.
The objective of this study is to assess whether IDA in Thai women impairs immune response to the JE and the Typhoid Vi-PS vaccine and whether fortification iron improves their response.
In this double-blind randomized controlled trial, IDA women will be assigned to two study groups: group 1 (fortification group) will receive iron-fortified biscuits (15mg iron as ferrous fumarate) for 56 days; group 2 (control group) will receive non-fortified biscuits for 56 days. All women will receive live attenuated JE and Typhoid Vi-PS vaccine on study day 28. Vaccine response will be measured 28 days after vaccination (on day 56) in both groups.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron-fortified cookies, Japanese encephalitis (JE) vaccine, Typhoid Vi polysaccharide (Vi-PS) vaccine, non-fortified cookies
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-fortified cookiesOther
Study cookies fortified with ferrous fumarate, providing 15 mg of elemental iron in each portion.
Japanese encephalitis (JE) vaccineBiological
All participants will be administered the live attenuated JE vaccine
Typhoid Vi polysaccharide (Vi-PS) vaccineBiological
All participants will be administered the typhoid Vi-PS vaccine
non-fortified cookiesOther
Study cookies containing no iron
| Study group | Role | What they receive |
|---|---|---|
| Iron fortification group | Experimental | Participants assigned to this group will receive iron-fortified cookies daily for the whole study duration Receives: Other: Iron-fortified cookies; Biological: Japanese encephalitis (JE) vaccine; Biological: Typhoid Vi polysaccharide (Vi-PS) vaccine |
| Control group | Placebo comparator | Participants assigned to this group will receive the same cookies containing no iron daily for the whole study duration Receives: Biological: Japanese encephalitis (JE) vaccine; Biological: Typhoid Vi polysaccharide (Vi-PS) vaccine; Other: non-fortified cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoglobulin G (IgG) concentrations against Salmonella Typhi
Measured: day 28 (time of vaccination)
Immunoglobulin A (IgA) concentrations against Salmonella Typhi
Measured: day 28 (time of vaccination)
Immunoglobulin G (IgG) concentrations against Salmonella Typhi
Measured: day 56 (4 weeks after vaccination)
Immunoglobulin A (IgA) concentrations against Salmonella Typhi
Measured: day 56 (4 weeks after vaccination)
Neutralizing antibodies against Japanese encephalitis
Measured: day 28 (time of vaccination)
Neutralizing antibodies against Japanese encephalitis
Measured: day 56 (4 weeks after vaccination)
Secondary outcomes (30)
Hemoglobin concentration (g/dL)
Measured: day 0
Hemoglobin concentration (g/dL)
Measured: day 28
Hemoglobin concentration (g/dL)
Measured: day 56
zinc protoporphyrin (ZnPP) concentration (µmol/mol heme)
Measured: day 0
zinc protoporphyrin (ZnPP) concentration (µmol/mol heme)
Measured: day 28
zinc protoporphyrin (ZnPP) concentration (µmol/mol heme)
Measured: day 56
serum iron (SFe) concentration (ng/µl)
Measured: day 0
serum iron (SFe) concentration (ng/µl)
Measured: day 28
serum iron (SFe) concentration (ng/µl)
Measured: day 56
total iron binding capacity (µg/dL)
Measured: day 0
total iron binding capacity (µg/dL)
Measured: day 28
total iron binding capacity (µg/dL)
Measured: day 56
transferrin saturation (TSAT) (%)
Measured: day 0
transferrin saturation (TSAT) (%)
Measured: day 28
transferrin saturation (TSAT) (%)
Measured: day 56
plasma ferritin (PF) concentration (µg/L)
Measured: day 0
plasma ferritin (PF) concentration (µg/L)
Measured: day 28
plasma ferritin (PF) concentration (µg/L)
Measured: day 56
soluble transferrin receptor (sTfR) concentration (mg/L)
Measured: day 0
soluble transferrin receptor (sTfR) concentration (mg/L)
Measured: day 28
soluble transferrin receptor (sTfR) concentration (mg/L)
Measured: day 56
C-reactive protein (CRP) concentration (mg/L)
Measured: day 0
C-reactive protein (CRP) concentration (mg/L)
Measured: day 28
C-reactive protein (CRP) concentration (mg/L)
Measured: day 56
alpha-glycoprotein (AGP) concentration (g/L)
Measured: day 0
alpha-glycoprotein (AGP) concentration (g/L)
Measured: day 28
alpha-glycoprotein (AGP) concentration (g/L)
Measured: day 56
retinol-binding protein concentration (µmol/L)
Measured: day 0
retinol-binding protein concentration (µmol/L)
Measured: day 28
retinol-binding protein concentration (µmol/L)
Measured: day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start6 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Ministry of Health, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027801
- Sponsor's protocol ID
- VEST
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity: a Randomized Controlled Trial in Iron Deficient Thai Women
- ClinicalTrials.gov ID
- NCT06027801
- Acronym / sponsor ID
- VEST
- Conditions
- Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol University, Ministry of Health, Thailand
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Sep 2023 (actual)
- 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.
Iron deficiency (ID) anaemia (IDA) is a global public health problem, with the highest prevalence in Africa and in South-East Asia. While immunization programs have achieved high global coverage, vaccines often underperform in low- and middle-income countries (LMIC). The cause remains uncertain, but undernutrition, including ID, likely plays a role. Our recent in vitro and in vivo studies have shown the importance of iron status in adaptive immunity and vaccine response. Hypoferremia blunted T cell, B cell, and neutralizing antibody responses to influenza virus infection in mice, allowing the virus to persist. Iron deficient anaemic Kenyan women receiving intravenous iron at time of vaccination had a better immune response to the first dose of the ChAdOx Coronavirus 19 (COVID-19) vaccine and yellow fever vaccine. Japanese encephalitis and typhoid fever are endemic in Thailand. Vaccines are available but show variable efficacy. Whether ID impairs adult vaccine response to the live attenuated Japanese encephalitis (JE) and the Typhoid Vi polysaccharide (Vi-PS) vaccine and whether iron repletion via iron fortification improves vaccine response is uncertain.
The objective of this study is to assess whether IDA in Thai women impairs immune response to the JE and the Typhoid Vi-PS vaccine and whether fortification iron improves their response.
In this double-blind randomized controlled trial, IDA women will be assigned to two study groups: group 1 (fortification group) will receive iron-fortified biscuits (15mg iron as ferrous fumarate) for 56 days; group 2 (control group) will receive non-fortified biscuits for 56 days. All women will receive live attenuated JE and Typhoid Vi-PS vaccine on study day 28. Vaccine response will be measured 28 days after vaccination (on day 56) in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron fortification group | Experimental | Other: Iron-fortified cookies, Biological: Japanese encephalitis (JE) vaccine, Biological: Typhoid Vi polysaccharide (Vi-PS) vaccineParticipants assigned to this group will receive iron-fortified cookies daily for the whole study duration |
| Control group | Placebo comparator | Biological: Japanese encephalitis (JE) vaccine, Biological: Typhoid Vi polysaccharide (Vi-PS) vaccine, Other: non-fortified cookiesParticipants assigned to this group will receive the same cookies containing no iron daily for the whole study duration |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- Female aged 18-49 years.
- Diagnosed with anaemia (i.e. hemoglobin (Hb) concentration <12 g/dl), but no severe anaemia (Hb <8 g/dl), and iron deficiency (ZnPP >40 µmol/mol)
- Anticipated residence in the area for the study duration
Key exclusion criteria (6 listed)
- Pregnant (confirmed by rapid test during screening and at time of vaccination), lactating or planning pregnancy during the trial.
- Blood transfusion or intravenous iron treatment within 4 months of study start
- Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
- Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
- Treatment with supplemental iron two weeks prior to enrolment
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 |
|---|---|---|
| Iron-fortified cookiesStudy cookies fortified with ferrous fumarate, providing 15 mg of elemental iron in each portion. | Other | Iron fortification group |
| Japanese encephalitis (JE) vaccineAll participants will be administered the live attenuated JE vaccine | Biological | Control group, Iron fortification group |
| Typhoid Vi polysaccharide (Vi-PS) vaccineAll participants will be administered the typhoid Vi-PS vaccine | Biological | Control group, Iron fortification group |
| non-fortified cookiesStudy cookies containing no iron | Other | Control group |
Primary outcome
Immunoglobulin G (IgG) concentrations against Salmonella Typhi
Time frame: day 28 (time of vaccination)
Immunoglobulin A (IgA) concentrations against Salmonella Typhi
Time frame: day 28 (time of vaccination)
Immunoglobulin G (IgG) concentrations against Salmonella Typhi
Time frame: day 56 (4 weeks after vaccination)
Immunoglobulin A (IgA) concentrations against Salmonella Typhi
Time frame: day 56 (4 weeks after vaccination)
Neutralizing antibodies against Japanese encephalitis
Time frame: day 28 (time of vaccination)
Neutralizing antibodies against Japanese encephalitis
Time frame: day 56 (4 weeks after vaccination)
30 secondary outcomes
Hemoglobin concentration (g/dL)
Time frame: day 0
Hemoglobin concentration (g/dL)
Time frame: day 28
Hemoglobin concentration (g/dL)
Time frame: day 56
zinc protoporphyrin (ZnPP) concentration (µmol/mol heme)
Time frame: day 0
zinc protoporphyrin (ZnPP) concentration (µmol/mol heme)
Time frame: day 28
zinc protoporphyrin (ZnPP) concentration (µmol/mol heme)
Time frame: day 56
serum iron (SFe) concentration (ng/µl)
Time frame: day 0
serum iron (SFe) concentration (ng/µl)
Time frame: day 28
serum iron (SFe) concentration (ng/µl)
Time frame: day 56
total iron binding capacity (µg/dL)
Time frame: day 0
total iron binding capacity (µg/dL)
Time frame: day 28
total iron binding capacity (µg/dL)
Time frame: day 56
transferrin saturation (TSAT) (%)
Time frame: day 0
transferrin saturation (TSAT) (%)
Time frame: day 28
transferrin saturation (TSAT) (%)
Time frame: day 56
plasma ferritin (PF) concentration (µg/L)
Time frame: day 0
plasma ferritin (PF) concentration (µg/L)
Time frame: day 28
plasma ferritin (PF) concentration (µg/L)
Time frame: day 56
soluble transferrin receptor (sTfR) concentration (mg/L)
Time frame: day 0
soluble transferrin receptor (sTfR) concentration (mg/L)
Time frame: day 28
soluble transferrin receptor (sTfR) concentration (mg/L)
Time frame: day 56
C-reactive protein (CRP) concentration (mg/L)
Time frame: day 0
C-reactive protein (CRP) concentration (mg/L)
Time frame: day 28
C-reactive protein (CRP) concentration (mg/L)
Time frame: day 56
alpha-glycoprotein (AGP) concentration (g/L)
Time frame: day 0
alpha-glycoprotein (AGP) concentration (g/L)
Time frame: day 28
alpha-glycoprotein (AGP) concentration (g/L)
Time frame: day 56
retinol-binding protein concentration (µmol/L)
Time frame: day 0
retinol-binding protein concentration (µmol/L)
Time frame: day 28
retinol-binding protein concentration (µmol/L)
Time frame: day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-fortified cookies, Japanese encephalitis (JE) vaccine and Typhoid Vi polysaccharide (Vi-PS) vaccine in people with Iron Deficiency Anemia, run by University of Oxford at 1 site in Thailand.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Stoffel, PhD (044 632 83 93 ext. +41, nicole.stoffel@rdm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin G (IgG) concentrations against Salmonella Typhi (time frame: day 28 (time of vaccination)). The study lists 6 primary outcomes in all. 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 29 Nov 2023.