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Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity

NCT ID: NCT06027801

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-06

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Iron fortification group

Participants assigned to this group will receive iron-fortified cookies daily for the whole study duration

Group Type EXPERIMENTAL

Iron-fortified cookies

Intervention Type OTHER

Study cookies fortified with ferrous fumarate, providing 15 mg of elemental iron in each portion.

Japanese encephalitis (JE) vaccine

Intervention Type BIOLOGICAL

All participants will be administered the live attenuated JE vaccine

Typhoid Vi polysaccharide (Vi-PS) vaccine

Intervention Type BIOLOGICAL

All participants will be administered the typhoid Vi-PS vaccine

Control group

Participants assigned to this group will receive the same cookies containing no iron daily for the whole study duration

Group Type PLACEBO_COMPARATOR

Japanese encephalitis (JE) vaccine

Intervention Type BIOLOGICAL

All participants will be administered the live attenuated JE vaccine

Typhoid Vi polysaccharide (Vi-PS) vaccine

Intervention Type BIOLOGICAL

All participants will be administered the typhoid Vi-PS vaccine

non-fortified cookies

Intervention Type OTHER

Study cookies containing no iron

Interventions

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Iron-fortified cookies

Study cookies fortified with ferrous fumarate, providing 15 mg of elemental iron in each portion.

Intervention Type OTHER

Japanese encephalitis (JE) vaccine

All participants will be administered the live attenuated JE vaccine

Intervention Type BIOLOGICAL

Typhoid Vi polysaccharide (Vi-PS) vaccine

All participants will be administered the typhoid Vi-PS vaccine

Intervention Type BIOLOGICAL

non-fortified cookies

Study cookies containing no iron

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mahidol University

Roi Et, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Nicole Stoffel, PhD

Role: CONTACT

Phone: 044 632 83 93

Email: [email protected]

Pattanee Winichagoon, Prof

Role: CONTACT

Phone: 66-2-800-2380

Email: [email protected]

Facility Contacts

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Sueppong Gowachirapant, PhD

Role: primary

Other Identifiers

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VEST

Identifier Type: -

Identifier Source: org_study_id