Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity: a Randomized Controlled Trial in Iron Deficient Thai Women

Status: Unknown
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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). 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Thailand
Mahidol University
RECRUITING
Roi Et
Contact Information
Primary
Nicole Stoffel, PhD
nicole.stoffel@rdm.ox.ac.uk
044 632 83 93
Backup
Pattanee Winichagoon, Prof
pattanee.win@mahidol.ac.th
66-2-800-2380
Time Frame
Start Date: 2023-09-06
Completion Date: 2024-12-30
Participants
Target number of participants: 150
Treatments
Experimental: Iron fortification group
Participants assigned to this group will receive iron-fortified cookies daily for the whole study duration
Placebo_comparator: Control group
Participants assigned to this group will receive the same cookies containing no iron daily for the whole study duration
Sponsors
Collaborators: Ministry of Health, Thailand, Mahidol University
Leads: University of Oxford

This content was sourced from clinicaltrials.gov

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