Iron and Immune Response to Vaccine (IRONMUM)

Launched by UNIVERSITY OF OXFORD · May 17, 2022

Keywords

ClinConnect Summary

This is a prospective interventional open label cohort study with an exploratory framework. After assessment of gestation by routine ultrasound, women will be invited to participate if they have a viable, singleton pregnancy with a gestation \< 28 weeks. Consenting pregnant women will be enrolled at first antenatal clinic \[7\] visit and receive tetanus and diphtheria immunisation after confirmation of vaccination history, and SARS-CoV-2 immunisation (first dose if indicated). All women will be classified as non-anaemic or anaemic based on haematocrit (Haematocrit\<33% in first trimester (d...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Viable singleton pregnancy\<28 weeks confirmed by ultrasound
• • 2. 18 years and older
• • 3. Willingness and ability to comply with the study protocol for the duration of the study
• • 4. Can understand information about the study and provide consent
• Exclusion Criteria:
• • 1. Any diphtheria-tetanus vaccine within the previous 2 years
• • 2. History of allergic reaction to diphtheria-tetanus or COVID-19 vaccine
• • 3. Haematocrit \<21% or Haematocrit \>50%
• • 4. Known severe haemoglobinopathy (HbE/beta-thalassaemia syndrome, beta-thalassaemia major or HbH syndrome)\* or G6PD deficiency
• • \* Iron supplementation is safe in pregnant women with haemoglobin E, alpha-thalassemia 1, or beta-thalassemia carriers.
• • 5. HIV-positive
• • 6. Slide confirmed presence of malaria
• • 7. Fever (defined at \>37.5°C)
• • 8. Symptoms of COVID (these women will be PCR tested as routine in clinic)
• • 9. Known severe medical or obstetric complication e.g. valvular heart disease, placenta praevia
• • 10. Known or clinical vitB12 deficiency as indicated by megaloblastic anaemia (pernicious anaemia or clinical symptoms)