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Pregnancy, Arsenic and Immune Response
Pregnancy, Arsenic and Immune Response

NCT03930017

CompletedN/A

Sponsor: Johns Hopkins Bloomberg School of Public Health

Conditions: Arsenic--Toxicology, Immunologic Disorders Complicating Pregnancy, Vaccine Response Impaired, Micronutrient Deficiency, Influenza

Interventions: Seasonal influenza vaccine - VAXIGRIP TETRA influenza vaccine (quadrivalent, split virion, inactivated)

Countries: Bangladesh

As the global availability of vaccines increases, and reaches areas disproportionately affected by arsenic and malnutrition, resolving questions about potential environmental and biologic barriers to maternal immunization has become increasingly urgent. It is not known whether arsenic, a known developmental toxicant, can alter maternal immune responses to vaccination and whether exposure to arsenic during pregnancy can impair the transfer of maternal vaccine-induced antibody to the newborn. Moreover, factors known to affect arsenic metabolism and toxicity outcomes, particularly micronutrients critical in one-carbon metabolism, have not been evaluated in studies of arsenic immunotoxicity and vaccine-induced protection in mothers and their newborns. The objective in this study is to investigate whether maternal arsenic exposure and one-carbon metabolism micronutrient deficiencies alter maternal and newborn measures of vaccine-induced protection, respiratory morbidity, and systemic immune function following influenza vaccination during pregnancy.

Eligibility overview

Sex: FEMALE

Age: 13 Years to 45 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

Women who:

* are within 13-16 weeks of gestational age (GA) of pregnancy;
* are between 13 and 45 years of age;
* are married;
* provide informed consent for herself and assent for her unborn child;
* agree to receive the seasonal influenza vaccine (VAXIGRIP® TETRA seasonal quadrivalent inactivated influenza vaccine, Sanofi Pasteur) upon study enrollment.

Exclusion Criteria:

Women who:

* have pre-existing immune-related health condition (e.g., immunodeficiency, lupus, chronic infection, or cancer);
* previous or current use of immune-altering drug/therapy (e.g., steroids);
* have already received influenza vaccination for the current season.
Locations (1)
  • Gaibandha, Bangladesh