Pregnancy, Arsenic and Immune Response

Summary

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.

Conditions

• Arsenic--Toxicology
• Immunologic Disorders Complicating Pregnancy
• Vaccine Response Impaired
• Micronutrient Deficiency
• Influenza

Interventions

BIOLOGICAL

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

Influenza virus (quadrivalent, split virion, inactivated) of the strains that comply with the World Health Organization (WHO) recommendations (Northern Hemisphere) and European Union (EU) decision for the 2018/2019 season. The quadrivalent vaccine is propagated in fertilised hens' eggs from healthy chicken flocks.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  collaborator INDUSTRY

• Institute of Epidemiology, Disease Control and Research

  collaborator OTHER

• Johns Hopkins Bangladesh - The JiVitA Project Site

  collaborator UNKNOWN

• University of Graz

  collaborator OTHER

• Columbia University

  collaborator OTHER

• UNC Gillings School of Global Public Health

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Christopher D Heaney, PhD · Johns Hopkins Bloomberg School of Public Health

Eligibility

Min Age

13 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-14

Primary Completion

2020-01-06

Completion

2020-01-06

FDA Drug

Yes

Countries

• Bangladesh

Study Locations