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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03930017
Recruitment Status Enrolling by invitation
First Posted April 29, 2019
Last update posted May 6, 2019
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.
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. The hypothesis is that maternal arsenic exposure and one-carbon metabolism micronutrient deficiencies alter maternal and newborn influenza antibody titer and avidity, respiratory infection morbidity, and markers of systemic immune function following maternal influenza vaccination during pregnancy. This study leverages a comprehensive pregnancy surveillance system at the JiVitA Maternal and Child Health and Nutrition Research Project site in Bangladesh (hereafter JiVitA) to pursue the following three aims: Aim 1. Establish whether arsenic exposure during pregnancy alters maternal and newborn influenza antibody titer and avidity following maternal influenza vaccination. Aim 2. Determine whether markers of systemic immune function mediate the association between arsenic exposure and respiratory illness in pregnant women and their newborns. Aim 3. Assess whether arsenic exposure and one-carbon metabolism micronutrient deficiencies during pregnancy have a joint effect on markers of systemic immune function and respiratory illness in mothers and their newborns. This study will yield three expected outcomes. First, it will fill critical knowledge gaps about whether arsenic exposure and one-carbon metabolism micronutrient deficiencies alter immune responses to a vaccination with known benefits for mothers and their newborns. Second, it will increase understanding of arsenic-associated respiratory morbidity and specific immune function pathways between arsenic exposure and respiratory morbidity in mothers and their newborns. Finally, as the global availability of vaccines increases, improving knowledge of potential environmental and biologic barriers to maternal and newborn vaccine-induced protection could lead to improved vaccine regimens (targeted vaccination campaigns, higher vaccine doses, and/or additional booster immunizations) to restore vaccine-induced protection in arsenic-exposed and malnutrition-affected populations of pregnant women and newborns worldwide.
Venous blood will be collected at a volume of ~24 milliliter (mL) / visit from mothers and ~1.5 mL / visit from newborns. Urine will be collected from mother and baby in whatever volume is provided at the time. Saliva will be collected in whatever volume is provided using the Oracol sampler sponge collection device (Malvern Medical Developments Ldt, Worcester, UK). Samples will be transported to the nearest JiVitA field office in a temperature monitored cooler on ice within 1hr of collection and processed within 4hrs thereafter.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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.
- 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.
JiVitA Maternal and Child Health and Nutrition Research Program
Johns Hopkins Bloomberg School of Public Health
Sanofi Pasteur, a Sanofi Company
Institute of Epidemiology, Disease Control and Research
Johns Hopkins Bangladesh - The JiVitA Project Site
University of Graz
UNC Gillings School of Global Public Health
Principal Investigator: Christopher D Heaney, PhD Johns Hopkins Bloomberg School of Public Health
Heaney CD, Kmush B, Navas-Acien A, Francesconi K, Gössler W, Schulze K, Fairweather D, Mehra S, Nelson KE, Klein SL, Li W, Ali H, Shaikh S, Merrill RD, Wu L, West KP Jr, Christian P, Labrique AB. Arsenic exposure and hepatitis E virus infection during pregnancy. Environ Res. 2015 Oct;142:273-80. doi: 10.1016/j.envres.2015.07.004. Epub 2015 Jul 15.