Malaria vaccine trials in pregnant women: An imperative without precedent

Healy, Sara A.; Fried, Michal; Richie, Thomas L.; Bok, Karin; Little, Maggie; August, Allison; Riley, Laura E.; Swamy, Geeta K.; Wylie, Blair J.; Menéndez, Clara; Muehlenbachs, Atis; Doumbo, Ogobara K.; Greenwood, Brian; Hoffman, Stephen L.; Duffy, Patrick E.

doi:10.1016/j.vaccine.2018.12.025

Cited by 27 publications

(25 citation statements)

References 5 publications

(7 reference statements)

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“…Multiple factors complicate the introduction of new vaccines, including epidemiological data on specific disease burden and background on pregnancy outcomes in the target population [21][22][23].…”

Section: Introductionmentioning

confidence: 99%

Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali

Andemel

Gaoussou²,

Issiaka³

et al. 2020

Reprod Health

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Background: In sub-Saharan Africa, malaria continues to scourge the population and is the primary cause of morbidity and mortality in young children and pregnant women. As current preventative measures such as intermittent preventive treatment and use of insecticide-treated nets provide incomplete protection, several malaria vaccines are currently under development, including one to specifically prevent pregnancy malaria. Prior to conducting vaccine trials, it is important to obtain background information on poor pregnancy outcomes in the target population to establish a baseline. Methods: Pregnant women presenting at community health care centers for antenatal care were recruited to the study. Gestational age was determined by ultrasound examination following recruitment. Antenatal care and pregnancy outcome information were collected during a visit 4-8 weeks post-delivery. Results: One thousand eight hundred fifty women completed the study, and analysis included 1814 women after excluding multiple gestations (n = 26) and missing/incomplete data (n = 10). The percentage (95% CI) of adverse pregnancy outcomes is as follows: miscarriage, 0.28% (0.04-0.52); stillbirth, 1.93% (1.30-2.56); early neonatal death, 1.65% (1.03-2.24); late neonatal death, 0.39%, (0.10-0.68); and preterm delivery (PTD), 4.74% (3.76-5.73). The percentages of early and late neonatal deaths and PTD were significantly higher (p < 0.01) in primigravid compared to multigravid women. In primigravidae, 3.1, 1.1 and 7.1% of pregnancies resulted in early neonatal death, late neonatal death and PTD, respectively, while these outcomes in multigravidae were 1.0, 0.1 and 2.7%, respectively. Major malformations were identified in 4 newborns. Conclusions: Low gravidity and young age predict perinatal death and PTD. The information collected here can be used as a baseline for adverse pregnancy outcomes in future vaccine trials in pregnant women.

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Section: Introductionmentioning

confidence: 99%

Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali

Andemel

Gaoussou²,

Issiaka³

et al. 2020

Reprod Health

Self Cite

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“…Vaccine development is advanced, but no vaccines against CMV are currently licensed (49). Pregnant women are at increased susceptibility for malaria-related disease, complications, and death, and maternal immunization should be considered during reviews of phase IV safety data and for future trials of the PfSPZ malaria vaccine, which is in phase 2 testing (50). A monovalent pertussis vaccine may be used in maternal and birth dosing regimens, be more affordable than the Tdap vaccine, and reduce the immune modulation in infants described above (51).…”

Section: The Next Generation Of Neonatal and Maternal Immunization Rementioning

confidence: 99%

The Fifth International Neonatal and Maternal Immunization Symposium (INMIS 2019): Securing Protection for the Next Generation

Sadarangani

Kollmann

Bjornson

et al. 2021

mSphere

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Despite significant progress in reaching some milestones of the United Nations Sustainable Development Goals, neonatal and early infant morbidity and mortality remain high, and maternal health remains suboptimal in many countries. Novel and improved preventative strategies with the potential to benefit pregnant women and their infants are needed, with maternal and neonatal immunization representing effective approaches. Experts from immunology, vaccinology, infectious diseases, clinicians, industry, public health, and vaccine-related social sciences convened at the 5th International Neonatal and Maternal Immunization Symposium (INMIS) in Vancouver, Canada, from 15 to 17 September 2019. We critically evaluated the lessons learned from recent clinical studies, presented cutting-edge scientific progress in maternal and neonatal immunology and vaccine development, and discussed maternal and neonatal immunization in the broader context of infectious disease epidemiology and public health. Focusing on practical aspects of research and implementation, we also discussed the safety, awareness, and perception of maternal immunization as an existing strategy to address the need to improve maternal and neonatal health worldwide. The symposium provided a comprehensive scientific and practical primer as well as an update for all those with an interest in maternal and neonatal infection, immunity, and vaccination. The summary presented here provides an update of the current status of progress in maternal and neonatal immunization.

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“…Currently, vaccination in pregnancy relies upon the following principles: Evidence of safety of vaccination for the mother and fetus Evidence of maternal vaccination providing protection to the fetus and newborn, as is done in influenza and tetanus/pertussis vaccination Transplacental passage of IgG antibodies that are triggered or boosted by immunisation and cause seropositivity in newborns and infants Evidence that newborns and infants do not produce a rapid antibody titre following active immunisation ( 1 ). …”

Section: Introductionmentioning

confidence: 99%

“…Evidence that newborns and infants do not produce a rapid antibody titre following active immunisation ( 1 ).…”

Section: Introductionmentioning

confidence: 99%

“…Malaria in pregnancy is associated with fetal growth restriction, preeclampsia, preterm delivery, miscarriage, stillbirth, neonatal death, maternal anaemia and maternal death ( 27 ). In pregnancy, Plasmodium parasites sequester in the placenta and bind to glycosaminoglycan chondroitin sulfate A (CSA) on the syncytiotrophoblast lining of the maternal blood space, causing placental malaria and poor placentation, impaired vascularisation and subsequent placental dysfunction ( 1 ). Furthermore, maternal effects of malaria such as significant anaemia and organ damage results in adverse pregnancy outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Future vaccines in pregnancy

Vress

2021

Best Practice & Research Clinical Obstetrics & Gynaecol

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Vaccination in pregnancy provides an important opportunity to target illnesses that are known to impact particularly on pregnant women, fetal development and cause newborn illness. The ability to create antibodies via safe vaccination that cross the placenta can provide protection against maternal, congenital and newborn infection. There are currently multiple vaccines being developed which have direct benefits for pregnant women and their newborns. Group B Streptococcus, Respiratory Syncytial Virus, Cytomegalovirus, Zika, Ebola, Malaria and coronavirus SARS-CoV-2 are all being researched with the view to developing a safe vaccine available for pregnant women. There is also an increased movement towards including pregnant women in vaccine development and trials, challenging the historical, ethical and medicolegal arguments against their involvement in such research.

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Malaria vaccine trials in pregnant women: An imperative without precedent

Cited by 27 publications

References 5 publications

Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali

Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali

The Fifth International Neonatal and Maternal Immunization Symposium (INMIS 2019): Securing Protection for the Next Generation

Future vaccines in pregnancy

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