Moving targets: The challenges of studying infectious diseases among pregnant women in resource limited settings

Divala, Titus; Mungwira, Randy G.; Laufer, Miriam K.

doi:10.1016/j.vaccine.2015.08.042

Cited by 16 publications

(33 citation statements)

References 24 publications

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“…Several review articles have summarized challenges in conducting studies that involve pregnant women in low- and middle-income countries 320 , 322 . Reaching women during the early stages of their pregnancy may be challenging in societies where women are reluctant about revealing their pregnancy early 322 , and may miss the window of enrollment and vaccine administration. In addition, accurate estimation of gestational age, which is important in assessing pregnancy outcomes ( e.g.…”

Section: Considerations About Options To Generate Pivotal Licensure Dmentioning

confidence: 99%

Group B Streptococcus vaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries

et al. 2016

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Globally, group B Streptococcus (GBS) remains the leading cause of sepsis and meningitis in young infants, with its greatest burden in the first 90 days of life. Intrapartum antibiotic prophylaxis (IAP) for women at risk of transmitting GBS to their newborns has been effective in reducing, but not eliminating, the young infant GBS disease burden in many high income countries. However, identification of women at risk and administration of IAP is very difficult in many low and middle income country (LMIC) settings, and is not possible for home deliveries. Immunization of pregnant women with a GBS vaccine represents an alternate pathway to protecting newborns from GBS disease, through the transplacental antibody transfer to the fetus in utero. This approach to prevent GBS disease in young infants is currently under development, and is approaching late stage clinical evaluation. This manuscript includes a review of the natural history of the disease, global disease burden estimates, diagnosis and existing control options in different settings, the biological rationale for a vaccine including previous supportive studies, analysis of current candidates in development, possible correlates of protection and current status of immunogenicity assays. Future potential vaccine development pathways to licensure and use in LMICs, trial design and implementation options are discussed, with the objective to provide a basis for reflection, rather than recommendations.

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Section: Considerations About Options To Generate Pivotal Licensure Dmentioning

confidence: 99%

Group B Streptococcus vaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries

et al. 2016

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“…Immunization of pregnant women with a GBS vaccine represents an alternate pathway to protect newborns from GBS disease, through the transplacental antibody transfer to the fetus in utero. This approach is currently under development to licensure and use in low and middle income country [39][40][41].…”

Section: Discussionmentioning

confidence: 99%

Group B Streptococcal Meningitis in the First Year of Life: A Nationwide Surveillance Study in Cuba, 1998-2016

Orl

Meneses

Ortega

et al. 2017

JPNC

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Neonatal and young infant GBS disease can be classified into early-onset disease (EOD, onset during the first 6 days of life), and late-onset disease (LOD, onset between days 7-89 of life). It is estimated that 60.00-90.00 % of EOD occurs on the first day of life [3,4]. In the first week of life, invasive disease may appear early and frequently can cause bacteremia or pneumonia. After this period, transmission can be associated with medical care or community [5]. In most cases, it can manifests clinically as bacteremia, but also as meningitis. Both clinical forms can cause high case-fatality rate (CFR), causing often severe permanent neurological sequel [6]. The epidemiology of GBS disease considerably varies geographically and over time. A recent meta-analysis of worldwide published studies reported a mean global incidence of 0.53/1000 live births and a mean CFR of 9.60 % [7]. GBS is a Gram-positive bacterium, and there are 10 serotypes based on their capsular polysaccharide composition (Ia, Ib, II-IX). The polysaccharide capsule is a major virulence factor contributing to bacterial evasion of phagocytic clearance [8]. Serotype III is the most common invasive isolates and accounts for 30.00-50.00% of EOD and majority of LOD [7,9]. The bacteria colonize the human vagina, upper gastrointestinal and respiratory tract of healthy humans. The entrance door is often not obvious, but may be through the skin, genital, urinary and respiratory tract. Vertical transmission (mother to child) from colonized mothers can lead to invasive disease in their offspring. Later on, it transmission Volume 7 Issue 3-2017

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“…Studies in LMICs need to address a series of typical methodological challenges [12] . For example, baseline incidence rates of pregnancy and neonatal outcomes collected through previous studies or public records inform a series of sample size calculation data.…”

Section: Study Specific Considerations For Immunization In Pregnancy mentioning

confidence: 99%

Immunization in pregnancy clinical research in low- and middle-income countries – Study design, regulatory and safety considerations

Kochhar

Bonhoeffer

Jones

et al. 2017

Vaccine

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Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally.

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Moving targets: The challenges of studying infectious diseases among pregnant women in resource limited settings

Cited by 16 publications

References 24 publications

Group B Streptococcus vaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries

Group B Streptococcus vaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries

Group B Streptococcal Meningitis in the First Year of Life: A Nationwide Surveillance Study in Cuba, 1998-2016

Immunization in pregnancy clinical research in low- and middle-income countries – Study design, regulatory and safety considerations

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