Infectivity and Immunogenicity of Live-Attenuated Respiratory Syncytial Virus Vaccines in Human Immunodeficiency Virus-Exposed Uninfected Children.

Background: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory illness among young children. Human immunodeficiency virus (HIV)-exposed, uninfected (HEU) children experience a higher burden of RSV disease and have immune abnormalities that may influence their responses to live-attenuated RSV vaccines.

Methods: In a pooled analysis of clinical trials of 7 live-attenuated, intranasal RSV vaccines conducted by the IMPAACT Network among children 6 to <25 months of age with serum RSV-neutralizing titers of <1:40, the infectivity and immunogenicity of these vaccines were compared among HEU and HIV-unexposed, uninfected (HUU) children.

Identifying WHO global priority endemic pathogens for vaccine research and development (R&D) using multi-criteria decision analysis (MCDA): an objective of the Immunization Agenda 2030.

Background: To date, global priorities for new vaccine R&D have not been systematically identified for endemic pathogens. As part of Immunisation Agenda 2030 (IA2030), we have systematically identified priority endemic pathogens for new vaccine R&D based on country and regional stakeholder values to address this need.

Methods: MCDA surveys targeting policy makers and immunisation stakeholders in each World Health Organization (WHO) region were used to weight eight criteria for prioritisation.

Vaccine decision-making among pregnant women: a protocol for a cross-sectional mixed-method study in Brazil, Ghana, Kenya and Pakistan.

Maternal immunization is a critical strategy to prevent both maternal and infant morbidity and mortality from several infectious diseases. When the first COVID-19 vaccines became available during the pandemic, there was mixed messaging and confusion amongst the broader public and among those associated with health care systems about the recommendations for COVID-19 vaccinations in pregnancy in many countries. A multi-country, mixed-methods study is being undertaken to describe how vaccine decision-making occurs amongst pregnant and postpartum women, with a focus on COVID-19 vaccines.

Early, robust mucosal secretory IgA but not IgG response to SARS-CoV-2 spike in oral fluid is associated with faster viral clearance and COVID-19 symptom resolution.

Background: High priority efforts are underway to support the development of novel mucosal COVID-19 vaccines, such as the US Government's Project NextGen and the Center for Epidemic Preparedness Innovations' goal to respond to the next pandemic with a new vaccine in 100 days. However, there is limited consensus about the complementary role of mucosal immunity in disease progression and how to evaluate immunogenicity of mucosal vaccines. This study investigated the role of oral mucosal antibody responses in viral clearance and COVID-19 symptom duration.

Maternal Immunization Decision-Making Among Pregnant and Lactating People in Kenya: A Qualitative Exploration of Peer Influences on Vaccine Decision-Making for a Future RSV Vaccine.

Introduction: Respiratory syncytial virus (RSV) is a leading cause of respiratory illness in infants globally, with new maternal RSV vaccines on the horizon. Vaccine decision-making during pregnancy is shaped by individual, interpersonal, community, and societal factors. This study explored key interpersonal influences on maternal vaccine decision-making among pregnant and lactating people (PLP) and community members in Kenya.

The Full Value of Vaccine Assessments Concept-Current Opportunities and Recommendations.

For vaccine development and adoption decisions, the 'Full Value of Vaccine Assessment' (FVVA) framework has been proposed by the WHO to expand the range of evidence available to support the prioritization of candidate vaccines for investment and eventual uptake by low- and middle-income countries. Recent applications of the FVVA framework have already shown benefits. Building on the success of these applications, we see important new opportunities to maximize the future utility of FVVAs to country and global stakeholders and provide a proof-of-concept for analyses in other areas of disease control and prevention.

Lessons learned from COVID-19 vaccine acceptance among pregnant and lactating women from two districts in Kenya to inform demand generation efforts for future maternal RSV vaccines.

Background: Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory infections globally, with most RSV-related deaths occurring in infants < 6 months of age. The highest burden of RSV is in low-and-middle income countries, and in sub-Saharan Africa, RSV may be responsible for almost half of all hospital admissions with severe or very severe pneumonia among infants under 1 year. There is a maternal RSV vaccine on the horizon.

key antecedents and questions for acceptance of a future maternal GBS vaccine: Perspectives of pregnant women, lactating women, and community members in Kenya.

Group B streptococcus (GBS) is a leading global cause of neonatal sepsis and meningitis, stillbirth, and puerperal sepsis. While intrapartum antibiotic prophylaxis (IAP) is a currently available GBS disease prevention strategy, IAP is programmatically complex to implement, precluding use in low- and middle-income countries. In Kenya, 2% of stillbirths are attributable to GBS infection.

The full value of immunisation against respiratory syncytial virus for infants younger than 1 year: effects beyond prevention of acute respiratory illness.

Respiratory syncytial virus (RSV) is a leading cause of severe respiratory illness and death among children worldwide, particularly in children younger than 6 months and in low-income and middle-income countries. Feasible and cost-effective interventions to prevent RSV disease are not yet widely available, although two new products aimed at preventing RSV disease-long-acting monoclonal antibodies and maternal vaccines-have been licensed within the past 2 years. The primary target of these products is reduction of the substantial burden of RSV-associated acute lower respiratory tract infections (LRTI) in infants younger than 1 year.

Characterizing Attitudes Toward Maternal RSV Vaccines Among Pregnant and Lactating Persons in Kenya: Key Considerations for Demand Generation Efforts for Vaccine Acceptance.

This study examined attitudes toward maternal RSV vaccines among pregnant and lactating persons in Kenya. First pregnancy was associated with higher vaccine hesitancy among pregnant and lactating people, and social norms were associated with higher vaccine hesitancy among lactating people. Understanding maternal RSV attitudes is critical for vaccine acceptance.

RSV awareness, risk perception, causes, and terms: Perspectives of pregnant and lactating women in Kenya to inform demand generation efforts for maternal RSV vaccines.

Respiratory syncytial virus (RSV) causes a substantial proportion of acute lower respiratory tract infections (LRTI) among infants. In low- and middle-income countries, RSV may be responsible for approximately 40% of all hospital admissions of infants less than one year. A safe and immunogenic RSV vaccine, given to pregnant persons, is imminent.

Effect of infant viral respiratory disease on childhood asthma in a non-industrialized setting.

Background: There are limited data from non-industrialized settings on the effects of early life viral respiratory disease on childhood respiratory illness. We followed a birth cohort in tropical Ecuador to understand how early viral respiratory disease, in the context of exposures affecting airway inflammation including ascariasis, affect wheezing illness, asthma, and rhinoconjunctivitis in later childhood.

Methods: A surveillance cohort nested within a birth cohort was monitored for respiratory infections during the first 2 years in rural Ecuador and followed for 8 years for the development of wheeze and rhinoconjunctivitis.

Sources of COVID-19 Vaccine Promotion for Pregnant and Lactating Women in Bangladesh.

COVID-19 vaccines are an effective public health intervention to reduce COVID-19-related morbidity and mortality. Given that pregnant and lactating women have a higher risk of severe COVID-19 complications, it is paramount to understand the factors that inform vaccine decision-making among this population. In this study, we sought to identify facilitators and barriers to COVID-19 vaccine acceptance and vaccine promotion in pregnant and lactating women in Bangladesh.

COVID-19 vaccine eligibility of pregnant and lactating women in Bangladesh: Gap between policy and policy interpretation among policymakers and healthcare workers.

SARS-CoV-2 infection in pregnancy is associated with a greater risk of maternal and newborn morbidity and maternal death. Bangladesh confirmed its first COVID-19 case in March of 2020, and vaccination rollout started in January of 2021. In Bangladesh, pregnant women are allowed to receive COVID-19 vaccines during pregnancy with qualifications while lactating women are permitted to receive COVID-19 vaccines with no qualifications as of October 2021.

Evaluation of the Live-Attenuated Intranasal Respiratory Syncytial Virus (RSV) Vaccine RSV/6120/ΔNS2/1030s in RSV-Seronegative Young Children.

Background: Respiratory syncytial virus (RSV) is the leading cause of pediatric lower respiratory illness (LRI) and a vaccine for immunization of children is needed. RSV/6120/ΔNS2/1030s is a cDNA-derived live-vaccine candidate attenuated by deletion of the interferon antagonist NS2 gene and the genetically stabilized 1030s missense polymerase mutation in the polymerase, conferring temperature sensitivity.

Methods: A single intranasal dose of RSV/6120/ΔNS2/1030s was evaluated in a double-blind, placebo-controlled trial (vaccine to placebo ratio, 2:1) at 105.

Value profile for respiratory syncytial virus vaccines and monoclonal antibodies.

Respiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV vaccine exists to help prevent the millions of illnesses and hospitalizations and tens of thousands of young lives taken each year. Monoclonal antibody (mAb) prophylaxis exists for prevention of RSV in a small subset of very high-risk infants and young children, but the only currently licensed product is impractical, requiring multiple doses and expensive for the low-income settings where the RSV disease burden is greatest. A robust candidate pipeline exists to one day prevent RSV disease in infant and pediatric populations, and it focuses on two promising passive immunization approaches appropriate for low-income contexts: maternal RSV vaccines and long-acting infant mAbs.

Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody Responses After Community Infections in Children and Adults.

Background: We compared postinfection severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody (nAb) responses among children and adults while the D614G-like strain and Alpha, Iota, and Delta variants circulated.

Methods: During August 2020-October 2021, households with adults and children were enrolled and followed in Utah, New York City, and Maryland. Participants collected weekly respiratory swabs that were tested for SARS-CoV-2 and had sera collected during enrollment and follow-up.

COVID-19 vaccine decision-making among pregnant and lactating women in Bangladesh.

Pregnant and lactating women's vaccine decision-making process is influenced by many factors. Pregnant women were at increased risk for severe disease and poor health outcomes from COVID-19 at various time points during the pandemic. COVID-19 vaccines have been found to be safe and protective during pregnancy and while breastfeeding.