RSV Vaccine Research Articles

Clinical validation of an RSV neutralization assay and analysis of cross-sectional sera associated with 2021-2023 RSV outbreaks to investigate the immunity debt hypothesis.

Population surveillance studies of serum-neutralizing activity against RSV are crucial for evaluating RSV vaccine efficacy and vulnerabilities to new strains. Here, we designed and validated a high-throughput assay for assessing anti-RSV neutralizing activity, standardized its measurements for comparison with other methodologies, and demonstrated its applicability to real-world samples. Our assay is precise, linear, and yields measurements consistent with other standardized assays, offering a methodology useful for large-scale studies of RSV immunity. We also find no significant difference in neutralizing titers among adults between those taken before and after large RSV outbreaks associated with the latter stages of the coronavirus disease of 2019 (COVID-19) public health emergency, underlining the need for a greater understanding of the dynamics of serological responses to RSV infection.

Vaccinations in pulmonary diseases - part 2: herpes zoste, RSV, pneumococcal infection and pertussis

RSV is a common cause of respiratory tract infections, posing a risk of severe disease, particularly for newborns and infants, as well as in older individuals with pre-existing conditions. Two safe and effective RSV vaccines were approved in 2023. These vaccines elicit protective antibodies and offer robust protection with no additional benefit from annual boosters. Both vaccines have been approved for individuals aged 60 years and older, while one of the vaccines has also been approved in pregnant women to elicit maternal immunity for passive protection of the unborn child. In Germany, RSV vaccination is currently recommended for all individuals aged 75 years and older, as well as people aged 60-74 years of age with severe underlying conditions. PNEUMOCOCCAL INFECTION: Streptococcus pneumoniae is a primary cause of community-acquired pneumonia (CAP). Since early 2022, a 20-valent conjugate vaccine (PCV20) is approved and recommended for people over 60 years of age and individuals over 18 years of age with risk factors. PCV20 replaces the 23-valent polysaccharide vaccine (PPV23) previously recommended for those over 60 years of age. Although viewed primarily as a childhood disease, the majority of infections affect adults. Patients with chronic respiratory diseases are at a higher risk for severe clinical course of pertussis infection. It has therefore been recommended that all adults should get a pertussis booster with their next scheduled tetanus vaccination, given as a combination vaccine (Tdap). For risk groups (healthcare personnel, community facilities) a booster vaccination every 10 years is recommended. Herpes Zoster (shingles) is caused by the varicella-zoster virus, and reactivations can lead to painful skin lesions and potential complications such as herpes zoster oticus, meningitis, or postherpetic neuralgia. People with chronic lung diseases such as COPD or asthma are at increased risk of herpes zoster-related complications. A recombinant adjuvanted inactivated vaccine was approved in 2018 and offers robust protection against herpes zoster and its complications. The vaccine is recommended for all people over 60 years of age and for certain risk groups over 50 years of age.

Vaccination against RSV infections - update and perspective

Almost 60 years after a disastrous clinical vaccine trial in children, which resulted in enhanced disease and even deaths, the world of RSV vaccination is currently undergoing a dramatic positive change and development, closely linked to advances in new vaccine technologies. Three licensed safe and highly efficacious vaccines, Abrysvo, Arexvy and mRESVIA, reduce the incidence of RSV lower respiratory disease by 80% in people older than 60 years of age. Questions regarding long-term protection and effectiveness in specific risk groups with chronic medical conditions remain, and furthermore, innovative and safe concepts to actively vaccinate pregnant women and infants to prevent severe RSV infections - also in these high-risk populations - are eagerly awaited.Passive vaccination with the long-acting monoclonal antibody Nirsevimab for prevention of severe disease in the first RSV season of infants is a major innovation in global health and the importance and benefits of reducing the number of intramuscular injections for high-risk children is immense. In the coming years, results of numerous pediatric candidate RSV vaccine studies are expected, although particular caution seems advisable for historical reasons. In summary, the field of RSV vaccination has been revolutionized in the last 2 years and we will see further significant progress soon.

Real-world effectiveness studies of the benefit of RSV vaccines

Real-world effectiveness studies of the benefit of RSV vaccines

Limited RSV Vaccine Administration: A Case for Redesigning the Preventive Care Model

Limited RSV Vaccine Administration: A Case for Redesigning the Preventive Care Model

Combination seasonal vaccines for influenza, RSV, SARS-CoV-2, and other pathogens.

Combination seasonal vaccines for influenza, RSV, SARS-CoV-2, and other pathogens.

Respiratory Syncytial Virus Risk Profile in Hospitalized Infants and Comparison with Influenza and COVID-19 Controls in Valladolid, Spain, 2010-2022.

We aimed to describe the risk profile of RSV infections among children aged ≤ 24months in Valladolid from January 2010 to August 2022 and to compare them with influenza and COVID-19 controls. We conducted a retrospective cohort study of all laboratory-confirmed RSV, influenza, and COVID-19 infections. We analyzed risk factors for RSV hospitalization and severity (length-of-stay ≥ 8 days, intensive-care-unit admission, in-hospital death or readmission < 30days) and compared severity between hospitalized RSV patients vs. influenza and COVID-19 controls using multivariable logistic regression models. We included 1507 patients with RSV (1274 inpatient), 32 with influenza, and 52 COVID-19 controls. Hospitalized RSV (mean age 5.3months) and COVID-19 (4months) were younger than influenza (9.1months) patients. Sixteen percent of patients had RSV within the first month of life. Most infants did not have comorbidities (74% RSV, 56% influenza, and 69% COVID-19). Forty-one percent of patients with RSV and influenza were coinfected vs. 27% COVID-19 (p = 0.04). Among RSV, hospitalization risk factors were prematurity (adjusted OR 3.11 [95% CI 1.66, 4.44]) and coinfection (2.03 [1.45, 2.85]). Risks for higher severity were maternal smoking (1.89 [1.07, 3.33]), prematurity (2.31 [1.59, 3.34]), chronic lung disease (2.20 [1.06, 4.58]), neurodevelopmental condition (4.28 [2.10, 8.73]), and coinfection (2.67 [2.09, 3.40]). Breastfeeding was protective against hospitalization (0.87 [0.80, 0.95]) and severity (0.81 [0.74, 0.88]), while complete vaccination schedule was protective against severity (0.51 [0.27, 0.97]). RSV had 2.47 (1.03, 5.96) higher risk of experiencing any severe outcome compared to influenza and did not show significant differences vs. COVID-19. RSV hospitalizations were more frequent and severe than influenza, while severity was comparable to the early pandemic COVID-19. Currently, both influenza and COVID-19 vaccines are included in the maternal and childhood Spanish immunization schedule between the ages of 6 and 59months. RSV monoclonal antibody is recommended for ≤ 6months but a third of patients were aged 6-24months. Maternal RSV vaccination can protect their children directly from birth and indirectly through breastfeeding.

Immediate post-discharge care among US adults hospitalized with respiratory syncytial virus infection

BackgroundRespiratory Syncytial Virus (RSV) is an important pathogen causing acute respiratory illnesses in adults. RSV infection can lead to severe outcomes, including hospitalizations and even death. Despite the increased recognition of the burden in older adults, immediate post-discharge care needs among adults hospitalized with RSV are not well characterized and have not been compared to other serious medical conditions (such as influenza, acute myocardial infarction (MI), and stroke) for which there have been long-standing disease prevention efforts.ObjectivesThis study aims to describe the immediate post-discharge care needs among adults hospitalized with RSV in the United States and descriptively compare it to those hospitalized with influenza, acute MI, or stroke.DesignRetrospective observational cohort study.PatientsAdults aged ≥ 18 years, hospitalized with a primary diagnosis of RSV, influenza, acute MI, or stroke from January 01, 2016, to December 31, 2019, were identified from the Premier Healthcare Database using the International Classification of Diseases (ICD-10) codes.Main measuresImmediate post-discharge care was categorized into three different levels of care based on the discharge dispositions. Descriptive analyses were performed.Key resultsIn total, 3,629 RSV, 303,577 influenza, 388,682 acute MI, and 416,750 stroke hospitalizations were identified, the majority occurred among patients aged ≥ 65 years. Professional home care needs were the highest for RSV hospitalizations (19.1%), followed by influenza (17.7%), stroke (15.4%), and acute MI (9.8%). Additionally, institutional care needs immediately following discharge were similar for RSV, influenza, and acute MI hospitalizations (14.2%, 15.8%, and 14.1%, respectively).ConclusionsImmediate post-discharge care needs among adults hospitalized with RSV, especially in older adults, can be considerable and comparable to influenza and acute MI discharges. With recently approved RSV vaccines, efforts to increase vaccination in older adults are needed to prevent RSV and associated healthcare consequences.

Impact of respiratory syncytial virus infection among patients with hematological cancer in the era of post-coronavirus pandemic.

400 Background: Two vaccine is recently approved for elderly patient with compromised immunity. Despite the recommendation by Center for Disease Control and Prevention (CDC), RSV vaccination is remains low among patient with hematological malignancy, when compare to influenza vaccination. Thus, we conducted an observational study to estimate the impact of RSV infection among patients with hematological malignancy. Methods: We conducted a population-based retrospective cohort utilized the TritNetx dataset, which consist of patients across 63 U.S. healthcare organization. This study included patient who had respiratory viral infection after a diagnosis of hematological malignancy during 6/1/2022 - 4/1/2022. Hematological malignancy was identified using ICD-10 codes. CPT code and ICD-10 code were used to identify diagnosis of respiratory viral infection after respiratory pathogen panel testing. Patient who was diagnosed with RSV, influenza or COVID-19 were paired based on the following variable, including demographics, body mass index, comorbidities, and anti-neoplastic therapy. Hazard ratio (HR) was estimated by Cox proportional hazard regression models and log-rank test. Risk ratio (RR) was calculated by logistic regression. Results: A total of 6,088 patients with hematological malignancy contracted RSV, influenza or COVID during the observation period. When compare to influenza, patients with RSV infection were associate with high healthcare utilization, including emergency visit (HR: 1.20, 95% CI:[1.00-1.41]), and hospitalization (HR: 1.29, 95% CI:[1.06-1.57]). RSV infection was also resulted in higher acuity including viral pneumonia (HR: 15.42, 95% CI:[9.26-25.68]), use of antibiotics (HR: 1.54, 95% CI:[1.28-1.86]), renal replacement therapy (HR: 2.09, 95% CI:[1.10-3.96]), and acute respiratory failure (HR: 1.54, 95% CI:[1.14-2.07]). When compare to COVID-19, RSV infection showed similar trend including more frequent emergency visit (HR: 1.30, 95% CI:[1.10-1.54]), and high risk of developing viral pneumonia (HR 23.48, 95% CI: [12.79-43.09]). Interestingly, the intubation rate, 28 days all-cause mortality and 90 days all-cause mortality were similar between the three cohort. Conclusions: RSV infection was associated with higher rate of pneumonia and healthcare utilization. RSV vaccination should be considered to prevent RSV-associated morbidity among patients with hematological malignancy.

RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy.

In May 2023, The United States Food and Drug Administration (FDA) approved a Pfizer©-sponsored (COMPANY, CITY, STATE, COUNTRY) bivalent RSVpreF (respiratory syncytial virus prefusion F protein-based vaccine) RSV vaccine (AbrysvoTM [COMPANY, CITY, STATE, COUNTRY]) for use during pregnancy to prevent neonatal/infant RSV infection. In February of 2022, FDA trials sponsored by GSK© (COMPANY, CITY, STATE, COUNTRY) on a similar RSVpreF RSV vaccine were halted because of the identification of a safety signal related to preterm births. As these vaccines use nearly identical pre-fusion F-protein technology, we sought to synthesize and evaluate the existing high-quality literature on their effectiveness and safety. From inception until March 15, 2024, we searched for randomized controlled trials (RCTs) on this topic. We used Review Manager (RevMan 5.4.1) (COMPANY, CITY, STATE, COUNTRY) to perform the analysis with 95% confidence intervals and risk ratios (RR). Our search yielded three large RCTs. From a safety perspective, many maternal side effects were greater in the RSVpreF group, with an increased incidence of local reactions (RR, 5.98 [3.68, 6.83]; P=0.01; I2=0%), blood disorders (RR, 1.07 [0.69, 1.66]; P=0.78; I2=0%), fatigue (RR, 1.05 [1.00, 1.10]; P=0.07; I2=0%), joint pain (RR, 1.60, 1.39 [0.68, 2.86]; P=0.37; I2=59%), cardiac disorders (RR, 1.19 [0.80, 1.77]; P=0.38; I2=0%), headache (RR, 0.80 [0.30, 2.10]; P=0.65; I2=0%), fever (RR, 0.90 [0.20, 4.16]; P=0.89; I2=57%), gastrointestinal disorders (RR, 1.04 [0.70, 1.56]; P=0.83; I2=0%), and pregnancy complications (RR, 1.01 [0.65, 1.56]; P=0.97; I2=17%). The vaccinated group demonstrated significant reduction RSV-lower respiratory tract disease (LRTD) cases (RR, 0.44 [0.33, 0.57]; P=0.01), severe LRT illness (RR, 0.29 [0.19, 0.44]; P=0.01), and hospitalizations (RR, 0.40 [0.24, 0.67]; P=0.005). RSVpreF vaccination was associated with a higher incidence of preterm delivery (RR, 1.24 [1.08, 1.44]; P=0.03); however, no significant difference in neonatal deaths was observed (RR, 1.42 [0.70, 2.89]; P=0.34). RSVpreF vaccination results in systemic adverse events and an increase in preterm delivery. Vaccination appeared to have acceptable short-term safety for newborns, but did not produce a significant decrease in neonatal death.

Severity of respiratory syncytial virus compared with SARS-CoV-2 and influenza among hospitalised adults ≥65 years

Our aim was to estimate the risk of pneumonia, admission to intensive care unit (ICU) or death in individuals ≥65 years old admitted to hospital with RSV, compared to influenza or COVID-19. We included hospitalised patients from Severe Acute Respiratory Infection Surveillance in Spain between 2021-2024, aged ≥65 years, laboratory confirmed for RSV, influenza or SARS-CoV-2. Using a binomial regression with logarithmic link, we estimated the relative risk (RR) of pneumonia, ICU admission and in-hospital mortality, in patients with RSV compared to influenza or SARS-CoV-2, adjusting for age, sex, season and comorbidities. We stratified the estimates by vaccination status for influenza or SARS-CoV2. Among patients unvaccinated for influenza or SARS-CoV-2, those with RSV had similar or lower risk of pneumonia [vs. influenza: RR=0.91 (95% Confidence Interval: 0.72-1.16); vs. SARS-CoV-2: 0.81 (0.67-0.98)], ICU admission [vs. influenza: 0.93 (0.41-2.08); vs. SARS-CoV-2: 1.10 (0.61-1.99)] and mortality [vs. influenza: 0.64 (0.32-1.28); vs. SARS-CoV-2: 0.56 (0.30-1.04)]. Among the vaccinated, results were largely similar except for a higher risk of ICU admission with RSV [vs. influenza: 2.13(1.16-3.89); vs. SARS-CoV-2: 1.83 (1.02-3.28)] CONCLUSIONS: RSV presented similar or lower intrinsic severity than influenza or SARS-CoV2. Among vaccinated patients, RSV was associated to higher ICU-admission, suggesting the potential for preventive RSV vaccination.

June 2024 ACIP Meeting Update: Influenza, COVID-19, RSV, and Other Vaccines.

The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The ACIP met June 26 through 28, 2024. This update summarizes the proceedings of this meeting, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include COVID-19 and influenza vaccine recommendations for the 2024 to 2025 season, meningococcal vaccination considerations, information regarding preferred Haemophilus influenzae type B containing vaccines for American Indian and Alaskan Native infants, and updates regarding implementation and effectiveness of RSV immunization in pregnant people and infants.

Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged ≥60 years: A phase 1, randomized, observer-blind, placebo-controlled trial

BackgroundRespiratory syncytial virus (RSV) represents a global health concern, including in older adults. This study assessed the safety and immunogenicity of mRNA-1345, an investigational mRNA RSV vaccine, in adults aged ≥60 years of Japanese descent. MethodsIn this phase 1, randomized, observer-blind, placebo-controlled study, participants were randomized to receive one injection of mRNA-1345 100 μg or placebo. Solicited local and systemic adverse reactions (ARs) were collected within 7 days following injection. Unsolicited adverse events (AEs) were collected up to 28 days after injection; AEs of special interest, medically attended AEs, and serious AEs were collected through end of study. Immunogenicity was assessed at baseline and months 1, 2, 3, and 6 following injection. ResultsTwenty-five adults of Japanese descent aged ≥60 years received one injection of mRNA-1345 100 μg (n = 21) or placebo (n = 4). mRNA-1345 was well-tolerated; the most common local and systemic solicited ARs were injection site pain, and fatigue and myalgia, respectively, which were generally mild to moderate and transient. No serious AEs were reported. Neutralizing (nAb) and binding (bAb) antibodies were detectable at baseline, consistent with prior RSV exposure. mRNA-1345 boosted RSV nAb titers and preF bAb concentrations 1 month post-injection (geometric mean fold rise: RSV-A nAb, 11.2; RSV-B nAb, 6.6; preF bAb, 9.1). Titers among mRNA-1345 recipients remained above baseline through 6 months. ConclusionsmRNA-1345 100 μg was well-tolerated among older adults of Japanese descent and induced nAbs and bAbs which were durable through 6 months, supporting its continued development. Trial registrationClinicalTrials.gov, NCT04528719.

Louis Bont – leading efforts to find an RSV vaccine

Louis Bont – leading efforts to find an RSV vaccine

RSV Vaccine Effectiveness Against Hospitalization Among US Adults 60 Years and Older

This study evaluates the effectiveness of the respiratory syncytial virus vaccine against hospitalization for acute respiratory illness among US adults aged 60 years and older.

Maternal RSV Vaccine—Weighing Benefits and Risks

Maternal RSV Vaccine—Weighing Benefits and Risks

Residency in Long-Term Care Facilities: An Important Risk Factor for RSV Hospitalization.

Older age and comorbid conditions increase risk for severe RSV. Skilled nursing (SNF) and assisted living (AL) facilities represent an intersection of risk factors. In a 3-year prospective study (Rochester, NY) we compared population-based incidence of RSV-associated hospitalization for community-dwelling, SNF and AL adults ≥65 years. Median age was 76, 83 and 86 years, respectively, and dementia and CHF more prevalent among SNF and assisted living residents. Average annual incidence was 117 (95%CI:104-132), 440 (95%CI:307-629) and 740/100,000 persons (95%CI:523-1045) for community-dwelling, SNF and AL adults ≥65 years, respectively, demonstrating need for unequivocal RSV vaccine recommendations in SNF and AL residents.

Another (and comparable) RSV vaccine for older adults

Another (and comparable) RSV vaccine for older adults

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

IntroductionRespiratory 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.MethodsThis qualitative study conducted in-depth interviews with six pregnant people, 18 lactating people, and 10 community members in one rural and one urban county in Kenya. Data were analyzed using a grounded theory approach.ResultsParticipants identified the pregnant person themself, male partners, other family members, peers, and healthcare providers (HCPs) as key influences on the maternal immunization decision-making process. The majority of interviewed PLP believed that decision-making during pregnancy should be left to themselves due to autonomy and their role as the primary caregiver. Community members, including male partners, also identified pregnant people as the key decision-maker. While some PLP said they deferred to male partners to make vaccine decisions, more felt that men were not as informed on maternal and child issues as themselves or other female peers and relatives. HCPs emerged as important influences and information sources for PLP during decision-making.DiscussionUnderstanding who influences vaccine-decision making during pregnancy will help inform demand generation strategies, and in turn, uptake of future maternal vaccines, including RSV vaccines. Given the strong role HCPs and peers have in the decision-making process, targeting key potential influences is essential to improve vaccine acceptance.

Three RSV vaccines now recommended for many older adults; what about travellers?

Three RSV vaccines now recommended for many older adults; what about travellers?