Characterizing U.S. mothers with high human papillomavirus vaccine intent yet unvaccinated adolescents.

HPV vaccination rates remain suboptimal in the United States. While the current literature focuses on expressly hesitant parents, few studies have examined parents with "high intent", or those indicating they definitely will vaccinate and have had the opportunity but not yet vaccinated their adolescents. Our objective was to differentiate characteristics of mothers with high intent from those who already vaccinated their adolescents using various socioeconomic, previous vaccine decision-making, and healthcare provider relationship-related variables. English-speaking mothers or female guardians of adolescents ages 11-14 years living in low HPV vaccine uptake states within the U.S. in September 2018 were recruited from a national survey panel as part of a larger study. We assessed HPV vaccine status of their adolescents and categorized respondents into two categories: Already Vaccinated and High Intent. We assessed differences using a multivariable logistic regression model. Among 2406 mothers, 18% reported high intent vs. 82% already having vaccinated. Mothers with high intent were more likely to identify as non-Hispanic White (p = 0.01), to have a younger adolescent (p < 0.001), and to report not receiving a provider HPV vaccination recommendation (p < 0.001). Mothers who estimated that half/more (vs. less) of their child's friends have received/will receive the vaccine had higher odds of already vaccinating (p < 0.001). Our findings suggest that clinicians may be able to improve HPV vaccination uptake within their practices by giving repeated, high-quality recommendations to parents of children who are not yet vaccinated. Additionally, these findings indicate perceived social norms may play a large role in on-time vaccine uptake. Reassuring hesitant parents that most parents accept the vaccine may also improve uptake in clinical practice.

Human papillomavirus: optimizing opportunities for prevention.

PURPOSE OF REVIEW: Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections worldwide and is a precursor to anogenital and oropharyngeal cancers. Effective prevention is available through HPV vaccination and emerging evidence demonstrates the potential to significantly impact HPV-associated disease through reductions in the incidence of genital warts, precancerous cervical lesions, and cervical cancer. Indications have also recently expanded to include the prevention of oropharyngeal cancer, an outcome that has been increasing in incidence for men and women. Yet despite demonstrated effectiveness, the potential for broader impact and well-established routine recommendations for administration to adolescents, barriers to vaccine uptake persist. The purpose of this review is to provide an update on HPV prevention in the US, including trends in disease burden, HPV vaccine effectiveness, evolving vaccine recommendations and opportunities and barriers to their implementation. RECENT FINDINGS: Several studies have demonstrated that HPV vaccination has the potential to prevent most HPV-attributable cancers. Ongoing research addresses questions related to duration of protection, effectiveness in vulnerable populations, vaccine schedules and strategies to improve access and optimize uptake. SUMMARY: To ensure continued impact on the prevention of HPV-associated disease and subsequent cancer, it is crucial to address gaps in vaccine uptake. A strong recommendation for all persons for whom HPV vaccines are indicated, alongside initiatives to increase awareness of HPV vaccination and address specific concerns, can improve uptake among hesitant populations. Globally, efforts to bolster immunization programs are needed to broaden access to HPV vaccination.

Understanding Barriers and Facilitators to Maternal Immunization: A Systematic Narrative Synthesis of the Published Literature.

INTRODUCTION: Vaccines are being developed against Group B Streptococcus and respiratory syncytial virus. These vaccines are designed to be given to pregnant women to protect infants; thus, their success depends on uptake in this population. Maternal immunization programs have struggled to achieve target coverage rates. This systematic narrative synthesis aims to define the most important barriers and facilitators for maternal immunization and to identify priority areas for future research. METHODS: A search strategy was developed in Medline and adapted according to the requirements of additional search engines. Two reviewers independently reviewed the studies, using pre-specified inclusion and exclusion criteria. Results sections of included studies were coded, and thematic analysis was used to identify prominent themes. RESULTS: 321 studies were included in the final review. Most studies came from North America (37%), Europe (26%) or East Asia, Australia and New Zealand (22%). Low-and middle-income countries were under-represented. Five percent of studies came from Sub-Saharan Africa, and 2% came from South Asia. The prominent factors impacting maternal immunization were provider recommendation, perceived risks and benefits of maternal vaccines for the infant, race, birthplace, and access to healthcare. Few studies explored reasons behind racial and socioeconomic disparities in maternal immunization rates. DISCUSSION: A strong provider recommendation, equitable access to prenatal care and messaging that focuses on vaccine safety and infant benefits emerged as the key components for optimising vaccine uptake among pregnant women. Research among healthcare providers, minority groups and in low- and-middle-income countries was lacking. In anticipation of the expansion of maternal immunization programmes, focused research is needed to address these gaps and inform a successful public health strategy.

Impact of 13-Valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Carriage Rates of Streptococcus pneumoniae in a Rural Community in the Dominican Republic.

BACKGROUND: Invasive pneumococcal disease (IPD) leads to thousands of pediatric deaths annually. Pneumococcal colonization precedes IPD. In 2013, the Dominican Republic introduced the 13-valent pneumococcal conjugate vaccine (PCV13) into its routine infant immunization program, with doses at ages 2, 4, and 12 months. Prevalence of pneumococcal nasopharyngeal colonization was evaluated post-PCV13 introduction. METHODS: A prospective cohort study of 125 children aged 2-35 months was conducted in a rural Dominican Republic community November 2016 through July 2017. Nasopharyngeal swabs and clinical and vaccination data were collected at enrollment and 4-6 months later. Serotypes included in PCV13 were defined as vaccine-type. Colonization rates and serotype distribution were compared at baseline and follow-up, and the association between colonization and vaccination status among the entire cohort was evaluated at each time point. RESULTS: Of 125 children enrolled, 118 (94%) completed follow-up. Overall and vaccine-type pneumococcal colonization rates were 62% and 25%, respectively, at baseline and 60% and 28% at follow-up. Among children age-eligible for 3 doses, 50% and 51% were fully vaccinated at baseline and follow-up, respectively. At baseline assessment, children up-to-date for age for PCV13 were less likely to be colonized with vaccine-type pneumococci than children not up-to-date, and the same was found for fully vaccinated children (3 doses) compared to those not fully vaccinated (odds ratios [ORs], 0.38 [95% confidence interval {CI}, .18-.79], and 0.14 [95% CI, .04-.45], respectively). The same associations were not found at follow-up assessment. CONCLUSIONS: Three years post -PCV13 introduction, vaccine-type colonization rates remained high. Low vaccination coverage for 3 PCV13 doses may have contributed. The protective effect of PCV13 on vaccine-type carriage suggests an increase in PCV13 coverage could lead to substantial declines in pneumococcal vaccine-type carriage.

Effect of Haemophilus influenzae Type b and 13-Valent Pneumococcal Conjugate Vaccines on Childhood Pneumonia Hospitalizations and Deaths in Botswana.

BACKGROUND: Globally, pneumonia is the leading cause of death among children. Few data exist regarding the effect of Haemophilus influenzae type b (Hib) vaccine and 13-valent pneumococcal conjugate vaccine (PCV-13) on the burden of childhood pneumonia in African settings. METHODS: We collected data on children aged 1 to 59 months at 3 hospitals in Botswana. Hib vaccine and PCV-13 were introduced in Botswana in November 2010 and July 2012, respectively. We compared pneumonia hospitalizations and deaths prevaccine (January 2009 to October 2010) with postvaccine (January 2013 to December 2017) using seasonally adjusted, interrupted time-series analyses. RESULTS: We identified 6943 pneumonia hospitalizations and 201 pneumonia deaths. In the prevaccine period, pneumonia hospitalizations and deaths increased by 24% (rate, 1.24; 95% CI, .94-1.64) and 59% (rate, 1.59; 95% CI, .87-2.90) per year, respectively. Vaccine introduction was associated with a 48% (95% CI, 29-62%) decrease in the number of pneumonia hospitalizations and a 50% (95% CI, 1-75%) decrease in the number of pneumonia deaths between the end of the prevaccine period (October 2010) and the beginning of the postvaccine period (January 2013). During the postvaccine period, pneumonia hospitalizations and deaths declined by 6% (rate, .94; 95% CI, .89-.99) and 22% (rate, .78; 95% CI, .67-.92) per year, respectively. CONCLUSIONS: Pneumonia hospitalizations and deaths among children declined sharply following introduction of Hib vaccine and PCV-13 in Botswana. This effect was sustained for more than 5 years after vaccine introduction, supporting the long-term effectiveness of these vaccines in preventing childhood pneumonia in Botswana.

Resurgence of measles in the United States: how did we get here?

PURPOSE OF REVIEW: In September 2019, the United States was at risk of losing measles elimination status due to several large-scale outbreaks resulting in more than 1200 confirmed cases across 31 states. This resurgence caps approximately 10 years of increasing incidence, marked by a highly publicized outbreak in 2015 associated with Disneyland when an infected traveler from the Philippines unknowingly spread the virus to susceptible park visitors and the recently ended large outbreak in undervaccinated Orthodox Jewish communities in New York City and Rockland counties. This review highlights current literature elucidating factors associated with current trends in measles epidemiology in the United States, the public health implications of current measles outbreaks and a path forward for addressing challenges contributing to the resurgence of measles in the United States and globally. RECENT FINDINGS AND SUMMARY: As the most highly transmissible vaccine preventable disease, measles is especially sensitive to changes in herd immunity, the impact of vaccine refusal and globalization. Results highlight the confluence of these factors in current outbreaks, provide tools to predict outbreak risk, demonstrate the growing impact of misinformation and evaluate the impact of policy approaches for outbreak control and prevention.

Interpretation of pediatric chest radiographs by non-radiologist clinicians in Botswana using World Health Organization criteria for endpoint pneumonia.

BACKGROUND: In low- and middle-income countries, chest radiographs are most frequently interpreted by non-radiologist clinicians. OBJECTIVE: We examined the reliability of chest radiograph interpretations performed by non-radiologist clinicians in Botswana and conducted an educational intervention aimed at improving chest radiograph interpretation accuracy among non-radiologist clinicians. MATERIALS AND METHODS: We recruited non-radiologist clinicians at a referral hospital in Gaborone, Botswana, to interpret de-identified chest radiographs for children with clinical pneumonia. We compared their interpretations with those of two board-certified pediatric radiologists in the United States. We evaluated associations between level of medical training and the accuracy of chest radiograph findings between groups, using logistic regression and kappa statistics. We then developed an in-person training intervention led by a pediatric radiologist. We asked participants to interpret 20 radiographs before and immediately after the intervention, and we compared their responses to those of the facilitating radiologist. For both objectives, our primary outcome was the identification of primary endpoint pneumonia, defined by the World Health Organization as presence of endpoint consolidation or endpoint effusion. RESULTS: Twenty-two clinicians interpreted chest radiographs in the primary objective; there were no significant associations between level of training and correct identification of endpoint pneumonia; concordance between respondents and radiologists was moderate (κ=0.43). After the training intervention, participants improved agreement with the facilitating radiologist for endpoint pneumonia from fair to moderate (κ=0.34 to κ=0.49). CONCLUSION: Non-radiologist clinicians in Botswana do not consistently identify key chest radiographic findings of pneumonia. A targeted training intervention might improve non-radiologist clinicians' ability to interpret chest radiographs.

The prevalence and clinical characteristics of pertussis-associated pneumonia among infants in Botswana.

BACKGROUND: There are scant data on the prevalence and clinical course of pertussis disease among infants with pneumonia in low- and middle-income countries. While pertussis vaccination coverage is high (≥90%) among infants in Botswana, human immunodeficiency virus (HIV) infection affects nearly one-third of pregnancies. We aimed to evaluate the prevalence and clinical course of pertussis disease in a cohort of HIV-unexposed uninfected (HUU), HIV-exposed uninfected (HEU), and HIV-infected infants with pneumonia in Botswana. METHODS: We recruited children 1-23 months of age with clinical pneumonia at a tertiary care hospital in Gaborone, Botswana between April 2012 and June 2016. We obtained nasopharyngeal swab specimens at enrollment and tested these samples using a previously validated in-house real-time PCR assay that detects a unique sequence of the porin gene of Bordetella pertussis. RESULTS: B. pertussis was identified in 1/248 (0.4%) HUU, 3/110 (2.7%) HEU, and 0/33 (0.0%) HIV-infected children. All pertussis-associated pneumonia cases occurred in infants 1-5 months of age (prevalence, 1.0% [1/103] in HUU and 4.8% [3/62] in HEU infants). No HEU infants with pertussis-associated pneumonia were taking cotrimoxazole prophylaxis at the time of hospital presentation. One HUU infant with pertussis-associated pneumonia required intensive care unit admission for mechanical ventilation, but there were no deaths. CONCLUSIONS: The prevalence of pertussis was low among infants and young children with pneumonia in Botswana. Although vaccination against pertussis in pregnancy is designed to prevent classical pertussis disease, reduction of pertussis-associated pneumonia might be an important additional benefit.

Vaccine Hesitancy in Pediatric Primary Care Practices.

Understanding how pediatric practices handle parental vaccine hesitancy is important as it impacts the efficiency and effectiveness of pediatric practices. In total, 21 semi-structured interviews with pediatric practice staff within a primary care network were conducted between May 2012 and March 2013. Thematic analysis focused on the barriers and challenges of vaccine hesitancy and strategies to reduce the burden at the practice level. Barriers and challenges of vaccine hesitancy included time constraints, administrative challenges, financial challenges and strained patient-provider relationships. Strategies to minimize the burden of vaccine hesitancy included training for vaccine counseling, screening for vaccine hesitancy prior to immunization visits, tailored vaccine counseling, and primary care provider visits for follow-up immunization. Pediatric practices reported many challenges when caring for vaccine-hesitant families. Multiple strategies were identified to reduce the burden of vaccine hesitancy, which future studies should explore to determine how effective they are in increasing vaccine acceptance in pediatric practices.

Immunogenicity of Current and Next-Generation Pneumococcal Conjugate Vaccines in Children: Current Challenges and Upcoming Opportunities.

Global use of pneumococcal conjugate vaccines (PCVs) with increasingly broader serotype coverage has helped to reduce the burden of pneumococcal disease in children and adults. In clinical studies comparing PCVs, higher-valency PCVs have met noninferiority criteria (based on immunoglobulin G geometric mean concentrations and response rates) for most shared serotypes. A numeric trend of declining immunogenicity against shared serotypes with higher-valency PCVs has also been observed; however, the clinical relevance is uncertain, warranting additional research to evaluate the effectiveness of new vaccines. Novel conjugation processes, carriers, adjuvants, and vaccine platforms are approaches that could help maintain or improve immunogenicity and subsequent vaccine effectiveness while achieving broader protection with increasing valency in pneumococcal vaccines.

PCV15, a pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in infants and children.

INTRODUCTION: Streptococcus pneumoniae is a causative agent of pneumonia and acute otitis media (AOM), as well as invasive diseases such as meningitis and bacteremia. PCV15 (V114) is a new 15-valent pneumococcal conjugate vaccine (PCV) approved for use in individuals ≥6 weeks of age for the prevention of pneumonia, AOM, and invasive pneumococcal disease. AREAS COVERED: This review summarizes the V114 Phase 3 development program leading to approval in infants and children, including pivotal studies, interchangeability and catch-up vaccination studies, and studies in at-risk populations. An integrated safety summary is presented in addition to immunogenicity and concomitant use of V114 with other routine pediatric vaccines. EXPERT OPINION: Across the development program, V114 demonstrated a safety profile that is comparable to PCV13 in infants and children. Immunogenicity of V114 is comparable to PCV13 for all shared serotypes except serotype 3, where V114 demonstrated superior immunogenicity. Higher immune responses were demonstrated for V114 serotypes 22F and 33F. Results of the ongoing study to evaluate V114 efficacy against vaccine-type pneumococcal AOM and anticipated real-world evidence studies will support assessment of vaccine effectiveness and impact, with an additional question of whether higher serotype 3 immunogenicity translates to better protection against serotype 3 pneumococcal disease.

Understanding healthcare providers' preferred attributes of pediatric pneumococcal conjugate vaccines in the United States.

As higher-valent pneumococcal conjugate vaccines (PCVs) become available for pediatric populations in the US, it is important to understand healthcare provider (HCP) preferences for and acceptability of PCVs. US HCPs (pediatricians, family medicine physicians and advanced practitioners) completed an online, cross-sectional survey between March and April 2023. HCPs were eligible if they recommended or prescribed vaccines to children age <24 months, spent ≥25% of their time in direct patient care, and had ≥2 y of experience in their profession. The survey included a discrete choice experiment (DCE) in which HCPs selected preferred options from different hypothetical vaccine profiles with systematic variation in the levels of five attributes. Relative attribute importance was quantified. Among 548 HCP respondents, the median age was 43.2 y, and the majority were male (57.9%) and practiced in urban areas (69.7%). DCE results showed that attributes with the greatest impact on HCP decision-making were 1) immune response for the shared serotypes covered by PCV13 (31.4%), 2) percent of invasive pneumococcal disease (IPD) covered by vaccine serotypes (21.3%), 3) acute otitis media (AOM) label indication (20.3%), 4) effectiveness against serotype 3 (17.6%), and 5) number of serotypes in the vaccine (9.5%). Among US HCPs, the most important attribute of PCVs was comparability of immune response for PCV13 shared serotypes, while the number of serotypes was least important. Findings suggest new PCVs eliciting high immune responses for serotypes that contribute substantially to IPD burden and maintaining immunogenicity against serotypes in existing PCVs are preferred by HCPs.

Trends in Streptococcus pneumoniae Antimicrobial Resistance in US Children: A Multicenter Evaluation.

Background: Antimicrobial resistance (AMR) poses a significant challenge for treating pneumococcal disease. This study assessed AMR trends in Streptococcus pneumoniae from US children. Methods: We evaluated antibiotic resistance, defined as facility antimicrobial susceptibility reports of intermediate/resistant, in 30-day nonduplicate S pneumoniae isolates from children (<18 years of age) with invasive (blood or cerebrospinal fluid/neurological) or noninvasive (respiratory or ear/nose/throat) isolates at 219 US hospital inpatient/outpatient settings in the BD Insights Research Database (January 2011-February 2020). We used descriptive statistics to characterize the percentage of antimicrobial-resistant isolates and generalized estimating equations to assess variations in resistance over time. Results: Of 7605 S pneumoniae isolates analyzed, 6641 (87.3%) were from noninvasive sources. Resistance rates were higher in noninvasive versus invasive isolates. Isolates showed high observed rates of resistance to ≥1 drug class (56.8%), ≥2 drug classes (30.7%), macrolides (39.9%), and penicillin (39.6%) and significant annual increases in resistance to ≥1 drug class (+0.9%), ≥2 drug classes (+1.8%), and macrolides (+5.0%). Conclusions: Among US children over the last decade, S pneumoniae isolates showed persistently high rates of resistance to antibiotics and significant increases in ≥1 drug class, ≥2 drug classes, and macrolide resistance rates. Efforts to address AMR in S pneumoniae may require vaccines targeting resistant serotypes and antimicrobial stewardship efforts.

College health administrator's perceptions of the impacts of COVID-19 on college immunization programs.

College immunization policies vary. To evaluate the landscape of college immunization programs, we distributed a 45-item survey to college health administrators between July and September 2021. Items measured perceptions of institutionally recommended and required vaccines, enforcement strategies, barriers to vaccine uptake, and the impact of the COVID-19 pandemic. Of 566 invitations sent, only 66 college health administrators completed the survey (11.7% response rate). The majority of participating institutions (89%) required at least one vaccine, with measles-mumps-rubella (MMR) being the most commonly required (83%). Geographic region, school type, or size was not significantly correlated with immunization policies but state-level political leanings were. Common barriers to vaccine program implementation identified by respondents included student-based and institutional concerns. The COVID-19 pandemic was described as both exacerbating existing immunization program barriers and providing opportunities to strengthen programs. Future work will evaluate identified themes in a larger study population and monitor change in perceptions over time.

Pneumococcal Vaccine Breakthrough and Failure in Infants and Children: A Narrative Review.

Globally, Streptococcus pneumoniae is a leading cause of vaccine-preventable morbidity and mortality in infants and children. In recent decades, large-scale pediatric immunization programs have substantially reduced the incidence of invasive pneumococcal disease. Despite this, residual vaccine-type pneumococcal disease remains in the form of vaccine breakthrough and vaccine failure. This targeted literature review aims to discuss aspects of vaccine breakthrough and failure in infants and children, including disease epidemiology, clinical presentation, risk factors, vaccination schedules, vaccine serotypes, correlates of protection, comorbidities, disease surveillance, and potential implications for future vaccine development.

Preparing for Group B Streptococcus vaccine. Attitudes of pregnant women in two countries.

Group B Streptococcus (GBS) vaccines, designed to be given to pregnant women, are in clinical trials. There is an opportunity to conduct preparatory research now to understand the drivers of and barriers to GBS vaccine acceptance. This will enable targeted interventions so that delays in vaccine uptake might be avoided. A multicenter, mixed-methodology, cross-sectional study evaluated the acceptability of a hypothetical GBS vaccine among pregnant women in two countries with differing health systems. Pregnant women in Philadelphia, US, and Dublin, Ireland, completed an electronic survey and a Discrete Choice Experiment. Five hundred and two women were included in the final analysis. Fifty-three percent of US and 30% of Irish participants reported both awareness and understanding of GBS. The median likelihood score for vaccine receipt (measured on a 10-point scale) was 9 (US: 9 (IQR 7-10), IRL: 9 (IQR 6-10)). Among the US participants, identifying as Black or African American was associated with a lower likelihood of vaccine receipt. Possession of a college degree was associated with increased likelihood of vaccine receipt. Perceived infant benefit was the most important driver of GBS vaccine acceptance. Safety concerns about a novel vaccine was the most prominent barrier identified. Good GBS vaccine uptake is achievable through strong messaging that highlights vaccine safety and the potential infant benefits. Preparation for vaccine implementation should include efforts to increase awareness among pregnant women about GBS infection and a continued focus on improving acceptability of currently recommended maternal vaccines, particularly in population subgroups with low uptake of maternal immunizations.

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study.

Sickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD. A total of 103 children aged 5 to 17 years with SCD were randomized and received a single dose of V114 or Prevnar 13 (PCV13). Safety was evaluated as the proportion of participants with adverse events (AEs). Serotype-specific immunoglobulin G (IgG) levels and opsonophagocytic activity (OPA) were measured immediately before vaccination and 30 days after vaccination. Overall, the rates of injection-site and systemic AEs reported after vaccination were similar between the vaccination groups. Up to 6 months after vaccination, serious AEs were those expected for patients with SCD, and none were assessed to be vaccine related. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) for the 13 shared serotypes were generally comparable between recipients of V114 and PCV13. Additionally, V114 induced immune responses to serotypes 22F and 33F, which are not included in PCV13. The safety and tolerability profiles of V114 were consistent with those reported for PCV13. Immune responses following vaccination with V114 were generally comparable to PCV13 for the shared serotypes and higher for unique serotypes 22F and 33F. These results support the use of V114 in children with SCD. This trial was registered at www.clinicaltrials.gov as #NCT03731182.

Safety and Immunogenicity of V114 in Preterm Infants: A Pooled Analysis of Four Phase Three Studies.

BACKGROUND: Risk of invasive pneumococcal disease is 3-fold higher in preterm versus full-term infants. V114 is a 15-valent pneumococcal conjugate vaccine (PCV) containing the 13 serotypes in PCV13 plus 2 unique serotypes, 22F and 33F. A pooled subgroup analysis was performed in preterm infants (<37 weeks gestational age) enrolled in 4 pediatric phase 3 studies evaluating the safety and immunogenicity of different 4-dose regimens of V114 or PCV13. METHODS: Healthy preterm infants were randomized 1:1 to receive V114/PCV13 in the 4 studies. Safety was evaluated as the proportion of participants with adverse events (AEs) following receipt of PCV. Serotype-specific antipneumococcal immunoglobulin G (IgG) geometric mean concentrations, IgG response rates and opsonophagocytic activity geometric mean titers were measured at 30 days postdose 3, pretoddler dose and 30 days postdose 4. RESULTS: V114 and PCV13 were administered to 174 and 180 participants, respectively. Mean gestational age was 35.4 weeks (range: 27 - <37 weeks). Proportions of participants with AEs were comparable between vaccination groups; most AEs experienced were of short duration (≤3 days) and mild-to-moderate intensity. V114-elicited IgG geometric mean concentrations, IgG response rates and opsonophagocytic activity geometric mean titers were generally comparable to PCV13 for the 13 shared serotypes and higher for serotypes 22F and 33F at 30 days postdose 3 and postdose 4. CONCLUSIONS: In preterm infants, V114 was well tolerated and induced comparable immune responses to PCV13 for the 13 shared serotypes and higher immune responses to serotypes 22F and 33F. Results support the use of V114 in preterm infants.

A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV.

OBJECTIVES: To evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV. DESIGN: This phase 3 study (NCT03921424) randomized participants 6-17 years of age with HIV (CD4 + T-cell count ≥200 cells/µl, plasma HIV RNA <50 000 copies/ml) to receive V114 or 13-valent PCV (PCV13) in a double-blind manner on Day 1, followed by PPSV23 at Week 8. METHODS: Adverse events (AEs), pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) were evaluated 30 days after each vaccination. RESULTS: The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group ( n  = 203) and 69.6% in the PCV13 group ( n  = 204); respective proportions post-PPSV23 were 75.4% ( n  = 203) and 77.2% ( n  = 202). There were no vaccine-related serious AEs. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally comparable between V114 and PCV13 for shared serotypes at Day 30, and were higher for V114 compared with PCV13 for the additional V114 serotypes 22F and 33F. Approximately 30 days after PPSV23, IgG GMCs and OPA GMTs were generally comparable between the V114 and PCV13 groups for all 15 serotypes in V114. CONCLUSIONS: In children with HIV, a sequential administration of V114 followed 8 weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.