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108 result(s) for "Gallagher, Katherine E."
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Lessons learnt from human papillomavirus (HPV) vaccination in 45 low- and middle-income countries
To synthesise lessons learnt and determinants of success from human papillomavirus (HPV) vaccine demonstration projects and national programmes in low- and middle-income countries (LAMICs). Interviews were conducted with 56 key informants. A systematic literature review identified 2936 abstracts from five databases; after screening 61 full texts were included. Unpublished literature, including evaluation reports, was solicited from country representatives; 188 documents were received. A data extraction tool and interview topic guide outlining key areas of inquiry were informed by World Health Organization guidelines for new vaccine introduction. Results were synthesised thematically. Data were analysed from 12 national programmes and 66 demonstration projects in 46 countries. Among demonstration projects, 30 were supported by the GARDASIL® Access Program, 20 by Gavi, four by PATH and 12 by other means. School-based vaccine delivery supplemented with health facility-based delivery for out-of-school girls attained high coverage. There were limited data on facility-only strategies and little evaluation of strategies to reach out-of-school girls. Early engagement of teachers as partners in social mobilisation, consent, vaccination day coordination, follow-up of non-completers and adverse events was considered invaluable. Micro-planning using school/ facility registers most effectively enumerated target populations; other estimates proved inaccurate, leading to vaccine under- or over-estimation. Refresher training on adverse events and safe injection procedures was usually necessary. Considerable experience in HPV vaccine delivery in LAMICs is available. Lessons are generally consistent across countries and dissemination of these could improve HPV vaccine introduction.
Temporal trends of SARS-CoV-2 seroprevalence during the first wave of the COVID-19 epidemic in Kenya
Observed SARS-CoV-2 infections and deaths are low in tropical Africa raising questions about the extent of transmission. We measured SARS-CoV-2 IgG by ELISA in 9,922 blood donors across Kenya and adjusted for sampling bias and test performance. By 1st September 2020, 577 COVID-19 deaths were observed nationwide and seroprevalence was 9.1% (95%CI 7.6-10.8%). Seroprevalence in Nairobi was 22.7% (18.0-27.7%). Although most people remained susceptible, SARS-CoV-2 had spread widely in Kenya with apparently low associated mortality. The reported burden of SARS-CoV-2 has been relatively low in tropical Africa compared to Europe and the Americas, but estimating true infection rates is challenging. Here, the authors screen blood donors in Kenya for SARS-CoV-2 antibodies and describe spatiotemporal seroprevalence dynamics.
Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries
Background Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. Methods A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90–70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. Results All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. Conclusions Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social mobilisation, consent, and acceptability lessons were consistent across world regions and HPV vaccination projects/programmes. These can be used to guide HPV vaccination communication strategies without additional formative research.
The impact of a human papillomavirus (HPV) vaccination campaign on routine primary health service provision and health workers in Tanzania: a controlled before and after study
Background The burden of cervical cancer and shortage of screening services in Tanzania confers an urgent need for human papillomavirus (HPV) vaccination. However, the sustainability and impact of another new vaccine campaign in an under-resourced health system requires consideration. We aimed to determine the impact of the government’s school-based HPV vaccine campaign in Kilimanjaro region on the provision of routine primary health services and staff workload. Methods Data on daily numbers of consultations were collected from health facility register books in 63 dispensaries and health centres in North-West Tanzania for 20 weeks in 2014. Changes in outpatient, antenatal care (ANC), family planning (FP) and immunisation service activity levels before, during and after the two HPV vaccination campaigns in 2014 in 30 facilities within Kilimanjaro region (‘intervention facilities’) were compared with changes in activity levels in 33 facilities in Arusha region (‘controls’). Qualitative interviews were conducted with health workers in Kilimanjaro region who delivered HPV vaccination and those who remained at the facility during in-school HPV vaccine delivery to explore perceptions of workload and capacity. Results Health facility activity levels were low and very variable in both regions. Controlling for district, facility type, catchment population, clinical staff per 1000 catchment population and the timing of other campaigns, no evidence of a decrease in consultations at the health facility during HPV vaccination week was found across outpatient, ANC, routine immunisation and FP services. However, compared to the average week before and after the campaign, health workers reported longer working hours and patient waiting times, feeling over-stretched and performing duties outside their normal roles whilst colleagues were absent from the facility conducting the HPV vaccine campaign. Conclusion Qualitative interviews with health workers revealed that staff absence from the health facility is common for a number of reasons, including vaccination campaigns. Health workers perceived that the absence of their colleagues increased the workload at the health facility. The numbers of consultations for each service on ‘normal days’ were low and highly variable and there was no clear detrimental effect of the HPV vaccination campaign on routine health service activity.
COVID-19 Vaccine Acceptability Among Healthcare Facility Workers in Sierra Leone, the Democratic Republic of Congo and Uganda: A Multi-Centre Cross-Sectional Survey
Objectives: This cross-sectional survey explored COVID-19 vaccine acceptability among public healthcare facility workers in Kambia (Sierra Leone), Goma (Democratic Republic of Congo) and Masaka (Uganda).Methods: Questionnaire-based interviews conducted between April–October 2021 explored participants’ knowledge and perceptions of, and attitudes towards, the COVID-19 pandemic and COVID-19 vaccines, as well as COVID-19 vaccine acceptability (defined as uptake of ≥1 dose or intent to get vaccinated).Results: Whilst most ( n = 444; 81.8%) of the 543 participants had one or more concerns about COVID-19 vaccines, 487 (89.7%) nonetheless perceived that they were important for pandemic control. Most participants from Kambia or Masaka either were vaccinated ( n = 137/355; 38.6%) or intended to get vaccinated ( n = 211/355; 59.4%) against COVID-19. In Goma, all 188 participants were unvaccinated; only 81 (43.1%) participants intended to get vaccinated, and this was associated with positive perceptions about COVID-19 vaccines. In Goma, the most common reasons for not wanting a COVID-19 vaccine were concerns that the vaccines were new ( n = 75/107; 70.1%) and fear of side effects ( n = 74/107; 69.2%).Conclusion: Reported COVID-19 vaccine acceptability was high among healthcare facility workers in Kambia and Masaka. The lower vaccine acceptability in Goma may highlight the importance of social mobilisation and accurate, accessible information that addresses specific concerns.
Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials
•We reviewed the efficacy and immunogenicity of 1 vs. 0, 2 or 3 HPV vaccine doses in clinical trials.•HPV16/18 infection was rare in all HPV vaccine recipients, regardless of number of doses received (3, 2 or 1).•Frequency of infection was significantly lower in 1-dose recipients than in unvaccinated controls.•Most vaccine recipients produced HPV16/18 antibodies, but titres were lower with 1 dose compared to 2 or 3 doses.•1-dose results are promising, and ongoing purpose-designed, prospectively randomised trials will provide further evidence. This study aimed to systematically review the literature on the efficacy and immunogenicity of single-dose HPV vaccination compared to no vaccination or multi-dose schedules among vaccine trial participants. Medline, EMBASE, Global Health Database and Cochrane Central Register of Controlled Trials were searched for publications and conference abstracts (dated January 1999-August 2018) using MeSH and non-MeSH terms for human papillomavirus AND vaccines AND (immunogenicity OR efficacy/effectiveness) AND dosage. Search results were screened against pre-specified eligibility criteria. Data were extracted from included articles, and a narrative synthesis conducted on efficacy against HPV16/18 infection and humoral immunogenicity. Seven of 6,523 unique records identified were included in the review. Six were nested observational studies of participants randomised to receive two or three doses in three large HPV vaccine trials, in which some participants did not complete their allocated schedules. One small pilot study prospectively allocated participants to receive one or no vaccine dose. Frequency of HPV16/18 infection was low (e.g. <1% for 12-month-persistent infection) in all vaccinated participants up to seven years post vaccination and did not significantly differ by number of doses (p > 0.05 in all cases). Frequency of infection was significantly lower in one-dose recipients compared to unvaccinated controls (p < 0.01 for all infection endpoints in each study). HPV16/18 seropositivity rates were high in all HPV vaccine recipients (100% in three of four studies reporting this endpoint), though antibody levels were lower with one compared to two or three doses. This review supports the premise that one HPV vaccine dose may be as effective in preventing HPV infection as multi-dose schedules in healthy young women. However, it also highlights the paucity of available evidence from purpose-designed, prospectively-randomised trials. Results from ongoing clinical trials assessing the efficacy and immunogenicity of single-dose HPV vaccination compared to currently-recommended schedules are awaited.
Surveillance of endemic human coronaviruses (HCoV-NL63, OC43 and 229E) associated with childhood pneumonia in Kilifi, Kenya
Introduction: Human coronaviruses (HCoVs) circulate endemically in human populations, often with seasonal variation. We describe the long-term patterns of paediatric disease associated with three of these viruses, HCoV-NL63, OC43 and 229E, in coastal Kenya. Methods: Continuous surveillance of pneumonia admissions was conducted at the Kilifi county hospital (KCH) located in the northern coastal region of Kenya. Children aged <5 years admitted to KCH with clinically defined syndromic severe or very severe pneumonia were recruited. Respiratory samples were taken and tested for 15 virus targets, using real-time polymerase chain reaction. Unadjusted odds ratios were used to estimate the association between demographic and clinical characteristics and HCoV positivity. Results: From 2007 to 2019, we observed 11,445 pneumonia admissions, of which 314 (3.9%) tested positive for at least one of the HCoV types surveyed in the study. There were 129 (41.1%) OC43, 99 (31.5%) 229E, 74 (23.6%) NL63 positive cases and 12 (3.8%) cases of HCoV to HCoV coinfection.  Among HCoV positive cases, 47% (n=147) were coinfected with other respiratory virus pathogens. The majority of HCoV cases were among children aged <1 year (66%, n=208), though there was was no change in the proportion infected by age. HCoV-OC43 was predominant of the three HCoV types throughout the surveillance period. Evidence for seasonality was not identified. Conclusions: Overall, 4% of paediatric pneumonia admissions were associated with three endemic HCoVs, with a high proportion of cases co-occurring with another respiratory virus, no clear seasonal pattern, and with the age-distribution of cases following that of pneumonia admissions (i.e. highest in infants). These observations suggest, at most, a small severe disease contribution of endemic HCoVs in this tropical setting and offer insight into their potential future burden and epidemiological characteristics.
Pneumococcal carriage prevalence, serotype distribution, and vaccine coverage in Ethiopia 12 years after pneumococcal vaccine introduction
Ethiopia introduced the 10-valent pneumococcal conjugate vaccine (PCV10, GlaxoSmithKline plc.) in 2011 and switched to 13-valent vaccine (PCV13, Pfizer Inc.) in 2020. In 2023, we conducted a study in four settings in Ethiopia to determine the vaccine coverage, residual vaccine-type carriage prevalence, serotype distribution, and factors associated with carriage across all age groups. A cross-sectional survey was conducted in urban and rural areas of eastern and southwest Ethiopia in 2023. In total, 50 participants in each of 10 age groups (<1, 1–2, 3–4, 5–9, 10–14, 15–19, 20–39, 40–49, 50–59, and ≥ 60 years) were randomly selected using population registers in Harar, Kersa and Gilgel Gibe demographic surveillance systems, and using random GPS points for Jimma city. After informed consent, data on socioeconomic characteristics and vaccine coverage were collected. A single nasopharyngeal swab was collected and cultured for pneumococci. Pneumococci were serotyped using latex agglutination and confirmatory Quellung reaction. A total of 2006 participants were enrolled. The age-standardized population prevalence of pneumococcal carriage (all serotypes) in rural settings was 56 % (95 %CI 48–64 %) in the east and 26 % (95 %CI 20–31 %) in the southwest, and in urban settings, 15 % (95 %CI 11–20 %) in the east and 16 % (95 %CI 12–19 %) in the southwest. PCV13 serotype carriage prevalence among children aged <5 years ranged from 7.4 to 9.3 % in the urban areas, to 16–22 % in the rural areas. Coverage of the third dose of PCV, recorded in vaccination cards of participants aged <5 years, was 49 %–87 % in the urban areas; it was much lower at 13–22 % in the rural areas. There is considerable residual circulation of vaccine serotypes in Ethiopia, particularly in rural areas and the east, and low vaccine coverage. Pneumococcal epidemiology varies by geographical region and urban/rural setting, implying an unequal burden of pneumococcal disease across the country 12 years post-PCV introduction. •A cross-sectional survey was conducted in urban and rural areas of eastern and southwest Ethiopia.•nasopharyngeal swabs were cultured and serotyped for pneumococci.•PCV13-type carriage prevalence in children <5 years old was 7–9 % in urban, and 16–22 % in rural areas.•Third dose PCV coverage, in children <5 years old, was 49–87 % in urban, and 13–22 % in rural areas.
Effect of mass campaigns with full and fractional doses of pneumococcal conjugate vaccine (Pneumosil) on the reduction of nasopharyngeal pneumococcal carriage in Niger: a three-arm, open-label, cluster-randomised trial
In settings with low pneumococcal conjugate vaccine (PCV) coverage, multi-age cohort mass campaigns could increase population immunity, and fractional dosing could increase affordability. We aimed to evaluate the effect of mass campaigns on nasopharyngeal pneumococcal carriage of Pneumosil (PCV10) in children aged 1–9 years in Niger. In this three-arm, open-label, cluster-randomised trial, 63 clusters of one to four villages in Niger were randomly assigned (3:3:1) using block randomisation to receive campaigns consisting of a single full dose of a 10-valent PCV (Pneumosil), a single one-fifth dose of Pneumosil, or no campaign. Independently sampled carriage surveys were done among 2268 households 6 months before and after vaccination, collecting nasopharyngeal swabs from healthy children for culture and serotyping; those with contraindication to nasopharyngeal swabbing were excluded. The primary outcome was nasopharyngeal carriage of vaccine-serotype pneumococcus. We tested whether vaccine-type carriage was reduced in full-dose versus control clusters; and whether fractional doses were non-inferior to full-doses (lower bound 95% CI more than –7·5%), using generalised estimating equations to analyse cluster summaries at baseline and follow-up, controlling for covariates to estimate risk differences and their 95% CIs. The study is registered with ClinicalTrials.gov (NCT05175014) and the Pan-African Clinical Trials Registry (PACTR20211257448484). Surveys were done between Dec 22, 2021, and March 18, 2022, and between Dec 12, 2022, and March 9, 2023. The vaccination campaign ran from June 15 to Aug 2, 2022. Participants' characteristics were consistent across surveys and groups. Pre-vaccination, vaccine-type carriage was 15·6% (149 of 955 participants) in the full-dose group, 17·9% (170 of 948) in the fractional-dose group, and 18·8% (60 of 320) in the control group. Post-vaccination, vaccine-type carriage was 4·6% (44 of 967) in the full-dose group, 8·0% (77 of 962) in the fractional-dose group, and 16·5% (53 of 321) in the control group. The primary analysis showed a risk difference of –16·2% (95% CI –28·6 to –3·0) between the full-dose group and control group (p=0·002 for superiority), and –3·8% (–6·1 to –1·6) between the full-dose group and fractional-dose group, meeting the non-inferiority criteria. No adverse events were judged to be related to vaccination. Multi-age cohort campaigns had a marked effect on vaccine-type carriage and fractional-dose campaigns met non-inferiority criteria. Such campaigns should be considered in low-coverage settings, including humanitarian emergencies, to accelerate population protection. EDCTP2 programme supported by the EU. For the French translation of the abstract see Supplementary Materials section.
Fractional Doses of Pneumococcal Conjugate Vaccine — A Noninferiority Trial
Pneumococcal conjugate vaccines are an important but costly part of childhood vaccination. This trial assessed immunogenicity of fractional-dose regimens — a key consideration as countries transition out of Gavi support.