Preference for utilitarian or hedonic value options during a pandemic crisis: The moderation effects of childhood socioeconomic status and sensation-seeking.

This research investigated hospitality consumers' relative preferences for utilitarian or hedonic value under COVID-19 pandemic conditions. A series of four experiments and one secondary data analysis showed that the salience of the infectious disease threat increased consumers' preferences for hospitality options that provide relatively more utilitarian than hedonic value. Additionally, we identified two individual differences (i.e., childhood socioeconomic status (SES) & sensation-seeking) that moderated the effect of the infectious disease threat on the preferred hospitality consumption value. Specifically, the higher the childhood SES, the higher was the preference for the utilitarian value option, and the lower the level of sensation-seeking, the greater was the preference for the utilitarian value option. This research extends our understanding of the influence of the infectious disease threat on preference changes in hospitality decisions.

Ebola Virus Glycoprotein IgG Seroprevalence in Community Previously Affected by Ebola, Sierra Leone.

We explored the association of Ebola virus antibody seropositivity and concentration with potential risk factors for infection. Among 1,282 adults and children from a community affected by the 2014-2016 Ebola outbreak in Sierra Leone, 8% were seropositive for virus antibodies but never experienced disease symptoms. Antibody concentration increased with age.

Preference for robot service or human service in hotels? Impacts of the COVID-19 pandemic.

Robots and artificial intelligence (AI) technologies are becoming more prominent in the tourism industry. Nowadays, consumers are faced with multiple options involving both human and robot interactions. A series of experimental studies were implemented. Four experiments demonstrated that consumers had a more positive attitude toward robot-staffed (vs. human-staffed) hotels when COVID-19 was salient. The results were different from previous studies, which were conducted before the COVID-19 pandemic. Since the moderating role of perceived threat in consumers' preference for robot-staffed hotels was significant, the respondents' preference was attributed to the global health crisis. This research provides a number of theoretical and managerial implications by improving the understanding of technology acceptance during a health crisis.

pfhrp2 and pfhrp3 Gene Deletions That Affect Malaria Rapid Diagnostic Tests for Plasmodium falciparum: Analysis of Archived Blood Samples From 3 African Countries.

BACKGROUND: Malaria rapid diagnostic tests (mRDTs) that target histidine-rich protein 2 (HRP2) are important tools for Plasmodium falciparum diagnosis. Parasites with pfhrp2/3 gene deletions threaten the use of these mRDTs and have been reported in Africa, Asia, and South America. We studied blood samples from 3 African countries to determine if these gene deletions were present. METHODS: We analyzed 911 dried blood spots from Ghana (n = 165), Tanzania (n = 176), and Uganda (n = 570). Plasmodium falciparum infection was confirmed by 18S rDNA polymerase chain reaction (PCR), and pfhrp2/3 genes were genotyped. True pfhrp2/3 gene deletions were confirmed if samples were (1) microscopy positive; (2) 18S rDNA PCR positive; (3) positive for merozoite surface protein genes by PCR or positive by loop-mediated isothermal amplification; or (4) quantitative PCR positive with >5 parasites/µL. RESULTS: No pfhrp2/3 deletions were detected in samples from Ghana, but deletions were identified in Tanzania (3 pfhrp2; 2 pfhrp3) and Uganda (7 pfhrp2; 2 pfhrp3). Of the 10 samples with pfhrp2 deletions, 9 tested negative by HRP2-based mRDT. CONCLUSIONS: The presence of pfhrp2/3 deletions in Tanzania and Uganda, along with reports of pfhrp2/3-deleted parasites in neighboring countries, reinforces the need for systematic surveillance to monitor the reliability of mRDTs in malaria-endemic countries.

Safety Culture and Perioperative Quality at the Volta River Authority Hospital in Akosombo, Ghana.

BACKGROUND: The Volta River Authority Hospital (VRAH) is a district hospital associated with a large public works project in Akosombo, Ghana, that has developed a reputation for high-quality care. We hypothesized that this stems from a culture of safety and standardized processes typical of high-risk engineering environments. To investigate this, we evaluated staff and patient perceptions of safety and quality, as well as perioperative process variability. MATERIALS AND METHODS: The Safety Attitudes Questionnaire (SAQ) and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys were used to evaluate staff and patient perceptions of safety. Perioperative general surgery and obstetrical procedure observations generated process maps, which were analyzed for variability and waste. RESULTS: Thirty-one SAQs were administered. 83% of workers held a positive perception of teamwork, and 77.4% held a positive perception of safety culture. Fifteen HCAHPS surveys of surgical inpatients showed a median hospital rating of 10 [IQR 8.5-10] on a ten-point scale. 90% gave maximal scores for pain management and 84.4% for nurse communication. Ten general surgery and obstetrical procedures were observed for which process map analysis was notable for no consistent waste steps and 100% adherence to the World Health Organization Safe Surgery Checklist. CONCLUSIONS: Surveys suggest an institutional commitment to safety with strong teamwork culture and patient communication. Perioperative process mapping supports this culture, with low levels of variability and waste, and is useful for evaluating standardization of care. VRAH demonstrates the feasibility of delivering high standards of perioperative care in a low-resource setting.

Sex composition of living children in a matrilineal inheritance system and its association with pregnancy intendedness and postpartum family planning intentions in rural Ghana.

BACKGROUND: Sex composition of living children within the context of "sex preference" and its association with various reproductive health outcomes has been extensively studied in South and South East Asia. Although sex preference has been observed in sub-Saharan Africa, there is paucity of research on sex composition of living children and its association with reproductive health behaviours and outcomes, particularly in a matrilineal inheritance system. The purpose of the study was to explore the existence of sex preference in a matrilineal inheritance system. Specifically, the study sought to better understand the issues by examining the sex composition of living children and how it is associated with reproductive outcomes such as pregnancy intendedness and intention to use postpartum family planning among women in a matrilineal area of Ghana. METHODS: This was a cross sectional study conducted at four selected health facilities in the Mfantseman municipality of the Central Region of Ghana. Out of the 1914 pregnant women attending antenatal clinic selected using total enumeration, from 2nd January to 30th April 2012, 1091 with living children and complete socio-demographic data were recruited for this study. Descriptive, chi square and multivariate logistic regression analyses were conducted. RESULTS: The mean age of the 1091 respondents in this study was 28.2 ± 6.0 years with mean gestational age of 26.7 ± 6.6 weeks. Whilst 78% of the women had at least a son, 71% had at least a daughter, with those having only sons exceeding those with only daughters by 6.3%. Also, majority of the women with more sons than daughters did not intend their current pregnancies. These observations, coupled with a sex ratio of 109 males to 100 females, inferred the existence of son preference. The levels of unintended pregnancy and intention to use postpartum family planning were high (70% and 78% respectively). There was an association between sex composition of living children and unintended pregnancy but no association between sex composition of living children and intention to use postpartum family planning. Women with only sons were 50% less likely to have unintended pregnancies compared to those with equal number of sons and daughters [AOR 0.5, 95% CI (0.3-0.8)]. Similarly, women over 30 years were 80% less likely to have unintended pregnancies compared to those 15-19 years [AOR 0.2, 95% CI (0.1-0.6)]. The women with parity of 5 or more and resident in Anomabo were more likely to have unintended pregnancy compared to those with parity of up to two [AOR 3.8, 95% CI (1.7-8.59)] and those resident in Saltpond [AOR 1.8, 95%CI (1.1-2.8), respectively. In addition, the women resident in Anomabo were more likely to have intention to use postpartum family planning compared to those in Saltpond [AOR 1.8, 95% CI (1.0-3.3)]. CONCLUSION: There was persistence of more sons than daughters born in a predominantly matrilineal inheritance system and sex composition of living children had significant association with pregnancy intendedness but not with intention to use postpartum family planning.

Associated Factors and Quality of Care Received among Maternal Deaths at a Regional Hospital in Ghana: Maternal Death Audit Review.

Maternal death audits are crucial to the reduction of maternal deaths. The aim of this study was to identity factors contributing to maternal deaths at Eastern Regional Hospital of Ghana. Quantitative and qualitative methods were used. Quantitative data on all the maternal deaths from January to December 2012 was extracted from completed audit forms and patients records using a standardized questionnaire. The data were analyzed in Epi-info. Qualitative data was collected through in-depth interviews and focus group discussions with health staff to assess care received and factors leading to death. A total of 43 maternal deaths occurred out of which 37 (86%) were audited. Major causes of deaths were pregnancy induced hypertension (27%) and abortion (21%). Late referrals, poor supervision of junior staff, inadequate numbers of senior clinicians, lack of intensive care facility as well as unavailability and insufficient blood and blood products were the main contributory factors to the deaths. Tertiary health institutions should be adequately equipped, staffed, and funded to address these causes of maternal death.

Should consent forms used in clinical trials be translated into the local dialects? A survey among past participants in rural Ghana.

BACKGROUND: Obtaining informed consent is part of the expression of the principle of participant autonomy during clinical trials. It is critical that participants understand the content of informed consent forms and remain in a position to seek independent advice on its content. We conducted a survey among past participants of a clinical trial in the Kassena-Nankana Districts of rural northern Ghana about the usefulness of informed consent forms that are written in the local dialects. The written forms of local dialects are largely undeveloped. METHOD: We contacted a randomly selected sample of caregivers whose children were enrolled in a completed clinical trial and interviewed them using a structured questionnaire. Analysis sought to determine participants' preference and whether or not they were likely to find confidants who will be able to read, understand and give advice on the content of the informed consent form to them when they take the informed consent forms home. RESULTS: We interviewed 394 caregivers, 88.6% of whom were women. About half (54%) of the respondents wanted the informed consent forms to be in the English language. Caregivers with higher than primary level education were more likely to prefer the informed consent form to be in English than those with no formal education (74% versus 26%, p = 0.04). The majority (85%) indicated that they would be able to find close confidants who would be able to read and explain it to them if it is in English. In contrast, only 8% thought they would be able to do the same if the informed consent form was written in the local language. Respondents were more likely to find close confidants to read and explain the informed consent form if it were written in English than if it were written in the local language (94% versus 19%, p value < 0.01). CONCLUSION: The practice of translating informed consent forms into undeveloped local dialects and giving such copies to trial participants to send home needs to be re-evaluated. In populations where the written forms of local dialects are undeveloped and literacy is low, the use of local dialect versions of informed consent forms could ironically enhance the vulnerability of trial participants.

Monitoring malaria using health facility based surveys: challenges and limitations.

BACKGROUND: Health facility data are more readily accessible for operational planning and evaluation of disease control programmes. The importance, potential challenges and limitations of using facility based survey as an alternative tool for monitoring changes in local malaria epidemiology were examined. METHODS: The study involved six areas within the administrative divisions of The Gambia. The areas were selected to reflect socioeconomic and malaria transmission intensities across the country. The study design involved an age stratified cross sectional surveys that were conducted during the wet season in 2008 and in the 2009 during the dry season. Participants were patients attending clinics in six health centres and the representative populations from the catchment communities of the health centres. RESULTS: Overall participants' characteristics were mostly not comparable in the two methodological approaches in the different seasons and settings. More females than males were enrolled (55.8 vs. 44.2 %) in all the surveys. Malaria infection was higher in the surveys in health centres than in the communities (p < 0.0001) and also in males than in females (OR = 1.3; p < 0.001). Males were less likely than females to sleep under an insecticide treated net in the communities (OR = 1.6; 95 % CI 1.3, 1.9) and in the health centres (OR = 1.3; 95 % CI 1.1, 1.5). Representativeness of the ethnic groups was better in the health centre surveys than in the community surveys when compared to the 2003 national population census in The Gambia. CONCLUSION: Health facility based survey though a potential tool for monitoring changes in the local epidemiology of malaria will require continuous validation of the facility and participants sociodemograhic characteristics as these may change over time. The effects of health seeking practices on service utilization and health facility surveys as an approach will also need continuous review.

Implementation of the integrated management of childhood illness with parasitological diagnosis of malaria in rural Ghana: health worker perceptions.

BACKGROUND: Timely and appropriate management of febrile illness among children under five years of age will contribute to achieving Millennium Development Goal-4. The revised World Health Organization-Global Malaria Programme's policy on test-based management of malaria must integrate effectively into the Integrated Management of Childhood Illness (IMCI). This study reports on perceptions of health workers on the health system factors influencing effective delivery of test-based diagnosis of malaria with IMCI. METHODS: A qualitative study was conducted among a range of health workers at different levels of the health system in the Brong Ahafo Region of Ghana. Interview transcripts were transferred into Nvivo 8 software for data management and analysis. A frame-work approach at two levels was used in the analysis, which included the processes required for implementation of test-based management of malaria and the health systems context. RESULTS: Forty-nine in-depth interviews were conducted. The National Health Insurance Scheme (NHIS) was perceived to have led to an increase in health facility attendance, thereby increasing the workload of health workers. Workload was reported as the main reason that health workers were not able to complete all of the examinations included in the IMCI algorithm. The NHIS financing guidelines were seen to be determining diagnosis and treatment practices by health-care givers. Concern was expressed about the erratic supply of malaria rapid diagnostic test kits (RDTs), the quality of RDTs related to potential false negative results when clinical symptoms were consistent with malaria. IMCI was seen as important but practically impossible to fully implement due to workload. CONCLUSIONS: Implementation of the WHO-revised IMCI guideline is confronted with a myriad of health systems challenges. The perceptions of front-line health workers on the accuracy and need for RDTs together with the capacity of health systems to support implementation plays a crucial role. The NHIS financing guidelines of diagnostics and treatments are influencing clinical decision-making in this setting. Further study is needed to understand the impact of the NHIS on the feasibility of integrating test-based management for malaria into the IMCI guidelines.

Predictors of abortions in Rural Ghana: a cross-sectional study.

BACKGROUND: Abortion continues to be used as a method of family planning by many women. The complications of unsafe abortions are a major contributor to maternal mortality in sub-Saharan Africa, including Ghana. This study explored the influence of socio-demographic characteristics on abortions in 156 communities within the Kintampo Health and Demographic Surveillance System (KHDSS) area located in the middle part of Ghana. METHODS: A survey on Sexual and Reproductive Health among a representative sample of females aged 15-49 years was conducted in 2011. They were asked about the outcome of pregnancies that occurred between January 2008 and December 2011. Data on their socio-demographic characteristics including household assets were accessed from the database of the KHDSS. Univariate and multivariate random effects logistic regression models were used to explore the predictors of all reported cases of abortion (induced or spontaneous) and cases of induced abortion respectively. RESULTS: A total of 3554 women were interviewed. Of this total, 2197 women reported on the outcomes of 2723 pregnancies that occurred over the period. The number of all reported cases of abortions (induced and spontaneous) and induced abortions were 370 (13.6%) and 101 (3.7%) respectively. Unmarried women were more likely to have abortion as compared to married women (aOR = 1.77, 95% CI [1.21-2.58], p = 0.003). Women aged 20-29 years were 43% less likely to have abortion in comparison with those within the ages 13-19 years (aOR = 0.57, 95% CI [0.34-0.95], p = 0.030). Women with primary, middle/junior high school (JHS) and at least secondary education had higher odds of having abortion as compared to women without education. Compared with the most poor women, wealthiest women were three-fold likely to have abortion. Unmarried women had higher odds of having induced abortion as compared to married women (aOR = 7.73, 95% CI [2.79-21.44], p < 0.001). Women aged 20-29 years, 30-39 years and 40-49 years were less likely to have induced abortion as compared to those 13-19 years of age. CONCLUSION: Extra efforts are needed to ensure that family planning services, educational programs on abortion and abortion care reach the target groups identified in this study.

Management of febrile children under five years in hospitals and health centres of rural Ghana.

BACKGROUND: The case management of febrile children in hospitals' and health centres' pre-roll out of the new WHO policy on parasitological diagnosis was assessed. The delivery of artemisinin combination therapy (ACT) at these two levels of the health system was compared. METHODS: Structured observations and exit interviews of 1,222 febrile children attending five hospitals and 861 attending ten health centres were conducted in six districts of the Brong Ahafo Region of Ghana. Effectiveness of delivery of case management of malaria was assessed. Proportions of children receiving ACT, anti-malarial monotherapy and antibiotics were described. Predictors of: a febrile child being given an ACT, a febrile child being given an antibiotic and of carers knowing how to correctly administer the ACT were assessed using logistic regression models stratified by hospitals and health centres. RESULTS: The system's effectiveness of delivering an ACT to febrile children diagnosed with malaria (parasitologically or clinically) was 31.4 and 42.4% in hospitals and health centres, respectively. The most ineffective process was that of ensuring that carers knew how to correctly administer the ACT. Overall 278 children who were not given an ACT were treated with anti-malarial monotherapy other than quinine. The majority of these children, 232/278 were given amodiaquine, 139 of these were children attending hospitals and 93 attending health centres. The cadre of health staff conducting consultation was a common predictor of the outcomes of interest. Presenting symptoms and examinations conducted were predictive of being given an ACT in hospitals and antibiotic in hospitals and health centres but not of being given an ACT in health centres. Treatment-seeking factors were predictive of being given an ACT if it was more than seven days since the fever began and an antibiotic in hospitals but not in health centres. CONCLUSION: Interventions to improve adherence to negative parasitological tests are needed, together with guidance on dispensing of antibiotics, but improving the education of carers on how to administer ACT will lead to the greatest immediate increase in the effectiveness of case management. Guidance is needed on implementation of the new test-based treatment for malaria policy in health facilities.

Determinants of unintended pregnancies in rural Ghana.

BACKGROUND: Unintended pregnancies may carry serious consequences for women and their families, including the possibility of unsafe abortion, delayed prenatal care, poor maternal mental health and poor child health outcomes. Although between 1993 and 2008, unintended births decreased from 42% to 37% in Ghana, the rate of decline is low, whilst levels are still very high. This raises the need to understand factors associated with unintended pregnancies, especially among women in rural settings where the rates and risks are highest to help improve maternal health. METHOD: We collected data from 1,914 pregnant women attending antenatal clinic between January 2012 and April 2012 in four health facilities in the Mfantseman Municipal of the Central Region of Ghana. We used bivariate and multivariate logistic regression analyses to explore how socio-demographic characteristics, past reproductive health experiences, partner characteristics and relations, awareness and past experience with contraceptives, influenced the status of women's current pregnancy (whether intended or unintended). RESULTS: The mean age of the 1,914 respondents in this study was 25.6 ± 6.5 years. Seventy percent (70%) said the pregnancies they were carrying were unintended. The odds of carrying unintended pregnancy among women with five or more children were higher than those with one to two children [AOR 6.06, 95% CI (3.24-11.38) versus AOR 1.48, 95% CI (1.14-1.93)]. Women with other marital arrangements showed significantly higher odds of carrying unintended pregnancy compared to those married by ordinance (Muslim or Christian wedding). Women not living with their partners exhibited increased odds of having unintended pregnancies compared to women who lived with their partners (AOR 1.72, 95% CI: 1.28 - 2.30). Awareness of traditional methods of family planning (withdrawal and rhythm) was associated with lower odds of having unintended pregnancy compared to non-awareness (AOR 0.66, 95% CI (0.49-0.89). CONCLUSIONS: In this study, important risk factors associated with unintended pregnancies were: parity, living arrangements with partner, marriage by ordinance and awareness of traditional, non-pharmacological contraceptive methods. Family planning interventions targeting different groups of women, especially during the postpartum period, would be essential to reduce rates of unintended pregnancies and promote positive health outcomes.

Prevalence of clinically captured and confirmed malaria among HIV seropositve clinic attendants in five hospitals in Ghana.

BACKGROUND: Malaria is associated with an increase in HIV viral load and a fall in CD4-cell count. Conversely, HIV infection disrupts the acquired immune responses to malaria and the efficacy of antimalarial drugs. This study was carried out in five Ghanaian hospitals to estimate the prevalence of clinically confirmed malaria among HIV patients by evaluating their hospital records. METHODS: This retrospective descriptive cross sectional study reviewed and collected data on malaria, using Case Record Forms from HIV patients' folders in five hospitals in Ghana. RESULTS: There were 933 patients records made up of 272 (29.2%) males and 661 (70.8%) females. Majority of the patients were aged between 21-40 (63.6%) years and the rest were between the ages 1-20 (2.8%) years, 41-60 (31.6%) years and 61-80 (2.1%) years of age.A total of 38.1% (355/933) of the patients were clinically suspected of having clinical malaria. Of these 339 (95.5%) were referred to the laboratory for confirmation of the diagnosis of malaria. Only 4.4% (15/339) of patients tested were confirmed as cases of malaria among the patients that were clinically suspected of having malaria and subsequently confirmed. Fever, was not significantly associated with a confirmed diagnosis of malaria [OR = 3.11, 95% CI: (0.63, 15.37), P = 0.142]. CONCLUSIONS: There was a 4.4% prevalence of confirmed malaria and 38.1% of presumptively diagnosed malaria from the case records of HIV patients from the selected hospitals in Ghana.

Multimorbidity of chronic diseases among adult patients presenting to an inner-city clinic in Ghana.

BACKGROUND: Very little is known about multimorbidity and chronic diseases in low and middle income countries, particularly Sub-Saharan Africa, and more information is needed to guide the process of adapting the health systems in these countries to respond adequately to the increasing burden of chronic diseases. We conducted a hospital-based survey in an urban setting in Ghana to determine the prevalence of multimorbidity and its associated risk factors among adult patients presenting to an inner city clinic. METHODS: Between May and June 2012, we interviewed adult patients (aged 18 years and above) attending a routine outpatient clinic at an inner-city hospital in Accra using a structured questionnaire. We supplemented the information obtained from the interviews with information obtained from respondents' health records. We used logistic regression analyses to explore the risk factors for multimorbidity. RESULTS: We interviewed 1,527 patients and retrieved matching medical records for 1,399 (91.6%). The median age of participants was 52.1 years (37-64 years). While the prevalence of multimorbidity was 38.8%, around half (48.6%) of the patients with multimorbidity were aged between 18-59 years old. The most common combination of conditions was hypertension and diabetes mellitus (36.6%), hypertension and musculoskeletal conditions (19.9%), and hypertension and other cardiovascular conditions (11.4%). Compared with patients aged 18-39 years, those aged 40-49 years (OR 4.68, 95% CI: 2.98-7.34), 50-59 years (OR 12.48, 95% CI: 8.23-18.92) and 60 years or older (OR 15.80, 95% CI: 10.66-23.42) were increasingly likely to present with multimorbidity. While men were less likely to present with multimorbidity, (OR 0.71, 95% CI: 0.45-0.94, p = 0.015), having a family history of any chronic disease was predictive of multimorbidity (OR 1.43, 95% CI: 1.03-1.68, p = 0.027). CONCLUSIONS: Multimorbidity is a significant problem in this population. By identifying the risk factors for multimorbidity, the results of the present study provide further evidence for informing future policies aimed at improving clinical case management, health education and medical training in Ghana.

Factors influencing the intention of women in rural Ghana to adopt postpartum family planning.

BACKGROUND: Uptake of postpartum family planning (PPFP) remains low in sub-Saharan Africa and very little is known about how pregnant women arrive at their decisions to adopt PPFP. This information is needed to guide the development of interventions to promote PPFP. METHODS: We conducted a survey among pregnant women attending antenatal clinics in a rural district in Ghana. We used univariate and multivariate logistic regression analysis to explore how knowledge of various family planning (FP) methods, past experience with their use and the acceptability of PPFP to male partners and close relations influenced the intention of pregnant women to adopt PPFP. RESULTS: We interviewed 1914 pregnant women in four health facilities. About 84% considered PPFP acceptable, and 70% intended to adopt a method. The most preferred methods were injectables (31.5%), exclusive breastfeeding (16.7%), and oral contraceptive pills (14.8%). Women whose first choice of PPFP method were injectables were more likely to be women who had had past experience with its use (O.R = 2.07, 95% C.I. 1.50-2.87). Acceptability of PPFP by the pregnant woman (O.R. = 3.21, 1.64-6.26), perception of partner acceptability (O.R. = 3.20, 1.94-5.48), having had prior experience with the use of injectables (O.R. = 3.72, 2.61-5.30) were the strongest predictors of the intention to adopt PPFP. Conversely women who knew about the diaphragm (O.R. = 0.59, 0.38-0.93) and those who had past experience with IUD use (O.R. = 0.13, 0.05-0.38) were less likely to want to adopt PPFP. CONCLUSIONS: Acceptability of PPFP to the pregnant woman, male partner approval, and past experience with the use of injectables are important factors in the PPFP decisions of women in this population. Antenatal and early postnatal care need to be adapted to take these factors into consideration.

The Effect of Previous Exposure to Malaria Infection and Clinical Malaria Episodes on the Immune Response to the Two-Dose Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen.

We assessed whether the immunogenicity of the two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen with a 56-day interval between doses was affected by exposure to malaria before dose 1 vaccination and by clinical episodes of malaria in the period immediately after dose 1 and after dose 2 vaccinations. Previous malaria exposure in participants in an Ebola vaccine trial in Sierra Leone (ClinicalTrials.gov: NCT02509494) was classified as low, intermediate, and high according to their antibody responses to a panel of Plasmodium falciparum antigens detected using a Luminex MAGPIX platform. Clinical malaria episodes after vaccinations were recorded as part of the trial safety monitoring. Binding antibody responses against the Ebola virus (EBOV) glycoprotein (GP) were measured 57 days post dose 1 and 21 days post dose 2 by ELISA and summarized as Geometric Mean Concentrations (GMCs). Geometric Mean Ratios (GMRs) were used to compare groups with different levels of exposure to malaria. Overall, 587 participants, comprising 188 (32%) adults (aged ≥ 18 years) and 399 (68%) children (aged 1-3, 4-11, and 12-17 years), were included in the analysis. There was no evidence that the anti-EBOV-GP antibody GMCs post dose 1 and post dose 2 differed between categories of previous malaria exposure. There was weak evidence that the GMC at 57 days post dose 1 was lower in participants who had had at least one episode of clinical malaria post dose 1 compared to participants with no diagnosed clinical malaria in the same period (GMR = 0.82, 95% CI: 0.69-0.98, p-value = 0.02). However, GMC post dose 2 was not reduced in participants who experienced clinical malaria post-dose 1 and/or post-dose 2 vaccinations. In conclusion, the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen is immunogenic in individuals with previous exposure to malaria and in those who experience clinical malaria after vaccination. This vaccine regimen is suitable for prophylaxis against Ebola virus disease in malaria-endemic regions.

Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial.

BACKGROUND: Children account for a substantial proportion of cases and deaths during Ebola virus disease outbreaks. We aimed to evaluate the safety and immunogenicity of a booster dose of the Ad26.ZEBOV vaccine in children who had been vaccinated with a two-dose regimen comprising Ad26.ZEBOV as dose one and MVA-BN-Filo as dose two. METHODS: We conducted an open-label, non-randomised, phase 2 trial at one clinic in Kambia Town, Sierra Leone. Healthy children, excluding pregnant or breastfeeding girls, who had received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in a previous study, and were aged 1-11 years at the time of their first vaccine dose, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) and were followed up for 28 days. Primary outcomes were safety (measured by adverse events) and immunogenicity (measured by Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration) of the booster vaccine dose. Safety was assessed in all participants who received the booster vaccination; immunogenicity was assessed in all participants who received the booster vaccination, had at least one evaluable sample after the booster, and had no major protocol deviations that could have influenced the immune response. This trial is registered with ClinicalTrials.gov, NCT04711356. FINDINGS: Between July 8 and Aug 18, 2021, 58 children were assessed for eligibility and 50 (27 aged 4-7 years and 23 aged 9-15 years) were enrolled and received an Ad26.ZEBOV booster vaccination, more than 3 years after receiving dose one of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. The booster was well tolerated. The most common solicited local adverse event during the 7 days after vaccination was injection site pain, reported in 18 (36%, 95% CI 23-51) of 50 participants. The most common solicited systemic adverse event during the 7 days after vaccination was headache, reported in 11 (22%, 12-36) of 50 participants. Malaria was the most common unsolicited adverse event during the 28 days after vaccination, reported in 25 (50%, 36-64) of 50 participants. No serious adverse events were observed during the study period. 7 days after vaccination, the Ebola virus glycoprotein-specific IgG binding antibody geometric mean concentration was 28 561 ELISA units per mL (95% CI 20 255-40 272), which was 44 times higher than the geometric mean concentration before the booster dose. 21 days after vaccination, the geometric mean concentration reached 64 690 ELISA units per mL (95% CI 48 356-86 541), which was 101 times higher than the geometric mean concentration before the booster dose. INTERPRETATION: A booster dose of Ad26.ZEBOV in children who had received the two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen more than 3 years earlier was well tolerated and induced a rapid and robust increase in binding antibodies against Ebola virus. These findings could inform Ebola vaccination strategies in paediatric populations. FUNDING: Innovative Medicines Initiative 2 Joint Undertaking. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone.

BACKGROUND: This study assessed the safety and immunogenicity of the Ad26.ZEBOV and MVA-BN-Filo Ebola virus (EBOV) vaccine regimen in infants aged 4-11 months in Guinea and Sierra Leone. METHODS: In this phase 2, randomised, double-blind, active-controlled trial, we randomly assigned healthy infants (1:1 in a sentinel cohort, 5:2 for the remaining infants via an interactive web response system) to receive Ad26.ZEBOV followed by MVA-BN-Filo (Ebola vaccine group) or two doses of meningococcal quadrivalent conjugate vaccine (control group) administered 56 days apart. Infants were recruited at two sites in west Africa: Conakry, Guinea, and Kambia, Sierra Leone. All infants received the meningococcal vaccine 8 months after being randomly assigned. The primary objective was safety. The secondary objective was immunogenicity, measured as EBOV glycoprotein-binding antibody concentration 21 days post-dose 2, using the Filovirus Animal Non-Clinical Group ELISA. This study is registered with ClinicalTrials.gov (NCT03929757) and the Pan African Clinical Trials Registry (PACTR201905827924069). FINDINGS: From Aug 20 to Nov 29, 2019, 142 infants were screened and 108 were randomly assigned (Ebola vaccine n=75; control n=33). The most common solicited local adverse event was injection-site pain (Ebola vaccine 15 [20%] of 75; control four [12%] of 33). The most common solicited systemic adverse events with the Ebola vaccine were irritability (26 [35%] of 75), decreased appetite (18 [24%] of 75), pyrexia (16 [21%] of 75), and decreased activity (15 [20%] of 75). In the control group, ten (30%) of 33 had irritability, seven (21%) of 33 had decreased appetite, three (9%) of 33 had pyrexia, and five (15%) of 33 had decreased activity. The frequency of unsolicited adverse events was 83% (62 of 75 infants) in the Ebola vaccine group and 85% (28 of 33 infants) in the control group. No serious adverse events were vaccine-related. In the Ebola vaccine group, EBOV glycoprotein-binding antibody geometric mean concentrations (GMCs) at 21 days post-dose 2 were 27 700 ELISA units (EU)/mL (95% CI 20 477-37 470) in infants aged 4-8 months and 20 481 EU/mL (15 325-27 372) in infants aged 9-11 months. The responder rate was 100% (74 of 74 responded). In the control group, GMCs for both age groups were less than the lower limit of quantification and the responder rate was 3% (one of 33 responded). INTERPRETATION: Ad26.ZEBOV and MVA-BN-Filo was well tolerated and induced strong humoral responses in infants younger than 1 year. There were no safety concerns related to vaccination. FUNDING: Janssen Vaccines & Prevention and Innovative Medicines Initiative 2 Joint Undertaking. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.