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.

The ten-year risk of developing cardiovascular disease among public health workers in North-Central Nigeria using Framingham and atherogenic index of plasma risk scores.

BACKGROUND: Estimation of total cardiovascular disease (CVD) risk with the use of risk prediction charts such as the Framingham risk score and Atherogenic index of plasma score is a huge improvement on the practice of identifying and treating each of the risk factors such as high blood pressure and elevated blood cholesterol. The estimation of the total risk highlights that CVD risk factors occur together and thereby predicts who should be treated. There is scarcity of data on the risk scoring of adults in Nigeria including health workers. Therefore, this study was done to estimate the cardiovascular risks of health workers in public health services in north-central Nigeria. METHODS: A cross-sectional survey was performed using validated Framingham risk score calculator and calculation of risk based on the lipid profile of 301 randomly selected health workers in North-central Nigeria. Descriptive analysis was done using frequency counts and percentages while inferential statistics were done using chi square and correlation analyses using statistical Package for Social Sciences (SPSS) version 21.0. The confidence level was 95% and the level of significance was set at 0.05. RESULTS: The 10-year risk of developing CVD was generally low in the health workers. Using Framingham risk score, 98.3% of health workers have low risk, 1.0% have moderate risk and 0.7% have high risk. Among the cadres of health workers, 1.5% of the nurses have moderate risk while 2.5% of the doctors and 3.3% of the CHEWs have high risk of developing CVD in 10 years. Using Atherogenic index of plasma scoring, only 2% of the health workers have high risk, 4.7% have intermediate risk while 93.4% have low risk. Across the cadres, 6.3% of the nurses and 3.3% of the CHEWs have intermediate risk while 2.4% of the nurses and 3.3% of the CHEWs have high risk. These findings were however not statistically significant. CONCLUSIONS: The 10-year risk of developing cardiovascular disease was low in the health workers in this study using both Framingham's risk score and atherogenic index of plasma scores.

Improving malaria preventive practices and pregnancy outcomes through a health education intervention: A randomized controlled trial.

BACKGROUND: The prevalence of malaria in pregnancy and its complications, remain very high in Nigeria. This study aimed to determine the effects of a malaria health educational intervention based on the information-motivation-behavioural skills (IMB) model on malaria preventive practices and pregnancy outcomes. METHODS: The study was a randomized controlled parallel-group study, where 372 randomly selected antenatal care attendees were randomly assigned to one of either two groups after collecting baseline data. The intervention group then received a four-hour health education intervention in Hausa language, which was developed based on the IMB model, while the control group received a similarly designed health education on breastfeeding. Follow up data were then collected from the participants at a first (2 months post-intervention) and second (4 months post-intervention) follow up, and at the end of their pregnancies. RESULTS: For both groups, reported ITN use had increased from baseline (Intervention: Often-14.0%, Almost always-9.1; Control: Often-12.4%; Almost always 16.1%) to the time of second follow up (Intervention: Often -28.10%, Almost always-24.5; Control: Often-17.2%; Almost always 19.5%). Reported IPTp uptake at second follow up was also higher for the intervention group (Intervention: Two doses-59.0%, Three doses 22.3%; Control group: Two doses-48.4%, Three doses-7.0%). The drop in the haematocrit levels was greater for the control group (32.42% to 30.63%) compared to the intervention group (33.09% to 31.93%). The Generalized Linear Mixed Models (GLMM) analysis revealed that the intervention had significantly improved reported ITN use, reported IPTp uptake, and haematocrit levels, but had no significant effect on the incidence of reported malaria diagnosis or babies' birth weights. CONCLUSIONS: The intervention was effective in improving ITN use, IPTp uptake, and haematocrit levels. It is, therefore, recommended for the modules to be adopted and incorporated into the routine antenatal care programmes in health centres with predominantly Hausa speaking clients. TRIAL REGISTRATION: Pan African Clinical Trial Registry, PACTR201610001823405. Registered 26 October 2016, www.pactr.org .

Determinants of uptake of first dose of intermittent preventive treatment among pregnant women in a secondary health Centre in Maiduguri, Nigeria.

BACKGROUND: Studies on uptake of first dose of intermittent preventive treatment in pregnancy (IPTp) are lacking, despite it being a predictor of subsequent doses. This study aimed at assessing the determinants of uptake of first dose of IPTp among pregnant women at the State Specialist Hospital, Maiduguri. METHODS: A cross-sectional study was conducted, in which respondents were selected using a systematic random sampling method, and structured questionnaires were used to obtain information from them. Chi-squared test was used to determine factors associated with uptake of first IPTp dose, while a further multivariate logistic regression was performed to determine its predictors. RESULTS: Three hundred and eighty respondents answered the survey, whose ages ranged from 15 to 45 years, and 86.8% were multigravid. Sixty five percent of them were aware of IPTp, and 34.7% believed that IPTp could be harmful to their pregnancies. Over a half of the respondents (52.9%) believed that taking all their IPTp medicines was very good for their pregnancies, while 45.0% felt that taking their IPTp medicines was very pleasant. Only two respondents (0.5%) stated that it was very untrue that their significant others thought that they should take all their IPTp medicines. Half of the respondents said it was very easy for them to take all their IPTp medicines even if they were experiencing mild discomforts while taking them. Less than a half (42.37%) had received their first dose of IPTp. In bivariate as well as multivariate analysis, only higher level of knowledge was significantly associated with uptake of first IPTp dose. Those with better knowledge of IPTp were about twice more likely to have taken their first dose of IPTp, compared to those with lower knowledge of IPTp (AOR = 1.85; 95% CI: 1.17-2.92). CONCLUSIONS: Knowledge of IPTp as well as its uptake, were sub-optimal in this study. Since knowledge of IPTp significantly predicts uptake of the first dose of IPTp, there is the need to implement health education campaigns to raise the awareness of pregnant women and their families on the need to receive and comply with it.

Validity and reliability of a Hausa language questionnaire assessing information, motivation and Behavioural skills for malaria prevention during pregnancy.

BACKGROUND: Many studies on malaria knowledge, attitude and practice among pregnant women have been conducted in Hausa speaking communities in Nigeria. Despite this, no standard and uniform instrument for assessing this important public health problem has been developed in the Hausa language, even though it is widely spoken. The aim of this study was to develop and validate a questionnaire in Hausa language assessing information, motivation, and behavioural skills for malaria prevention during pregnancy. METHODS: The questionnaire was first developed in English language, and then assessed for its contents by a team of experts. It was then forwardly translated to Hausa, and backwardly translated again to English by independent language experts. These two English versions were then compared by a Public Health expert, following which the questionnaire was administered to 190 Hausa speaking antenatal care attendees. Exploratory factor analysis was performed on the data collected. Sixty three out of the 190 respondents were invited after 2 weeks to answer the same questionnaire, following which reliability tests were performed. RESULTS: The questionnaire showed good internal consistency, with Cronbach's alpha values of 0.859, 0.890 and 0.773 for information, motivation and behavioural skills constructs respectively. The motivation and behavioural skills constructs were able to delineate their items into three and two sub-sections respectively. The factor loadings for the two constructs ranged from 0.610 to 0.965. As for test retest reliability, the Krippendorff's alpha values for the items of the motivation section ranged from 0.941 to 0.996; that for behavioural skills ranged from 0.810 to 0.953, while for frequency of ITN use, it was 0.988. The Cohen's kappa values for the information section ranged from 0.689-0.974, except the item for 'fever' (zazzabi) which was 0.382, and was as such reworded to a simpler terminology 'hotness of the body' (zafin jiki). CONCLUSIONS: The Hausa language IMB questionnaire on malaria in pregnancy demonstrated good validity, and a high level of reliability. It is as such recommended for use among Hausa speaking communities to ensure uniformity and objectivity.

An information-motivation-behavioural skills analysis of long-lasting insecticidal net use among pregnant women in a hospital in North-Eastern Nigeria.

BACKGROUND: Sleeping under a long-lasting insecticidal net (LLIN) is recommended for all pregnant women in sub-Saharan Africa, due to the high prevalence of malaria infection and its associated complications in the region. Despite this, LLIN use has still remained sub-optimal among pregnant women in Maiduguri, Nigeria. Understanding the interplay of factors influencing this important health behaviour would guide the development of interventions to promote its adoption. METHODS: Data was collected from 380 randomly selected antenatal care attendees of a hospital in Maiduguri, using structured questionnaires. This data was then used to test the Information-Motivation-Behavioural Skills (IMB) model, for model fit, and interrelations among the constructs, using the structural equation modelling analysis with Smart-PLS. RESULTS: Information and motivation were significantly related to behavioural skills (r = 0.29, p < 0.001 and r = 0.37, p < 0.001, respectively); and also to behaviour (r = 0.22, p < 0.001 and r = 0.11, p = 0.033 respectively). Behavioural skills however, did not significantly relate to behaviour (r = 0.03, p = 0.278). CONCLUSION: These findings highlight the potential usefulness of the IMB model in guiding interventions for promoting LLIN use among this group. More emphasis should also be laid on boosting levels of information and motivation among the target group.

Effects of a health educational intervention on malaria knowledge, motivation, and behavioural skills: a randomized controlled trial.

BACKGROUND: The levels of insecticide-treated net use among pregnant women and uptake of intermittent preventive treatment in pregnancy, have been sub-optimal in Nigeria. Previous studies have reported positive correlations between knowledge, attitude and practice of malaria preventive measures. It has also been reported that information and motivation, act through a mediator (behavioural skills), to cause a health behaviour change. The aim of this study was as such to develop, implement, and assess the effects of a health educational intervention based on the information-motivation-behavioural skills (IMB) model on the levels of knowledge, motivation, and behavioural skills for ITN use and IPTp uptake among pregnant women in a hospital in north-eastern Nigeria. METHODS: This was a randomized controlled parallel-group trial in which 372 antenatal care attendees were randomly assigned to either an intervention or control group after collecting baseline data using a structured questionnaire. The intervention group received a 4-h health education on malaria, guided by a module developed based on the IMB theory, while the control group received health education on breastfeeding for a similar duration and by the same facilitator. Follow-up data were subsequently collected at 2 months and at 4 months post-intervention using the same questionnaire. The generalized linear mixed models analysis was used to determine the between-group and within-group effects of the intervention. The intention-to-treat analysis was used after missing data had been replaced. This was followed by a sensitivity analysis, where the analyses were repeated without replacing the missing values. RESULTS: The intervention was significant in achieving a 12.75% (p < 0.001), 8.55% (p < 0.001), and 6.350% (p < 0.001) higher total knowledge, motivation, and behavioural skills scores respectively, for the intervention group over the control group. The sensitivity analysis revealed no great differences in the effect sizes, even when missing data were not replaced. CONCLUSION: The intervention module was effective in improving knowledge, motivation and behavioural skills. It is as such recommended to be adopted and incorporated into the routine antenatal health education schedules. It is also recommended that booster doses of the module be given say 2 months after the first dose to sustain levels of motivation and behavioural skills. Trial registration Pan African Clinical Trial Registry, PACTR201610001823405. Registered 26 October 2016, http://www.pactr.org.

Knowledge, motivation, self-efficacy, and their association with insecticidal net use among pregnant women in a secondary health centre in Maiduguri, Nigeria.

BACKGROUND: Despite the high prevalence of malaria among pregnant women and its associated complications, the level of compliance with insecticide-treated nets (ITN) remains very low. Motivation and self-efficacy have been reported as important determinants of health behaviour, and may be important factors to consider in developing health intervention programmes. The aim of this study was to determine the knowledge, motivation and self-efficacy of ITN use, and their association with its practice, among pregnant women in a secondary health centre in Maiduguri. METHODS: The study utilized a cross-sectional study design, using a structured and pre-tested questionnaire to obtain information from 380 respondents. Respondents were classified as ITN users if they slept under an ITN for at least 3 days in a week, while those who did not at all, or slept under it less frequently were classified as ITN non-users. Chi squared test was performed to test the bivariate association between ITN use and each of the items of the questionnaire. A further multivariate logistic regression was performed to determine the predictors of ITN use. RESULTS: The respondents' ages ranged from 15 to 45 years, with median (interquartile range) age of 25 (8) years. Eighty percent of them were aware of ITN, but 50.5% believed ITNs could be dangerous. Only 5.5% and 0.8% respectively felt that sleeping under and ITN was either just bad or very bad for their health. Thirty-five percent of the respondents were ITN users. Not having a previous miscarriage (OR = 2.38; 95% CI 1.41-4.03, p = 0.001), knowledge that ITNs were not to be washed after every 1 month (OR = 3.60; 95% CI 1.18-11.06), significant others thinking they should sleep under an ITN (OR = 3.06; 95% CI 1.35-6.96), ability to effectively persuade others to sleep under an ITN (OR = 2.37; 95% CI 1.14-4.94) were significantly associated with ITN use. CONCLUSIONS: A large proportion of pregnant women in this study were not sleeping under ITNs. The development of health promotion interventions aimed at boosting their self-efficacies for ITN use, and improving social support from their spouses are, therefore, recommended. Health education on ITN use should also be incorporated into post-abortal management.