Safety and protective efficacy of PfSPZ Vaccine administered to HIV-negative and -positive Tanzanian adults.

BACKGROUNDSanaria PfSPZ Vaccine, composed of attenuated Plasmodium falciparum (Pf) sporozoites (SPZ), protects against malaria. We conducted this clinical trial to assess the safety and efficacy of PfSPZ Vaccine in HIV-positive (HIV+) individuals, since the HIV-infection status of participants in mass vaccination programs may be unknown.METHODSThis randomized, double-blind, placebo-controlled trial enrolled 18- to 45-year-old HIV-negative (HIV-) and well-controlled HIV+ Tanzanians (HIV viral load <40 copies/mL, CD4 counts >500 cells/µL). Participants received 5 doses of PfSPZ Vaccine or normal saline (NS) over 28 days, followed by controlled human malaria infection (CHMI) 3 weeks later.RESULTSThere were no solicited adverse events in the 9 HIV- and 12 HIV+ participants. After CHMI, 6 of 6 NS controls, 1 of 5 HIV- vaccinees, and 4 of 4 HIV+ vaccinees were Pf positive by quantitative PCR (qPCR). After immunization, anti-Pf circumsporozoite protein (anti-PfCSP) (isotype and IgG subclass) and anti-PfSPZ antibodies, anti-PfSPZ CD4+ T cell responses, and Vδ2+ γδ CD3+ T cells were nonsignificantly higher in HIV- than in HIV+ vaccinees. Sera from HIV- vaccinees had significantly higher inhibition of PfSPZ invasion of hepatocytes in vitro and antibody-dependent complement deposition (ADCD) and Fcγ3B binding by anti-PfCSP and ADCD by anti-cell-traversal protein for ookinetes and SPZ (anti-PfCelTOS) antibodies.CONCLUSIONSPfSPZ Vaccine was safe and well tolerated in HIV+ vaccinees, but not protective. Vaccine efficacy was 80% in HIV- vaccinees (P = 0.012), whose sera had significantly higher inhibition of PfSPZ invasion of hepatocytes and enrichment of multifunctional PfCSP antibodies. A more potent PfSPZ vaccine or regimen is needed to protect those living with HIV against Pf infection in Africa.TRIAL REGISTRATIONClinicalTrials.gov NCT03420053.FUNDINGEquatorial Guinea Malaria Vaccine Initiative (EGMVI), made up of the Government of Equatorial Guinea Ministries of Mines and Hydrocarbons, and Health and Social Welfare, Marathon Equatorial Guinea Production Limited, Noble Energy, Atlantic Methanol Production Company, and EG LNG; Swiss government, through ESKAS scholarship grant no. 2016.0056; Intramural Research Program of the National Institute of Allergy and Infectious Diseases, NIH; NIH grant 1U01AI155354-01.

Determinants of willingness to pay for community-based health insurance scheme among households in rural community of southern Ethiopia.

BACKGROUND: Community-based health insurance programs are being acknowledged as effective strategies to attain universal health coverage and mitigate the financial catastrophic shock of the community. Even though Ethiopia has been focusing on the implementation and expansion of a community-based health insurance (CBHI) program since 2011, only a small number of people are enrolled, which might be attributed to a lack of willingness towards the program. The purpose of this study is to determine the willingness to pay for community-based health insurance and associated factors among households in the rural community of Gombora District, Hadiya Zone, southern Ethiopia. METHODS: Using the multistage systematic random sampling technique, a sample of 421 households was chosen for a community-based cross-sectional study. The desired information was gathered using a pre-tested, structured, interviewer-administered questionnaire. The data was entered using Epi-Data V3.1 and exported to SPSS version 24.0 for statistical analysis. Bivariable and multivariable logistic regression analyses were performed to determine the variables associated with the willingness to pay for community-based health insurance. RESULTS: The study showed that 67.1% of respondents expressed a willingness to pay for community-based health insurance. The mean amount of money they are willing to pay for the scheme is 178.41 (± 57.21) Ethiopian Birr (ETB), or 6.43 (± 2.06) USD per household per annum in 2020. Based on multiple logistic regression analysis, belonging to Rich household compared to poor (AOR: 2.78, 95% CI: 1.54, 5.03), having a household head who can read and write (AOR: 2.90, 95% CI: 1.39, 6.05), family size greater than five (AOR: 1.76, 95% CI: 1.06, 2.92), indigenous community insurance (iddir) participation (AOR: 2.83, 95% CI: 1.61, 4.96), and the presence of chronic illness (AOR: 1.94, 95% CI: 1.21, 3.12), were significantly associated with the willingness to pay for a CBHI scheme. CONCLUSION: Households' willingness to pay for a CBHI scheme was found to be significantly influenced by poor household wealth status, household heads who cannot read and write, households with less than or equal to five family members, households who participate in greater or equal to two indigenous community insurance participations, and the absence of chronic illness within the household. Therefore, factors affecting households' willingness to pay should be considered and massive community mobilization needs to be done to strengthen and increase household membership during the implementation of the CBHI scheme, especially in rural areas.

"Magnitude of community-based health insurance utilization and associated factors in Bassona Worena District, North Shoa Zone, Ethiopia: a community-based cross-sectional study".

INTRODUCTION: The health insurance system has been proven to offer effective and efficient health care for the community, particularly community-based health insurance is expected to ensure health care access for people with low economic status and vulnerable groups. Despite the significance of evidence-based systems and implementation, there is a limited report about the magnitude of CBHI utilization. Therefore, this study was done to assess factors associated with community-based health insurance utilization in Basona Worena District, North Shewa Zone, Ethiopia. METHOD: A community-based cross-sectional study was employed. We have included 530 households from 6 randomly selected kebeles. The data was entered using Epi-Data V 3.1 and exported to SPSS version 20.0 for statistical analysis. Bi-variable and multivariable logistic regression analyses were computed to determine factors associated with community-based health insurance utilization. RESULT: The study finding shows that 58.6% of the respondents were members of community-based health insurance. Respondents who had primary and secondary education levels were 2 times more likely to be members than those who had no formal education. As compared to those who had awareness, respondents who had no awareness about CBHI were 0.27 times less likely to be insured. Respondents who did not experience illness were 0.27 times less likely to be members than respondents who experienced illness. CONCLUSION: Educational status, awareness about CBHI, perception of CBHI scheme and illness experience of family influence CBHI utilization. There is a need to strengthen awareness creation to improve the CBHI utilization.

Emergency capacity analysis in Ethiopia: Results of a baseline emergency facility assessment.

INTRODUCTION: In Ethiopia, the specialty of Emergency Medicine is a relatively new discipline. In the last few decades, policymakers have made Emergency Medicine a priority for improving population health. This study aims to contribute to this strengthening of Emergency Medicine, by conducting the country's first baseline gap analysis of Emergency Medicine Capacity at the pre-hospital and hospital level in order to help identify needs and areas for intervention. METHODS: This is a cross sectional investigation that utilized a convenience sampling of 22 primary, general and tertiary hospitals. Trained personnel visited the hospitals and conducted 4-hour interviews with hospital administrators and emergency care area personnel. The tool used in the interview was the Columbia University sidHARTe Program Emergency Services Resource Assessment Tool (ESRAT) to evaluate both emergency and trauma capacity in different regions of Ethiopia. The findings of this survey were then compared against two established standards: the World Health Organization's Essential Package of Emergency Care (EPEC), as well as those set by Ethiopia's Federal Ministry of Health. RESULTS: The tool assessed the services provided at each hospital and evaluated the infrastructure of emergency care at the facility. Triage systems differed amongst the hospitals surveyed though triaging and emergency unit infrastructures were relatively similar amongst the hospitals. There was a marked variability in the level of training, guidelines, staffing, disaster preparedness, drug availability, procedures performed, and quality assurance measures from hospital to hospital. Most regional and district hospitals did not have nurses or doctors trained in Emergency Medicine and over 70% of the hospitals did not have written guidelines for standardized emergency care. CONCLUSION: This gap analysis has revealed numerous inconsistencies in health care practice, resources, and infrastructure within the scope of Emergency Medicine in Ethiopia. Major gaps were identified, and the results of this assessment were used to devise action priorities for the Ministry of Health. Much remains to be done to strengthen Emergency Medicine in Ethiopia, and numerous opportunities exist to make additional short and long-term improvements.

Trends and barriers of emergency medical service use in Addis Ababa; Ethiopia.

BACKGROUND: The increasing burdens of trauma and time sensitive non-communicable disease in Addis Ababa necessitate a robust emergency medical care system. The objectives of this study were to assess the proportion of patients who used emergency medical services (EMS) and to quantitatively and qualitatively assess barriers to EMS utilization in Addis Ababa. METHODS: A cross-sectional quantitative and qualitative study was conducted on patients who visited five selected public hospitals in Addis Ababa with specific emergency conditions. Data were collected by trained nurses using a standardized questionnaire. Descriptive statistics and logistic regression was done on cleaned and coded quantitative data using SPSS version 20. Thematic analysis was performed on the qualitative data. Ethical approval was obtained prior to the study. RESULTS: A total of 429 participants completed the survey with a non-response rate of 5.1%. The most common emergency scene was the home (n = 222, 51.8%) followed by road side (n = 159, 37.1%). Only 87(20.3%) patients arrived by ambulance, though a majority (53.4%) of participants recalled at least one access number for an ambulance service and 96.3% stated that ambulances were an important part of the continuum of care for their emergency condition. A higher proportion of participants believed that ambulance transportation is generally safer (n = 341, 78.5%) and faster (n = 298, 69.5%) than emergency transport by taxi or private car. Patients who were non-Amharic speaking had a negative association with arriving by ambulance (P = 0.001, OR 0.47; C.I, 0.31, 0.71). The median acceptable time to get the ambulance (according to respondent's perception) was 16 min but actually perceived ambulance waiting time was 40 min. CONCLUSION: EMS utilization in Addis Ababa is relatively low and emergency patients are instead being transported by taxi or private car. Perceived longer ambulance waiting time and language barriers may have contributed for low utilization. Findings of this study suggest an action to improve access by improving ambulance availability while simultaneously enhancing the public's knowledge and perception of EMS in Addis Ababa.

Advancing Global Health through Development and Clinical Trials Partnerships: A Randomized, Placebo-Controlled, Double-Blind Assessment of Safety, Tolerability, and Immunogenicity of PfSPZ Vaccine for Malaria in Healthy Equatoguinean Men.

Equatorial Guinea (EG) has implemented a successful malaria control program on Bioko Island. A highly effective vaccine would be an ideal complement to this effort and could lead to halting transmission and eliminating malaria. Sanaria® PfSPZ Vaccine (Plasmodium falciparum sporozoite Vaccine) is being developed for this purpose. To begin the process of establishing the efficacy of and implementing a PfSPZ Vaccine mass vaccination program in EG, we decided to conduct a series of clinical trials of PfSPZ Vaccine on Bioko Island. Because no clinical trial had ever been conducted in EG, we first successfully established the ethical, regulatory, quality, and clinical foundation for conducting trials. We now report the safety, tolerability, and immunogenicity results of the first clinical trial in the history of the country. Thirty adult males were randomized in the ratio 2:1 to receive three doses of 2.7 × 105 PfSPZ of PfSPZ Vaccine (N = 20) or normal saline placebo (N = 10) by direct venous inoculation at 8-week intervals. The vaccine was safe and well tolerated. Seventy percent, 65%, and 45% of vaccinees developed antibodies to Plasmodium falciparum (Pf) circumsporozoite protein (PfCSP) by enzyme-linked immunosorbent assay, PfSPZ by automated immunofluorescence assay, and PfSPZ by inhibition of sporozoite invasion assay, respectively. Antibody responses were significantly lower than responses in U.S. adults who received the same dosage regimen, but not significantly different than responses in young adult Malians. Based on these results, a clinical trial enrolling 135 subjects aged 6 months to 65 years has been initiated in EG; it includes PfSPZ Vaccine and first assessment in Africa of PfSPZ-CVac. ClinicalTrials.gov identifier: NCT02418962.