An ancillary care policy in a vaccine trial conducted in a resource-constrained setting: evaluation and policy recommendations.

INTRODUCTION: Clear guidelines to implement ancillary care (AC) in clinical trials conducted in resource-constrained settings are lacking. Here, we evaluate an AC policy developed for a vaccine trial in the Democratic Republic of the Congo and formulate policy recommendations. METHODS: To evaluate the AC policy, we performed a longitudinal cohort study, nested in an open-label, single-centre, randomised Ebola vaccine trial conducted among healthcare personnel. Participants' demographic information, residence distance to the study site and details on the financial and/or medical support provided for any (serious) adverse events ((S)AE) were combined and analysed. To assess the feasibility of the AC policy, an expenditure analysis of the costs related to AC support outcomes was performed. RESULTS: Enrolment in this evaluation study started on 29 November 2021. The study lasted 11 months and included 655 participants from the Ebola vaccine trial. In total, 393 participants used the AC policy, mostly for AE management (703 AE and 94 SAE) via medication provided by the study pharmacy (75.3%). Men had a 35.2% (95% CI 4.0% to 56.6%) lower likelihood of reporting AE compared with women. Likewise, this was 32.3% lower (95% CI 5.8% to 51.4%) for facility-based compared with community-based healthcare providers. The daily AE reporting was 78.8% lower during the passive vs the active trial stage, and 97.4% lower during unscheduled vs scheduled visits (p<0.001). Participants living further than 10 km from the trial site more frequently reported the travel distance as a reason for not using the policy (p<0.04). In practice, only 1.1% of the operational trial budget was used for AC policy support. CONCLUSION: The trial design, study population and local health system impacted the use of the AC policy. Nonetheless, the AC policy implementation in this remote and resource-constrained setting was feasible, had negligible budgetary implications and contributed to participants' healthcare options and well-being.

When money talks: Judging risk and coercion in high-paying clinical trials.

Millions of volunteers take part in clinical trials every year. This is unsurprising, given that clinical trials are often much more lucrative than other types of unskilled work. When clinical trials offer very high pay, however, some people consider them repugnant. To understand why, we asked 1,428 respondents to evaluate a hypothetical medical trial for a new Ebola vaccine offering three different payment amounts. Some respondents (27%) used very high pay (£10,000) as a cue to infer the potential risks the clinical trial posed. These respondents were also concerned that offering £10,000 was coercive- simply too profitable to pass up. Both perceived risk and coercion in high-paying clinical trials shape how people evaluate these trials. This result was robust within and between respondents. The link between risk and repugnance may generalize to other markets in which parties are partially remunerated for the risk they take and contributes to a more complete understanding of why some market transactions appear repugnant.

Willingness to pay for an Ebola vaccine during the 2014-2016 ebola outbreak in West Africa: Results from a U.S. National sample.

The 2014-2016 Ebola virus outbreak in West Africa led to advances in the development of vaccines against Ebola. This study examined factors associated with willingness to pay for an Ebola vaccine among a U.S. national sample during the recent Ebola outbreak. From April 30-May 8, 2015, a national survey was conducted using the GfK Group's KnowlegePanel®. Main outcome measures included willingness to pay at least $1; more than $50; and more than $100 for an Ebola vaccine. Analyses were conducted using weighted multivariable logistic regression. Among participants (N = 1,447), 583 (40.3%) would not pay for an Ebola vaccine; 864 (59.7%) would pay at least $1. Among those willing to pay at least $1: 570 (66.0%) would pay $1-50; 174 (20.1%) would pay $51-100; and 120 (13.9%) would pay more than $100. Willingness to pay at least $1 for an Ebola vaccine was associated with international travel; interest in getting an Ebola vaccine; and beliefs that the U.S. government should spend money to control Ebola and assume worldwide leadership in confronting emerging epidemics. Willingness to pay more than $50 was associated with similar variables. Willingness to pay more than $100 was associated with international travel; interest in getting an Ebola vaccine; information seeking; and beliefs that the U.S. government should assume worldwide leadership in confronting emerging epidemics. International travel and interest in an Ebola vaccine were key predictors of willingness to pay across all price points. Understanding willingness to pay for vaccines against emerging infectious diseases remains critical.

Knowledge and attitudes about Ebola vaccine among the general population in Sierra Leone.

BACKGROUND: Clinical trials of Ebola vaccine are ongoing. Before it becomes commercially available, understanding the Ebola vaccine-related knowledge and attitude of the general population is imperative to developing an effective vaccine coverage strategy. METHODS: We conducted a survey including 400 participants from general communities of the West Area Rural District, Sierra Leone. Knowledge and attitudes about Ebola vaccine were investigated, and the determinants of having knowledge and a positive attitude toward accepting vaccination were identified. RESULTS: Over half (55.8%) of the participants were aware of Ebola vaccine. About 60% of the participants were willing to be study subjects if the Ebola vaccine clinical trial were conducted in their communities. Most of the participants (72.5%) were willing to take Ebola vaccination if it was free of charge. Given that the vaccination was not free, the proportion willing to pay a fee to take the vaccination declined dramatically to 26.6%. Using a forward step-wise logistic model, monthly salary was identified as the single determinant (OR for every 100,000 Leones increase: 1.17, 95%CI: 1.04-1.31) for awareness of Ebola vaccine, which was identified as the determinant (OR: 1.88, 95%CI: 1.17-3.02) for free vaccination uptake willingness. The combination of monthly salary, monthly average income of family members and their interaction was found to be associated with charged vaccination uptake willingness. DISCUSSION: Measures are still needed to promote the Ebola vaccine awareness and knowledge updating. Free or low-priced vaccine could increase the vaccination acceptability of the general community population significantly.

The Ebola Vaccine, Iatrogenic Injuries, and Legal Liability.

Amir Attaran and Kumanan Wilson propose a compensation system for vaccine injuries, based on no-fault principles, to ensure that recipients of Ebola vaccines are fairly compensated in cases of iatrogenic harm.

Addressing fear, fighting complacency.

Nature has us wired instinctively to be cautious of things that are unknown or unfamiliar. Children may fear the dark, but even as adults we remain afraid of things that go bump in the night.

Acceptability and Willingness-to-Pay for a Hypothetical Ebola Virus Vaccine in Nigeria.

BACKGROUND: Ebola virus disease is a highly virulent and transmissible disease. The largest recorded fatality from Ebola virus disease epidemic is ongoing in a few countries in West Africa, and this poses a health risk to the entire population of the world because arresting the transmission has been challenging. Vaccination is considered a key intervention that is capable of arresting further spread of the disease and preventing future outbreak. However, no vaccine has yet been approved for public use, although various recombinant vaccines are undergoing trials and approval for public use is imminent. Therefore, this study aimed to determine the acceptability of and willingness-to-pay for Ebola virus vaccine by the public. METHODS: The study was a community-based cross-sectional qualitative and quantitative interventional study conducted in two communities, each in two states in Nigeria. An interviewer-administered questionnaire was used to collect information on respondents' knowledge of the Ebola virus, the ways to prevent the disease, and their preventive practices, as well as their acceptability of and willingness-to-pay for a hypothetical vaccine against Ebola virus disease. The association between acceptability of the vaccine and other independent variables were evaluated using multivariate regression analysis. RESULTS: Ebola virus disease was considered to be a very serious disease by 38.5% of the 582 respondents (224/582), prior to receiving health education on Ebola virus and its vaccine. Eighty percent (80%) accepted to be vaccinated with Ebola vaccine. However, among those that accepted to be vaccinated, most would only accept after observing the outcome on others who have received the vaccine. More than 87.5% was willing to pay for the vaccine, although 55.2% was of the opinion that the vaccine should be provided free of charge. CONCLUSION: The level of acceptability of Ebola virus vaccine among respondents was impressive (though conditional), as well as their willingness to pay for it if the vaccine is not publicly funded. In order to achieve a high uptake of the vaccine, information and education on the vaccine should be extensively shared with the public prior to the introduction of the vaccine, and the vaccine should be provided free of charge by government.