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Journal ArticleDOI

Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India

TL;DR: A community-based vaccine trial to assess the efficacy of live attenuated influenza vaccine and inactivated influenza vaccine in rural north India was conducted and lessons may help investigators to confront similar challenges in other LMICs.
Abstract: Evidence on influenza vaccine effectiveness from low and middle countries (LMICs) is limited due to limited institutional capacities; lack of adequate resources; and lack of interest by ministries of health for influenza vaccine introduction. There are concerns that the highest ethical standards will be compromised during trials in LMICs leading to mistrust of clinical trials. These factors pose regulatory and operational challenges to researchers in these countries. We conducted a community-based vaccine trial to assess the efficacy of live attenuated influenza vaccine and inactivated influenza vaccine in rural north India. Key regulatory challenges included obtaining regulatory approvals, reporting of adverse events, and compensating subjects for trial-related injuries; all of which were required to be completed in a timely fashion. Key operational challenges included obtaining audio-visual consent; maintaining a low attrition rate; and administering vaccines during a narrow time period before the influenza season, and under extreme heat. We overcame these challenges through advanced planning, and sustaining community engagement. We adapted the trial procedures to cope with field conditions by conducting mock vaccine camps; and planned for early morning vaccination to mitigate threats to the cold chain. These lessons may help investigators to confront similar challenges in other LMICs.
Citations
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Journal ArticleDOI
TL;DR: In this article, the absolute and relative efficacy of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine(IIV) among children aged 2 to 10 years in rural India through a randomized, triple-blind, placebo-controlled trial conducted over 2 years.
Abstract: Background Influenza is a cause of febrile acute respiratory infection (FARI) in India; however, few influenza vaccine trials have been conducted in India. We assessed absolute and relative efficacy of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) among children aged 2 to 10 years in rural India through a randomized, triple-blind, placebo-controlled trial conducted over 2 years. Methods and findings In June 2015, children were randomly allocated to LAIV, IIV, intranasal placebo, or inactivated polio vaccine (IPV) in a 2:2:1:1 ratio. In June 2016, vaccination was repeated per original allocation. Overall, 3,041 children received LAIV (n = 1,015), IIV (n = 1,010), nasal placebo (n = 507), or IPV (n = 509). Mean age of children was 6.5 years with 20% aged 9 to 10 years. Through weekly home visits, nasal and throat swabs were collected from children with FARI and tested for influenza virus by polymerase chain reaction. The primary outcome was laboratory-confirmed influenza-associated FARI; vaccine efficacy (VE) was calculated using modified intention-to-treat (mITT) analysis by Cox proportional hazards model (PH) for each year. In Year 1, VE was 40.0% (95% confidence interval (CI) 25.2 to 51.9) for LAIV and 59.0% (95% CI 47.8 to 67.9) for IIV compared with controls; relative efficacy of LAIV compared with IIV was -46.2% (95% CI -88.9 to -13.1). In Year 2, VE was 51.9% (95% CI 42.0 to 60.1) for LAIV and 49.9% (95% CI 39.2 to 58.7) for IIV; relative efficacy of LAIV compared with IIV was 4.2% (95% CI -19.9 to 23.5). No serious adverse vaccine-attributable events were reported. Study limitations include differing dosage requirements for children between nasal and injectable vaccines (single dose of LAIV versus 2 doses of IIV) in Year 1 and the fact that immunogenicity studies were not conducted. Conclusions In this study, we found that LAIV and IIV vaccines were safe and moderately efficacious against influenza virus infection among Indian children. Trial registration Clinical Trials Registry of India CTRI/2015/06/005902.

5 citations

Journal ArticleDOI
TL;DR: In this article, the authors describe unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India and describe the ethical issues faced.
Abstract: This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health.

2 citations

Journal ArticleDOI
TL;DR: The influenza vaccine is presently widely used around the world and in use in many countries, and many countries already implemented influenza vaccination into national vaccination programme.
Abstract: Influenza virus, an important pathogenic virus causes influenza infection which is an important public health problem. Due to the possibility of the worldwide pandemic, several public health manipulations against influenza are presently implemented. In general, a patient with influenza infection is managed by standard antiviral drug1, though the prevention is better than correction by treatment. An important primary prevention is influenza vaccination2. The influenza vaccine is presently widely used around the world. Many countries already implemented influenza vaccination into national vaccination programme2. In South Asia also, the influenza vaccine is available and in use.

2 citations

References
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Journal ArticleDOI
04 Nov 2013-Vaccine
TL;DR: Standardized cost-effectiveness studies of influenza vaccination of WHO-recommended risk groups' methods are urgently needed because decision makers in lower income countries lack economic data to support influenza vaccine policy decisions, especially of pregnant women.

172 citations


"Challenges in conducting a communit..." refers background in this paper

  • ...Evidence on effectiveness from low and middle income countries (LMICs) is limited.(1,2) The paucity of research is due to limited institutional capacities in laboratory and field research and lack of adequate resources....

    [...]

Journal ArticleDOI
TL;DR: A new rule enacted by the government of India that allows foreign pharmaceutical companies and other interested parties to conduct clinical trials of new drugs in India at the same time that trials of the same phase are being conducted in other countries is discussed.
Abstract: Drs. Samiran Nundy and Chandra Gulhati discuss a new rule enacted by the government of India that allows foreign pharmaceutical companies and other interested parties to conduct clinical trials of new drugs in India at the same time that trials of the same phase are being conducted in other countries.

162 citations

Journal ArticleDOI
25 Oct 2013-Vaccine
TL;DR: Seasonal influenza vaccines can provide protection in children, the elderly and patients with coronary syndromes in MICs, and seem to be equally effective as compared to high income countries.

48 citations


"Challenges in conducting a communit..." refers background in this paper

  • ...Evidence on effectiveness from low and middle income countries (LMICs) is limited.(1,2) The paucity of research is due to limited institutional capacities in laboratory and field research and lack of adequate resources....

    [...]

Journal ArticleDOI
TL;DR: The media messages put forth by different stakeholders in two Ebola vaccine trials that became controversial in Ghana are studied to identify points of concern that can inform health communication, suggesting that this tool may be valuable in future epidemics and crises.
Abstract: Communication is of paramount importance in responding to health crises. We studied the media messages put forth by different stakeholders in two Ebola vaccine trials that became controversial in Ghana. These interactions between health authorities, political actors, and public citizens can offer key lessons for future research. Through an analysis of online media, we analyse stakeholder concerns and incentives, and the phases of the dispute, to understand how the dispute evolved to the point of the trials being suspended, and analyse what steps might have been taken to avert this outcome. A web-based system was developed to download and analyse news reports relevant to Ebola vaccine trials. This included monitoring major online newspapers in each country with planned clinical trials, including Ghana. All news articles were downloaded, selecting out those containing variants of the words “Ebola,” and “vaccine,” which were analysed thematically by a team of three coders. Two types of themes were defined: critiques of the trials and rebuttals in favour of the trials. After reconciling differences between coders’ results, the data were visualised and reviewed to describe and interpret the debate. A total of 27,460 articles, published between 1 May and 30 July 2015, were collected from nine different newspapers in Ghana, of which 139 articles contained the keywords and met the inclusion criteria. The final codebook included 27 themes, comprising 16 critiques and 11 rebuttals. After coding and reconciliation, the main critiques (and their associated rebuttals) were selected for in-depth analysis, including statements about the trials being secret (mentioned in 21% of articles), claims that the vaccine trials would cause an Ebola outbreak in Ghana (33%), and the alleged impropriety of the incentives offered to participants (35%). Perceptions that the trials were “secret” arose from a combination of premature news reporting and the fact that the trials were prohibited from conducting any publicity before being approved at the time that the story came out, which created an impression of secrecy. Fears about Ebola being spread in Ghana appeared in two forms, the first alleging that scientists would intentionally infect Ghanaians with Ebola in order to test the vaccine, and the second suggesting that the vaccine might give trial participants Ebola as a side-effect – over the course of the debate, the latter became the more prominent of the two variants. The incentives were sometimes criticised for being coercively large, but were much more often criticised for being too small, which may have been related to a misperception that the incentives were meant as compensation for the trials’ risks, which were themselves exaggerated. The rumours captured through this research indicate the variety of strong emotions drawn out by the trials, highlighting the importance of understanding the emotional and social context of such research. The uncertainty, fear, and distrust associated with the trials draw from the contemporary context of the Ebola outbreak, as well as longstanding historical issues in Ghana. By analysing the debate from its inception, we can see how the controversy unfolded, and identify points of concern that can inform health communication, suggesting that this tool may be valuable in future epidemics and crises.

48 citations

Journal ArticleDOI
TL;DR: Influenza circulation in tropics and subtropics reveals a complex seasonal pattern with year‐round circulation in some areas and biannual peaks in others, with some areas experiencing year-round peaks and others experiencing seasonal peaks.
Abstract: Introduction Influenza circulation in tropics and subtropics reveals a complex seasonal pattern with year‐round circulation in some areas and biannual peaks in others.

40 citations

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What are the challenges of conducting a community needs assessment in foreign countries?

The provided paper is about the challenges of conducting a community-based influenza vaccine trial in a rural community in northern India. It does not specifically mention the challenges of conducting a community needs assessment in foreign countries.