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  • In two studies are reported by W

    2019-04-28

    In , two studies are reported by W Abdullah Brooks and colleagues and John C Victor and colleagues that present the safety and efficacy results for an Indian-made Russian-backbone LAIV given to young children in Bangladesh and Senegal. Both studies were randomised controlled trials, and both confirmed LAIV safety in children aged 2–5 years. Reactions within 7 days of vaccine receipt were mostly mild, and were most commonly cough (6·5% in Bangladesh and 9·7% in Senegal) and runny nose (6·1% and 17·1%). This good safety profile is in concordance with the findings in an earlier safety and immunogenicity LAIV trial done in Bangladesh in 2012. Also of note is that Abdullah and colleagues\' study in Bangladesh included a large cohort of children with history of EVP-6124 and wheezing, and no increase in any safety signals was seen in these children following the receipt of the LAIV. The vaccine efficacy differed notably between the two countries, from 57·5% (95 CI 43·6 to 68·0) in Bangladesh to 0·0% (–26·4 to 20·9) in Senegal, despite use of the same LAIV lot. Attack rates for H1N1pdm09 viruses were high in both studies, and the absence of vaccine efficacy in Senegal was mainly due to the lack of protection against this strain, which was the predominant vaccine-matched strain, and high circulation of mismatched influenza B strains during the trial. Victor and colleagues could find no clear explanation for the discrepancy in vaccine efficacy between study sites. I suggest that the most reasonable explanations would be the low temperature stability of the H1N1dpm09 LAIV component. The A/California strain has 47Glu residue in the haemagglutinin 2 subunit that renders the virus unstable. Although the shelf life and the cold chain of the vaccine had been monitored rigorously by the manufacturer, a very hot environment in Senegal might have negatively affected the infectivity of the H1N1dpm09 component. Immunisation in an air-conditioned environment might help to maintain virus infectivity.
    Efforts to address malnutrition, maternal and child mortality, and other global health priorities are heavily reliant on behaviour change, including adoption and correct use of health technology, and following treatment recommendations. One long-standing concern is the limited effectiveness of many behaviour change interventions, even when exposure to intervention activities is adequate, and activities are implemented with high fidelity. A second concern is low coverage of proven behaviour change interventions, under conditions of routine programme implementation. Those people who are not reached might be the poorest or most vulnerable, and therefore the ones who stand to gain the most from the intervention. Target of emotional drivers such as affiliation (social inclusion), nurture, and disgust, has been identified as one way to increase the effectiveness of behaviour change interventions, with disgust considered appropriate specifically for promoting avoidance of sources of infection. The investigation by Katie Greenland and colleagues of a behaviour change intervention for diarrhoea control in Zambia represents an attempt to operationalise this concept of harnessing emotional drivers to increase uptake of desired behaviours under routine conditions. The authors categorise their trial as a proof of concept, and lay out their theory of change to demonstrate how intervention activities bring about changes in protective and treatment-related health behaviours. The intervention promotes four very different behaviours. Intervention uptake goals vary, from establishing a new and permanent habit (handwashing with soap), to a temporary habit (exclusive breastfeeding), to the immediate response to a sick child (preparation of oral rehydration salt solution and zinc treatment for childhood diarrhoea). Furthermore, the emotional drivers the intervention aims to encourage might apply to the four behaviours in different ways. Implicit in the authors\' theory of change is a concern for intervention fidelity, “the degree to which an intervention is delivered as intended”. Kim and colleagues identify four aspects of implementation fidelity that warrant attention in a community based study: adherence, dosage and exposure, quality of delivery, and participant responsiveness. Greenland and colleagues assert that their study “demonstrate[ed] that a model based on emotional drivers may prompt change in exclusive breastfeeding behaviour”. Using disgust for promotion of handwashing as one example, Greenland and colleagues do not present evidence that the change agents (Komboni housewives) received training or guidelines on how to create feelings of disgust when interacting with the community, or followed these guidelines (adherence). Dosage and exposure to activities eliciting feelings of disgust are not presented, nor do we learn if people actually felt disgusted when exposed to these activities (participant responsiveness). Further, we question whether the change agents operationalised disgust to a sufficient degree as so to elicit a behavioural response. The concept of sufficient quantities is crucial for interventions targeting emotions such as disgust. Nicholson and colleagues indicate that it is not necessarily an individual\'s tendency (propensity) to feel disgusted that leads to effects on behaviour, but rather the degree (sensitivity) to which that disgust is felt. Greenland and colleagues present no data on intervention fidelity in this paper, so we cannot judge if this study constitutes a fair test of the effectiveness of emotional drivers in increasing uptake of these four behaviours. When we fail to observe changes in behaviour, we are not in a position to know if the problem lies with the limited technical effectiveness of the intervention, or insufficient exposure to intervention activities for change to occur.