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BackgroundLong-lasting insecticidal bed nets (LLINs) are a key measure for preventing malaria and their evaluation is coordinated by the World Health Organization Pesticide Evaluation Scheme (WHOPES). LifeNet® was granted WHOPES time-limited interim recommendation in 2011 after successful Phase I and Phase II evaluations. Here, we evaluated the durability and community acceptance of LifeNet® in a Phase III trial from June 2014 to June 2017 in Benin rural area.MethodsA prospective longitudinal, cluster-randomized, controlled trial with households as the unit of observation was designed to assess the performance of LifeNet® over a three-year period, using a WHOPES fully recommended LLIN (PermaNet® 2.0) as a positive control. The primary outcomes were the bioassay performance using WHO cone assays and tunnel tests, the insecticide content and physical integrity.ResultsAt baseline, 100% of LLINs were within the tolerance limits of their target deltamethrin concentrations. By 36 months only 17.3% of LifeNet® and 8.5% of PermaNet® LLINs still were within their target deltamethrin concentrations. Despite these low rates, 100% of both LLINs meet WHO efficacy criteria (≥ 80% mortality or ≥ 95% knockdown or tunnel test criteria of ≥ 80% mortality or ≥ 90% blood-feeding inhibition) after 36 months using WHO cone bio-assays and tunnel tests. The proportion of LLINs in good physical condition was 33% for LifeNet® and 29% for PermaNet® after 36 months. After 36 M the survivorship was 21% and 26% for LifeNet® and PermaNet® respectively. Although both LLINs were well accepted by the population, complaints of side effects were significantly higher among LifeNet® users than PermaNet® ones.ConclusionLifeNet® LLINs did meet WHO criteria for bio-efficacy throughout the study period and were well accepted by the population. This is an important step towards getting a full WHO recommendation for use in malaria endemic countries.</div

Insecticide content (g/kg) in LifeNet and PermaNet 2.0 at 0, 12, 24 and 36 months after distribution.

Insecticide content (g/kg) in LifeNet and PermaNet 2.0 at 0, 12, 24 and 36 months after distribution.</p

Proportion of LLINs meeting WHOPES efficacy criteria (knockdown ≥ 95% or mortality ≥ 80%) according to cone tests.

Proportion of LLINs meeting WHOPES efficacy criteria (knockdown ≥ 95% or mortality ≥ 80%) according to cone tests.</p

Summary of LLINs sampling scheme during the study.

Summary of LLINs sampling scheme during the study.</p

Survivorship of LifeNet and PermaNet LLINs.

BackgroundLong-lasting insecticidal bed nets (LLINs) are a key measure for preventing malaria and their evaluation is coordinated by the World Health Organization Pesticide Evaluation Scheme (WHOPES). LifeNet® was granted WHOPES time-limited interim recommendation in 2011 after successful Phase I and Phase II evaluations. Here, we evaluated the durability and community acceptance of LifeNet® in a Phase III trial from June 2014 to June 2017 in Benin rural area.MethodsA prospective longitudinal, cluster-randomized, controlled trial with households as the unit of observation was designed to assess the performance of LifeNet® over a three-year period, using a WHOPES fully recommended LLIN (PermaNet® 2.0) as a positive control. The primary outcomes were the bioassay performance using WHO cone assays and tunnel tests, the insecticide content and physical integrity.ResultsAt baseline, 100% of LLINs were within the tolerance limits of their target deltamethrin concentrations. By 36 months only 17.3% of LifeNet® and 8.5% of PermaNet® LLINs still were within their target deltamethrin concentrations. Despite these low rates, 100% of both LLINs meet WHO efficacy criteria (≥ 80% mortality or ≥ 95% knockdown or tunnel test criteria of ≥ 80% mortality or ≥ 90% blood-feeding inhibition) after 36 months using WHO cone bio-assays and tunnel tests. The proportion of LLINs in good physical condition was 33% for LifeNet® and 29% for PermaNet® after 36 months. After 36 M the survivorship was 21% and 26% for LifeNet® and PermaNet® respectively. Although both LLINs were well accepted by the population, complaints of side effects were significantly higher among LifeNet® users than PermaNet® ones.ConclusionLifeNet® LLINs did meet WHO criteria for bio-efficacy throughout the study period and were well accepted by the population. This is an important step towards getting a full WHO recommendation for use in malaria endemic countries.</div

Physical condition of LifeNet and PermaNet LLINs based on the proportionate hole index (pHI).

Box plot indicating median and 95% confidence interval, dashed line = threshold of good net condition (pHI ≥64).</p

Bio-efficacy of LifeNet and PermaNet LLINs against <i>An</i>. <i>gambiae</i> Kisumu strain.

(A) and (B) show knockdown and mortality rates using cone bio-assays, while (C) and (D) display mortality and blood feeding rates using tunnel tests. Boxes display the median value, 25th and 75th percentiles. The whiskers show the 5th/95th percentiles and the dots indicate the outliers. Dashed lines indicate threshold of WHOPES efficacy criteria.</p

Proportions of LLIN usage throughout the study period.

Proportions of LLIN usage throughout the study period.</p

Population size and LLIN distribution and coverage in each village.

Population size and LLIN distribution and coverage in each village.</p

Proportion of LLIN users who declared at least one side effect at 1 week and 1 month after LLIN distribution.

Proportion of LLIN users who declared at least one side effect at 1 week and 1 month after LLIN distribution.</p