Abstract
BackgroundIn 2000/2001, the Australian Defense Forces (ADF), in collaboration with SmithKline Beecham and the United States Army, conducted a field trial to evaluate the safety, tolerability and efficacy of tafenoquine and mefloquine/primaquine for the prophylaxis of malaria amongst non-immune Australian soldiers deployed to East Timor (now called Timor Leste) for peacekeeping operations. The lack of a concurrent placebo control arm prevented an internal estimate of the malaria attack rate and so the protective efficacy of the study regimens was not determined at the time.MethodsIn a retrospective analysis of the trial results, the all species malaria attack rate was estimated for the prophylactic phase of the study which was defined as the period between administration of the first prophylactic dose and the first dose of post-deployment medication. First, the Plasmodium vivax attack rate was estimated during the prophylactic phase of the deployment by adjusting the observed P. vivax relapse rate during post-deployment to account for the known anti-relapse efficacies (or effectiveness) of the study medications (determined from prior studies). The all species malaria attack rate (P. vivax and Plasmodium falciparum) was then determined by adjusting the P. vivax attack rate based on the ratio of P. falciparum to P. vivax observed during prior ADF deployments to Timor Leste. This estimated all species malaria attack rate was then used as the ‘constant estimated attack rate’ in the calculation of the protective efficacy of tafenoquine and mefloquine during the prophylactic phase of the deployment.ResultsThe estimated attack rate during the prophylactic phase of the study was determined to be 7.88%. The protective efficacies of tafenoquine and mefloquine, with corresponding 95% confidence intervals (95% CI), were determined to be 100% (93%-100%) and 100% (79%-100%) respectively.ConclusionsThe protective efficacy of tafenoquine (200 mg per day for three days, followed by weekly 200 mg maintenance doses) is similar to that of the weekly standard of care (mefloquine, 250 mg).
Highlights
In 2000/2001, the Australian Defense Forces (ADF), in collaboration with SmithKline Beecham and the United States Army, conducted a field trial to evaluate the safety, tolerability and efficacy of tafenoquine and mefloquine/ primaquine for the prophylaxis of malaria amongst non-immune Australian soldiers deployed to East Timor for peacekeeping operations
In 2000/2001, the safety, tolerability and efficacy of weekly tafenoquine and mefloquine were evaluated in malaria non-immune Australian soldiers from the 1st Battalion, Royal Australian Regiment (1RAR) deployed on peacekeeping operations to Timor Leste and who volunteered to participate in a Phase 3 study [6]
All species attack rates were substantially lower for subsequent deployments, ranging from 0.53
Summary
In 2000/2001, the Australian Defense Forces (ADF), in collaboration with SmithKline Beecham and the United States Army, conducted a field trial to evaluate the safety, tolerability and efficacy of tafenoquine and mefloquine/ primaquine for the prophylaxis of malaria amongst non-immune Australian soldiers deployed to East Timor ( called Timor Leste) for peacekeeping operations. In 2000/2001, the safety, tolerability and efficacy of weekly tafenoquine and mefloquine were evaluated in malaria non-immune Australian soldiers from the 1st Battalion, Royal Australian Regiment (1RAR) deployed on peacekeeping operations to Timor Leste and who volunteered to participate in a Phase 3 study [6]. In that study, which is referred to as Study 033 from here on, the protective efficacy of tafenoquine was not calculated because the study lacked a concurrent placebo control arm. The study team concluded that both tafenoquine and mefloquine were effective since no malaria cases were observed during the prophylactic phase of the study, and the observation of Plasmodium vivax relapses during followup, together with epidemiology data from military and civilian sources suggested substantial exposure to malaria [7,8,9,10]
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