Clinical development of new prophylactic antimalarial drugs after the 5th Amendment to the Declaration of Helsinki

References

• Anon2002Fair benefits for research in developing countriesScience2982133412481120
   PubMed Web of Science ®Google Scholar
• BairdJKBasriHSubiantoB1995Treatment of chloroquine-resistant Plasmodium vivax with chloroquine and primaquine or halofantrineJ Infect Dis1711678827769318
   PubMed Web of Science ®Google Scholar
• BairdJKLaceyMDBasriH2001Randomized, parallel placebo-controlled trial of primaquine for malaria prophylaxis in Papua, IndonesiaClin Infect Dis221990711712091
   PubMed Web of Science ®Google Scholar
• BairdJSchwartzEHoffmanS2007Prevention and treatment of vivax malariaCurr Infect Dis Rep9394617254503
   PubMedGoogle Scholar
• BautistaCTChanASRyanJR2006Epidemiology and spatial analysis of malaria in the Northern Peruvian AmazonAm J Trop Med Hyg7512162217172396
   PubMed Web of Science ®Google Scholar
• BejonPAndrewsLAndersonRF2005Calculation of liver-to-blood inocula, parasite growth rates, and preerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoitesJ Infect Dis1916192615655787
   PubMed Web of Science ®Google Scholar
• BermanJDNeilsenRChulayJD2001Causal prophylactic efficacy of atovaquone-proguanil (MalaroneTM) in a human challenge modelTrans R Soc Med Hyg9542932
   PubMed Web of Science ®Google Scholar
• Bill and Melinda Gates Foundation2007Eradication of malaria [online]. Accessed November 28, 2007. URL: http://www.gatesfoundation.org/MediaCenter/Speeches/Co-ChairSpeeches/BillgSpeeches/BGSpeech-MalariaForum-071017.htm
   Google Scholar
• Biomarkers Definitions Working Group2001Biomarkers and surrogate endpoints: preferred definitions and conceptual frameworkClin Pharmacol Ther69899511240971
   PubMed Web of Science ®Google Scholar
• BlackmerJHaddadH2005The Declaration of Helsinki: an update on paragraph 30CMAJ1739
   Web of Science ®Google Scholar
• BoggildAKPariseMELewisLS2007Atovaquone-proguanil: report from the CDC expert meeting on malaria chemoprophylaxis (II)Am J Trop Med Hyg762082317297027
   PubMed Web of Science ®Google Scholar
• BruecknerRPCosterTWescheDL1998aProphylaxis of Plasmodium falciparum infection in a human challenge model with WR 238605, a new 8-aminoquinoline antimalarialAntimicrob Agents Chemo4212934
   PubMed Web of Science ®Google Scholar
• BruecknerRPLasseterKCLinET1998bFirst-time-in humans safety and pharmacokinetics of WR238605, a new antimalarialAm J Top Med Hyg586459
   PubMed Web of Science ®Google Scholar
• BruecknerRPOhrtCBairdJK20018-AminoquinolinesRosenthalPJAntimalarial chemotherapy: Mechanisms of action, resistance, and new directions in drug discoveryNew JerseyThe Humana Press, Inc
   Google Scholar
• BryanJP2006Cost considerations of malaria chemoprophylaxis including use of primaquine for primary or terminal chemoprophylaxisAm J Trop Med Hyg754165016968914
   PubMed Web of Science ®Google Scholar
• CarlsonRVBoydKMWebbDJ2004The revision of the Declaration of Helsinki: past, present and futureBr J Clin Pharmacol576957315151515
   PubMed Web of Science ®Google Scholar
• ChandramohanDOwusu-AgyeiSCarneiroI2005Cluster ran-domised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in GhanaBMJ3317273316195288
   PubMed Web of Science ®Google Scholar
• ChenLHKeystoneJS2005New strategies for the prevention of malaria in travelersInfect Dis Clin N Am19185210
   PubMed Web of Science ®Google Scholar
• ChenLHWilsonMESchlagenhaufP2006Prevention of malaria in long-term travelersJAMA29622344417090770
   PubMed Web of Science ®Google Scholar
• ChristenDSteffenRSchlagenhaufP2006Deaths caused by malaria in Switzerland 1988–2002Am J Trop Med Hyg7511889417172391
   PubMed Web of Science ®Google Scholar
• ChurchLWLeTPBryanJP1997Clinical manifestations of Plasmodium falciparum malaria experimentally induced by mosquito challengeJ Infect Dis175915209086149
   PubMed Web of Science ®Google Scholar
• DavisTMHungTYSimIK2005Piperaquine: a resurgent antimalarial drugDrugs65758715610051
   PubMed Web of Science ®Google Scholar
• DruilhePPradierOParentG1986Levels of antibodies to Plasmodium sporozoite surface antigens reflect malaria transmission and are persistent in the absence of reinfectionInfect Immun5339373525412
   PubMed Web of Science ®Google Scholar
• DunachieSJWaltherMEpsteinJE2006A DNA prime-modified vaccinia virus Ankara boost vaccine encoding thrombospondin-related adhesion protein but no circumsporozoite protein partially protects healthy malaria-naïve adults against Plasmodium falciparum sporozoite challengeInfect Immun7459334216988273
   PubMed Web of Science ®Google Scholar
• DunneMWSinghNShuklaM2005A multicenter study of azithro-mycin, alone and in combination with chloroquine, for the treatment of acute uncomplicated Plasmodium falciparum malaria in IndiaJ Infect Dis1911582815838784
   PubMed Web of Science ®Google Scholar
• EdsteinMDKoteckaBMAndersonKL2005Lengthy antimalarial activity of atovaquone in human plasma following atovaquone-proguanil administrationAntimicr Agents Chemo4944212
   PubMed Web of Science ®Google Scholar
• EganACrawleyJSchellenbergD2005Intermittent preventive treatment for malaria control in infants: moving towards evidence-based policy and public health actionTrop Med Int Health108151716135186
   PubMed Web of Science ®Google Scholar
• EmmanuelEJMillerFG2001The ethics of placebo-controlled trials-a middle groundN Engl J Med3459151911565527
   PubMed Web of Science ®Google Scholar
• ForsterHPEmanuelEGradyC2001The 2000 revision of the Declaration of Helsinki: a step forward or more confusionLancet25914495311705513
   PubMed Web of Science ®Google Scholar
• GeerligsPDBrabinBJEggelteTA2003Analysis of the effects of malaria chemoprophylaxis in children on haematological responses, morbidity and mortalityBull World Health Organ812051612764517
   PubMed Web of Science ®Google Scholar
• GlaxoSmithKline2004Malarone™ (atovaquone-proguanil) [prescribing information]Research Triangle Park, NCGlaxoSmith Kline
   Google Scholar
• GreenwoodBM1989The microepidemiology of malaria and its importance to malaria controlTrans R Soc Trop Med Hyg832592576161
   PubMedGoogle Scholar
• GreenwoodBMDavidPHOtoo-Forbes1995Mortality and morbidity from malaria after stopping malaria chemoprophylaxisTrans R Soc Trop Med Hyg89629338594677
   PubMed Web of Science ®Google Scholar
• HaleBROwusu-AgyeiSFryauffDJ2003A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparumClin Infect Dis36541912594633
   PubMed Web of Science ®Google Scholar
• HasugianARPurbaHLKenangalemE2007Dihydroartemisinin-piperaquine versus artesunate-amodiaquine: superior efficacy and post-treatment prophylaxis against multi-drug-resistant Plasmodium falciparum and Plasmodium vivax malariaClin Inf Dis44106774
   PubMed Web of Science ®Google Scholar
• HeppnerDGKesterKEOckenhouseCF2005aToward an RTS, S-based, multi-stage, multiantigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of ResearchVaccine17–18224350
   Web of Science ®Google Scholar
• HeppnerDGWalshDSUthaimongkolN2005bRandomized, controlled double-blind trial of daily oral azithromycin in adults for the prophylaxis of Plasmodium vivax malaria in Western ThailandAm J Trop Med Hyg73842916282291
   PubMed Web of Science ®Google Scholar
• HillDRBairdJKPariseME2006Primaquine: Report from CDC expert meeting on malaria chemoprophylaxisAm J Trop Med Hyg7540115
   Web of Science ®Google Scholar
• HoghBClarkePDCamusD2000Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune travelers: a randomized, double blind studyLancet35618889411130385
   PubMed Web of Science ®Google Scholar
• KiousBM2001The Nuremburg Code: Its history and implicationsPrinceton J Bioethics4719
   PubMedGoogle Scholar
• La VaqueTJRossiterT2001The ethical use of placebo controls in clinical research: The Declaration of HelsinkiApp Psychophysiol Biofeedback262337
   PubMed Web of Science ®Google Scholar
• LapierreDIDuparcS2007The industry perspective on the Declaration of HelsinkiCongress of International Society of Tropical Medicine, 2007, Vancouver, Canada. Abstract SY0602.
   Google Scholar
• LegrosFBouchaudOAncelleT2007Risk factors for imported fatal Plasmodium falciparum malaria, France, 1996–2003Emerg Infect Dis13883817553228
   PubMed Web of Science ®Google Scholar
• LellBKucknerDNdjaveM1998Randomised placebo-controlled study of atovaquone plus proguanil for malaria prophylaxis in childrenLancet351709139504515
   PubMed Web of Science ®Google Scholar
• LellBFaucherJFMisinouMA2000Malaria chemoprophylaxis with tafenoquine: a randomized studyLancet3552041510885356
   PubMed Web of Science ®Google Scholar
• LieRKEmanuelEGradyC2004The standard of care debate: the Declaration of Helsinki versus the international consensus opinionJ Med Ethics30190315082816
   PubMed Web of Science ®Google Scholar
• LingJBairdJKFryauffDJ2002Randomized, placebo-controlled trial of atovaquone/proguanil for the prevention of Plasmodium falciparum or Plasmodium vivax malaria among migrants to Papua, IndonesiaClin Infect Dis358253312228819
   PubMed Web of Science ®Google Scholar
• LooareesuwanSChulayJDCanfieldCJ1999Malarone™ (atovaquone and proguanil hydrochloride): A review of its clinical development for the treatment of malariaAm J Trop Med Hyg605334110348225
   PubMed Web of Science ®Google Scholar
• MacateEAidePAponteJJ2006Intermittent preventive treatment for malaria control administered at the time of routine vaccinations in Mozambican infants: a randomized, placebo-controlled trialJ Infect Dis1942768516826474
   PubMed Web of Science ®Google Scholar
• MacklinR2001After Helsinki: unresolved issues in international researchKennedy Inst Ethics J11173612166444
   PubMed Web of Science ®Google Scholar
• MagillAJ2004Malaria: Epidemiology and risk to the travelerKeystoneJKozarskyPFreedmanDTravel medicine. Chapter 12. Edinburgh, ScotlandMosby
   Google Scholar
• MarraFSalzmanJREnsomMHH2003Atovaquone-proguanil for pro-phylaxis and treatment of malariaAnn Pharmacother3712667512921511
   PubMed Web of Science ®Google Scholar
• MenendezCKahigwaEHirtR1997Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anemia and malaria in Tanzanian infantsLancet350844509310602
   PubMed Web of Science ®Google Scholar
• MilhousWK2001Development of new drugs for chemoprophylaxis of malariaMed Trop614850
   PubMedGoogle Scholar
• MillerFGGradyC2001The ethical challenge of infection-inducing challenge experimentsClin Infect Dis3310283311528576
   PubMed Web of Science ®Google Scholar
• MillerKDLobelHOSatrialeRF1986Severe cutaneous reactions among American travellers taking pyrimethamine-sulfadoxine (Fansidar) for malaria prophylaxisAm J Trop Med Hyg35451582939735
   PubMed Web of Science ®Google Scholar
• MillerRSWongsrichanalaiCBuathongN2006Effective treatment of uncomplicated Plasmodium falciparum malaria with azithromycin-quinine combinations: a randomized, dose-ranging studyAm J Top Med Hyg734016
   Web of Science ®Google Scholar
• MuentenerPSchlagenhaufPSteffenR1999Imported malaria (1985–1995): Trends and perspectivesBull World Health Org775606610444879
   PubMed Web of Science ®Google Scholar
• NasveldPBrennanLKitchenerS2002aA randomised, double-blind comparative study to evaluate the safety, tolerability and effectiveness of tafenoquine and mefloquine for the prophylaxis of malaria in non-immune Australian soldiers [abstract]Annual Meeting of the Americal Society of Tropical Medicine and Hygiene2002. Abstract 326.
   Google Scholar
• NasveldPKitchenerSEdsteinM2002bComparison of tafenoquine WR238605 and primaquine in the post exposure (terminal) prophylaxis of vivax malaria in Australian Defense Forces PersonnelTrans R Soc Trop Med Hyg96683412625150
   PubMed Web of Science ®Google Scholar
• NewmanRDPariseMEBarberAM2004Malaria-related deaths among U.S. travelers, 1963–2001Ann Intern Med1415475515466772
   PubMed Web of Science ®Google Scholar
• NoedlHKrudsoodSChalermatranaK2006Azithromycin combination therapy with artesunate or quinine for the treatment of uncomplicated Plasmodium falciparum malaria in adults: a randomized, phase 2 clinical trial in ThailandClin Infect Dis4312647117051490
   PubMed Web of Science ®Google Scholar
• NostenF2000Prophylactic effect of Malarone against malaria: all good news?Lancet3561864511130375
   PubMed Web of Science ®Google Scholar
• Novartis. 2006. Novartis accelerates production of life-saving malaria treatment Coartem [online]. Accessed June 15, 2007. URL: http://hugin.info/134323/R/1030389/165274.pdf
   Google Scholar
• OhrtCDoolanDBriceG2007Plasmodium antibodies as surrogate markers of malaria exposure5th European Congress on Tropical Medicine and International HealthAmsterdam, NetherlandsMay 2007
   Google Scholar
• OhrtCRichieTRWidjajaH1997Mefloquine compared with doxycycline for the prophylaxis of malaria in Indonesian soldiers. A randomized, double-blind, placebo-controlled trialAnn Intern Med126963729182474
   PubMed Web of Science ®Google Scholar
• O'MearaWPBremanJGMcKenzieFE2005The promise and potential challenges of intermittent preventive treatment for malaria in infants (IPTi)Malar J4315644136
   PubMed Web of Science ®Google Scholar
• Orlandi-PradinesEPenhoatKDurandC2006Antibody responses to several malaria pre-erythrocytic antigens as a marker of malaria exposure among travelersAm J Trop Med Hyg749798516760507
   PubMed Web of Science ®Google Scholar
• OverboschDSchilthuisHBienzleU2001Atovaquone-proguanil versus mefloquine for malaria prophylaxis in non-immune travelers: Results from a randomized double-blind studyClin Infect Dis3310152111528574
   PubMed Web of Science ®Google Scholar
• PetersW1999The evolution of tafenoquine: antimalarial for a new millennium?J R Soc Med923455210615272
   PubMed Web of Science ®Google Scholar
• PetersonE2004Malaria chemoprophylaxis: when should we use it and what are the options?Expert Rev Anti Infect Ther21193215482177
   PubMedGoogle Scholar
• ReynoldsT2000The ethics of placebo-controlled trialsAnn Intern Med13349110975985
   PubMed Web of Science ®Google Scholar
• RiisP2003Thirty years of bioethics: the Helsinki Declaration 1964–2003New Rev Bioethics1155
   PubMedGoogle Scholar
• RitzhauptLBetleyBAHirsch2007Safety assessment of azithromycin plus chloroquine for the treatment and prevention of malaria [abstract]56th Annual Meeting of the American Society of Tropical Medicine and Hygiene2007Philadelphia, USA517
   Google Scholar
• RosenJBBremanJG2004Malaria intermittent preventive treatment in infants, chemoprophylaxis, and childhood vaccinationsLancet3631386815110499
   PubMed Web of Science ®Google Scholar
• Sanofi-Synthelabo1999Primaquine brand of phosphate tablet [product information]Sanofi-SynthelaboNew York
   Google Scholar
• SchellenbergDMenendezCKahigwaE2001Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trialLancet3571471711377597
   PubMed Web of Science ®Google Scholar
• SchellenbergDCisseBMenendezC2006The IPTi Consortium: research for policy and actionTrends Parasitol2229630016713739
   PubMed Web of Science ®Google Scholar
• SimonR2000Are placebo-controlled clinical trials ethical or needed when alternative treatment exists?Ann Intern Med133474510975967
   PubMed Web of Science ®Google Scholar
• ShanksGDGordonDMKlotzFW1998Efficacy and safety of atovaquone/proguanil as suppressive prophylaxis for Plasmodium falciparum malariaClin Infect Dis2749499770146
   PubMed Web of Science ®Google Scholar
• ShanksGDRagamaBOAlooAJ1999Time to reappearance of malaria parasites following various drug treatment regimens in a holoendemic area of western KenyaTrans R Soc Trop Med Hyg93304510492766
   PubMed Web of Science ®Google Scholar
• ShanksGDKainKCKeystoneJS2001aMalaria chemoprophylaxis in the age of drug resistance. II. Drugs that may be available in the futureClin Infect Dis33381511438908
   PubMed Web of Science ®Google Scholar
• ShanksGDOlooAJAlemanGM2001bA new primaquine analog, tafenoquine (WR238605), for prophylaxis against Plasmodium falciparum malariaClin Infect Dis3319687411700577
   PubMed Web of Science ®Google Scholar
• ShanksGDEdsteinMD2005Modern malaria prophylaxisDrugs6510912110
   Web of Science ®Google Scholar
• ShanksGDMagillAJFreedmanDO2007Drug free holidays: Pre-travel versus during travel malaria prophylaxisAm J Trop Med Hyg771217620622
   PubMed Web of Science ®Google Scholar
• ShapiroTARanasinhaCDKumarN1999Prophylactic activity of atovaquone against Plasmodium falciparum in humansAm J Trop Med Hyg60831610344660
   PubMed Web of Science ®Google Scholar
• ShrettaRBrughaRRobbA2000Sustainability, affordability and equity of corporate drug donations: the case of MalaroneLancet35517182010905260
   PubMed Web of Science ®Google Scholar
• ShrettaRWaltGBrughaR2001A political analysis of corporate drug donations: the example of Malarone in KenyaHealth Policy Plan161617011358917
   PubMed Web of Science ®Google Scholar
• SukwaTYMulengaMChisdakaN1999A randomized, double-blind, placebo-controlled field trial to determine the efficacy and safety of Malarone™ (atovaquone/proguanil) for the prophylaxis of malaria in ZambiaAm J Trop Med Hyg60521510348223
   PubMed Web of Science ®Google Scholar
• TaylorWRRichieTLFryauffDJ1999Malaria prophylaxis using azithromycin: a double-blind, placebo-controlled trial in Irian Jaya, IndonesiaClin Infect Dis28748110028075
   PubMed Web of Science ®Google Scholar
• [UNFPA] United Nations Food Program2007State of world population 2007United Nations Population Fund, New YorkNew York
   Google Scholar
• [USAID] United States Agency for International Development2007President’s malaria initiative [online]. Accessed November 28, 2007. URL: http://www.fightingmalaria.gov/
   Google Scholar
• [USCDC] United States Center for Diseases Control and Prevention2008CDC health information for international travel 2008 [online]. Accessed July 11, 2007. URL: http://wwwn.cdc.gov/travel/contentYel-lowBook.aspx
   Google Scholar
• [USFDA] United States Food and Drug Administration2000FDA approves Malarone for prevention and treatment of malaria” [online]. Accessed June 15, 2007. URL: http://www.fda.gov/bbs/topics/ANSWERS/ANS01026.html
   Google Scholar
• [USFDA] United States Food and Drug Administration2001Guidance for industry: Acceptance of foreign clinical studies [online]. Accessed July 11, 2007. URL: http://www.fda.gov/cder/guidance/fstud.pdf
   Google Scholar
• [USFDA] United States Food and Drug Administration2005Guidance for industry: Pharmacogenomic data submissionsUnited States Department of Health and Human ServicesRockville, MD, United States
   Google Scholar
• [USFDA] United States Food and Drug Administration2007Malaria: Developing drug and non-vaccine products for treatment and prophylaxis (draft guidance for industry)United States Department of Health and Human ServicesRockville, MD
   Google Scholar
• [USCEDER] Center for Drug Evaluation and Research2007Frequently asked questions on drug development and investigational new drug applications [online]. Accessed November 14, 2007. URL: http://www.fda.gov/cder/about/smallbiz/faq.htm#Introduction
   Google Scholar
• van der BergJDDuvenageCSRoskellNS1999Safety and efficacy of atovaquone and proguanil hydrochloride for the prophylaxis of Plasmodium falciparum malaria in South AfricaClin Ther21741910363739
   PubMed Web of Science ®Google Scholar
• VerhageDFTelgtDSBousemaJT2005Clinical outcome of experimental human malaria induced by Plasmodium falciparum-infected mosquitoesNeth J Med6352815768480
   PubMed Web of Science ®Google Scholar
• WagnerJAWilliamsSAWebsterCJ2007Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugsClin Pharmacol Ther81104717186007
   PubMed Web of Science ®Google Scholar
• WalshDSLooareesuwanSWilairatanaP1999Randomized dose-ranging study of the safety and efficacy of WR 238605 (tafenoquine) in the prevention of relapse of Plasmodium vivax malaria in ThailandJ Infect Dis1801282710479159
   PubMed Web of Science ®Google Scholar
• WalshDSWilaratanaPTangDB2004Randomized trial of 3-dose regimens of tafenoquine (WR238605) versus low-dose primaquine for preventing Plasmodium vivax malaria relapseClin Infect Dis39109510315486831
   PubMed Web of Science ®Google Scholar
• WaltherMThompsonFMDunachieS2006Safety, immunogenicity, and efficacy of prime-boost immunization with recombinant poxvirus FP9 and modified vaccinia virus Ankara encoding the full-length Plasmodium falciparum circumsporozoite proteinInfect Immun7427061616622207
   PubMed Web of Science ®Google Scholar
• WangRRichieTLBaracerosMF2005Boosting of DNA vaccine-elicited gamma interferon responses in humans by exposure to malaria parasitesInfect Immun7328637215845492
   PubMed Web of Science ®Google Scholar
• WeissWROlooAJJohnsonA1995Daily primaquine is effective for prophylaxis against falciparum malaria in Kenya: comparison with mefloquine, doxycycline, and chloroquine plus proguanilJ Infect Dis171167182
   Web of Science ®Google Scholar
• [WMA] World Medical Association2004World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [online]. Accessed June 15, 2007. URL: http://www.wma.net/e/policy/b3.htm
   Google Scholar
• [WHO] World Health Organization2005World Malaria Report 2005World Health OrganizationGeneva
   Google Scholar