Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children.

Abstract:

BACKGROUND:There has been much debate about the appropriate statistical methodology for the evaluation of malaria field studies and the challenges in interpreting data arising from these trials. METHODS:The present paper describes, for a pivotal phase III efficacy of the RTS, S/AS01 malaria vaccine, the methods of the statistical analysis and the rationale for their selection. The methods used to estimate efficacy of the primary course of vaccination, and of a booster dose, in preventing clinical episodes of uncomplicated and severe malaria, and to determine the duration of protection, are described. The interpretation of various measures of efficacy in terms of the potential public health impact of the vaccine is discussed. CONCLUSIONS:The methodology selected to analyse the clinical trial must be scientifically sound, acceptable to regulatory authorities and meaningful to those responsible for malaria control and public health policy.

journal_name

Malar J

journal_title

Malaria journal

authors

Lievens M,Aponte JJ,Williamson J,Mmbando B,Mohamed A,Bejon P,Leach A

doi

10.1186/1475-2875-10-222

subject

Has Abstract

pub_date

2011-08-04 00:00:00

pages

222

issn

1475-2875

pii

1475-2875-10-222

journal_volume

10

pub_type

杂志文章,随机对照试验
  • Relevant microclimate for determining the development rate of malaria mosquitoes and possible implications of climate change.

    abstract:BACKGROUND:The relationship between mosquito development and temperature is one of the keys to understanding the current and future dynamics and distribution of vector-borne diseases such as malaria. Many process-based models use mean air temperature to estimate larval development times, and hence adult vector densitie...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-9-196

    authors: Paaijmans KP,Imbahale SS,Thomas MB,Takken W

    更新日期:2010-07-09 00:00:00

  • Markers of sulfadoxine-pyrimethamine resistance in Eastern Democratic Republic of Congo; implications for malaria chemoprevention.

    abstract:BACKGROUND:Sulfadoxine-pyrimethamine (SP) is a cornerstone of malaria chemoprophylaxis and is considered for programmes in the Democratic Republic of Congo (DRC). However, SP efficacy is threatened by drug resistance, that is conferred by mutations in the dhfr and dhps genes. The World Health Organization has specified...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-019-3057-7

    authors: van Lenthe M,van der Meulen R,Lassovski M,Ouabo A,Bakula E,Badio C,Cibenda D,Okell L,Piriou E,Grignard L,Lanke K,Rao B,Bousema T,Roper C

    更新日期:2019-12-18 00:00:00

  • The thermostability of the RTS,S/AS01 malaria vaccine can be increased by co-lyophilizing RTS,S and AS01.

    abstract:BACKGROUND:Developing thermostable vaccines is a challenge for pharmaceutical companies due to the inherent instability of biological molecules in aqueous solution. The problem is even more stringent in regions subjected to high temperatures in which protective cold chain is difficult to maintain due to a lack of infra...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-020-03253-1

    authors: Fortpied J,Collignon S,Moniotte N,Renaud F,Bayat B,Lemoine D

    更新日期:2020-06-08 00:00:00

  • A novel in vitro model reveals distinctive modulatory roles of Plasmodium falciparum and Plasmodium vivax on naïve cell-mediated immunity.

    abstract:BACKGROUND:To date, human peripheral blood mononuclear cells (PBMCs) have been used mainly in immune stimulation assays and the interpretation of data can be influenced by the previous immunological history of donors and cross reactivity with other infectious agents. Resolving these limitations requires an alternative ...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-017-1781-4

    authors: Chitsanoor S,Somsri S,Panburana P,Mungthin M,Ubalee R,Emyeam M,Jongwutiwes S,Sattabongkot J,Udomsangpetch R

    更新日期:2017-03-27 00:00:00

  • Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use.

    abstract:BACKGROUND:Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an ev...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-6-12

    authors: Atemnkeng MA,De Cock K,Plaizier-Vercammen J

    更新日期:2007-01-26 00:00:00

  • Post-exposure serological responses to malaria parasites in potential blood donors.

    abstract:BACKGROUND:Cases of transfusion-transmitted malaria have been described around the world and highlighted in some studies. Semi-immune individuals are more likely to transmit malaria as they may be asymptomatic. Some countries allow blood donations only based on epidemiological criteria while others reinforce their crit...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-016-1586-x

    authors: Portugal-Calisto D,Ferreira AR,Silva MS,Teodósio R

    更新日期:2016-11-09 00:00:00

  • Intrarectal quinine for treating Plasmodium falciparum malaria: a systematic review.

    abstract:BACKGROUND:In children with malaria caused by Plasmodium falciparum, quinine administered rectally may be easier to use and less painful than intramuscular or intravenous administration. The objective of this review was to compare the effectiveness of intrarectal with intravenous or intramuscular quinine for treating f...

    journal_title:Malaria journal

    pub_type: 杂志文章,meta分析,评审

    doi:10.1186/1475-2875-4-24

    authors: Eisenhut M,Omari A,MacLehose HG

    更新日期:2005-05-18 00:00:00

  • Development, validation and evaluation of a rapid PCR-nucleic acid lateral flow immuno-assay for the detection of Plasmodium and the differentiation between Plasmodium falciparum and Plasmodium vivax.

    abstract:BACKGROUND:Molecular tools are very sensitive and specific and could be an alternative for the diagnosis of malaria. The complexity and need for expensive equipment may hamper implementation and, therefore, simplifications to current protocols are warranted. METHODS:A PCR detecting the different Plasmodium species and...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-11-279

    authors: Mens PF,Moers AP,de Bes LM,Flint J,Sak JR,Keereecharoen L,van Overmeir C,Verweij JJ,Hallett RL,Wihokhoen B,Proux S,Schallig HD,van Amerongen A

    更新日期:2012-08-17 00:00:00

  • pLDH level of clinically isolated Plasmodium vivax and detection limit of pLDH based malaria rapid diagnostic test.

    abstract:BACKGROUND:The malaria rapid diagnostic tests (RDTs) are now widely used in the world. Compared to Plasmodium falciparum, a poor sensitivity of RDTs was reported against Plasmodium vivax based on the adopted antibody against pan-Plasmodium antigen lactate dehydrogenase (pLDH) or aldolase. Levels of pLDH were measured f...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-12-181

    authors: Jang JW,Cho CH,Han ET,An SS,Lim CS

    更新日期:2013-06-03 00:00:00

  • Prevalence of G6PD Viangchan variant in malaria endemic areas in Lao PDR: an implication for malaria elimination by 2030.

    abstract:BACKGROUND:Primaquine is effective against the latent liver stage of Plasmodium vivax. Eliminating the latent liver stage of P. vivax is one of the necessary conditions to achieve the goal of malaria elimination in Lao People's Democratic Republic (PDR) by 2030. However, people with glucose-6-phosphate dehydrogenase (G...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-019-2715-0

    authors: Ong KIC,Iwagami M,Araki H,Khattignavong P,Soundala P,Keomalaphet S,Prasayasith P,Lorpachan L,Xangsayalath P,Pongvongsa T,Hongvanthong B,Brey PT,Kano S,Jimba M

    更新日期:2019-03-12 00:00:00

  • Detection of asymptomatic carriers of malaria in Kohat district of Pakistan.

    abstract:BACKGROUND:Kohat district is one of the medium intensity malaria transmission areas in Pakistan where asymptomatic carriers are likely to form a reservoir of infection. This study was done to explore the possibility of using microscopy, rapid diagnostic testing (RDT), real time polymerase chain reaction (RT-PCR) and RT...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-018-2191-y

    authors: Naeem MA,Ahmed S,Khan SA

    更新日期:2018-01-22 00:00:00

  • Sample size determination for estimating antibody seroconversion rate under stable malaria transmission intensity.

    abstract:BACKGROUND:In the last decade, several epidemiological studies have demonstrated the potential of using seroprevalence (SP) and seroconversion rate (SCR) as informative indicators of malaria burden in low transmission settings or in populations on the cusp of elimination. However, most of studies are designed to contro...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-015-0661-z

    authors: Sepúlveda N,Drakeley C

    更新日期:2015-04-03 00:00:00

  • Mutational analysis of Plasmodium falciparum dihydrofolate reductase and dihydropteroate synthase genes in the interior division of Sabah, Malaysia.

    abstract:BACKGROUND:The sulphadoxine/pyrimethamine (SDX/PYR) combination had been chosen to treat uncomplicated falciparum malaria in Malaysia for more than 30 years. Non-silent mutations in dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) genes are responsible for the resistance to pyrimethamine and sulphadox...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-12-445

    authors: Lau TY,Sylvi M,William T

    更新日期:2013-12-10 00:00:00

  • Transcript and protein expression profile of PF11_0394, a Plasmodium falciparum protein expressed in salivary gland sporozoites.

    abstract:BACKGROUND:Plasmodium falciparum malaria is a significant problem around the world today, thus there is still a need for new control methods to be developed. Because the sporozoite displays dual infectivity for both the mosquito salivary glands and vertebrate host tissue, it is a good target for vaccine development. M...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-11-80

    authors: Schlarman MS,Roberts RN,Kariuki MM,LaCrue AN,Ou R,Beerntsen BT

    更新日期:2012-03-23 00:00:00

  • Improving access to health care for malaria in Africa: a review of literature on what attracts patients.

    abstract:BACKGROUND:Increasing access to health care services is considered central to improving the health of populations. Existing reviews to understand factors affecting access to health care have focused on attributes of patients and their communities that act as 'barriers' to access, such as education level, financial and ...

    journal_title:Malaria journal

    pub_type: 杂志文章,评审

    doi:10.1186/1475-2875-11-55

    authors: Kizito J,Kayendeke M,Nabirye C,Staedke SG,Chandler CI

    更新日期:2012-02-23 00:00:00

  • Towards improved uptake of malaria chemoprophylaxis among West African travellers: identification of behavioural determinants.

    abstract:BACKGROUND:Malaria is a potentially lethal illness for which preventive measures are not optimally used among all travellers. Travellers visiting friends and relatives in their country of origin (VFRs) are known to use chemoprophylaxis less consistently compared to tourist travellers. In this study, factors explaining ...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-12-360

    authors: Wieten RW,Harting J,Biemond PM,Grobusch MP,van Vugt M

    更新日期:2013-10-10 00:00:00

  • Health worker performance in the management of paediatric fevers following in-service training and exposure to job aids in Kenya.

    abstract:BACKGROUND:Improving the way artemether-lumefantrine (AL) is provided to patients attending clinics is critical to maximize the benefit of this new medicine. In 2007, a new initiative was launched in one part of Kenya to improve malaria case-management through enhanced in-service training and provision of job aids. ME...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-9-261

    authors: Wasunna B,Zurovac D,Bruce J,Jones C,Webster J,Snow RW

    更新日期:2010-09-18 00:00:00

  • Malaria and large dams in sub-Saharan Africa: future impacts in a changing climate.

    abstract:BACKGROUND:Sub-Saharan Africa (SSA) has embarked on a new era of dam building to improve food security and promote economic development. Nonetheless, the future impacts of dams on malaria transmission are poorly understood and seldom investigated in the context of climate and demographic change. METHODS:The distributi...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-016-1498-9

    authors: Kibret S,Lautze J,McCartney M,Nhamo L,Wilson GG

    更新日期:2016-09-05 00:00:00

  • Plasmodium falciparum exposure in utero, maternal age and parity influence the innate activation of foetal antigen presenting cells.

    abstract:BACKGROUND:Malaria in pregnancy is associated with immunological abnormalities in the newborns, such as hampered T-helper 1 responses and increased T-regulatory responses, while the effect of maternal Plasmodium falciparum infection on foetal innate immunity is still controversial. MATERIALS AND METHODS:The immunophen...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-8-251

    authors: Fievet N,Varani S,Ibitokou S,Briand V,Louis S,Perrin RX,Massougbogji A,Hosmalin A,Troye-Blomberg M,Deloron P

    更新日期:2009-11-05 00:00:00

  • Interferon-gamma responses to Plasmodium falciparum liver-stage antigen-1 and merozoite-surface protein-1 increase with age in children in a malaria holoendemic area of western Kenya.

    abstract::BACKGROUND: In areas of high-level, year-round malaria transmission, morbidity and mortality due to malaria decrease after the first two to three years of life. This reduction may be related to the development of cellular immunity to specific antigens expressed in the different life-cycle stages of Plasmodium falcipar...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-2-37

    authors: Chelimo K,Sumba PO,Kazura JW,Ofula AV,John CC

    更新日期:2003-11-05 00:00:00

  • Analysis of polymorphisms in Plasmodium falciparum genes related to drug resistance: a survey over four decades under different treatment policies in Brazil.

    abstract:BACKGROUND:Anti-malarial resistance in Plasmodium falciparum remains an obstacle for malaria control. Resistance-associated genes were analysed in Brazilian samples over four decades to evaluate the impact of different treatment regimens on the parasite genetic profile. METHODS:Samples were collected on filter paper f...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-13-372

    authors: Inoue J,Lopes D,do Rosário V,Machado M,Hristov AD,Lima GF,Costa-Nascimento MJ,Segurado AC,Di Santi SM

    更新日期:2014-09-19 00:00:00

  • The development of loop-mediated isothermal amplification targeting alpha-tubulin DNA for the rapid detection of Plasmodium vivax.

    abstract:BACKGROUND:Malaria that is caused by Plasmodium vivax is the most widely distributed human malaria. Its recent resurgence in many parts of the world, including the Republic of Korea (ROK), emphasizes the importance of improved access to the early and accurate detection of P. vivax to reduce disease burden. In this stud...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-13-248

    authors: Dinzouna-Boutamba SD,Yang HW,Joo SY,Jeong S,Na BK,Inoue N,Lee WK,Kong HH,Chung DI,Goo YK,Hong Y

    更新日期:2014-06-30 00:00:00

  • Open-source satellite enumeration to map households: planning and targeting indoor residual spraying for malaria.

    abstract:BACKGROUND:Defining the number and location of sprayable structures (houses) is foundational to plan and monitor indoor residual spray (IRS) implementation, a primary intervention used to control the transmission of malaria. Only by mapping the location and type of all sprayable structures can IRS operations be planned...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-015-0831-z

    authors: Kamanga A,Renn S,Pollard D,Bridges DJ,Chirwa B,Pinchoff J,Larsen DA,Winters AM

    更新日期:2015-09-17 00:00:00

  • Acceptance of a malaria vaccine by caregivers of sick children in Kenya.

    abstract:BACKGROUND:Several malaria vaccines are currently in clinical trials and are expected to provide an improved strategy for malaria control. Prior to introduction of a new vaccine, policymakers must consider the socio cultural environment of the region to ensure widespread community approval. This study investigated the ...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-13-172

    authors: Ojakaa DI,Jarvis JD,Matilu MI,Thiam S

    更新日期:2014-05-05 00:00:00

  • Association between malaria immunity and pregnancy outcomes among Malawian pregnant women receiving nutrient supplementation.

    abstract:BACKGROUND:Malaria antibody responses measured at delivery have been associated with protection from maternal anaemia and low birth weight deliveries. Whether malarial antibodies present in the first half of pregnancy may protect from these or other poor birth outcomes is unclear. To determine whether malaria antibodie...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-016-1597-7

    authors: Chandrasiri UP,Fowkes FJ,Beeson JG,Richards JS,Kamiza S,Maleta K,Ashorn P,Rogerson SJ

    更新日期:2016-11-09 00:00:00

  • Field deployment of loop-mediated isothermal amplification for centralized mass-screening of asymptomatic malaria in Zanzibar: a pre-elimination setting.

    abstract:BACKGROUND:Molecular tools for detection of low-density asymptomatic Plasmodium infections are needed in malaria elimination efforts. This study reports results from the hitherto largest implementation of loop-mediated isothermal amplification (LAMP) for centralized mass screening of asymptomatic malaria in Zanzibar. ...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-015-0731-2

    authors: Morris U,Khamis M,Aydin-Schmidt B,Abass AK,Msellem MI,Nassor MH,González IJ,Mårtensson A,Ali AS,Björkman A,Cook J

    更新日期:2015-05-17 00:00:00

  • Mass testing and treatment for malaria in low transmission areas in Amhara Region, Ethiopia.

    abstract:BACKGROUND:In areas with ongoing malaria transmission, strategies to clear parasites from populations can reduce infection and transmission. The objective of this paper was to describe a malaria mass testing and treatment (MTAT) intervention implemented in six kebeles (villages) in Amhara Region, Ethiopia, at the begin...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/s12936-016-1333-3

    authors: Scott CA,Yeshiwondim AK,Serda B,Guinovart C,Tesfay BH,Agmas A,Zeleke MT,Guesses GS,Ayenew AL,Workie WM,Steketee RW,Earle D,Bezabih B,Getachew A

    更新日期:2016-06-02 00:00:00

  • Intradermal immunization of mice with radiation-attenuated sporozoites of Plasmodium yoelii induces effective protective immunity.

    abstract:BACKGROUND:Intravenous injection of mice with attenuated Plasmodium berghei sporozoites induces sterile immunity to challenge with viable sporozoites. Non-intravenous routes have been reported to yield poor immunity. Because intravenous immunization has been considered to be unacceptable for large scale vaccination of ...

    journal_title:Malaria journal

    pub_type: 杂志文章

    doi:10.1186/1475-2875-9-362

    authors: Voza T,Kebaier C,Vanderberg JP

    更新日期:2010-12-15 00:00:00

  • Atovaquone-proguanil in the treatment of imported uncomplicated Plasmodium falciparum malaria: a prospective observational study of 553 cases.

    abstract:BACKGROUND:Each year, thousands of cases of uncomplicated malaria are imported into Europe by travellers. Atovaquone-proguanil (AP) has been one of the first-line regimens used in France for uncomplicated malaria for almost ten years. While AP's efficacy and tolerance were evaluated in several trials, its use in "real ...

    journal_title:Malaria journal

    pub_type: 杂志文章,多中心研究

    doi:10.1186/1475-2875-12-399

    authors: Cordel H,Cailhol J,Matheron S,Bloch M,Godineau N,Consigny PH,Gros H,Campa P,Bourée P,Fain O,Ralaimazava P,Bouchaud O

    更新日期:2013-11-07 00:00:00

  • A simple and fast method to exclude high Plasmodium falciparum parasitaemia in travellers with imported malaria.

    abstract:BACKGROUND:Counts of malaria parasites in peripheral blood are important to assess severity of Plasmodium falciparum malaria. Thin and thick smears are routinely used for this purpose. METHODS:In this study the Binax NOW Malaria Test, an easy-to-perform rapid diagnostic test, with Histidine Rich Protein-2 (HRP-2) and ...

    journal_title:Malaria journal

    pub_type: 杂志文章,多中心研究

    doi:10.1186/1475-2875-10-300

    authors: van Gool T,van Wolfswinkel ME,Koelewijn R,van Thiel PP,Jacobs J,van Hellemond JJ,van Genderen PJ

    更新日期:2011-10-14 00:00:00