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2. Community knowledge, attitude, practices and beliefs associated with persistence of malaria transmission in North-western and Southern regions of Tanzania

Author

Liheluka, Edwin A., Massawe, Isolide S., Chiduo, Mercy G., Mandara, Celine I., Chacky, Frank, Ndekuka, Leah, Temba, Filbert F., Mmbando, Bruno P., Seth, Misago D., Challe, Daniel P., Makunde, Williams H., Mhina, Athanas D., Baraka, Vito, Segeja, Method D., Derua, Yahya A., Batengana, Bernard M., Hayuma, Paul M., Madebe, Rashid A., Malimi, Masunga C., Mandike, Renata, Mkude, Sigsbert, Molteni, Fabrizio, Njau, Ritha, Mohamed, Ally, Rumisha, Susan F., and Ishengoma, Deus S.

Published
2023
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4. Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Published
2023
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6. Understanding pre‐hospital disease management of fever and diarrhoea in children—Care pathways in rural Tanzania.

Author

Lamshöft, Maike Maria, Liheluka, Edwin, Ginski, Greta, Lusingu, John P. A., Minja, Daniel, Gesase, Samwel, Mbwana, Joyce, Gesase, George, Rautman, Lydia, Loag, Wibke, May, Jürgen, Dekker, Denise, and Krumkamp, Ralf

Abstract

Objective: Many children in sub‐Saharan Africa die from infectious diseases like malaria, pneumonia, and diarrhoea that can be prevented by early diagnosis, effective and targeted treatment. This study aimed to gain insights into case management practices by parents before they present their children to hospital. Methods: We conducted a cross‐sectional study among 332 parents attending a district hospital with their under‐fives symptomatic with fever and/or diarrhoea between November 2019 and July 2020 in rural Tanzania. Timely and targeted treatment was defined as seeking health care within 24 h of fever onset, and continued fluid intake in case of diarrhoea. Results: The main admission diagnoses were acute respiratory infections (61.8%), malaria (25.3%), diarrhoea (18.4%) and suspected sepsis (8.1%). The majority of children (91%) received treatment prior to admission, mostly antipyretics (75.6%), local herbal medicines (26.8%), and antibiotics (17.8%)—half of them without prescription from a clinician. For diarrhoea, the use of oral rehydration solution was rare (9.0%), although perceived as easily accessible and affordable. 49.4% of the parents presented their children directly to the hospital, 23.2% went to a pharmacy/drug shop and 19.3% to a primary health facility first. Malaria symptoms began mostly 3 days before the hospital visit; only 25.4% of febrile children visited any health facility within 24 h of disease onset. Prior use of local herbal medicine (AOR = 3.2; 95% CI 1.4–7.3), visiting the pharmacy (adjusted Odds Ratio [AOR] = 3.1; 95% confidence interval [CI]: 1.0–9.8), the dispensary being the nearest health facility (AOR = 3.0; 95% CI: 1.5–6.2), and financial difficulties (AOR = 2.2; 95% CI 1.1–4.5) were associated with delayed treatment. Conclusion: This study suggests that antipyretics and antibiotics dispensed at pharmacies/drug shops, as well as use of local herbal medicines, delay early diagnosis and treatment, which can be life‐threatening. Pharmacies/drug shops could be integrated as key focal points for sensitising community members on how to respond to paediatric illnesses and encourage the use of oral rehydration solutions. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania:methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T.R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean Pierre, Lusingu, John P.A., Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T.R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean Pierre, and Lusingu, John P.A.

Abstract

Background: It has been more than 20 years since the malaria epidemiologic shift to school-aged children was noted. In the meantime, school-aged children (5–15 years) have become increasingly more vulnerable with asymptomatic malaria prevalence reaching up to 70%, making them reservoirs for subsequent transmission of malaria in the endemic communities. Intermittent Preventive Treatment of malaria in schoolchildren (IPTsc) has proven to be an effective tool to shrink this reservoir. As of 3rd June 2022, the World Health Organization recommends IPTsc in moderate and high endemic areas. Even so, for decision-makers, the adoption of scientific research recommendations has been stifled by real-world implementation challenges. This study presents methodology, challenges faced, and mitigations used in the evaluation of the implementation of IPTsc using dihydroartemisinin-piperaquine (DP) in three councils (Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC) of Tanga Region, Tanzania so as to understand the operational feasibility and effectiveness of IPTsc on malaria parasitaemia and clinical malaria incidence. Methods: The study deployed an effectiveness-implementation hybrid design to assess feasibility and effectiveness of IPTsc using DP, the interventional drug, against standard of care (control). Wards in the three study councils were the randomization unit (clusters). Each ward was randomized to implement IPTsc or not (control). In all wards in the IPTsc arm, DP was given to schoolchildren three times a year in four-month intervals. In each council, 24 randomly selected wards (12 per study arm, one school per ward) were chosen as representatives for intervention impact evaluation. Mixed design methods were used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive health package for schoolchildren. The study reimagined an existing school health programme for Neglected Tropical Diseases (NT

Published
2023

10. Additional file 9 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 9: Appendix S9. Clinical episodes recording form.

Published
2023
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11. Additional file 2 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 2: Appendix S2. Drug dispensing log.

Published
2023
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12. Additional file 3 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 3: Appendix S3. Drug dispensing information sheet.

Published
2023
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13. Additional file 1 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 1: Appendix S1. Drug accountability log.

Published
2023
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14. Additional file 8 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 8: Appendix S8. Referral form.

Published
2023
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15. Additional file 6 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 6: Appendix S6. Supervision form.

Published
2023
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16. Additional file 4 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 4: Appendix S4. Adverse drug reaction reporting form.

Published
2023
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17. Additional file 5 of Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation

Author

Makenga, Geofrey, Seth, Misago D., Baraka, Vito, Mmbando, Bruno P., Challe, Daniel P., Francis, Filbert, Mhina, Athanas, Minja, Daniel T. R., Chiduo, Mercy, Mandara, Celine, Liheluka, Edwin, Gesase, Samwel, Segeja, Method, Mtove, George, Kamugisha, Mathias, Lusasi, Abdallah, Chacky, Frank, David, Anna, Thawer, Sumaiyya, Mohamed, Ally, Lazaro, Samwel, Molteni, Fabrizio, Nkayamba, Alex, Van geertruyden, Jean-Pierre, and Lusingu, John P. A.

Abstract

Additional file 5: Appendix S5. IPTsc coverage assessment form.

Published
2023
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18. Additional file 2 of Seroprevalence of SARS-CoV-2 antibodies among children and adolescents recruited in a malariometric survey in north-eastern Tanzania July 2021

Author

Lyimo, Eric, Fougeroux, Cyrielle, Malabeja, Anangisye, Mbwana, Joyce, Hayuma, Paul M., Liheluka, Edwin, Turner, Louise, Gesase, Samwel, Lavstsen, Thomas, Lusingu, John P. A., Minja, Daniel T. R., and Wang, Christian W.

Abstract

Additional file 2 The number of SARS-CoV-2 seropositive and negative infants in Kwamasimba and Mkokola villages based on age in months.

Published
2022
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19. Prevalence of asymptomatic malaria, submicroscopic parasitaemia and anaemia in Korogwe District, north-eastern Tanzania

Author

Hayuma, Paul M, Wang, Christian W, Liheluka, Edwin, Baraka, Vito, Madebe, Rashid A, Minja, Daniel T R, Misinzo, Gerald, Alifrangis, Michael, Lusingu, John P A, Hayuma, Paul M, Wang, Christian W, Liheluka, Edwin, Baraka, Vito, Madebe, Rashid A, Minja, Daniel T R, Misinzo, Gerald, Alifrangis, Michael, and Lusingu, John P A

Abstract

BACKGROUND: Asymptomatic malaria infections largely remain undetected and act as a reservoir for continuous transmission. The study assessed the prevalence of submicroscopic asymptomatic malaria infections and anaemia in two rural low (300 m above sea level) and highland (700 m asl) settings of Korogwe District north-eastern Tanzania.METHODS: A cross-sectional malariometric survey involving individuals aged 0-19 years was conducted in June 2018 in the two rural villages. Venous blood was collected from eligible study participants for estimation of haemoglobin level, detection of malaria by rapid diagnostic test (RDT), quantification of malaria parasitaemia by microscopy, as well as dried blood spot (DBS) for determining submicroscopic infections by PCR targeting the small subunit of the ribosomal ribonucleic acid (ssrRNA) of human Plasmodium.RESULTS: Out of 565 individuals tested, 211 (37.3%) were malaria positive based on RDT, whereas only 81 (14.3%) were positive by microscopy. There was no significant difference in the prevalence between the highland and the lowland village, p = 0.19 and p = 0.78 microscopy and RDT, respectively. Three out of 206 (1.5%) RDT/microscopy negative samples were P. falciparum positive by PCR. Of the 211 RDT and 81 microscopy positive, 130 (61.6%) and 33 (40.7%), respectively, were defined as being asymptomatic. Of the 565 individuals, 135 (23.9%) were anaemic (haemoglobin < 11 g/dL) out of which 5.2% were severely anaemic. The risk of being anaemic was significantly higher among individuals with asymptomatic malaria as compared to those without malaria as confirmed by RDT (AOR = 2.06 (95% CI 1.32-3.20) while based on microscopic results there was no significant differences observed (AOR = 2.09, 95% CI 0.98-4.47). Age and altitude had no effect on the risk of anaemia even after adjusting for asymptomatic malaria.CONCLUSIONS: Asymptomatic malaria is associated with an increased risk of having anaemia in the stu

Published
2021

20. Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa:an open-label 3-year extension study of a phase 3 randomised controlled trial

Author

Tinto, Halidou, Otieno, Walter, Gesase, Samwel, Sorgho, Hermann, Otieno, Lucas, Liheluka, Edwin, Valéa, Innocent, Sing'oei, Valentine, Malabeja, Anangisye, Valia, Daniel, Wangwe, Anne, Gvozdenovic, Emilia, Guerra Mendoza, Yolanda, Jongert, Erik, Lievens, Marc, Roman, François, Schuerman, Lode, Lusingu, John, Tinto, Halidou, Otieno, Walter, Gesase, Samwel, Sorgho, Hermann, Otieno, Lucas, Liheluka, Edwin, Valéa, Innocent, Sing'oei, Valentine, Malabeja, Anangisye, Valia, Daniel, Wangwe, Anne, Gvozdenovic, Emilia, Guerra Mendoza, Yolanda, Jongert, Erik, Lievens, Marc, Roman, François, Schuerman, Lode, and Lusingu, John

Abstract

Background: Results from a previous phase 3 study showed efficacy of the RTS,S/AS01 vaccine against severe and clinical malaria in children (in 11 sites in Africa) during a 3–4-year follow-up. We aimed to investigate malaria incidence up to 7 years postvaccination in three of the sites of the initial study. Methods: In the initial phase 3 study, infants aged 6–12 weeks and children aged 5–17 months were randomly assigned (1:1:1) to receive four RTS,S/AS01 doses (four-dose group), three RTS,S/AS01 doses and a comparator dose (three-dose group), or four comparator doses (control group). In this open-label extension study in Korogwe (Tanzania), Kombewa (Kenya), and Nanoro (Burkina Faso), we assessed severe malaria incidences as the primary outcome for 3 additional years (January, 2014, to December, 2016), up to 6 years (younger children) or 7 years (older children) postprimary vaccination in the modified intention-to-treat population (ie, participants who received at least one dose of the study vaccine). As secondary outcomes, we evaluated clinical malaria incidences and serious adverse events. This trial is registered with ClinicalTrials.gov, number NCT02207816. Findings: We enrolled 1739 older children (aged 5–7 years) and 1345 younger children (aged 3–5 years). During the 3-year extension, 66 severe malaria cases were reported, resulting in severe malaria incidence of 0·004 cases per person-years at risk (PPY; 95% CI 0–0·033) in the four-dose group, 0·007 PPY (0·001–0·052) in the three-dose group, and 0·009 PPY (0·001–0·066) in the control group in the older children category and a vaccine efficacy against severe malaria that did not contribute significantly to the overall efficacy (four-dose group 53·7% [95% CI −13·7 to 81·1], p=0·093; three-dose group 23·3% [–67·1 to 64·8], p=0·50). In younger children, severe malaria incidences were 0·007 PPY (0·001–0·058) in the four-dose group, 0·007 PPY (0·001–0·054) in the three-dose group, and 0·011 PPY (0·001–0·083) in t

Published
2019

21. A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants

Author

RTS,S Clinical Trials Partnership, Agnandji, Selidji Todagbe, Lell, Bertrand, Fernandes, José Francisco, Abossolo, Béatrice Peggy, Methogo, Barbara Gaelle Nfono Ondo, Kabwende, Anita Lumeka, Adegnika, Ayola Akim, Mordmüller, Benjamin, Issifou, Saadou, Kremsner, Peter Gottfried, Sacarlal, Jahit, Aide, Pedro, Lanaspa, Miguel, Aponte, John J, Machevo, Sonia, Acacio, Sozinho, Bulo, Helder, Sigauque, Betuel, Macete, Eusébio, Alonso, Pedro, Abdulla, Salim, Salim, Nahya, Minja, Rose, Mpina, Maxmillian, Ahmed, Saumu, Ali, Ali Mohammed, Mtoro, Ali Takadir, Hamad, Ali Said, Mutani, Paul, Tanner, Marcel, Tinto, Halidou, D'Alessandro, Umberto, Sorgho, Hermann, Valea, Innocent, Bihoun, Biébo, Guiraud, Issa, Kaboré, Berenger, Sombié, Olivier, Guiguemdé, Robert Tinga, Ouédraogo, Jean Bosco, Hamel, Mary J, Kariuki, Simon, Oneko, Martina, Odero, Chris, Otieno, Kephas, Awino, Norbert, McMorrow, Meredith, Muturi-Kioi, Vincent, Laserson, Kayla F, Slutsker, Laurence, Otieno, Walter, Otieno, Lucas, Otsyula, Nekoye, Gondi, Stacey, Otieno, Allan, Owira, Victorine, Oguk, Esther, Odongo, George, Woods, Jon Ben, Ogutu, Bernhards, Njuguna, Patricia, Chilengi, Roma, Akoo, Pauline, Kerubo, Christine, Maingi, Charity, Lang, Trudie, Olotu, Ally, Bejon, Philip, Marsh, Kevin, Mwambingu, Gabriel, Owusu-Agyei, Seth, Asante, Kwaku Poku, Osei-Kwakye, Kingsley, Boahen, Owusu, Dosoo, David, Asante, Isaac, Adjei, George, Kwara, Evans, Chandramohan, Daniel, Greenwood, Brian, Lusingu, John, Gesase, Samwel, Malabeja, Anangisye, Abdul, Omari, Mahende, Coline, Liheluka, Edwin, Malle, Lincoln, Lemnge, Martha, Theander, Thor G, Drakeley, Chris, Ansong, Daniel, Agbenyega, Tsiri, Adjei, Samuel, Boateng, Harry Owusu, Rettig, Theresa, Bawa, John, Sylverken, Justice, Sambian, David, Sarfo, Anima, Agyekum, Alex, Martinson, Francis, Hoffman, Irving, Mvalo, Tisungane, Kamthunzi, Portia, Nkomo, Rutendo, Tembo, Tapiwa, Tegha, Gerald, Tsidya, Mercy, Kilembe, Jane, Chawinga, Chimwemwe, Ballou, W Ripley, Cohen, Joe, Guerra, Yolanda, Jongert, Erik, Lapierre, Didier, Leach, Amanda, Lievens, Marc, Ofori-Anyinam, Opokua, Olivier, Aurélie, Vekemans, Johan, Carter, Terrell, Kaslow, David, Leboulleux, Didier, Loucq, Christian, Radford, Afiya, Savarese, Barbara, Schellenberg, David, Sillman, Marla, and Vansadia, Preeti

Subjects
parasitic diseases
Abstract

BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed. RESULTS: The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.).

Published
2012

22. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children

Author

RTS,S Clinical Trials Partnership, Agnandji, Selidji Todagbe, Lell, Bertrand, Soulanoudjingar, Solange Solmeheim, Fernandes, José Francisco, Abossolo, Béatrice Peggy, Conzelmann, Cornelia, Methogo, Barbara Gaelle Nfono Ondo, Doucka, Yannick, Flamen, Arnaud, Mordmüller, Benjamin, Issifou, Saadou, Kremsner, Peter Gottfried, Sacarlal, Jahit, Aide, Pedro, Lanaspa, Miguel, Aponte, John J, Nhamuave, Arlindo, Quelhas, Diana, Bassat, Quique, Mandjate, Sofia, Macete, Eusébio, Alonso, Pedro, Abdulla, Salim, Salim, Nahya, Juma, Omar, Shomari, Mwanajaa, Shubis, Kafuruki, Machera, Francisca, Hamad, Ali Said, Minja, Rose, Mtoro, Ali, Sykes, Alma, Ahmed, Saumu, Urassa, Alwisa Martin, Ali, Ali Mohammed, Mwangoka, Grace, Tanner, Marcel, Tinto, Halidou, D'Alessandro, Umberto, Sorgho, Hermann, Valea, Innocent, Tahita, Marc Christian, Kaboré, William, Ouédraogo, Sayouba, Sandrine, Yara, Guiguemdé, Robert Tinga, Ouédraogo, Jean Bosco, Hamel, Mary J, Kariuki, Simon, Odero, Chris, Oneko, Martina, Otieno, Kephas, Awino, Norbert, Omoto, Jackton, Williamson, John, Muturi-Kioi, Vincent, Laserson, Kayla F, Slutsker, Laurence, Otieno, Walter, Otieno, Lucas, Nekoye, Otsyula, Gondi, Stacey, Otieno, Allan, Ogutu, Bernhards, Wasuna, Ruth, Owira, Victorine, Jones, David, Onyango, Agnes Akoth, Njuguna, Patricia, Chilengi, Roma, Akoo, Pauline, Kerubo, Christine, Gitaka, Jesse, Maingi, Charity, Lang, Trudie, Olotu, Ally, Tsofa, Benjamin, Bejon, Philip, Peshu, Norbert, Marsh, Kevin, Owusu-Agyei, Seth, Asante, Kwaku Poku, Osei-Kwakye, Kingsley, Boahen, Owusu, Ayamba, Samuel, Kayan, Kingsley, Owusu-Ofori, Ruth, Dosoo, David, Asante, Isaac, Adjei, George, Chandramohan, Daniel, Greenwood, Brian, Lusingu, John, Gesase, Samwel, Malabeja, Anangisye, Abdul, Omari, Kilavo, Hassan, Mahende, Coline, Liheluka, Edwin, Lemnge, Martha, Theander, Thor, Drakeley, Chris, Ansong, Daniel, Agbenyega, Tsiri, Adjei, Samuel, Boateng, Harry Owusu, Rettig, Theresa, Bawa, John, Sylverken, Justice, Sambian, David, Agyekum, Alex, Owusu, Larko, Martinson, Francis, Hoffman, Irving, Mvalo, Tisungane, Kamthunzi, Portia, Nkomo, Ruthendo, Msika, Albans, Jumbe, Allan, Chome, Nelecy, Nyakuipa, Dalitso, Chintedza, Joseph, Ballou, W Ripley, Bruls, Myriam, Cohen, Joe, Guerra, Yolanda, Jongert, Erik, Lapierre, Didier, Leach, Amanda, Lievens, Marc, Ofori-Anyinam, Opokua, Vekemans, Johan, Carter, Terrell, Leboulleux, Didier, Loucq, Christian, Radford, Afiya, Savarese, Barbara, Schellenberg, David, Sillman, Marla, and Vansadia, Preeti

Subjects
parasitic diseases
Abstract

BACKGROUND: An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries. METHODS: From March 2009 through January 2011, we enrolled 15,460 children in two age categories--6 to 12 weeks of age and 5 to 17 months of age--for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories. RESULTS: In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64). CONCLUSIONS: The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .).

Published
2011

24. Community perceptions on the secondary health benefits established by malaria vaccine trials (RTS, S phase 2 and phase 3) at the Korogwe site in North Eastern Tanzania.

Author

Liheluka, Edwin A., Lusingu, John P., and Manongi, Rachel N.

Subjects
*MALARIA vaccines, *CLINICAL trials, *INFANTS, *VACCINATION
Abstract

Background: Studies conducted thus far have demonstrated that the malaria vaccine (RTS,S) has a promising safety profile. Within the context of planning for future vaccine trials and for the purpose of building on previous research that has been undertaken in sub-Saharan Africa with regard to community perceptions about clinical studies, this research aimed to explore the community perceptions on the secondary health benefits established by the malaria vaccine trials (RTS,S Phase 2 and Phase 3) at the Korogwe site in Tanzania. Methods: An exploratory qualitative study design was used. Participants were recruited from the Korogwe site. Sampling techniques were purposive and random. A total of five focus group discussions and six in-depth interviews were conducted. Interview guides with open-ended questions were employed to collect data. Male and female parents whose infants participated and those whose infants did not participate in the trials, health workers and community leaders were interviewed. Thematic analysis framework was used to analyse the data. Results: The activities of a malaria vaccine project appeared to be well known to the community. Respondents had largely positive views towards the secondary health benefits which have been established by malaria vaccine trials. The project has led to a massive investment in health care infrastructure and an improvement in health care services across the study areas. The project was perceived by the community to have established major secondary health benefits. Misconceptions amongst respondents, especially with regard to blood samples, were also observed in this study. Conclusion: Despite some misconceptions with regard to the conduct of malaria vaccine trials, especially on blood sampling, generally this study observed that most participants were positive about the secondary health benefits brought about by the malaria vaccine trials in Korogwe. [ABSTRACT FROM AUTHOR]

Published
2013
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25. Caretaker's Knowledge, Attitudes, and Practices Regarding the Causes, Treatments, and Risks of Diarrhea Among Under-Five Children in North-Eastern Tanzania: A Cross-Sectional Study.

Author

Liheluka EA, Bali T, Lyimo E, Dekker D, and Gibore NS

Abstract

Background . Pediatric diarrhea remains a public health concern. This study explored caretaker's knowledge, attitudes, and practices regarding the causes, treatments, and risks of diarrhea among under-fives in Korogwe and Handeni districts, north-eastern Tanzania. Methods . We conducted a qualitative, cross-sectional study. Participants were selected through purposive sampling. Data were gathered through in-depth interviews and focus group discussions, and they were analyzed using thematic analysis. Results . Most participants had good knowledge about the risks of diarrhea among under-fives. However, most participants had poor knowledge of the causes and treatments of diarrhea. A significant proportion of participants had negative attitudes and poor practices about the treatment of diarrhea. A small percentage of participants possessed positive attitudes and appropriate practices for managing diarrhea. Conclusion . To bridge the knowledge gaps among caretakers and promote positive attitudes and behaviors about the management of diarrheal diseases, health authorities are urged to strengthen health education in the study communities., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2024.)

Published
2024
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