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  1. Article ; Online: Mass Relapse Prevention to Reduce Transmission of Plasmodium vivax- A Systematic Review.

    Shah, Monica P / Westercamp, Nelli / Lindblade, Kim A / Hwang, Jimee

    The American journal of tropical medicine and hygiene

    2023  Volume 110, Issue 4_Suppl, Page(s) 38–43

    Abstract: Several temperate countries have used mass chemoprevention interventions with medicines of the 8-aminoquinoline class that prevent relapses from Plasmodium vivax before peak transmission to reduce transmission of malaria. The WHO commissioned a ... ...

    Abstract Several temperate countries have used mass chemoprevention interventions with medicines of the 8-aminoquinoline class that prevent relapses from Plasmodium vivax before peak transmission to reduce transmission of malaria. The WHO commissioned a systematic review of the literature and evidence synthesis to inform development of recommendations regarding this intervention referred to as "mass relapse prevention" (MRP). Electronic databases were searched, 866 articles screened, and 25 assessed for eligibility after a full-text review. Two nonrandomized studies were included, one from the Democratic People's Republic of Korea (391,357 participants) and the second from the Azerbaijan Soviet Socialist Republic (∼30,000 participants). The two studies administered a single round of primaquine over 14 days (0.25 mg/kg per day). From 1 to 3 months after the treatment round, the incidence of P. vivax infections was significantly lower in areas that received MRP than those that did not (pooled rate ratio [RR] 0.08, 95% CI 0.07-0.08). At 4 to 12 months after the treatment round, the prevalence of P. vivax infection was significantly lower in MRP villages than non-MRP villages (odds ratio 0.12, 95% CI 0.03-0.52). No severe adverse events were found. The certainty of evidence for all outcomes was very low and no conclusions as to the effectiveness or safety of MRP could be drawn. However, it is not likely that this intervention will be needed in the future as most temperate countries where P. vivax is transmitted are nearing or have already eliminated malaria.
    MeSH term(s) Humans ; Antimalarials/therapeutic use ; Plasmodium vivax ; Secondary Prevention ; Primaquine/therapeutic use ; Malaria, Vivax/drug therapy ; Malaria, Vivax/epidemiology ; Malaria, Vivax/prevention & control ; Recurrence
    Chemical Substances Antimalarials ; Primaquine (MVR3634GX1)
    Language English
    Publishing date 2023-12-20
    Publishing country United States
    Document type Systematic Review ; Journal Article
    ZDB-ID 2942-7
    ISSN 1476-1645 ; 0002-9637
    ISSN (online) 1476-1645
    ISSN 0002-9637
    DOI 10.4269/ajtmh.22-0727
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  2. Article ; Online: House modifications as a malaria control tool: how does local context shape participants' experience and interpretation in Uganda?

    Kayendeke, Miriam / Nabirye, Christine / Nayiga, Susan / Westercamp, Nelli / Gonahasa, Samuel / Katureebe, Agaba / Kamya, Moses R / Staedke, Sarah G / Hutchinson, Eleanor

    Malaria journal

    2023  Volume 22, Issue 1, Page(s) 244

    Abstract: Background: Evidence that house design can provide protection from malaria is growing. Housing modifications such as screening windows, doors, and ceilings, and attaching insecticide-impregnated materials to the eaves (the gap between the top of the ... ...

    Abstract Background: Evidence that house design can provide protection from malaria is growing. Housing modifications such as screening windows, doors, and ceilings, and attaching insecticide-impregnated materials to the eaves (the gap between the top of the wall and bottom of the roof), can protect against malaria. To be effective at scale, however, these modifications must be adopted by household residents. There is evidence that housing modifications can be acceptable, but in-depth knowledge on the experiences and interpretation of modifications is lacking. This qualitative study was carried out to provide a holistic account of the relationship between experiences and interpretations of four types of piloted housing modifications and the local context in Jinja, Uganda.
    Methods: Qualitative research was conducted between January to June 2021, before and during the installation of four types of housing modifications. The methods included nine weeks of participant observations in two study villages, nine focus group discussions with primary caregivers and heads of households (11-12 participants each), and nine key informant interviews with stakeholders and study team members.
    Results: Most residents supported the modifications. Experiences and interpretation of the housing modifications were shaped by the different types of housing in the area and the processes through which residents finished their houses, local forms of land and property ownership, and cultural and spiritual beliefs about houses.
    Conclusions: To maximize the uptake and benefit of housing modifications against malaria, programme development needs to take local context into account. Forms of local land and house ownership, preferences, the social significance of housing types, and religious and spiritual ideas shape the responses to housing modifications in Jinja. These factors may be important in other setting. Trial registration Trial registration number is NCT04622241. The first draft was posted on November 9th 2020.
    MeSH term(s) Humans ; Biological Transport ; Focus Groups ; Insecticides ; Malaria/prevention & control ; Uganda
    Chemical Substances Insecticides
    Language English
    Publishing date 2023-08-25
    Publishing country England
    Document type Clinical Trial ; Journal Article
    ZDB-ID 2091229-8
    ISSN 1475-2875 ; 1475-2875
    ISSN (online) 1475-2875
    ISSN 1475-2875
    DOI 10.1186/s12936-023-04669-1
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  3. Article ; Online: Efficacy of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria among Children in Western Kenya, 2016 to 2017.

    Westercamp, Nelli / Owidhi, Mary / Otieno, Kephas / Chebore, Winnie / Buff, Ann M / Desai, Meghna / Kariuki, Simon / Samuels, Aaron M

    Antimicrobial agents and chemotherapy

    2022  Volume 66, Issue 9, Page(s) e0020722

    Abstract: Antimalarial resistance threatens global malaria control efforts. The World Health Organization (WHO) recommends routine antimalarial efficacy monitoring through a standardized therapeutic efficacy study (TES) protocol. From June 2016 to March 2017, ... ...

    Abstract Antimalarial resistance threatens global malaria control efforts. The World Health Organization (WHO) recommends routine antimalarial efficacy monitoring through a standardized therapeutic efficacy study (TES) protocol. From June 2016 to March 2017, children with uncomplicated P. falciparum mono-infection in Siaya County, Kenya were enrolled into a standardized TES and randomized (1:1 ratio) to a 3-day course of artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP). Efficacy outcomes were measured at 28 and 42 days. A total of 340 children were enrolled. All but one child cleared parasites by day 3. PCR-corrected adequate clinical and parasitological response (ACPR) was 88.5% (95% CI: 80.9 to 93.3%) at day 28 for AL and 93.0% (95% CI: 86.9 to 96.4%) at day 42 for DP. There were 9.6 times (95% CI: 3.4 to 27.2) more reinfections in the AL arm compared to the DP arm at day 28, and 3.1 times (95% CI: 1.9 to 4.9) more reinfections at day 42. Both AL and DP were efficacious (per WHO 90% cutoff in the confidence interval) and well tolerated for the treatment of uncomplicated malaria in western Kenya, but AL efficacy appears to be waning. Further efficacy monitoring for AL, including pharmacokinetic studies, is recommended.
    MeSH term(s) Antimalarials/adverse effects ; Artemether/therapeutic use ; Artemether, Lumefantrine Drug Combination/therapeutic use ; Artemisinins/adverse effects ; Child ; Drug Combinations ; Ethanolamines/adverse effects ; Ethanolamines/therapeutic use ; Fluorenes/adverse effects ; Fluorenes/therapeutic use ; Folic Acid Antagonists ; Humans ; Infant ; Kenya ; Malaria/drug therapy ; Malaria, Falciparum/drug therapy ; Piperazines ; Plasmodium falciparum ; Quinolines/adverse effects ; Reinfection
    Chemical Substances Antimalarials ; Artemether, Lumefantrine Drug Combination ; Artemisinins ; Drug Combinations ; Ethanolamines ; Fluorenes ; Folic Acid Antagonists ; Piperazines ; Quinolines ; artenimol (6A9O50735X) ; piperaquine (A0HV2Q956Y) ; Artemether (C7D6T3H22J)
    Language English
    Publishing date 2022-08-29
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S. ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 217602-6
    ISSN 1098-6596 ; 0066-4804
    ISSN (online) 1098-6596
    ISSN 0066-4804
    DOI 10.1128/aac.00207-22
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  4. Article ; Online: Malaria chemoprophylaxis: a proven public health intervention for international travelers.

    Westercamp, Nelli / Arguin, Paul M

    Travel medicine and infectious disease

    2015  Volume 13, Issue 1, Page(s) 8–9

    MeSH term(s) Female ; Humans ; Malaria/mortality ; Malaria, Falciparum/mortality ; Male ; Travel
    Language English
    Publishing date 2015-01
    Publishing country Netherlands
    Document type Comment ; Editorial
    ZDB-ID 2170891-5
    ISSN 1873-0442 ; 1477-8939
    ISSN (online) 1873-0442
    ISSN 1477-8939
    DOI 10.1016/j.tmaid.2014.12.006
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  5. Article ; Online: Resident Perspectives on Work-Life Policies and Implications for Burnout.

    Westercamp, Nicole / Wang, Raziya S / Fassiotto, Magali

    Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry

    2017  Volume 42, Issue 1, Page(s) 73–77

    Abstract: Objective: As resident burnout increases, there is a need for better awareness, resources, and interventions. Challenges in balancing work and life priorities have been implicated in contributing to physician burnout. Institutional work-life policies ( ... ...

    Abstract Objective: As resident burnout increases, there is a need for better awareness, resources, and interventions. Challenges in balancing work and life priorities have been implicated in contributing to physician burnout. Institutional work-life policies (WLPs) are critical tools to meet work-life needs. This study investigates the influence of WLPs on residents' experiences.
    Methods: The authors emailed a SurveyMonkey link to the APA chief resident and Minority Fellow listservs and directly to 94 psychiatry program directors and 52 fellowship directors nationwide to distribute a survey to residents regarding WLP use and barriers, as well as burnout. Estimated response rate was 12-23%. The authors assessed the anonymous responses using SPSS to evaluate for relationships between awareness of WLPs, perceptions/barriers surrounding their usage, and burnout.
    Results: The authors analyzed 255 responses. Awareness and use of policies ranged from 2 to 33%. A prominent barrier to WLPs is that use results in shifting workload to co-residents (48% agree). Respondents who perceived leadership to view use of WLPs as a sign of weakness (16% agree) were less likely to use WLPs (t (89) = -3.52, p < 0.001, d = 0.61). Residents with burnout (41%) perceived vastly higher barriers to using WLPs as compared to those without burnout.
    Conclusions: This study supports the need for further investigation of WLPs to mitigate resident burnout and identifies important perceived barriers that affect the use of WLPs including low awareness, potential for shifting workload to co-residents, and negative perceptions of leadership attitudes toward WLPs.
    MeSH term(s) Burnout, Professional/psychology ; Female ; Humans ; Male ; Work-Life Balance/methods ; Workload/psychology
    Language English
    Publishing date 2017-08-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1045331-3
    ISSN 1545-7230 ; 1042-9670
    ISSN (online) 1545-7230
    ISSN 1042-9670
    DOI 10.1007/s40596-017-0757-6
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  6. Article ; Online: Opening the 'black box' of collaborative improvement: a qualitative evaluation of a pilot intervention to improve quality of malaria surveillance data in public health centres in Uganda.

    Hutchinson, Eleanor / Nayiga, Susan / Nabirye, Christine / Taaka, Lilian / Westercamp, Nelli / Rowe, Alexander K / Staedke, Sarah G

    Malaria journal

    2021  Volume 20, Issue 1, Page(s) 289

    Abstract: ... interviews with health workers and stakeholders (n = 20), and focus group discussions with health workers (n ...

    Abstract Background: Demand for high-quality surveillance data for malaria, and other diseases, is greater than ever before. In Uganda, the primary source of malaria surveillance data is the Health Management Information System (HMIS). However, HMIS data may be incomplete, inaccurate or delayed. Collaborative improvement (CI) is a quality improvement intervention developed in high-income countries, which has been advocated for low-resource settings. In Kayunga, Uganda, a pilot study of CI was conducted in five public health centres, documenting a positive effect on the quality of HMIS and malaria surveillance data. A qualitative evaluation was conducted concurrently to investigate the mechanisms of effect and unintended consequences of the intervention, aiming to inform future implementation of CI.
    Methods: The study intervention targeted health workers, including brief in-service training, plus CI with 'plan-do-study-act' (PDSA) cycles emphasizing self-reflection and group action, periodic learning sessions, and coaching from a CI mentor. Health workers collected data on standard HMIS out-patient registers. The qualitative evaluation (July 2015 to September 2016) included ethnographic observations at each health centre (over 12-14 weeks), in-depth interviews with health workers and stakeholders (n = 20), and focus group discussions with health workers (n = 6).
    Results: The results suggest that the intervention did facilitate improvement in data quality, but through unexpected mechanisms. The CI intervention was implemented as planned, but the PDSA cycles were driven largely by the CI mentor, not the health workers. In this context, characterized by a rigid hierarchy within the health system of limited culture of self-reflection and inadequate training and supervision, CI became an effective form of high-quality training with frequent supervisory visits. Health workers appeared motivated to improve data collection habits by their loyalty to the CI mentor and the potential for economic benefits, rather than a desire for self-improvement.
    Conclusions: CI is a promising method of quality improvement and could have a positive impact on malaria surveillance data. However, successful scale-up of CI in similar settings may require deployment of highly skilled mentors. Further research, focusing on the effectiveness of 'real world' mentors using robust study designs, will be required to determine whether CI can be translated effectively and sustainably to low-resource settings.
    MeSH term(s) Epidemiological Monitoring ; Pilot Projects ; Program Evaluation/statistics & numerical data ; Public Health/methods ; Public Health/statistics & numerical data ; Quality Improvement/statistics & numerical data ; Uganda
    Language English
    Publishing date 2021-06-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2091229-8
    ISSN 1475-2875 ; 1475-2875
    ISSN (online) 1475-2875
    ISSN 1475-2875
    DOI 10.1186/s12936-021-03805-z
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  7. Article ; Online: Plasmodium falciparum pfhrp2 and pfhrp3 Gene Deletions from Persons with Symptomatic Malaria Infection in Ethiopia, Kenya, Madagascar, and Rwanda.

    Rogier, Eric / McCaffery, Jessica N / Nace, Doug / Svigel, Samaly Souza / Assefa, Ashenafi / Hwang, Jimee / Kariuki, Simon / Samuels, Aaron M / Westercamp, Nelli / Ratsimbasoa, Arsène / Randrianarivelojosia, Milijaona / Uwimana, Aline / Udhayakumar, Venkatachalam / Halsey, Eric S

    Emerging infectious diseases

    2022  Volume 28, Issue 3, Page(s) 608–616

    Abstract: Histidine-rich protein 2 (HRP2)-based rapid diagnostic tests detect Plasmodium falciparum malaria and are used throughout sub-Saharan Africa. However, deletions in the pfhrp2 and related pfhrp3 (pfhrp2/3) genes threaten use of these tests. Therapeutic ... ...

    Abstract Histidine-rich protein 2 (HRP2)-based rapid diagnostic tests detect Plasmodium falciparum malaria and are used throughout sub-Saharan Africa. However, deletions in the pfhrp2 and related pfhrp3 (pfhrp2/3) genes threaten use of these tests. Therapeutic efficacy studies (TESs) enroll persons with symptomatic P. falciparum infection. We screened TES samples collected during 2016-2018 in Ethiopia, Kenya, Rwanda, and Madagascar for HRP2/3, pan-Plasmodium lactate dehydrogenase, and pan-Plasmodium aldolase antigen levels and selected samples with low levels of HRP2/3 for pfhrp2/3 genotyping. We observed deletion of pfhrp3 in samples from all countries except Kenya. Single-gene deletions in pfhrp2 were observed in 1.4% (95% CI 0.2%-4.8%) of Ethiopia samples and in 0.6% (95% CI 0.2%-1.6%) of Madagascar samples, and dual pfhrp2/3 deletions were noted in 2.0% (95% CI 0.4%-5.9%) of Ethiopia samples. Although this study was not powered for precise prevalence estimates, evaluating TES samples revealed a low prevalence of pfhrp2/3 deletions in most sites.
    MeSH term(s) Antigens, Protozoan/genetics ; Diagnostic Tests, Routine ; Ethiopia/epidemiology ; Gene Deletion ; Humans ; Kenya/epidemiology ; Madagascar/epidemiology ; Malaria ; Malaria, Falciparum/diagnosis ; Malaria, Falciparum/epidemiology ; Plasmodium falciparum/genetics ; Protozoan Proteins/genetics ; Rwanda/epidemiology
    Chemical Substances Antigens, Protozoan ; Protozoan Proteins
    Language English
    Publishing date 2022-02-22
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 1380686-5
    ISSN 1080-6059 ; 1080-6040
    ISSN (online) 1080-6059
    ISSN 1080-6040
    DOI 10.3201/eid2803.211499
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  8. Article ; Online: Could less be more? Accounting for fractional-dose regimens and different number of vaccine doses when measuring the impact of the RTS, S/AS01E malaria vaccine.

    Westercamp, Nelli / Osei-Tutu, Lawrence / Schuerman, Lode / Kariuki, Simon K / Bollaerts, Anne / Lee, Cynthia K / Samuels, Aaron M / Ockenhouse, Christian / Bii, Dennis K / Adjei, Samuel / Oneko, Martina / Lievens, Marc / Attobrah Sarfo, Maame Anima / Atieno, Cecilia / Bakari, Ashura / Sang, Tony / Kotoh-Mortty, Maame Fremah / Otieno, Kephas / Roman, François /
    Buabeng, Patrick Boakye Yiadom / Ntiamoah, Yaw / Ansong, Daniel / Agbenyega, Tsiri / Ofori-Anyinam, Opokua

    The Journal of infectious diseases

    2024  

    Abstract: Background: The RTS, S/AS01E malaria vaccine (RTS, S) is recommended for children in moderate-to-high Plasmodium falciparum malaria transmission areas. This phase 2b trial (NCT03276962) evaluates RTS, S fractional- and full-dose regimens in Ghana and ... ...

    Abstract Background: The RTS, S/AS01E malaria vaccine (RTS, S) is recommended for children in moderate-to-high Plasmodium falciparum malaria transmission areas. This phase 2b trial (NCT03276962) evaluates RTS, S fractional- and full-dose regimens in Ghana and Kenya.
    Methods: 1500 children aged 5-17 months were randomised (1:1:1:1:1) to receive RTS, S or rabies control vaccine. RTS, S groups received two full RTS, S doses at month (M)0/M1 followed by either full (groups R012-20, R012-14-26) or fractional (1/5) doses (groups Fx012-14-26, Fx017-20-32).
    Results: At M32 post-first dose, vaccine efficacy (VE) against clinical malaria (all episodes) ranged from 38% (R012-20; 95%CI: 24-49) to 53% (R012-14-26; 95%CI: 42-62). Vaccine impact estimates (cumulative number of malaria cases averted/1000 children vaccinated) were 1344 (R012-20), 2450 (R012-14-26), 2273 (Fx012-14-26), 2112 (Fx017-20-32). To account for differences in vaccine volume (fractional- versus full-dose), in a post-hoc analysis, we also estimated cases averted/1000 RTS, S full-dose equivalents: 336 (R012-20), 490 (R012-14-26), 874 (Fx012-14-26), 880 (Fx017-20-32).
    Conclusions: VE against clinical malaria was similar in all RTS, S groups. Vaccine impact accounting for full-dose equivalence suggests that using fractional-dose regimens could be a viable dose-sparing strategy. If borne out through trial end (M50), these observations underscore the means to reduce cost per regimen with a goal of maximising impact and optimising supply.
    Language English
    Publishing date 2024-03-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiae075
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  9. Article ; Online: Medical Male Circumcision Is Associated With Improvements in Pain During Intercourse and Sexual Satisfaction in Kenya.

    Nordstrom, Monica P C / Westercamp, Nelli / Jaoko, Walter / Okeyo, Timothy / Bailey, Robert C

    The journal of sexual medicine

    2017  Volume 14, Issue 4, Page(s) 601–612

    Abstract: ... MPC, Westercamp N, Jaoko W, et al. Medical Male Circumcision Is Associated With Improvements in Pain ...

    Abstract Background: Two cohort studies using data from randomized controlled trials in Africa offer the best evidence to date on the effects of voluntary medical male circumcision (VMMC) on male sexual function and satisfaction, suggesting no significant impairments in sexual function or satisfaction and some improvements in sexual function after male circumcision.
    Aim: To assess the effects of VMMC on sexual function and satisfaction in a large population-based cohort of men circumcised as adults and uncircumcised controls in Kenya.
    Methods: Sexual function and satisfaction of young (median age = 20 years) sexually active men (1,509 newly circumcised men and 1,524 age-matched uncircumcised controls after 5% loss to follow-up) were assessed at baseline and 6, 12, 18, and 24 months, with data collected in 2008 to 2012. Self-reported data on lack of sexual interest or pleasure, difficulty getting or maintaining erections, orgasm difficulties, premature ejaculation, pain during intercourse, and satisfaction with sexual intercourse were analyzed with mixed-effect models to detect differences between circumcised and uncircumcised men and changes over time.
    Outcomes: Changes over time in sexual interest, desire and pleasure, erectile and ejaculatory function, and pain during intercourse (dyspareunia) in circumcised and uncircumcised men; group differences in time trends; satisfaction with sexual performance; and enjoyment of sex before and after circumcision.
    Results: Sexual dysfunctions decreased in the two study groups from 17% to 54% at baseline to 11% to 44% at 24 months (P < .001), except dyspareunia, which decreased only in circumcised men (P < .001). Sexual satisfaction outcomes increased in the two study groups from 34% to 82% at baseline to 66% to 93% at 24 months (P < .001), with greater improvements in circumcised men (P < .001). On average, 97% of circumcised men were satisfied with sexual intercourse and 92% rated sex as more enjoyable or no different after circumcision compared with before circumcision.
    Clinical translation: Results are applicable to VMMC programs seeking to increase the acceptability of male circumcision as part of comprehensive HIV prevention.
    Strengths and limitations: Large-scale population-based longitudinal data restricted to sexually active individuals and adjusted for differences in baseline levels of outcomes and potential confounders are used. The questionnaire used, although not a standardized survey instrument, includes all major domains of male sexual function and satisfaction used in the most common standardized tools.
    Conclusions: Results are consistent with large cohort studies of VMMC using data from randomized controlled trials and indicate that VMMC has no significant detrimental effect or might have beneficial effects on male sexual function and satisfaction for the great majority of men circumcised as adults. Nordstrom MPC, Westercamp N, Jaoko W, et al. Medical Male Circumcision Is Associated With Improvements in Pain During Intercourse and Sexual Satisfaction in Kenya. J Sex Med 2017;14:601-612.
    MeSH term(s) Adult ; Circumcision, Male/psychology ; Circumcision, Male/statistics & numerical data ; Cohort Studies ; HIV Infections/prevention & control ; Humans ; Kenya ; Male ; Orgasm ; Pain/prevention & control ; Patient Satisfaction ; Penile Erection ; Pleasure ; Sexual Behavior/statistics & numerical data ; Surveys and Questionnaires ; Young Adult
    Language English
    Publishing date 2017-03-28
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2251959-2
    ISSN 1743-6109 ; 1743-6095
    ISSN (online) 1743-6109
    ISSN 1743-6095
    DOI 10.1016/j.jsxm.2017.02.014
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  10. Article ; Online: Feasibility, safety, and impact of the RTS,S/AS01

    Asante, Kwaku Poku / Mathanga, Don P / Milligan, Paul / Akech, Samuel / Oduro, Abraham / Mwapasa, Victor / Moore, Kerryn A / Kwambai, Titus K / Hamel, Mary J / Gyan, Thomas / Westercamp, Nelli / Kapito-Tembo, Atupele / Njuguna, Patricia / Ansong, Daniel / Kariuki, Simon / Mvalo, Tisungane / Snell, Paul / Schellenberg, David / Welega, Paul /
    Otieno, Lucas / Chimala, Alfred / Afari, Edwin A / Bejon, Philip / Maleta, Kenneth / Agbenyega, Tsiri / Snow, Robert W / Zulu, Madaliso / Chinkhumba, Jobiba / Samuels, Aaron M

    Lancet (London, England)

    2024  

    Abstract: Background: The RTS,S/AS01: Methods: In this prospective evaluation, 158 geographical clusters (66 districts in Ghana; 46 sub-counties in Kenya; and 46 groups of immunisation clinic catchment areas in Malawi) were randomly assigned to early or ... ...

    Abstract Background: The RTS,S/AS01
    Methods: In this prospective evaluation, 158 geographical clusters (66 districts in Ghana; 46 sub-counties in Kenya; and 46 groups of immunisation clinic catchment areas in Malawi) were randomly assigned to early or delayed introduction of RTS,S, with three doses to be administered between the ages of 5 months and 9 months and a fourth dose at the age of approximately 2 years. Primary outcomes of the evaluation, planned over 4 years, were mortality from all causes except injury (impact), hospital admission with severe malaria (impact), hospital admission with meningitis or cerebral malaria (safety), deaths in girls compared with boys (safety), and vaccination coverage (feasibility). Mortality was monitored in children aged 1-59 months throughout the pilot areas. Surveillance for meningitis and severe malaria was established in eight sentinel hospitals in Ghana, six in Kenya, and four in Malawi. Vaccine uptake was measured in surveys of children aged 12-23 months about 18 months after vaccine introduction. We estimated that sufficient data would have accrued after 24 months to evaluate each of the safety signals and the impact on severe malaria in a pooled analysis of the data from the three countries. We estimated incidence rate ratios (IRRs) by comparing the ratio of the number of events in children age-eligible to have received at least one dose of the vaccine (for safety outcomes), or age-eligible to have received three doses (for impact outcomes), to that in non-eligible age groups in implementation areas with the equivalent ratio in comparison areas. To establish whether there was evidence of a difference between girls and boys in the vaccine's impact on mortality, the female-to-male mortality ratio in age groups eligible to receive the vaccine (relative to the ratio in non-eligible children) was compared between implementation and comparison areas. Preliminary findings contributed to WHO's recommendation in 2021 for widespread use of RTS,S in areas of moderate-to-high malaria transmission.
    Findings: By April 30, 2021, 652 673 children had received at least one dose of RTS,S and 494 745 children had received three doses. Coverage of the first dose was 76% in Ghana, 79% in Kenya, and 73% in Malawi, and coverage of the third dose was 66% in Ghana, 62% in Kenya, and 62% in Malawi. 26 285 children aged 1-59 months were admitted to sentinel hospitals and 13 198 deaths were reported through mortality surveillance. Among children eligible to have received at least one dose of RTS,S, there was no evidence of an excess of meningitis or cerebral malaria cases in implementation areas compared with comparison areas (hospital admission with meningitis: IRR 0·63 [95% CI 0·22-1·79]; hospital admission with cerebral malaria: IRR 1·03 [95% CI 0·61-1·74]). The impact of RTS,S introduction on mortality was similar for girls and boys (relative mortality ratio 1·03 [95% CI 0·88-1·21]). Among children eligible for three vaccine doses, RTS,S introduction was associated with a 32% reduction (95% CI 5-51%) in hospital admission with severe malaria, and a 9% reduction (95% CI 0-18%) in all-cause mortality (excluding injury).
    Interpretation: In the first 2 years of implementation of RTS,S, the three primary doses were effectively deployed through national immunisation programmes. There was no evidence of the safety signals that had been observed in the phase 3 trial, and introduction of the vaccine was associated with substantial reductions in hospital admission with severe malaria. Evaluation continues to assess the impact of four doses of RTS,S.
    Funding: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.
    Language English
    Publishing date 2024-04-04
    Publishing country England
    Document type Journal Article
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(24)00004-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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