Last data update: Nov 04, 2024. (Total: 48056 publications since 2009)
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Mortality among children aged <5 years living with HIV who are receiving antiretroviral treatment - U.S. President's Emergency Plan for AIDS Relief, 28 supported countries and regions, October 2020-September 2022
Agathis NT , Faturiyele I , Agaba P , Fisher KA , Hackett S , Agyemang E , Mehta N , Kindra G , Morof DF , Mutisya I , Nyabiage L , Battey KA , Olotu E , Maphosa T , Motswere-Chirwa C , Ketlogetswe AT , Mafa-Setswalo J , Mazibuko S , de Deus MIT , Nhaguiombe HG , Machage EM , Mugisa B , Ogundehin DT , Mbelwa C , Birabwa E , Etima M , Adamu Y , Lawal I , Maswai J , Njeru D , Mwambona J , Nguhuni B , Mrina R , Hrapcak S , Siberry GK , Godfrey C , Wolf HT . MMWR Morb Mortal Wkly Rep 2023 72 (48) 1293-1299 Globally, children aged <5 years, including those living with HIV who are not receiving antiretroviral treatment (ART), experience disproportionately high mortality. Global mortality among children living with HIV aged <5 years receiving ART is not well described. This report compares mortality and related clinical measures among infants aged <1 year and children aged 1-4 years living with HIV with those among older persons aged 5-14, 15-49, and ≥50 years living with HIV receiving ART services at all clinical sites supported by the U.S. President's Emergency Plan for AIDS Relief. During October 2020-September 2022, an average of 11,980 infants aged <1 year and 105,510 children aged 1-4 years were receiving ART each quarter; among these infants and children receiving ART, 586 (4.9%) and 2,684 (2.5%), respectively, were reported to have died annually. These proportions of infants and children who died ranged from four to nine times higher in infants aged <1 year, and two to five times higher in children aged 1-4 years, than the proportions of older persons aged ≥5 years receiving ART. Compared with persons aged ≥5 years living with HIV, the proportions of children aged <5 years living with HIV who experienced interruptions in treatment were also higher, and the proportions who had a documented HIV viral load result or a suppressed viral load were lower. Prioritizing and optimizing HIV and general health services for children aged <5 years living with HIV receiving ART, including those recommended in the WHO STOP AIDS Package, might help address these disproportionately poorer outcomes. |
Sporozoite immunization: Innovative Translational Science to Support the Fight against malaria
Richie TL , Church LWP , Murshedkar T , Billingsley PF , James ER , Chen MC , Abebe Y , Natasha Kc , Chakravarty S , Dolberg D , Healy SA , Diawara H , Sissoko MS , Sagara I , Cook DM , Epstein JE , Mordmüller B , Kapulu M , Kreidenweiss A , Franke-Fayard B , Agnandji ST , López Mikue MA , McCall MBB , Steinhardt L , Oneko M , Olotu A , Vaughan AM , Kublin JG , Murphy SC , Jongo S , Tanner M , Sirima SB , Laurens MB , Daubenberger C , Silva JC , Lyke KE , Janse CJ , Roestenberg M , Sauerwein RW , Abdulla S , Dicko A , Kappe SHI , Sim BKL , Duffy PE , Kremsner PG , Hoffman SL . Expert Rev Vaccines 2023 22 (1) 964-1007 INTRODUCTION: Malaria, a devastating febrile illness caused by protozoan parasites, sickened 247,000,000 people in 2021 and killed 619,000, mostly children and pregnant women in sub-Saharan Africa. A highly effective vaccine is urgently needed, especially for Plasmodium falciparum (Pf), the deadliest human malaria parasite. AREAS COVERED: Sporozoites (SPZ), the parasite stage transmitted by Anopheles mosquitoes to humans, are the only vaccine immunogen achieving > 90% efficacy against Pf infection. This review describes > 30 clinical trials of PfSPZ vaccines in the U.S.A., Europe, Africa, and Asia, based on first-hand knowledge of the trials and PubMed searches of 'sporozoites,' 'malaria,' and 'vaccines.' EXPERT OPINION: First generation (radiation-attenuated) PfSPZ vaccines are safe, well tolerated, 80-100% efficacious against homologous controlled human malaria infection (CHMI) and provide 18-19 months protection without boosting in Africa. Second generation chemo-attenuated PfSPZ are more potent, 100% efficacious against stringent heterologous (variant strain) CHMI, but require a co-administered drug, raising safety concerns. Third generation, late liver stage-arresting, replication competent (LARC), genetically-attenuated PfSPZ are expected to be both safe and highly efficacious. Overall, PfSPZ vaccines meet safety, tolerability, and efficacy requirements for protecting pregnant women and travelers, with licensure for these populations possible within five years. Protecting children and mass vaccination programs to block transmission and eliminate malaria are long-term objectives. |
A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants
Agnandji ST , Lell B , Fernandes JF , Abossolo BP , Methogo BG , Kabwende AL , Adegnika AA , Mordmüller B , Issifou S , Kremsner PG , Sacarlal J , Aide P , Lanaspa M , Aponte JJ , Machevo S , Acacio S , Bulo H , Sigauque B , Macete E , Alonso P , Abdulla S , Salim N , Minja R , Mpina M , Ahmed S , Ali AM , Mtoro AT , Hamad AS , Mutani P , Tanner M , Tinto H , D'Alessandro U , Sorgho H , Valea I , Bihoun B , Guiraud I , Kaboré B , Sombié O , Guiguemdé RT , Ouédraogo JB , Hamel MJ , Kariuki S , Oneko M , Odero C , Otieno K , Awino N , McMorrow M , Muturi-Kioi V , Laserson KF , Slutsker L , Otieno W , Otieno L , Otsyula N , Gondi S , Otieno A , Owira V , Oguk E , Odongo G , Woods JB , Ogutu B , Njuguna P , Chilengi R , Akoo P , Kerubo C , Maingi C , Lang T , Olotu A , Bejon P , Marsh K , Mwambingu G , Owusu-Agyei S , Asante KP , Osei-Kwakye K , Boahen O , Dosoo D , Asante I , Adjei G , Kwara E , Chandramohan D , Greenwood B , Lusingu J , Gesase S , Malabeja A , Abdul O , Mahende C , Liheluka E , Malle L , Lemnge M , Theander TG , Drakeley C , Ansong D , Agbenyega T , Adjei S , Boateng HO , Rettig T , Bawa J , Sylverken J , Sambian D , Sarfo A , Agyekum A , Martinson F , Hoffman I , Mvalo T , Kamthunzi P , Nkomo R , Tembo T , Tegha G , Tsidya M , Kilembe J , Chawinga C , Ballou WR , Cohen J , Guerra Y , Jongert E , Lapierre D , Leach A , Lievens M , Ofori-Anyinam O , Olivier A , Vekemans J , Carter T , Kaslow D , Leboulleux D , Loucq C , Radford A , Savarese B , Schellenberg D , Sillman M , Vansadia P . N Engl J Med 2012 367 (24) 2284-95 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.). |
First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children
Agnandji ST , Lell B , Soulanoudjingar SS , Fernandes JF , Abossolo BP , Conzelmann C , Methogo BG , Doucka Y , Flamen A , Mordmüller B , Issifou S , Kremsner PG , Sacarlal J , Aide P , Lanaspa M , Aponte JJ , Nhamuave A , Quelhas D , Bassat Q , Mandjate S , Macete E , Alonso P , Abdulla S , Salim N , Juma O , Shomari M , Shubis K , Machera F , Hamad AS , Minja R , Mtoro A , Sykes A , Ahmed S , Urassa AM , Ali AM , Mwangoka G , Tanner M , Tinto H , D'Alessandro U , Sorgho H , Valea I , Tahita MC , Kaboré W , Ouédraogo S , Sandrine Y , Guiguemdé RT , Ouédraogo JB , Hamel MJ , Kariuki S , Odero C , Oneko M , Otieno K , Awino N , Omoto J , Williamson J , Muturi-Kioi V , Laserson KF , Slutsker L , Otieno W , Otieno L , Nekoye O , Gondi S , Otieno A , Ogutu B , Wasuna R , Owira V , Jones D , Onyango AA , Njuguna P , Chilengi R , Akoo P , Kerubo C , Gitaka J , Maingi C , Lang T , Olotu A , Tsofa B , Bejon P , Peshu N , Marsh K , Owusu-Agyei S , Asante KP , Osei-Kwakye K , Boahen O , Ayamba S , Kayan K , Owusu-Ofori R , Dosoo D , Asante I , Adjei G , Adjei G , Chandramohan D , Greenwood B , Lusingu J , Gesase S , Malabeja A , Abdul O , Kilavo H , Mahende C , Liheluka E , Lemnge M , Theander T , Drakeley C , Ansong D , Agbenyega T , Adjei S , Boateng HO , Rettig T , Bawa J , Sylverken J , Sambian D , Agyekum A , Owusu L , Martinson F , Hoffman I , Mvalo T , Kamthunzi P , Nkomo R , Msika A , Jumbe A , Chome N , Nyakuipa D , Chintedza J , Ballou WR , Bruls M , Cohen J , Guerra Y , Jongert E , Lapierre D , Leach A , Lievens M , Ofori-Anyinam O , Vekemans J , Carter T , Leboulleux D , Loucq C , Radford A , Savarese B , Schellenberg D , Sillman M , Vansadia P . N Engl J Med 2011 365 (20) 1863-75 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 .) |
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