Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-5 (of 5 Records) |
Query Trace: Muturi-Kioi V[original query] |
---|
Description of adverse events among adult men following voluntary medical male circumcision: Findings from a circumcision programme in two provinces of South Africa
Muchiri E , Charalambous S , Ginindza S , Maraisane M , Maringa T , Vranken P , Loykissoonlal D , Muturi-Kioi V , Chetty-Makkan CM . PLoS One 2021 16 (8) e0253960 BACKGROUND: Clinical trials showed strong evidence that voluntary medical male circumcision (VMMC) reduces the acquisition of HIV among heterosexual men by up to 60%. However, VMMC uptake in East and Southern Africa remains suboptimal, with safety concerns identified as a barrier to uptake. We investigated the occurrence and severity of adverse events (AEs) in a routine VMMC programme implemented in Gauteng and North West provinces of South Africa. METHODS: We describe the frequency and characteristics of AEs using routinely collected data from a VMMC programme implemented between 01 May 2013 and 31 December 2014. The surgical procedure was provided at fixed clinics and mobile units in three districts. Adult men undertaking the procedure were referred for follow-up appointments where AEs were monitored. RESULTS: A total of 7,963 adult men were offered the VMMC service with 7,864 (98.8%) met the age and consent requirements for inclusion in a research follow-up after the surgical procedure and were followed-up for potential AEs. In total, 37 (0.5%) patients reported AEs post-surgery with infection [11 (29.7%)] and excessive bleeding [11 (29.7%)] commonly reported AEs. In terms of severity, 14 (37.8%) were classified as mild, 13 (35.1%) as moderate, and 10 (27.0%) as severe. Further, 32 (86.5%) of the AEs were classified as definitely related to the surgical procedure, with 36 (97.5%) of all AEs resolving without sequelae. CONCLUSION: The VMMC programme was able to reach adult men at high risk of HIV acquisition. Reported AEs in the programme were minimal, with the observed safety profile comparable to clinical trial settings, suggesting that VMMC can be safely administered in a programmatic setting. |
Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial
RTS S Clinical Trials Partnership , Hamel MJ , Kariuki S , Oneko M , Odero C , Otieno K , Awino N , Muturi-Kioi V , Omoto J , Sang T , Odhiambo S , Laserson KF , Slutsker L . Lancet 2015 386 (9988) 31-45 BACKGROUND: The efficacy and safety of the RTS,S/AS01 candidate malaria vaccine during 18 months of follow-up have been published previously. Herein, we report the final results from the same trial, including the efficacy of a booster dose. METHODS: From March 27, 2009, until Jan 31, 2011, children (age 5-17 months) and young infants (age 6-12 weeks) were enrolled at 11 centres in seven countries in sub-Saharan Africa. Participants were randomly assigned (1:1:1) at first vaccination by block randomisation with minimisation by centre to receive three doses of RTS,S/AS01 at months 0, 1, and 2 and a booster dose at month 20 (R3R group); three doses of RTS,S/AS01 and a dose of comparator vaccine at month 20 (R3C group); or a comparator vaccine at months 0, 1, 2, and 20 (C3C [control group]). Participants were followed up until Jan 31, 2014. Cases of clinical and severe malaria were captured through passive case detection. Serious adverse events (SAEs) were recorded. Analyses were by modified intention to treat and per protocol. The coprimary endpoints were the occurrence of malaria over 12 months after dose 3 in each age category. In this final analysis, we present data for the efficacy of the booster on the occurrence of malaria. Vaccine efficacy (VE) against clinical malaria was analysed by negative binomial regression and against severe malaria by relative risk reduction. This trial is registered with ClinicalTrials.gov, number NCT00866619. FINDINGS: 8922 children and 6537 young infants were included in the modified intention-to-treat analyses. Children were followed up for a median of 48 months (IQR 39-50) and young infants for 38 months (34-41) after dose 1. From month 0 until study end, compared with 9585 episodes of clinical malaria that met the primary case definition in children in the C3C group, 6616 episodes occurred in the R3R group (VE 36·3%, 95% CI 31·8-40·5) and 7396 occurred in the R3C group (28·3%, 23·3-32·9); compared with 171 children who experienced at least one episode of severe malaria in the C3C group, 116 children experienced at least one episode of severe malaria in the R3R group (32·2%, 13·7 to 46·9) and 169 in the R3C group (1·1%, -23·0 to 20·5). In young infants, compared with 6170 episodes of clinical malaria that met the primary case definition in the C3C group, 4993 episodes occurred in the R3R group (VE 25·9%, 95% CI 19·9-31·5) and 5444 occurred in the R3C group (18·3%, 11·7-24·4); and compared with 116 infants who experienced at least one episode of severe malaria in the C3C group, 96 infants experienced at least one episode of severe malaria in the R3R group (17·3%, 95% CI -9·4 to 37·5) and 104 in the R3C group (10·3%, -17·9 to 31·8). In children, 1774 cases of clinical malaria were averted per 1000 children (95% CI 1387-2186) in the R3R group and 1363 per 1000 children (995-1797) in the R3C group. The numbers of cases averted per 1000 young infants were 983 (95% CI 592-1337) in the R3R group and 558 (158-926) in the R3C group. The frequency of SAEs overall was balanced between groups. However, meningitis was reported as a SAE in 22 children: 11 in the R3R group, ten in the R3C group, and one in the C3C group. The incidence of generalised convulsive seizures within 7 days of RTS,S/AS01 booster was 2·2 per 1000 doses in young infants and 2·5 per 1000 doses in children. INTERPRETATION: RTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3-4 year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission. FUNDING: GlaxoSmithKline Biologicals SA and the PATH Malaria Vaccine Initiative. |
Emergence of community-acquired, multidrug-resistant invasive nontyphoidal Salmonella disease in rural western Kenya, 2009-2013
Oneko M , Kariuki S , Muturi-Kioi V , Otieno K , Otieno VO , Williamson JM , Folster J , Parsons MB , Slutsker L , Mahon BE , Hamel MJ . Clin Infect Dis 2015 61 Suppl 4 S310-6 BACKGROUND: Nontyphoidal Salmonella (NTS), mainly serotypes Typhimurium and Enteritidis, cause invasive infections with high mortality in children in sub-Saharan Africa. Multidrug resistance is common, and resistance to third-generation cephalosporins has emerged. METHODS: We reviewed clinical features, outcomes, and antimicrobial resistance patterns in invasive NTS infections among children aged 6 weeks to 5 years participating in malaria vaccine studies in an area of high malaria and human immunodeficiency virus (HIV) transmission in Siaya, western Kenya. Blood culture was performed in hospitalized children and pediatric outpatients with prolonged fever. RESULTS: From July 2009 to December 2013, 1696 children aged 6 weeks to 17 months were enrolled into vaccine trials and followed for up to 53 months. We obtained 1692 blood cultures from 847 children. Of 134 bacterial pathogens isolated, 102 (76.1%) were Salmonella serogroup B or D. Invasive NTS disease occurred in 94 (5.5%) children, with an incidence of 1870, 4134, and 6510 episodes per 100 000 person-years overall, in infants, and in HIV-infected children, respectively. Malaria infection within the past 2 weeks occurred in 18.8% (3/16) of invasive NTS episodes in HIV-infected and 66.2% (53/80) in HIV-uninfected children. Case fatality rate was 3.1%. Salmonella group B resistant to ceftriaxone emerged in 2009 and 2010 (6.2% [2/32 isolates]), rising to 56.5% (13/23 isolates) in 2012 and 2013. CONCLUSIONS: Incidence of invasive NTS disease was high in this area of high malaria and HIV transmission, especially in HIV-infected children. Rapidly emerging resistance against ceftriaxone requires urgent reevaluation of antibiotic recommendations and primary prevention of exposure to Salmonella. |
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 .) |
- Page last reviewed:Feb 1, 2024
- Page last updated:Jan 27, 2025
- Content source:
- Powered by CDC PHGKB Infrastructure