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Impact of the COVID-19 pandemic on a clinical trial of pneumococcal vaccine scheduling (PVS) in rural Gambia.
Hossain, Ilias; Osei, Isaac; Lobga, Galega; Wutor, Baleng M; Olatunji, Yekini; Adefila, Williams; Adeshola, Banjo; Isa, Yasir; Nguyen, Cattram; Sonko, Kemo; Ceesay, Lamin; Baldeh, Bubacarr; Barrow, Omar; Young, Benjamin; Ceesay, Saidina; Nyassi, Abdoullah; Sarwar, Golam; Barjo, Ousman; M Drammeh, Momodou; Salaudeen, Rasheed; Mackenzie, Grant.
  • Hossain I; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia. Mohammad.Hossain@lshtm.ac.uk.
  • Osei I; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Lobga G; Faculty of Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
  • Wutor BM; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Olatunji Y; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Adefila W; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Adeshola B; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Isa Y; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Nguyen C; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Sonko K; Murdoch Children's Research Institute, Melbourne, Australia.
  • Ceesay L; Regional Health Directorate, Upper River Region, Ministry of Health, Basse, The Gambia.
  • Baldeh B; Regional Health Directorate, Upper River Region, Ministry of Health, Basse, The Gambia.
  • Barrow O; Regional Health Directorate, Central River Region, Ministry of Health, Bansang, The Gambia.
  • Young B; Regional Health Directorate, Central River Region, Ministry of Health, Bansang, The Gambia.
  • Ceesay S; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Nyassi A; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Sarwar G; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Barjo O; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • M Drammeh M; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Salaudeen R; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
  • Mackenzie G; Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, PO Box 273, Fajara, Banjul, The Gambia.
Trials ; 24(1): 271, 2023 Apr 14.
Article in English | MEDLINE | ID: covidwho-2296609
ABSTRACT
The COVID-19 pandemic represents an unprecedented challenge for clinical research. The Pneumococcal Vaccine Schedules (PVS) study is a non-inferiority, interventional trial in which infants resident in 68 geographic clusters are randomised to two different schedules for pneumococcal vaccination. From September 2019 onwards, all infants resident in the study area became eligible for trial enrolment at all Expanded Programme on Immunisation (EPI) clinics in the study area. Surveillance for clinical endpoints is conducted at all 11 health facilities in the study area. PVS is conducted as a collaboration between the Medical Research Council Unit The Gambia (MRCG) at LSHTM and the Gambian Ministry of Health (MoH). The COVID-19 pandemic caused many disruptions to PVS. MRCG instructed interventional studies that participant enrolment be suspended on 26 March 2020, and a public health emergency was declared in The Gambia on 28 March 2020. Enrolment in PVS restarted on 1 July 2020 and was suspended again on 5 August 2020 after The Gambia experienced a sharp increase in COVID-19 cases in late July 2020 and restarted again on 1 September 2020. During periods of suspended enrolment of infants at EPI clinics, PVS continued safety surveillance at health facilities, albeit with disruptions. During the periods of suspended enrolment, infants who had been enrolled before 26 March 2020 continued to receive the PCV schedule to which they had been randomly allocated based on their village of residence, whereas all other infants received the standard PCV schedule. Throughout 2020 and 2021, the trial faced numerous technical and operational challenges disruption to MoH delivery of EPI services and clinical care at health facilities; episodes of staff illness and isolation; disruption of MRCG transport, procurement, communications and human resource management; and also a range of ethical, regulatory, sponsorship, trial monitoring and financial challenges. In April 2021, a formal review concluded that the pandemic had not compromised the scientific validity of PVS and that the trial should continue as per protocol. The continuing challenges that COVID-19 poses to PVS, and other clinical trials will persist for some time.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Pneumococcal Vaccines / Equivalence Trials as Topic / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans / Infant Country/Region as subject: Africa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2023 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Pneumococcal Vaccines / Equivalence Trials as Topic / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans / Infant Country/Region as subject: Africa Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2023 Document Type: Article