Impact of the COVID-19 pandemic on a clinical trial of pneumococcal vaccine scheduling (PVS) in rural Gambia
AbstractThe 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 Me...
Source: Trials - April 14, 2023 Category: Research Source Type: clinical trials

Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-na ïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
DiscussionThis trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination.Trial registrationPan-African Clinical Trials Registry202008836432905.ClinicalTrials.govNCT04394689 (Source: Trials)
Source: Trials - September 14, 2022 Category: Research Source Type: clinical trials

A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21
Condition:   Malaria, Plasmodium Falciparum Intervention:   Biological: Matrix-M with RH5.2 VLP and/or R21 Sponsors:   University of Oxford;   European and Developing Countries Clinical Trials Partnership (EDCTP);   Medical Research Council Unit The Gambia at the LSHTM (MRCG) Not yet recruiting (Source:
Source: - May 3, 2022 Category: Research Source Type: clinical trials

A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to three-dose schedule of pneumococcal conjugate vaccination in rural Gambia: the PVS trial
DiscussionAnalysis will account for potential non-independence of measurements by cluster, comparing the population-level impact of the two schedules with interpretation at the individual level. The non-inferiority margin is informed by the ‘acceptable loss of effect’ of the alternative compared to the standard schedule. The secondary endpoints will provide substantial evidence to support the interpretation of the primary endpoint. PVS will evaluate the effect of transition from a standard 3+ 0 schedule to an alternative 1 +  1 schedule in a setting of high pneumococcal transmission. The results of PVS will infor...
Source: Trials - January 24, 2022 Category: Research Source Type: clinical trials

Pneumococcal conjugate vaccination schedules in infants —acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study
DiscussionAnalysis will account for potential non-independence of measurements by cluster and so interpretation of effects will be at the individual level (i.e. a population of individuals). PVS-AcqImm will evaluate whether acquisition of vaccine-type pneumococci is reduced by the alternative compared to the standard schedule, which is required if the alternative schedule is to be effective. Likewise, evidence of superior immune response at 18  months of age and safety of PCV co-administration with yellow fever vaccine will support decision-making regarding the use of the alternative 1+1 schedule. Acquisition and immunog...
Source: Trials - January 15, 2022 Category: Research Source Type: clinical trials

Adjunctive Ivermectin Mass Drug Administration for Malaria Control
Conditions:   Malaria,Falciparum;   Neglected Tropical Diseases;   Strongyloidiasis;   Lymphatic Filariasis;   Scabies;   Hook Worm;   Soil Transmitted Helminths Interventions:   Drug: Ivermectin;   Drug: Placebo;   Drug: Dihydroartemisinin-piperaquine Sponsors:   London School of Hygiene and Tropical Medicine;   Medical Research Council Unit, The Gambia;   Ministerio de Saude Publica, Guinee-Bissau;   Bandim Health Project;   Instituto Nacional de Estudos e Pesquisas, Guinee-Bissau Not yet recruiting (Source:
Source: - April 14, 2021 Category: Research Source Type: clinical trials