An Ancillary Study Protocol to GSK's Phase IIb Malaria Vaccine Trial Entitled "Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age"

Malaria Clinical Trial

Official title: An Ancillary Study Protocol to GlaxoSmithKline Phase IIb RTS,S/AS01E Malaria Vaccine Trial (Study Number 204889 [MALARIA-094]) Entitled, "Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age"

Status Completed

Clinical Trial Summary

The goal of the proposed amplicon sequencing and genotyping study is to assess vaccine efficacy against clinical and asymptomatic malaria infection using ultra-sensitive molecular amplification and sequencing methodology to detect Plasmodium falciparum (P. falciparum) parasites from serial blood samples to be collected from children immunized with the primary and yearly booster immunizations of the RTS,S/AS01E vaccine as part of their participation in Protocol MALARIA-094 (parent clinical study protocol). Genomic analysis will be performed on parasites from blood spot samples collected from children aged 5 17 months immunized with RTS,S/AS01E on different dosage and schedule regimens under the parent clinical study protocol.

Clinical Trial Description

This genotyping study of malaria parasites collected from serial blood samples following RTS,S/AS01E immunization will assess vaccine efficacy using molecular genetic data to identify first infections following vaccination, and to distinguish new from existing infections, using an amplicon sequencing-based strategy: deep sequencing of small, highly variable regions of the parasite genome to allow for both: 1. Highly sensitive detection of parasitemia (analogous to conventional polymerase chain reaction [PCR]-based detection), and 2. Identification of genetically distinct parasite populations within or between affected individuals. ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT03281291
• Study type: Observational
• Source: GlaxoSmithKline
• Status: Completed
• Start date: November 19, 2018
• Completion date: April 22, 2022