Clinical Trials Logo
  1. Home
  2. PLASMODIUM FALCIPARUM MALARIA
  3. NCT02252640

A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S

Plasmodium Falciparum Malaria Clinical Trial

Official title:
A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of Concomitant Administration of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01¬B + ChAd63 and MVA Encoding ME-TRAP and Also RTS,S/AS01B Alone

Clinical Trial Summary

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess:

1. The ability of the vaccines to prevent malaria infection.

2. The safety of the vaccines in healthy participants.

3. The response of the human immune system to the vaccines.

We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under carefully regulated conditions. We will follow participants closely to observe if and when they develop malaria. If the vaccine combination provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. We will also recruit 4 individuals to be control subjects - these participants won't receive any vaccinations but will be challenged with malaria.

Vaccinated volunteers who do not develop malaria infection in the blood after being infected with malaria by mosquito bite the first time may be invited back to be again infected with malaria in a repeat challenge experiment. This would happen approximately 5-7 months after the first challenge. The purpose of this second challenge will be to see how long the protection of the investigational vaccine against malaria lasts.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02252640
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2015
Completion date October 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT04577066 - Safety and Preliminary Protective Efficacy of Genetically Attenuated GA2 Parasites. Phase 1/Phase 2
Completed NCT01883609 - A Safety and Efficacy Study of ChAd63/MVA METRAP + RTS,S Phase 1/Phase 2
Completed NCT00593398 - Malarial Immunity in Pregnant Cameroonian Women
Completed NCT01659281 - Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand N/A
Completed NCT00074841 - Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India Phase 2/Phase 3
Recruiting NCT04416945 - Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic N/A
Completed NCT00314899 - Fetal Immunity to Falciparum Malaria
Completed NCT02867059 - SJ733 Induced Blood Stage Malaria Challenge Study Phase 1
Completed NCT00701961 - Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy Phase 2/Phase 3
Completed NCT00338520 - Hyperphenylalaninemia in Cerebral Malaria N/A
Completed NCT00707200 - The Cytoadherence in Pediatric Malaria (CPM) Study N/A
Completed NCT00393757 - Malaria Transmission and Immunity in Highland Kenya
Completed NCT03783299 - Targeted Active Case Detection Among High Risk Populations in Southern Lao Peoples Democratic Republic Phase 4
Completed NCT02614404 - Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria Phase 1
Completed NCT00358332 - Phase I Pediatric FMP2.1/AS02A Trial in Mali Phase 1
Completed NCT00730782 - Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers Phase 1
Completed NCT00349713 - FMP2.1 Trial in Bandiagara, Mali Phase 1
Recruiting NCT05052502 - Targeting High Risk Populations With Enhanced Reactive Focal Mass Drug Administration in Thailand N/A
Completed NCT04093765 - Mass Screening and Treatment for Reduction of Falciparum Malaria N/A
Completed NCT03764527 - Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar Phase 4