First field efficacy trial of the ChAd63 MVA ME-TRAP vectored malaria vaccine candidate in 5-17 months old infants and children

• DOI: 10.1371/journal.pone.0208328
• Publication Date: 2018-12-12T18:41:50Z
• Authors: Alfred B. Tiono; Issa Nébié; Nicholas Anagnostou; Aboubacar S. Coul...; Georgina Bowyer; Erika Lam; Edith C. Bougouma; Alphonse Ouedraogo; Jean Baptist B. Yaro; Aïssata Barry; Rachel Roberts; Tommy Rampling; Carly Bliss; Susanne Hodgson; Alison Lawrie; Amidou Ouedraogo; Egeruan Babatunde...; Katie J. Ewer; Nicola K. Viebig; Amidou Diarra; Odile Leroy; Philip Bejon; Adrian V. S. Hill; Sodiomon B. Sirima
• Keywords: Male; 0301 basic medicine; Science; T-Lymphocytes; Vaccine efficacy; Plasmodium falciparum; Immunology; Enzyme-Linked Immunosorbent Assay; Vaccinia virus; Kaplan-Meier Estimate; Modified vaccinia Ankara; Parasitemia; Malaria vaccine; Biochemistry; Gene; 03 medical and health sciences; Double-Blind Method; Virology; Malaria Vaccines; Health Sciences; Vaccinia; Humans; Global Impact of Arboviral Diseases; Clinical endpoint; Internal medicine; Biology; Regimen; Immunology and Microbiology; Vaccines; Recombinant DNA; FOS: Clinical medicine; Q; Vaccination; R; Public Health, Environmental and Occupational Health; Vaccine trial; Infant; Life Sciences; Kenya; Malaria; 3. Good health; Clinical trial; Leukocytes, Mononuclear; Adenoviruses, Simian; Medicine; Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome; Female; Research Article

Background Heterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified Vaccinia Virus Ankara (MVA) vectored vaccines is a strategy previously shown to provide substantial protective efficacy against P. falciparum infection in United Kingdom adult Phase IIa sporozoite challenge studies (approximately 20–25% sterile protection similar numbers showing clear delay time patency), greater point trial Kenyan adults. Methodology We conducted the first IIb clinical assessing safety, immunogenicity of ChAd63 MVA ME-TRAP 700 healthy malaria exposed children aged 5–17 months highly endemic transmission area Burkina Faso. Results was be safe immunogenic but induced only moderate T cell responses (median 326 SFU/106 PBMC (95% CI 290–387)) many fold lower than previous trials. No significant observed during follow up period, primary endpoint estimate by proportional analysis being 13.8% (95%CI -42.4 47.9) at sixth month post 3.1% -15.0 18.3; p = 0.72) Cox regression. Conclusions This study has confirmed vaccine regimen infants prior exposure malaria. But no this very malaria-endemic setting. Trial registration ClinicalTrials.gov NCT01635647. Pactr.org PACTR201208000404131.