Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial.

Adult Antibody Formation / drug effects B-Lymphocytes / drug effects Double-Blind Method Humans Infant Kenya / epidemiology Malaria Vaccines / administration & dosage Malaria, Falciparum / drug therapy Plasmodium falciparum / drug effects Sporozoites / drug effects T-Lymphocytes / drug effects Vaccination Vaccines, Attenuated / administration & dosage

Journal

Nature medicine

ISSN: 1546-170X

Titre abrégé: Nat Med

Pays: United States

ID NLM: 9502015

Informations de publication

Date de publication:
09 2021

Historique:

received: 16 03 2021

accepted: 16 07 2021

pubmed: 15 9 2021

medline: 9 10 2021

entrez: 14 9 2021

Statut: ppublish

Résumé

The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naïve adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily induced in humans after vaccination. However, previous malaria exposure can limit immune responses and vaccine efficacy (VE) in adults. We hypothesized that infants with less previous exposure to malaria would have improved immunity and protection. We conducted a multi-arm, randomized, double-blind, placebo-controlled trial in 336 infants aged 5-12 months to determine the safety, tolerability, immunogenicity and efficacy of the PfSPZ Vaccine in infants in a high-transmission malaria setting in western Kenya ( NCT02687373 ). Groups of 84 infants each received 4.5 × 10

Identifiants

DOI: 10.1038/s41591-021-01470-y PMID: 34518679

pubmed: 34518679

doi: 10.1038/s41591-021-01470-y

pii: 10.1038/s41591-021-01470-y

doi:

Substances chimiques

Malaria Vaccines 0

Vaccines, Attenuated 0

Banques de données

ClinicalTrials.gov

['NCT02687373']

Types de publication

Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

Pagination

1636-1645

Subventions

Organisme : NIAID NIH HHS

ID : R44 AI055229

Pays : United States

Organisme : NIAID NIH HHS

ID : R44 AI058375

Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

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