Safety and reactogenicity of an MSP-1 malaria vaccine candidate: a randomized phase Ib dose-escalation trial in Kenyan children.

ABSTRACT:

Objective

Our aim was to evaluate the safety, reactogenicity, and immunogenicity of an investigational malaria vaccine.

Design

This was an age-stratified phase Ib, double-blind, randomized, controlled, dose-escalation trial. Children were recruited into one of three cohorts (dosage groups) and randomized in 2:1 fashion to receive either the test product or a comparator.

Setting

The study was conducted in a rural population in Kombewa Division, western Kenya.

Participants

Subjects were 135 children, aged 12-47 mo.

Interventions

Subjects received 10, 25, or 50 microg of falciparum malaria protein 1 (FMP1) formulated in 100, 250, and 500 microL, respectively, of AS02A, or they received a comparator (Imovax (rabies vaccine).

Outcome measures

We perfor

SUBMITTER: Withers MR 

PROVIDER: S-EPMC1851726 | biostudies-literature | 2006 Nov

REPOSITORIES: biostudies-literature