Anaemia in a phase 2 study of a blood stage falciparum malaria vaccine.

ABSTRACT:

Background

A Phase 1-2b study of the blood stage malaria vaccine AMA1-C1/Alhydrogel was conducted in 336 children in Donéguébougou and Bancoumana, Mali. In the Phase 2 portion of the study (n = 300), no impact on parasite density or clinical malaria was seen; however, children who received the study vaccine had a higher frequency of anaemia (defined as haemoglobin < 8.5 g/dL) compared to those who received the comparator vaccine (Hiberix). This effect was one of many tested and was not significant after adjusting for multiple comparisons.

Methods

To further investigate the possible impact of vaccination on anaemia, additional analyses were conducted including patients from the Phase 1 portion of the study and controlling for baseline haemoglobin, haemoglobin types S or C, al

SUBMITTER: Ellis RD 

PROVIDER: S-EPMC3036666 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature