Premium
Safety in infants of SPf66, a synthetic malaria vaccine, delivered alongside the EPI
Author(s) -
Schellenberg D. M.,
Acosta C. J.,
Galindo C. M.,
Kahigwa E.,
Urassa H.,
Masanja H.,
Aponte J. J.,
Schellenberg J. R. M. Armstrong,
FraserHurt N.,
Lwilla F.,
Menendez C.,
Mshinda H.,
Tanner M.,
Alonso P. L.
Publication year - 1999
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1046/j.1365-3156.1999.00424.x
Subject(s) - reactogenicity , medicine , malaria , malaria vaccine , vaccination , immunization , adverse effect , clinical trial , tanzania , pediatrics , environmental health , immunology , plasmodium falciparum , antigen , environmental science , environmental planning
Summary The most likely mechanism to deliver a malaria vaccine in African countries is through the Expanded Program of Immunization (EPI). So far only SPf66, a multistage synthetic peptide, has shown any evidence of protection in Phase III field trials. In Tanzania, SPf66 reduced the risk of clinical malaria by 31% in children aged 1–5 years. In order to progress in the critical path of vaccine development and testing towards the implementation of a new vaccine in malaria control programs, we carried out a randomized double‐blind placebo controlled efficacy trial of SPf66 when given alongside the EPI scheme. Monitoring of safety and reactogenicity during this trial included detailed clinical and laboratory assessments on 98 infants and assessment of adverse effects within 1 h of vaccination for all 1207 children vaccinated. Surveillance systems monitored attendances as outpatients, admissions to hospital and fatal events in the community. No serious adverse effects were detected more frequently amongst SPf66 recipients compared to placebo. This first assessment in very young infants of a synthetic vaccine provides evidence of a good safety profile.