Safety in infants of SPf66, a synthetic malaria vaccine, delivered alongside the EPI
| Autor: | C. J. Acosta, Fred Lwilla, David Schellenberg, N. Fraser‐Hurt, H. Urassa, Honorati Masanja, Clara Menéndez, C. M. Galindo, H. Mshinda, Elizeus Kahigwa, P. L. Alonso, J. R. M. Armstrong Schellenberg, Marcel Tanner, John J. Aponte |
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| Rok vydání: | 1999 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Population Protozoan Proteins Tanzania law.invention Double-Blind Method Randomized controlled trial law Malaria Vaccines parasitic diseases medicine Humans education Adverse effect Vaccines Synthetic education.field_of_study Reactogenicity biology Malaria vaccine business.industry Infant Newborn Public Health Environmental and Occupational Health Infant Plasmodium falciparum medicine.disease biology.organism_classification Recombinant Proteins Malaria Vaccination Infectious Diseases Population Surveillance Immunology Female Parasitology business Program Evaluation |
| Zdroj: | Tropical Medicine & International Health. 4:377-382 |
| ISSN: | 1365-3156 1360-2276 |
| Popis: | The malaria parasite Plasmodium falciparum causes more morbidity and mortality than any other parasitic disease of man. However malaria control efforts have been frustrated by delays in the development of an effective vaccine. So far only SPf66 a multistage synthetic peptide has shown any evidence of protection in phase III vaccine field trials. Research has shown that SPf66 has an estimated combined efficacy of 23% in reducing the incidence of first attacks of clinical malaria and that further evaluation is warranted. Since most malaria disease and death is concentrated among very young children in sub-Saharan Africa the only realistic way to deliver a vaccine to that age group is through the Expanded Program of Immunization (EPI) which begins its schedule at birth. This paper reports the safety and reactogenicity of SPf66 when delivered alongside the EPI program to infants aged 1 2 and 7 months in southern Tanzania. The study was of randomized double-blind placebo-controlled design. The monitoring of safety and reactogenicity during the trial included detailed clinical and laboratory assessments on 98 infants and the assessment of adverse effects within 1 hour 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 among SPf66 recipients than among placebo recipients suggesting that this vaccine can be safely administered to very young infants. |
| Databáze: | OpenAIRE |
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