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Revista da Sociedade Brasileira de Medicina Tropical

Print version ISSN 0037-8682

Rev. Soc. Bras. Med. Trop. vol.29 no.5 Uberaba Sept./Oct. 1996

https://doi.org/10.1590/S0037-86821996000500014 

ARTICLES

 

Safety evaluation of SPF66 malaria vaccine in Brazil

 

 

LM. Urdaneta; A. Prata; C.J. Struchiner; C.E. Tosta; P. Tauil; M. Boulos

Adress to correspondence

 

 


ABSTRACT

The frequency and description of side effects secondaiy to the subcutaneous application of SPf66 malaria vaccine and placebo are reported for each dose of application in the participants of the vaccine efficacy trial in Brazil. Side effects evaluated two hours after each application were detected in 8.0%, 30.2% and 8.8%, for the Is', and 3"' dose, respectively, in the SPf66group, and in 7.0%, 8.5% and 2.9% in the placebo group. Local reactions such as mild inflammation, nodule and pain or erythema frequently accompanied by pruritus were the most common reactions detected in both groups (3-8%, 29.1% and 8.5% in the SPf66 group and 4.0%, 7.6% and 2.5% in the placebo group). Among vaccinees, local side effects after the 2nd dose were more frequent in females. Systemic side effects were expressed mainly through general symptoms referred by the participants and were most frequent after the 1st dose in both groups (4.3% in the SPf66 group and 3-0% in the placebo group). Muscle aches and fever were refewred by few participants. No severe adverse reactions were detected for either dose of application or group.

Keywords: Malaria vaccine. Vaccine safety. SPf66 efficacy trial.


RESUMO

A freqüência e descrição dos efeitos secundários à aplicação subcutânea da vacina antímalãrica SPf66 e placebo, são notificadas para cada dose nos participantes do estudo da eficácia vacinai no Brasil. Efeitos colaterais avaliados duas horas após a aplicação dos preparados foram detectados em 8,0%, 30,2% e 8,8% para a 1a, 2a e 3a doses, respectivamente, no grupo de vacinados; e em 7,0%, 8,5% e 2,9% no grupo que recebeu o placebo. Reações tais como inflamação leve, nódulo e dor freqüentemente acompanhadas de prurido, foram as reações locais mais freqüentes em ambos os grupos (3,8%, 29,1% e 8,5% no gmpo vacinado, e 4,0%, 7,6% e 2,5% no grupo placebo). No grupo que recebeu a vacina, as reações locais foram mais freqüentes em mulheres após a 2a dose. Os efeitos colaterais sistêmicos basearam-se em sinais e sintomas referidos pelos participantes. Foram mais freqüentes após a aplicação da 1a dose em ambos os grupos (4,3%, no grupo de vacinados e, 3,0%, no grupo placebo). Alguns participantes referiram mialgias e febre. Nenhum efeito colateral grave foi detectado em nenhuma dose de aplicação ou grupo.

Palavras-chaves: Vacina antimalãrica. Segurança SPf66. Ensaio de campo SPf66.


 

 

Full text available only in PDF format.

Texto completo disponível apenas em PDF.

 

 

REFERENCES

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9. Urdaneta M, PrataA, Struchiner CJ,Tosta CE,Tauil P, Boulos M. SPf66 vaccine trial in Brazil: Conceptual framework, study design and analytical approach. Revista da Sociedade Brasileira de MedicinaTropical 29:259-269,1996.         [ Links ]

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Recebido para publicação em 29/07/96.

 

 

Adress to correspondence:
Prof. Aluizio Prata.
Medicina Tropical/FMTM.
Caixa Postal:118, 38001-970
Uberaba, MG, Brasil.
Fax: 55-34-3127722, ramal 1279.

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