RESUMO
Ebola virus causes irregular outbreaks of severe hemorrhagic fever in equatorial Africa. Case mortality remains high; there is no effective treatment and outbreaks are sporadic and unpredictable. Studies of Ebola virus vaccine platforms in non-human primates have established that the induction of protective immunity is possible and safety and human immunogenicity has been demonstrated in a previous Phase I clinical trial of a 1st generation Ebola DNA vaccine. We now report the safety and immunogenicity of a recombinant adenovirus serotype 5 (rAd5) vaccine encoding the envelope glycoprotein (GP) from the Zaire and Sudan Ebola virus species, in a randomized, placebo-controlled, double-blinded, dose escalation, Phase I human study. Thirty-one healthy adults received vaccine at 2×10(9) (n=12), or 2×10(10) (n=11) viral particles or placebo (n=8) as an intramuscular injection. Antibody responses were assessed by ELISA and neutralizing assays; and T cell responses were assessed by ELISpot and intracellular cytokine staining assays. This recombinant Ebola virus vaccine was safe and subjects developed antigen specific humoral and cellular immune responses.
Assuntos
Adenovírus Humanos/genética , Vacinas contra Ebola/imunologia , Vetores Genéticos , Doença pelo Vírus Ebola/prevenção & controle , Proteínas do Envelope Viral/imunologia , Adolescente , Adulto , Animais , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Citocinas/imunologia , Método Duplo-Cego , Vacinas contra Ebola/efeitos adversos , Vacinas contra Ebola/genética , Ebolavirus/genética , Ebolavirus/imunologia , Ensaio de Imunoadsorção Enzimática , Feminino , Doença pelo Vírus Ebola/imunologia , Humanos , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Placebos/administração & dosagem , Linfócitos T/imunologia , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/genética , Vacinas Atenuadas/imunologia , Proteínas do Envelope Viral/genética , Adulto JovemRESUMO
The authors carried out comparative research into the topography and the histopathological nature of pharyngo-laryngeal cancers in Zaire and in countries in other continents. They found that in all countries, cancers of the larynx seem mainly located on the vocal cords, but that pharyngeal cancers, and more especially those in rhino-pharyngeal sites which are seen more often in Asiatic than in European countries, occur very frequently in Zaire. From the histopathological point of view, they show that contrary to the high frequency of differentiated spinocellular epitheliomas often described in European countries, most pharyngo-laryngeal cancers which they observed were usually undifferentiated epitheliomas.