Phase I clinical trial of an acellular pertussis vaccine composed of genetically detoxified pertussis toxin combined with FHA and 69 kDa.
An acellular pertussis vaccine composed of genetically detoxified pertussis toxin (PT-9K/129G), filamentous haemagglutinin (FHA) and pertactin (69 kDa protein) was evaluated in adult volunteers, in double blind, versus placebo. No fever was reported in either group. Mild local reactions were reported after injection of both vaccine and placebo. After the first dose a marked increase in antibodies to PT, FHA and 69 kDa protein was seen in vaccinated subjects with the exception of one who responded well to PT and FHA but did not show a humoral response to the 69 kDa protein. All vaccinees acquired cellular immunity against the three antigens. No significant variation was observed in the humoral or cellular responses after the second dose.
Podda
A
A
Sclavo Research Centre, Siena, Italy.
Nencioni
L
L
Marsili
I
I
Peppoloni
S
S
Volpini
G
G
Donati
D
D
Di Tommaso
A
A
De Magistris
M T
MT
Rappuoli
R
R
D018829:Adhesins, Bacterial; D000914:Antibodies, Viral / Q000096:biosynthesis; D001425:Bacterial Outer Membrane Proteins / Q000009:adverse effects* / Q000276:immunology; D001886:Bordetella pertussis / Q000276:immunology*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004797:Enzyme-Linked Immunosorbent Assay; D006388:Hemagglutinins / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D007111:Immunity, Cellular / Q000502:physiology; D008970:Molecular Weight; D010567:Pertussis Vaccine / Q000009:adverse effects* / Q000276:immunology; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D010566:Virulence Factors, Bordetella
D018829:Adhesins, Bacterial; D000914:Antibodies, Viral; D001425:Bacterial Outer Membrane Proteins; D006388:Hemagglutinins; D010567:Pertussis Vaccine; D015164:Vaccines, Inactivated; D010566:Virulence Factors, Bordetella; C065273:filamentous hemagglutinin adhesin, Bordetella pertussis; C068929:pertactin