ABSTRACT
TA-CIN is a vaccine that comprises the human papillomavirus (HPV) type 16 L2, E6 and E7 as a single fusion protein. In a mouse model, TA-CIN effectively prevented outgrowth of HPV16-positive tumour cells. To assess the safety and immunogenicity of TA-CIN, a dose escalating (26, 128, 533 micro g), double blind and placebo-controlled phase I study was conducted in 40 healthy volunteers. TA-CIN was administered without adjuvant by intramuscular injection on weeks 0, 4 and 8. No serious adverse events of the vaccination were reported during the study. Both IgG antibodies and proliferative responses against TA-CIN were elicited at all three doses. More importantly, T-cell immunity against the HPV16 E6 and E7 oncoproteins was detected by IFN gamma ELISPOT in 8/11 evaluable subjects vaccinated with the 533 micro g dose.
Subject(s)
Capsid Proteins , Capsid/immunology , Oncogene Proteins, Viral/immunology , Papillomaviridae/immunology , Papillomavirus Vaccines , Repressor Proteins , T-Lymphocytes/immunology , Vaccines, Synthetic/immunology , Viral Vaccines/immunology , Adult , Antibodies, Viral/blood , Female , Humans , Immunization , Immunoglobulin G/blood , Male , Middle Aged , Papillomavirus E7 Proteins , Vaccination , Viral Vaccines/adverse effectsSubject(s)
Bacterial Vaccines/administration & dosage , Typhoid-Paratyphoid Vaccines/administration & dosage , Vaccination , Adolescent , Adult , Antibodies, Bacterial/analysis , Bacterial Vaccines/adverse effects , Female , Humans , Male , Meningococcal Vaccines , Middle Aged , Neisseria meningitidis/immunology , Salmonella typhi/immunology , Single-Blind Method , Travel , Typhoid-Paratyphoid Vaccines/adverse effects , Vaccination/adverse effects , Vaccines, CombinedABSTRACT
Adult volunteers were immunised with a single dose of typhoid Vi capsular polysaccharide vaccine. After immunisation, 96% of the 103 subjects seroconverted and 94% had antibody levels above the protective threshold. Systemic reactions were uncommon, local reactions were mild and transient.
Subject(s)
Polysaccharides, Bacterial , Salmonella typhi/immunology , Vaccination , Adult , Antibodies, Bacterial/analysis , Humans , Polysaccharides, Bacterial/adverse effects , Typhoid Fever/immunology , Typhoid Fever/prevention & control , Vaccination/adverse effectsABSTRACT
A typhoid vaccine derived from the purified Vi capsular polysaccharide (CPS) antigen of Salmonella typhi was compared with a heat-killed whole-cell typhoid vaccine in 637 healthy male volunteers. The individuals were placed in three groups: group 1 received two doses of heat-killed whole-cell typhoid vaccine, at an interval of 28 days; group 2 received a single dose of typhoid Vi CPS vaccine followed after 28 days by water for injection; and group 3 received water for injection on the first occasion and a single dose of typhoid Vi CPS vaccine 28 days later. Local and systemic adverse reactions were recorded for 5 days following each injection. Subjects receiving the typhoid Vi CPS vaccine complained of fewer local adverse reactions on each of the first 3 days following immunization: on day 1, 18.6% of subjects given typhoid Vi CPS vaccine reported local reactions compared with 59.7% of those receiving heat-killed whole-cell vaccine (P less than 0.001). The percentage of subjects receiving the heat-killed whole-cell vaccine who complained of systemic reactions was more than twice that of subjects receiving the Vi CPS vaccine (7.9% and 3.4%, respectively, on day 1; P less than 0.01).
