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 effectsABSTRACT
We report a case of accidental severe hypothermia from cold exposure in a 31-month-old girl. The rectal temperature was 14.2 degrees C on presentation, and was accompanied by cardiac arrest. Other ominous laboratory markers for poor prognosis were also present. The child was successfully rewarmed by median sternotomy and full cardiopulmonary bypass. An amputation of one leg was required, but neurologic recovery was full. We emphasize the importance of timely, aggressive management in victims of severe hypothermia because of the tremendous potential for salvage despite catastrophic presentation.
