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Performance data

Clinical studies and publications3

Clinical data have been gathered in the fields of influenza, HIV and Hepatitis B vaccination. Several additional studies are currently ongoing (more information).

Influenza
In a trial run by a major health care company, the PlasmAcute technology was investigated in volunteers on influenza vaccines. Specific subtype antibodies were detected in all 9 vaccinated volunteers. In most cases B-cell antibodies present before seroconversions. Vaccine "non-responders" still demonstrated a B-cell response to the immunogen.

A full size paper was published at the International Congress Series 1219 (2001), 283-289. To view the article, click here.

Human Immunodeficiency Virus (HIV)
Early Detection of HIV-1 specific lymphocyte derived antibodies in a high risk population, to determine whether obtaining B-cell derived antibodies against HIV, using the PlasmAcute method, would detect acute HIV infection earlier than conventional serodiagnosis or possibly diagnosis by NAT and p24 antigen tests. A prospective cohort study at an STD clinic within a mining complex near Johannesburg, South Africa.  A total of 265 initially HIV-1 negative mineworkers were offered voluntary counselling and testing for HIV-1 as part of routine service provision. Study conclusions:

  • B-cell lysate-derived anti-HIV-1 antibodies can be detected prior to seroconversion, and earlier or contemporary with a positive HIV-1 viral load.
  • The PlasmAcute® technology offers an alternative strategy to nucleic acid testing in narrowing the window phase between initial HIV-1 infection and HIV-1 detection.
  • The technology could serve as a valuable tool for detection of early HIV-1 infection.
  • This would allow targeting of enhanced STI behavioural change interventions towards sero-converters and potentially prevent new HIV-1 infections.
  • Further investigation is required to establish whether the observation of transient antibody positive lysates represents exposure to HIV-1 virus without subsequent progression to infection. 

To view a poster presentation regarding this study, please click here. The poster was presented in August 2007 at the 17th meeting of the International Society for STD Research and the 10th World Congress of the International Union Against Sexually Transmitted Infections.

Hepatitis B Virus
Hepatitis B patients exhibit a particularly long 'window period', meaning they carry the virus for several weeks to months before it can be detected by regular immunoassay tests. PlasmAcute completed a clinical trial with 26 Hepatitis B vaccinated patients in Ghana to investigate if the window period could be shortened with the use of the PlasmAcute technology. 24 seronegative (susceptible) volunteers and two positive for anti-HBc (prior infection) were vaccinated on days 0, 40, and 6 months. Blood samples were collected at intervals of two days following the immunizations on day 0 and 40, and screened for HBV markers, HBsAg, and core antibodies (anti-HBc). Study findings:

  • In samples collected 5 to 21 days following the first injection of vaccine, anti-HBs were found in the B-cell lysate of 18/21 subjects with no antibodies detectable by sandwich immuno assay. 
  • In samples collected 4 to 9 days after the booster dose injected on day 40, anti-HBs were found in the B-cell of 16/19 subjects, accompanied by plasma antibodies in 8 subjects. 
  • In the volunteers with prior HBV infection, anti-HBs were shown in both B-cell lysate and plasma within 8 to 13 days. Primary immunisation with HBV vaccine appears to transiently elicit low affinity anti-HBs in B-cell lysate into plasma.

Published on 10 October 2007 in the journal Clinical and Vaccine Immunology - accessible online with free abstract.