Preclinical Studies
Extensive preclinical studies have been performed before the vaccine candidates are moved to clinical studies. These studies are to evaluate the safety, immunogenicity and protection of the vaccine candidates in different animal models.
Small Animals Studies
To establish the safety profile of the vaccine candidates, toxicity studies have been performed in accordance to the requirement of the regulatory authorities at the certified laboratories with established Good Laboratory Practices.
In addition, multiple immunogenicity studies have been performed in mice and have shown that the vaccine candidates are highly immunogenic. These results have been published in peer-reviewed scientific journals: Gomez 2008, Gomez 2007.
Non Human Primates Studies
A central tenet of EuroVacc is that macaque immunogenicity and subsequent efficacy studies are undertaken not only in preparation for but in parallel with human trials. The Non Human Primates (NHP) data aligned with phase I and phase II human immunogenicity data, provide a strategic basis for advancing specific vaccine candidates and immunization strategies to phase IIB/III development.
The NHP program undertakes three different types of studies:
- Immunogenicity studies of HIV-1 candidate vaccines to ensure that they induce the desired types of immune responses in primates and to select the most optimal prime boost combinations and schedule for clinical trial;
- Proof of principle vaccine efficacy studies are undertaken to determine if a specific vaccine strategy has the potential to induce protection against infection and/or disease;
- Exploration of novel immunization routes.
Non-Human Primates Studies
| Protocol Nr. | Description | Study Status | Publication |
| pcEV01 | Immunogenicity study of NYVAC alone and in different prime-boost combination | Completed | Mooij 2008  |
| pcEV02 | Immunogenicity study to evaluate if aerosolized NYVAC administered via the respiratory tract would induce more potent systemic as well as mucosal immune response compared to the intramuscular immunization route | Completed | Corbett 2008 |
| pcEV03 | Efficacy study to compare head to head immunogenicity and efficacy of DNA+NYVAC abd DNA+MVA | Completed | Mooij 2008 |
