Admedus (ASX:AHZ) has received the results and met the primary endpoint of safety for its Phase IIa herpes simplex (HSV-2) vaccine study.
The study enrolled a total of 44 subjects and a positive immune response to the vaccine was seen in most subjects.
The next step involves trialling a higher dosage in a Phase IIb study.
Wayne Paterson, CEO, commented: “The research provides a foundation for Admedus Limited to consider sponsorship possibilities for a study with a large enough population to determine the efficacy of the induced immune response against HSV-2.
“The results warrant examination of alternative delivery approaches and dosage variations to conclude whether there is a treatment benefit in a large population.”
Study details
A total of 44 subjects were enrolled in the study.
The subjects were equally allocated to the groups and 34 received vaccine while 10 received placebo.
All adverse events related to – or probably or possibly related to – the vaccine were considered mild, except for one adverse event, which was considered moderate, and none of these resulted in any subjects withdrawing from the study.
Results summary
The study’s primary endpoint met was met with no safety issues with the vaccine.
Results indicated that the vaccine strongly stimulated cellular activity and the viral shedding data shows greater reduction in viral shedding data in vaccine study subjects compared to placebo group.
There was no significant difference between the placebo and vaccine groups for viral outbreaks.
There was a longer time to recurrence in vaccine group compared to the placebo group.
Next steps
The next step is to seek to improve efficacy by:
- Trialling a higher does in a Phase IIb;
- Analysing other intradermal delivery methods; and
- Continuing to explore complementary approaches to improve immune response.
The HSV-2 virus
The herpes simplex virus, or herpes, is categorized into two types: herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2).
HSV-2 is a sexually transmitted infection that causes genital herpes and is lifelong and currently incurable.
An estimated 417 million people aged 15-49 (11%) worldwide have HSV-2 infection.
Infection with HSV-2 increases the risk of acquiring and transmitting HIV infection.