For those of you who are following herpes vaccines in development, the news out of Australia isn't bad. Or especially good.
Admedus released results from its Phase IIa (1) clinical trials of it herpes simplex 2 vaccine, and even the company didn't seem all that enthusiastic. That's OK. Unlike some other companies, they are not hyping early results to try and get funding or media coverage. The endpoint of the trial was safety, which was achieved, but not much else. The company said "positive immune response to the vaccine was seen in most [of the 34] subjects." (2)
Also reported:
- A positive immune response was seen in "most subjects."
- "[The vaccine] "strongly stimulated cellular activity.
- There was a reduction in viral shedding seem in the group that got the vaccine vs. the placebo group (data not given).
- Although there was a greater time interval in subjects who got the vaccine (data not given), there was no difference in the severity of the outbreaks
- The final Phase IIa results were similar to those in the 2016 interim analysis.
Impression: Hang on the your Valtrex, for now. These results are nothing to get excited about. The company is planning on running Phase IIb trials (3). I wish them luck.
Notes:
(1) Phase IIa trials are small pilot studies to look for efficacy or proof of concept.
(2) There were a total of 44 participants. Ten were in the placebo group and 34 in the treated group.
(3) Phase IIb trials enroll more participants. One goal is the determination of the optimum dose of the drug or vaccine (dose ranging studies). Additional safety and efficacy data are collected.
