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Western Blot accuracy when vaccinated
Hi...I'm female, 39. Seven years ago I took part in a clinical trial study for uninfected partners of people with genital herpes. I received an experimental vaccine and after a two year follow up, was declared immune and virus-free. Five years later I started to have strange prodrome-like symptoms, itching, tingling and localized redness on my inner labia. Swabs showed nothing, as there was really nothing to swab (no actual ulcers or blisters). After hunting down one of the original nurses in the study, I was informed the vaccine never made it to market, as long term results were inconclusive and only about 70%. I immediately went on Valtrex, terrified that I may have the virus and possibly could pass it on. I have experienced 2 or 3 more instances of those symptoms in the last 2 years, but never any blisters.
So now after two years of living in this not-knowing limbo, I've ordered a Western Blot kit from the U of W (I'm in Canada..don't get me started!). My question is this : I obviously will have some kind of antibodies present because of that vaccine, will the WB test actually show if I really have the HSV2 virus, or just antibodies? Am I wasting my time getting tested?
Thank-you...I'm at my wits end and this is really affecting my relationships.
So now after two years of living in this not-knowing limbo, I've ordered a Western Blot kit from the U of W (I'm in Canada..don't get me started!). My question is this : I obviously will have some kind of antibodies present because of that vaccine, will the WB test actually show if I really have the HSV2 virus, or just antibodies? Am I wasting my time getting tested?
Thank-you...I'm at my wits end and this is really affecting my relationships.
MEDICAL PROFESSIONAL
I agree with you, and probably that is what you actually were told. My guess is you misinterpreted what was said at the end of the study. No study participant should have gone away with the impression they would be protected against herpes, whether by vaccine or placebo. At the end of the research, the investigators were required (by study protocol and basic ethics) to tell both subjects that they were not necessarily protected, even if they got vaccine and not placebo, and that they should continue to take every precaution to protect themselves against herpes. If you read the consent form you signed, I'll bet you will see statements exactly like that.
I'm not accusing you. It is human nature to assume protection if you got the vaccine and not placebo. But I would be surprised if you actually were told that you were protected.
I'm not accusing you. It is human nature to assume protection if you got the vaccine and not placebo. But I would be surprised if you actually were told that you were protected.
MEDICAL PROFESSIONAL
There were 2 different study protocols, each done in 20-30 study centers around the world. The Halifax site apparently was one of them. gD means glycoprotein D, a protein from HSV-2 and the core of the vacccine. "Alum-MPL" is the adjuvant, i.e. a compound that stimulates the immune system to react more strongly to the gD.
If you would enjoy seeing the published results of the study you were in, go to the New England Journal of Medicine website http://content.nejm.org/, then search for the Novebmer 21, 2002 issue; or you can search by the name of the first author (L. Stanberry).
If you would enjoy seeing the published results of the study you were in, go to the New England Journal of Medicine website http://content.nejm.org/, then search for the Novebmer 21, 2002 issue; or you can search by the name of the first author (L. Stanberry).
I just wanted to say that this is a VERY interesting thread to read about ! Very informative on many levels.
grace
grace
Thank-you, doc, I'm definately going to check out that site...I can't believe my luck to have found someone who is not only aware, but was involved with that study! And just my opinion here, I don't know if it's always possible, but I believe that patients involved in such trials should ethically be informed when the trial proves to be a failure, or inconclusive, even after a few years. I was left thinking, as I'm sure many others were, that I was completely and unquestionably immune, which can lead a person be perhaps less than as careful as they should be..
again, thank you SO much for all your help...I've felt so lost and confused about this for so long..knowledge is power and I finally feel like I'm getting a handle on all this.
Keep up the good work, it's MUCH appreciated!
again, thank you SO much for all your help...I've felt so lost and confused about this for so long..knowledge is power and I finally feel like I'm getting a handle on all this.
Keep up the good work, it's MUCH appreciated!
MEDICAL PROFESSIONAL
I emailed this thread to my colleague Dr. Morrow, developer of the HSV Western blot test. She emailed back "She [meaning you] should have her clinician stipulate on the WB
request form that she received vaccine--to avoid an 'atypical' result."
request form that she received vaccine--to avoid an 'atypical' result."
I found the consent form today. I was a subject in a study conducted in Halifax, Nova Scotia in 1997..earlier than I thought. It WAS run by SmithKline Beecham Biologicals, principal investigator Dr. David Haase at the QE2 Health Sciences Center. The vaccine seemed to have been labelled " gD-Alum-MPL " if that makes any sense.
Yes, I DID receive the vaccine, and no, I'm not with the infected partner any more (ex-husband as of 2 years or so), hence my concern about whether I have the virus or not. It's become dificult to tell potential new partners that I "may" have the virus...uh..but not sure...!
Thank you so much for the info...I truly hope you're right and I test negative, or at least finally have a conclusive answer.
Yes, I DID receive the vaccine, and no, I'm not with the infected partner any more (ex-husband as of 2 years or so), hence my concern about whether I have the virus or not. It's become dificult to tell potential new partners that I "may" have the virus...uh..but not sure...!
Thank you so much for the info...I truly hope you're right and I test negative, or at least finally have a conclusive answer.
MEDICAL PROFESSIONAL
Presumably you were a subject in the initial trial of the SmithKlineBeecham (now GlaxoSmithKlein) HSV-2 vaccine trial. I was one of the investigators. (There was another trial by Chiron, but that vaccine was a bust and I think the study was complete before 7 years ago.) The GSK vaccine proved parly successful; 70% is about right. It is currently in expanded research trials. Whether it will ever come to market isn't clear, but it probably will, if the current trial has results similar to the earlier study. If it comes to market, it's at least a couple years in the future.
Presumably you also know you received vaccine, not placebo. If so, you are right that a standard HSV-2 antibody test will be positive, without necessarily indicating infection. However, the Western blot easily distinguishes vaccine effect from actual infection. Make sure your provider includes information with your blood specimen to tell the UW lab that you are a vaccine recipient. Or call the lab yourself, if the specimen already has been sent. (The lab probably would figure it out on their own, but this will make sure you are not told of a falsely positive result.)
Going back to your symptoms, they do not sound like herpes, and my bet is that WB will show only vaccine-related antibody. Of course if you are still in the relationship with your HSV-2 infected partner, you remain at some risk; and as you say, the vaccine is partly effective. The results of the study you were in suggest that although the vaccine was only 70% effective, in people who got HSV-2 despite the vaccine, their symtoms were absolultely typical--not the atypical symptoms you describe. Anyway, the WB will sort it out.
Just curious, were you by chance a study subject of Steve Sachs (Vancouver)? Or one of the other Canada study centers?
Best wishes-- HHH, MD
Presumably you also know you received vaccine, not placebo. If so, you are right that a standard HSV-2 antibody test will be positive, without necessarily indicating infection. However, the Western blot easily distinguishes vaccine effect from actual infection. Make sure your provider includes information with your blood specimen to tell the UW lab that you are a vaccine recipient. Or call the lab yourself, if the specimen already has been sent. (The lab probably would figure it out on their own, but this will make sure you are not told of a falsely positive result.)
Going back to your symptoms, they do not sound like herpes, and my bet is that WB will show only vaccine-related antibody. Of course if you are still in the relationship with your HSV-2 infected partner, you remain at some risk; and as you say, the vaccine is partly effective. The results of the study you were in suggest that although the vaccine was only 70% effective, in people who got HSV-2 despite the vaccine, their symtoms were absolultely typical--not the atypical symptoms you describe. Anyway, the WB will sort it out.
Just curious, were you by chance a study subject of Steve Sachs (Vancouver)? Or one of the other Canada study centers?
Best wishes-- HHH, MD
You are reading content posted in the STDs Forum
Herpes spreads by oral, vaginal and anal sex.
Herpes sores blister, then burst, scab and heal.
STIs are the most common cause of genital sores.
Millions of people are diagnosed with STDs in the U.S. each year.
STDs can't be transmitted by casual contact, like hugging or touching.
Syphilis is an STD that is transmitted by oral, genital and anal sex.
