Racing to Prevent Herpes Outbreaks
WHY YOU SHOULD CARE
They’re itching for help.
By Libby Coleman
The first day, Eli felt tingling sensations up his penis, circling his testicles and then surging down his legs. “I was thinking, ‘What the hell is this?’ ” Eli says. The next day brought sensations of burning and stabbing. Bedridden for hours, he finally went to the bathroom to pee but saw nothing visibly wrong. A quick Google search pointed him to one diagnosis: herpes.
Eli, sadly, is far from alone. The World Health Organization says almost half a billion people below the age of 50 suffer from herpes simplex virus type 2 (HSV-2), the kind that afflicts the genitals. A whopping 3.7 billion people have herpes simplex virus type 1 (HSV-1), the mostly oral kind. There are treatments, but so far no preventive solution. The quest for a herpes vaccine is “one of the biggest unsolved problems of infectious disease,” says William Halford, an associate professor at the Southern Illinois University School of Medicine.
“I’d love the peace of mind to know my partners were not at risk of getting herpes.”
But that may change. Halford is among a growing number of researchers questing for the herpes vaccine, both at medical schools and at biotech firms. All approach the vaccine differently, and if any of them are successful, they might just create the next human papillomavirus vaccine, which is now recommended for women below the age of 26. These days, epidemiologists are pretty optimistic that all the itching and burning will someday soon be prevented: “I think we’ll see the vaccine in the next five to ten years,” says Litjen Tan, a strategist at the Immunization Action Coalition. And that has people with herpes, like Ella Dawson, who has blogged about her disease for multiple outlets, thrilled: “I’d love the peace of mind to know my partners were not at risk of getting herpes,” she says.
If you’re surprised that the herpes vaccine is suddenly, um, sexy, well, you’re not alone. Overall vaccination research is on a “downward” trend, says Paul Offit, of the Vaccine Education Center at the Children’s Hospital of Philadelphia, even as biotech as a whole continues to grow. (IBIS research predicts a 50 percent rise in revenues, to $161 billion, by 2020.) What’s en vogue are CRISPR technology and cancer drugs. Vaccines saw the height of their success in the mid-1900s with the approval of polio, diphtheria, whooping cough and tetanus immunizations, and now the field has whittled down to four major vaccine developers: GSK, Merck, Pfizer and Sanofi. By the ’80s, thanks to popular reports that vaccines did more harm than good, the consumer base had shrunk for immunizations.
But the herpes vaccine has been a long time coming. Research began in the 1920s, and since then, pharma companies have made big bets on it, focusing on HSV-2. But failures in Phase 3 of clinical trials, the step before FDA approval and then manufacturing, have led to “the perception that developing a herpes vaccine is difficult and risky,” says Harvard professor and researcher David Knipe. Technology has changed, though, and today’s researchers are trying to crack the code using different techniques than their forbears. They might take a live attenuated version of the virus, except with a twist, such as deletion of the protein. In other cases, as at Duke University, they’re dipping into CRISPR and gene-editing technology.
Vaccines cost a lot of money to test, and so the underlying disease requires a critical mass of sufferers, Halford says. Herpes definitely has that, and economically, the vaccine could turn a profit. (A disease like syphilis is too rare to warrant the R&D costs, Offit says.) Herpes is not typically fatal — though there are exceptions — but because the disease is common, a successful, effective vaccine could earn routine recommendation status, says Offit. That means it would be recommended for all sexually active adults. Take that to the bank.
Even so, the risks for investors, researchers and clinical subjects are numerous. Finding investors can be tricky because payoff takes years and involves costly human clinical trials, says TomegaVax CEO Michael Tippie. “This is not an app. This is not a slam dunk,” he says, citing investors’ other, more promising options. A herpes vaccine is not even TomegaVax’s highest priority, he says; hepatitis B ranks higher on the firm’s list. And more vaccines die on whiteboards and in labs than make it into doctors’ offices. Especially when “the low-hanging fruit” vaccines have already been created, Tan says. What’s left are the trickier diseases like HSV-1 and HSV-2.
While Eli says he’s heard horror stories about friends participating in clinical trials for herpes vaccines — they complain mostly of the side effects — he also can’t wait for a vaccine to come out. “I don’t think anybody should have to experience this,” he says.