News Sexual Health

Herpes Vaccine Trial has Disappointing Results

Martha Kempner

The search for a vaccine to prevent Herpes faced a setback this month, when researchers published findings in the New England Journal of Medicine from a double-blind, placebo-controlled trial that found a new vaccine to be useless against Herpes Simplex Virus 2 (HSV-2).

While the HPV vaccine continues to garner attention and controversy, scientists continue to work on creating vaccines for other sexually transmitted diseases.  The search for a vaccine to prevent Herpes faced a setback this month, when researchers published findings in the New England Journal of Medicine from a double-blind, placebo-controlled trial that found a new vaccine to be useless against Herpes Simplex Virus 2 (HSV-2).  

HSV-2 is the virus which is primarily responsible for genital herpes though the disease can be caused by HSV-1, a different strain of the virus which more often causes oral herpes or cold sores to appear on the lips.  Both strains are sexually transmitted and can cause painful sores to appear on an individual’s genitals.  Many people infected with Herpes will never have an outbreak and may never be aware that they are infected while others will have recurrent outbreaks throughout their lives. 

According to the Centers for Disease Control and Prevention (CDC) a nationally representative study found that 16.2 percent of people ages 14 to 49 in the Untied States, or about one out of six, have HSV-2 infection. The CDC does say that the percentage of adults in the United States infected with HSV-2 has remained stable for many years.  Nonetheless, a vaccine to prevent the spread of this potentially painful disease would be a major step forward.  

Two previous studies of a HSV-2 vaccine suggested that it might be effective. For this study, researchers randomly assigned 8,323 uninfected women ages 18 to 30 to receive the herpes vaccine or a placebo. (Researchers used the shot for hepatitis A as the placebo.)  The study found that after 20 months, there was no significant difference in HSV-2 infection rates between the vaccine and placebo groups. The vaccine did provide some protection against HSV-1 genital infections.

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One of the study’s authors suggested that it might be time to change course. “The failure of the vaccine really suggests that we need to look at new approaches to HSV vaccine development,” said Dr. Peter A. Leone, an author of the study and professor of medicine at the University of North Carolina. An attenuated virus, like that used in vaccines against chickenpox, may prove more effective.

Roundups Sexual Health

This Week in Sex: The Sexually Transmitted Infections Edition

Martha Kempner

A new Zika case suggests the virus can be transmitted from an infected woman to a male partner. And, in other news, HPV-related cancers are on the rise, and an experimental chlamydia vaccine shows signs of promise.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Zika May Have Been Sexually Transmitted From a Woman to Her Male Partner

A new case suggests that males may be infected with the Zika virus through unprotected sex with female partners. Researchers have known for a while that men can infect their partners through penetrative sexual intercourse, but this is the first suspected case of sexual transmission from a woman.

The case involves a New York City woman who is in her early 20s and traveled to a country with high rates of the mosquito-borne virus (her name and the specific country where she traveled have not been released). The woman, who experienced stomach cramps and a headache while waiting for her flight back to New York, reported one act of sexual intercourse without a condom the day she returned from her trip. The following day, her symptoms became worse and included fever, fatigue, a rash, and tingling in her hands and feet. Two days later, she visited her primary-care provider and tests confirmed she had the Zika virus.

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A few days after that (seven days after intercourse), her male partner, also in his 20s, began feeling similar symptoms. He had a rash, a fever, and also conjunctivitis (pink eye). He, too, was diagnosed with Zika. After meeting with him, public health officials in the New York City confirmed that he had not traveled out of the country nor had he been recently bit by a mosquito. This leaves sexual transmission from his partner as the most likely cause of his infection, though further tests are being done.

The Centers for Disease Control and Prevention (CDC)’s recommendations for preventing Zika have been based on the assumption that virus was spread from a male to a receptive partner. Therefore the recommendations had been that pregnant women whose male partners had traveled or lived in a place where Zika virus is spreading use condoms or abstain from sex during the pregnancy. For those couples for whom pregnancy is not an issue, the CDC recommended that men who had traveled to countries with Zika outbreaks and had symptoms of the virus, use condoms or abstain from sex for six months after their trip. It also suggested that men who traveled but don’t have symptoms use condoms for at least eight weeks.

Based on this case—the first to suggest female-to-male transmission—the CDC may extend these recommendations to couples in which a female traveled to a country with an outbreak.

More Signs of Gonorrhea’s Growing Antibiotic Resistance

Last week, the CDC released new data on gonorrhea and warned once again that the bacteria that causes this common sexually transmitted infection (STI) is becoming resistant to the antibiotics used to treat it.

There are about 350,000 cases of gonorrhea reported each year, but it is estimated that 800,000 cases really occur with many going undiagnosed and untreated. Once easily treatable with antibiotics, the bacteria Neisseria gonorrhoeae has steadily gained resistance to whole classes of antibiotics over the decades. By the 1980s, penicillin no longer worked to treat it, and in 2007 the CDC stopped recommending the use of fluoroquinolones. Now, cephalosporins are the only class of drugs that work. The recommended treatment involves a combination of ceftriaxone (an injectable cephalosporin) and azithromycin (an oral antibiotic).

Unfortunately, the data released last week—which comes from analysis of more than 5,000 samples of gonorrhea (called isolates) collected from STI clinics across the country—shows that the bacteria is developing resistance to these drugs as well. In fact, the percentage of gonorrhea isolates with decreased susceptibility to azithromycin increased more than 300 percent between 2013 and 2014 (from 0.6 percent to 2.5 percent).

Though no cases of treatment failure has been reported in the United States, this is a troubling sign of what may be coming. Dr. Gail Bolan, director of CDC’s Division of STD Prevention, said in a press release: “It is unclear how long the combination therapy of azithromycin and ceftriaxone will be effective if the increases in resistance persists. We need to push forward on multiple fronts to ensure we can continue offering successful treatment to those who need it.”

HPV-Related Cancers Up Despite Vaccine 

The CDC also released new data this month showing an increase in HPV-associated cancers between 2008 and 2012 compared with the previous five-year period. HPV or human papillomavirus is an extremely common sexually transmitted infection. In fact, HPV is so common that the CDC believes most sexually active adults will get it at some point in their lives. Many cases of HPV clear spontaneously with no medical intervention, but certain types of the virus cause cancer of the cervix, vulva, penis, anus, mouth, and neck.

The CDC’s new data suggests that an average of 38,793 HPV-associated cancers were diagnosed each year between 2008 and 2012. This is a 17 percent increase from about 33,000 each year between 2004 and 2008. This is a particularly unfortunate trend given that the newest available vaccine—Gardasil 9—can prevent the types of HPV most often linked to cancer. In fact, researchers estimated that the majority of cancers found in the recent data (about 28,000 each year) were caused by types of the virus that could be prevented by the vaccine.

Unfortunately, as Rewire has reported, the vaccine is often mired in controversy and far fewer young people have received it than get most other recommended vaccines. In 2014, only 40 percent of girls and 22 percent of boys ages 13 to 17 had received all three recommended doses of the vaccine. In comparison, nearly 80 percent of young people in this age group had received the vaccine that protects against meningitis.

In response to the newest data, Dr. Electra Paskett, co-director of the Cancer Control Research Program at the Ohio State University Comprehensive Cancer Center, told HealthDay:

In order to increase HPV vaccination rates, we must change the perception of the HPV vaccine from something that prevents a sexually transmitted disease to a vaccine that prevents cancer. Every parent should ask the question: If there was a vaccine I could give my child that would prevent them from developing six different cancers, would I give it to them? The answer would be a resounding yes—and we would have a dramatic decrease in HPV-related cancers across the globe.

Making Inroads Toward a Chlamydia Vaccine

An article published in the journal Vaccine shows that researchers have made progress with a new vaccine to prevent chlamydia. According to lead researcher David Bulir of the M. G. DeGroote Institute for Infectious Disease Research at Canada’s McMaster University, efforts to create a vaccine have been underway for decades, but this is the first formulation to show success.

In 2014, there were 1.4 million reported cases of chlamydia in the United States. While this bacterial infection can be easily treated with antibiotics, it often goes undiagnosed because many people show no symptoms. Untreated chlamydia can lead to pelvic inflammatory disease, which can leave scar tissue in the fallopian tubes or uterus and ultimately result in infertility.

The experimental vaccine was created by Canadian researchers who used pieces of the bacteria that causes chlamydia to form an antigen they called BD584. The hope was that the antigen could prompt the body’s immune system to fight the chlamydia bacteria if exposed to it.

Researchers gave BD584 to mice using a nasal spray, and then exposed them to chlamydia. The results were very promising. The mice who received the spray cleared the infection faster than the mice who did not. Moreover, the mice given the nasal spray were less likely to show symptoms of infection, such as bacterial shedding from the vagina or fluid blockages of the fallopian tubes.

There are many steps to go before this vaccine could become available. The researchers need to test it on other strains of the bacteria and in other animals before testing it in humans. And, of course, experience with the HPV vaccine shows that there’s work to be done to make sure people get vaccines that prevent STIs even after they’re invented. Nonetheless, a vaccine to prevent chlamydia would be a great victory in our ongoing fight against STIs and their health consequences, and we here at This Week in Sex are happy to end on a bit of a positive note.

News Contraception

Funding Shortfall, Contraception Limits Mar GOP Zika Agreement

Christine Grimaldi

The Obama administration indicated that the latest House-passed Zika package is a non-starter for the president.

The $1.1 billion in Zika funding that Republicans railroaded through the U.S. House of Representatives around 3 a.m. Thursday underfunds the Obama administration’s request and limits access to contraceptive services, even though the disease can be sexually transmitted.

The largely party line 239-171 vote interrupted Democrats’ marathon, raucous sit-in demanding consideration of gun control proposals. House Speaker Paul Ryan (R-WI) called the House back into session shortly after 2:30 a.m. amid shouts of “No bill, no break!”

Rep. Jim McGovern (D-MA) attempted to request a final debate, otherwise known as a motion to recommit, on the conference report for Zika supplemental funding and fiscal year 2017 military construction and veterans affairs funding. The speaker pro tempore presiding over the House at the time instead spoke over McGovern and, in an unusual move, proceeded to a recorded vote without allowing debate on the measure, then adjourned the chamber early for its scheduled July 4 recess.

Congressional negotiators attempted to reconcile the differences between the House’s $622.1 million and the U.S. Senate’s $1.1 billion in Zika funding levels. Senate Appropriations Committee Vice Chair Barbara Mikulski (D-MD) in May called her chamber’s $1.1 billion “a bottom line, not a starting point for negotiations with the House.”

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Mikulski and other Democrats involved in the bicameral Zika negotiations ultimately refused to sign the final conference report (H. Rept. 114-640), slamming the Republican agreement for falling short of the $1.9 billion the Obama administration requested to combat Zika.

Democrats objected to the Zika package’s $750 million in offsets derived from leftover Ebola reserves, unspent Affordable Care Act funding for territories to establish health-care exchanges, and the U.S. Department of Health and Human Service’s administrative fund. “Offsetting emergency spending would set a precedent that will hinder our ability to respond to the next public health crisis, natural disaster, or national security event requiring emergency funding,” House Appropriations Committee Democrats, led by Rep. Nita Lowey (D-NY), said in a statement.

The latest stalemate comes as Zika infections are on the rise in the United States, according to Centers for Disease Control and Prevention (CDC) tracking. The CDC concluded that Zika causes microcephaly, an incurable neurological disorder that impairs brain and skull growth in utero, as well as other severe fetal brain defects.

Online requests for abortion medications have spiked in Latin American countries that issued warnings to pregnant people about Zika-related complications yet outlaw or restrict the procedure, according to a study published Wednesday in the New England Journal of Medicine.

Contraception Restrictions Anger Democrats

Democrats also decried language that they said would restrict access to contraceptive services for women in the United States and Puerto Rico.

Page 118 of the full conference report routes $95 million in Zika funds through the federal Social Services Block Grant program toward public health departments, hospitals, and Medicaid Managed Care clinics. This move “limits access to health care” in a sprawling territory with only 13 Medicaid Managed Care clinics, according to a Democratic summary obtained by Rewire.

“Of the 78 municipalities in Puerto Rico, only 12 include a Medicaid clinic. Twenty-six of the municipalities are not even adjacent to another municipality with a Medicaid clinic, and geographical conditions on the island (e.g., mountains) make travel between certain municipalities difficult,” the summary said. “For many women in Puerto Rico, this bill would make access to contraceptive services more difficult.”

The language also precludes awarding subgrants to outside groups “that could provide important services to hard-to-reach populations, especially hard-to-reach populations of women that want to access contraceptive services.”

Democrats alleged the Zika package takes similar restrictive actions on the international front.

“The Republican conference report does not explicitly prohibit funding for contraceptives or family planning activities in global health activities, but takes away the money, limits the use of funds, and forces USAID to rely on reprogramming which is a mechanism to slow the access to funds,” the summary said.

Specifically, Page 125 of the full conference report directs $145.5 million toward global health programs—nearly 60 percent below the administration’s request, according to the summary. The shortfall, along with a mandate to prioritize funds for mosquito control and vaccines, in effect leaves nothing for contraceptives or family planning programs to prevent sexual transmission of Zika.

Senate Minority Leader Harry Reid (D-NV) called the Republican agreement “more of the same anti-woman” tactics, including repeated votes to defund Planned Parenthood.

“Instead of responding to this emergency that is threatening American women, Republicans are using this awful virus as an excuse for another attack on women’s health,” Reid said on the Senate floor Thursday morning.

Response Indicates Rocky Path Forward

The Obama administration indicated that the latest House-passed Zika package is a non-starter for the president.

“This plan from Congressional Republicans is four months late and nearly a billion dollars short of what our public health experts have said is necessary to do everything possible to fight the Zika virus and steals funding from other health priorities,” White House Spokesperson Josh Earnest said in a statement.

“The fact that the Republican plan limits needed birth control services for women in the United States and Puerto Rico as we seek to stop the spread of a sexually transmitted disease is a clear indication they don’t take seriously the threat from the Zika virus or their responsibility to protect Americans.”

A Senate Democratic aide told Rewire it’s “extremely unlikely this gets through the Senate.”

Although the motion to proceed on the conference report will be privileged and not subject to debate, Republicans still need 60 votes for cloture to end debate on the underlying measure itself, the aide said.

“By preventing the funding from going to Planned Parenthood, suspending environmental safety regs, underfunding veterans, and making cuts from public health programs, Republicans have decided to go their own way and hold Zika funding hostage to their own extreme agenda,” the aide said.