Vaccines and Microbicides: The Long Road to Success

Cindra Feuer

HIV vaccine and microbicide researchers at the International AIDS Conference emphasized the need for truly novel ideas in moving forward in discovery.

"Failure informs future success." 
The HIV vaccine and microbicide researchers who took to the stage on
Monday to discuss the future of these experimental HIV prevention technologies
repeated this mantra throughout the symposium.  

The halted STEP vaccine study perhaps
best illustrates this point. Last year an interim analysis showed Merck’s
Ad-5 vaccine was ineffective and may have even enhanced risk of HIV
infection. But Susan Buchbinder, a STEP investigator, emphasized the
valuable lessons learned from the study: the utility of the test-of-concept
trial (Phase IIb) to give us quick answers; that we must recalibrate
the non-human primate model to better understand its applicability; and a wealth of data was mined, even leads on potential immune correlates.
Predicting a positive immune response remains an important yet elusive
goal in testing HIV vaccines.  

The panelists emphasized the need
for truly novel ideas in moving forward in vaccine discovery, some bordering
on weird science like reducing, not enhancing an immune response, promoting
more mutations, and using replicating viral vectors for vaccine delivery.
The Bill & Melinda Gates Foundation, characteristically leading
the charge, this year implemented its Grand Challenges Explorations,
a $100 million initiative to encourage bold and unconventional science.   

Although the microbicide research
field is no stranger to setbacks, Zeda Rosenberg, from the International
Partnership for Microbicides, spoke of the optimism around ARV-containing
candidates.  This new generation of microbicides is thought to
be more potent than its predecessor because of its known anti-HIV properties. 
Some microbicides contain combination ARVs, expected to offer multi-mechanism
protection.  

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Learning from past trials, or what
some would loosely call "failures," consistent use of the microbicide
in the intervention arm has proved to be a challenge. Responding to
this finding, microbicides are being designed for longer protection
to make adherence easier. Prospects include a once-daily or even a 30-day
microbicide delivered via a vaginal ring.  

A robust pipeline to hedge against
failures is needed in both vaccine and microbicide pursuits, panelists
agreed. "Nine out of 10 drugs or vaccines end with failures," said
Tachi Yamada of the Gates Foundation. "Success is about long-term
investment, not about today or tomorrow, but sometime in our lifetime."

Commentary Religion

Why Is Georgetown University Denying Freedom of Speech and Assembly? A Letter to the President

Erin Matson

On September 22, Georgetown University campus police removed from outside the school's front gates a small group of students who had been peacefully advocating for reproductive rights, women's rights, and equal rights regardless of sexual orientation.

Note: Rewire Editor at Large and Georgetown alum Erin Matson sent this letter in response to an incident concerning abortion rights and free speech that took place near campus on September 22. 

September 29, 2014

President John J. DeGioia
Georgetown University
Office of the President
204 Healy Hall
37th and O Streets, NW
Washington, D.C. 20057

Dear President DeGioia:

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We the undersigned 232 Georgetown University alumni are writing to express our dismay and strong concern regarding campus police’s September 22 removal of a small, peaceful group of students, representing H*yas for Choice, from a public sidewalk just outside the front gates.

In January, police removed students similarly tabling for H*yas for Choice from an on-campus location, ordering them to relocate to the very sidewalk from which they were removed last Monday. On both occasions, the students were quietly presenting an alternative view to official church teachings by advocating for reproductive rights, women’s rights, and equal rights regardless of sexual orientation.

These issues matter. They are both moral and practical. This is an age of social change and political polarization on issues pertaining to sexuality and human rights, on both a national and international scale.

Georgetown has long played a leadership role in policy debates as the premier institution of higher learning in our nation’s capital. It can no longer do so if only one view may be stated.

Further, this is a unique moment within the Catholic Church. Our first Jesuit pope has set a fresh tone. Many listened closely when Pope Francis indicated this view as pertains to abortion and gay rights: “The church sometimes has locked itself up in small things, in small-minded rules … We have to find a new balance.”

We the undersigned 232 alumni take the view that Georgetown should allow its students to take part in these discussions. We believe in open dialogue and debate.

In May of this year, the university revised its speech and expression policy to designate speech zones on campus. While this effort may have been designed to give clarity as to where H*yas for Choice and other unsponsored student groups may express their views, recent events demonstrate that such an objective has not been achieved. The designation of free speech zones in itself serves to segregate and stigmatize certain speakers. We also take concern with this most recent removal of speech from a public sidewalk in Washington, D.C.

Respectfully, we are requesting an affirmation that H*yas for Choice will be permitted to peacefully dialogue in the future.

Sincerely,

Sarah Audelo, SFS 2006
Melissa Adams, COL 2012
Sara Ainsworth, SFS 2014, L 2017
Arturo Altamirano, COL 2014
Jessica Ann, SFS 2014
Kate Appleton, COL 2003
Sara Appleton, COL 2012
Deanna Arthur, SFS 2014
Amy Baer, CAS 1988
Jonathan Balloch, COL 2011
Michael Balsan, COL 2012
Michael Barclay, COL 2012
Johanna Barron, COL 2010
Ksenya Belooussova, SFS 2014
Tyler Bilbo, COL 2012
Jordyne Blaise, COL 2006, L 2010
Alex Bozzette, SFS 2012
Ashley Bradylyons, SFS 2012
Jordan Braunfeld, COL 2014
Laura Brayton, MSB 2013
Peter Brigham, SFS 2014
Jheanelle Brown, SFS 2010
John Bufe, COL 2011, GS 2012
Elizabeth Buffone, COL 2014
Nikita Buley, MSB 2014
Gina Bull, SFS 2012
Donald F. Burke, III, MSB 2010
Robert Byrne, COL 2012
Rachel Calvert, COL 2014
Toby Campion, COL 2013
Kaitlin Carano, COL 2013
Juan Felipe Cardona, SFS 2014
Carolyn Junttila Carson, COL 2013
Mary Cass, COL 2012
Caitlin Cassidy, COL 2011
Michelle Cassidy, COL 2013
McKenzie Cato, COL 2012
Christina Cauterucci, COL 2010, SCS 2014
Irene Cavros, SFS 2014
Camila Chaudron, COL 2012
Soraya Chemaly, COL 1988
Celeste Chen, COL 2014
Laurel Chor, NHS 2012
Sophia Chung, COL 2014
Jonathan Cohn, COL 2010
Rachel S. Cohen, COL 2009
Madeline Elizabeth Collins, COL 2013
Elizabeth Cooper-Chrismon, SFS 2013
Bridget Copes, COL 2009
Jessica Corsi, SFS 2004
Bobby Courtney, COL 2011
Jessica Craige, SFS 2014
Christina Crisostomo, SFS 2013
Nicole Cronin, SFS 2010
Randy Crooks, SFS 2013
Frances Davila, SFS 2010
Catherine DeGennaro, COL 2013
Carlos DeLaTorre, COL 2013
Michael Deneen, COL 2014
Amelia Di Stefano, COL (FLL) 2012
Ellie DiBerardino, COL 2013
Kelly Differding, COL 2010
Zoe Disselkoen, SFS 2014
Amanda Dominguez, SFS 2014
Zosia Dunn, COL 2014
Kate Dylewsky, COL 2013
Victoria Edel, COL 2014
Mo Elleithee, SFS 1994
Ceyda Erten, SFS 2013
Joanne Esteban, SFS 2014
Gillian Evans, SFS 2012
Katherine Everitt, COL 2013
Claire Sunderland Ferguson, SFS 2013
Lawson Ferguson, SFS 2012, MSFS 2016
Guadalupe Fernandez, SFS 2014
Leigh Finnegan, COL 2013
Heather Flaherty, COL 2014
Lisa Frank, COL 2013
Alex Freeman, COL 2014
Stephanie Frenel, SFS 2012
Natalie Gallagher, COL 2013
Maya Gebeily, SFS 2013
Petar Georgiev, NHS 2013
Richa Goyal, SFS 2013
Leslie Gordon, COL 2009
Madelyne Greene, COL 2010
Joyce Gresko, L 2008
Elizabeth Gromet, COL 2014
Francisco J. Gutierrez, MSB 2013
Lanier Hagerty, SFS 2014
Rebecca Harris, MSB 2002
Brittany Harwood, SFS 2013
Rocio Hernandez, SFS 2011
Sarah David Heydemann, COL 2009
Haley Hirzel, COL 2014
Tanisha Humphrey, COL 2012
Kaan Inan, SFS 2014
Lina Jamis, COL 2012
Eun Sun Jang, SFS 2013
Charlotte Japp, COL 2013
Blake E Johnson, COL 2014
Sebastian Johnson, COL 2010
Ann Jung, SFS 2014
Upasana Kaku, SFS 2013
Codie Kane, COL 2012
Joe Kapusnick, SFS 2010
Sean Keady, SFS 2013
Jackie Kelley, COL 2007
Sean Kelly, SFS 2013
Anne Kenslea, COL 2013
Megan Kirby, COL 2012
Alisha Kramer, COL 2012
Samantha Kubek, COL 2013
Akari Kubo, SFS 2014
Catherine Kulick, COL 2014
Christian Lambert, SFS 2013
Capri LaRocca, SFS 2013
Nick Laskowski, COL 2003
Margaret Laush, SFS 2014
Jessica Lee, COL 2005
Brittanie Leibold, COL 2013
Taylor Lescallette, SFS 2012
Phoebe Lett, COL 2013
Zoe Lillian, COL 2013
Michael Lindvall, SFS 2013
Shiouyu Theresa Lou, SFS 2014
Jenna Lowenstein, COL 2009
Michael Madoff, SFS 2013
Kara Mahoney, COL 2007
Dr. Meredith M. Malburne-Wade, GS 2003
Andrew Malzberg, COL 2011
Elisa Manrique, COL 2014
Natalia Margolis, SFS 2013
Ian Martinez, GS 2004
Erin Matson, COL 2002
Benjamin McAfee, SFS 2012
Melissa McClure, COL 2013
Morgan McDaniel, SFS 2013
Chase Meacham, COL 2014
Evan Milberg, SCS 2013
Alex Miller, COL 2011
Cynthia Miller, COL 2002
Melissa Miller, COL 2011
Rehana Mohammed, SFS 2012
Shaella Morales, COL 2014
Rebecca Moses, COL 2012
Megha Motgi, SFS 2014
Anjani Nadadur, SFS 2012
Laura Narefsky, COL 2014
Jessica Natoli, COL 2014
Alfonso Fernández Navas, COL 2014
Eric Nemarich, COL 2014
Andrew Nolen, COL 2004
Anna Northrup (nee Johansson), COL 2006
Meghan O’Hearn, COL 2012
Rena Pacheco-Theard, SFS 2007
Keerat Pannu, SFS 2010
Irma Pérez, COL 2004
Zenen Jaimes Perez, SFS 2013
Emily Perkins, COL 2014
Hanna Perry, COL 2013
Alyssa Peterson, COL 2014
Hashim K. Pipkin, COL 2010
Allison Prescott, COL 2014
Liana Preudhomme, COL 2014
Caterina Profaci, COL 2012
Jennifer Ortiz Quezada, SFS 2013
Lauren Reese, COL 2012
Kate Reott, SFS 2013
Helah Robinson, SFS 2009
Aliz Rozell, SFS 2011
John Russell, COL 2009
Jenna Sackler, SFS 2014
Morgan Salomon, NHS 2012
Maria-Theresa Sanchez, SFS 2014
Talia Sandwick, COL 2009
Benjamin Santucci, SFS 2013
James Saucedo, MSB 2013
Kelly Sawyers, COL 2011
Gavin Schalliol, MAAS 2014
Mara Schechter, COL 2011
Jacob Schindler, SFS 2012
Emily Schuster, COL 2013
Katherina Shabalov, NHS 2014
Catherine Shi, MSB 2013
Beth Shook, COL 2009
Laura Shrum, NHS 2014
Deepa Sivarajan, COL 2012
Alison Smith, COL 2013
Jessica Smith, COL 2014
Daniel Solomon, SFS 2013
Colin Soper, COL 2012
Katherine Spiegel, COL 2014
Liam Stack, COL 2005
Cole Stangler, SFS 2013
Adele Stewart, NHS 2013
Natarajan Subramanian, SFS 2012
Marie Sullivan, COL 2014
Ariel Tabachnik, COL 2014
Adam Talbot, COL 2012
Neesha Tambe, COL 2013
Shuo Yan Tan, SFS 2012
Matt Taurchini, COL 2012
Kim Tay, COL 2014
Alexandra Theobald, SFS 2012
Sophia Topulos, COL 2012
Claudia Triana, SFS 2011
Michael Tubman, SFS 2003
Kat Tuckett, COL 2011
Madhuri Vairapandi, COL 2014
Alexandra Van Dine, SFS 2014
Joseph Vandegriff, COL 2014
Kalia Vang, COL 2013
Sarah Vazquez, COL 2013
Salome Viljoen, COL 2011
Allie Villarreal, COL 2012
Sara Wallace-Keeshen, SFS 2008
Mary Nancy Walter, COL 2014
Margaret Wardell, SFS 2014
Alyssa Warren, SFS 2012
Kelsey Warrick, COL 2014
Jared Watkins, COL 2011
Jasmine Wee, SFS 2013
Maura Weigel, COL 2010
Corey Wells, COL 2014
Taylor Wettach, SFS 2013
Claire Wheeler, COL 2012
Elspeth Williams, SFS 2008
Michael Wilson, COL 2005
Madeline Wiseman, COL 2013
Colleen Wood, SFS 2014
Ceecee Yao, COL 2013

Copies sent to:

Dr. Todd Olson
Dr. Jeanne Lord
Council Member David Grosso, L 2001

Roundups Sexual Health

This Week in Sex: At-Home STI Tests, New Virus-Killing Condom, and More

Martha Kempner

This week, LA County is reviving an at-home STI testing service, a new study shows that male circumcision can reduce rates of HIV among women as well as men, and an Australian company gets approval to produce a microbicide condom.

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

LA Considers Bringing Back At-Home STI Tests

With both chlamydia and gonorrhea rates on the rise, the Los Angeles County Health Department is once again trying to promote the availability of at-home testing for sexually transmitted infections (STIs). The program began in 2009 when the department bought 10,000 kits for about $450,000 and advertised their availability to women ages 12 to 25. The goal was to increase testing and treatment among young women who did not have easy access to clinics or other health-care providers. About 9,000 kits were distributed. Most were sent back to the department for testing, and of those sent back about 10 percent tested positive for chlamydia and 3 percent for gonorrhea. But a health department official told the Los Angeles Daily News that after the first few years, interest in the program waned.

Since that time, rates of both STIs have increased in the county. Between 2009 and 2013, cases of chlamydia rose by 8 percent, while gonorrhea rose by 45 percent. These changes show that the STI epidemic in the county is worse than in California as a whole; during the same time period statewide, cases of chlamydia actual fell slightly and rates of gonorrhea rose by 13 percent.

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Both chlamydia and gonorrhea are bacterial infections that are spread through genital secretions during oral, anal, or vaginal sex. They often have no symptoms, though they can cause some discharge and/or burning during urination in both men and women. Both can also be treated with antibiotics but if left untreated can cause pelvic inflammatory disease (PID), which in turn can cause scarring in the reproductive tract and infertility, mostly in women. An estimated 2.86 million cases of chlamydia and 820,000 cases of gonorrhea occur each year in the United States. Between 10 and 15 percent of chlamydia cases in women cause PID. Because most cases are asymptomatic, the Centers for Disease Control and Prevention (CDC) recommends annual chlamydia screening for all sexually active females 25 and under and for women older than 25 with risk factors such as a new sex partner or multiple partners.

At-home testing can be done by collecting a urine sample or using a cotton swab to collect secretions from the upper vagina. The sample is then sent to a lab. In the LA County program, women get their test results either through a website or via text message. Those who test positive are then told where they can go to get the antibiotics they need. Dr. Jonathan Fielding, director for the LA County Department of Public Health, told the LA Daily News, “This is a good approach for those who don’t feel comfortable going into a facility.”

For now the program remains limited to women because the county has not found a good home test for men, but Fielding did say they would look at that in the future.

Study: Male Circumcision Can Prevent HIV in Women

The results of a new study presented last week at the International AIDS Conference show that male circumcision can help reduce the spread of HIV among women as well as men. There have already been a number of studies that have shown that men who have been circumcised are at lower risk of contracting HIV. These results have led to interventions designed to increase the number of circumcised men in areas of Africa with a high prevalence of HIV. But until now, researchers were not sure whether such interventions also affected HIV rates in women.

This new study looked at women in Orange Farm, a town of 110,000 people outside of Johannesburg, South Africa. (One of the studies on male circumcision had taken place there as well.) Researchers surveyed 4,538 sexually active women ages 15 to 49 in three waves, in 2007, 2010, and 2012.

Participants were asked a number of questions about their sex lives, including the age at which they’d first had sexual intercourse, the number of lifetime partners they’d had, whether they’d always used condoms, and whether their partners were circumcised. Researchers also took blood to test the women for HIV. Among the 1,363 women who reported only having had circumcised partners, the HIV prevalence was 22.4 percent, compared with 36.6 percent among the remaining 3,175. According to analyses conducted by the researchers, this means that having only circumcised partners reduced these women’s risk of contracting HIV by 16.9 percent. Moreover, when researcher looked only at women under 29, they found a risk reduction of 20.3 percent.

Kevin Jean of the French National Institute for Health and Medical Research conducted the study and presented the results at the conference. He told the audience that the results provide a “compelling argument” to speed up interventions that provide voluntary male circumcision in areas with high rates of HIV.

Australia Approves Condom With STI-Killing Microbicide

Australian condom manufacturer Ansell, which makes LifeStyles brand condoms, has just won approval to start mass production in its home country on a condom lubricated with a microbicide that inactivates sexually transmitted viruses. Called Viva-Gel, the microbicide binds to viruses, preventing them from interacting with human cells. Viva-Gel has been shown to disable 99.9 percent of herpes, HIV, and human papillomavirus (HPV) cells on contact.

While this the gel should add extra protection for couples using condoms, many are still hoping that something will be released as a vaginal gel to help women—especially those whose partners refuse to wear condoms—protect themselves from STIs. It is not yet clear when such a product would be available, but Viva-Gel is in phase 3 clinical trials in the United States for use as a cure for bacterial vaginosis, a common infection caused by an imbalance of “good” and “bad” bacteria in a woman’s vagina. Though not an STI on its own, there is some evidence that sex, new sex partners, and multiple sex partners can contribute to an imbalance of bacteria in the vagina. More importantly, however, bacterial vaginosis can leave women more vulnerable to infection with other STIs.

The condom will be sold in Australia under the name LifeStyles Dual Protect. A Japanese condom-maker has also been approved to begin adding this microbicide to its condoms.

HPV Vaccine Rates Still Too Low

New data on vaccines among adolescents shows that despite a modest increase in overall vaccination coverage from 2012 to 2013, estimated coverage for the HPV vaccine remained low. In 2013, 57.3 percent of girls had received one dose of the HPV vaccine, compared to 53.8 percent the year before. More girls had received all three recommended doses in 2013 than in 2012 (37.6 percent, compared to 33.4 percent), but the CDC says this is still too low. In fact, the agency notes that if all pre-teen and teen girls got the HPV vaccine when they got other recommended vaccines for their age group (such as the vaccine for meningitis), 91.3 percent of all 13-year-old girls would have at least gotten the first dose. The actual numbers fall far short of that.

Vaccine coverage for young boys is even lower, but there was a bigger increase (13.8 percent) in the number of boys who got at least one dose of the HPV vaccine—it went from 20.8 percent in 2012 to 34.6 percent in 2013. There was also an increase in the percentage of boys ages 13 to 17 who had received all three doses (from 6.8 percent in 2012 to 13.9 percent in 2013).

The CDC pointed out that these data reflect great variation in vaccine rates between states. For example, only 39.9 percent of girls in Kansas received at least one dose, compared to 76.6 percent of those in Rhode Island. Similarly, only 11 percent of boys in Kansas received one dose, compared to 69.3 percent of boys in Rhode Island.

The slow uptake of the HPV vaccine is disappointing, as it has been shown to be very effective in preventing the strains of the virus that are most likely to lead to cervical cancer. A 2013 study, for example, found that the proportion of girls infected with the strains of the virus addressed by Gardasil (the first of the two HPV vaccines introduced) dropped from about 12 percent before the vaccine was available to 5 percent, which represents a drop of 56 percent. The drop applied to all teens, whether or not they were vaccinated. This may be a result of what public health experts refer to as “herd immunity”—if enough of the population is protected by a vaccine, that protection extends to the unvaccinated as well. Among girls who had gotten the vaccine, however, the drop in HPV infections was even higher, at 88 percent.

We can only imagine how far we could go in preventing HPV and cervical cancer if more young women and men were vaccinated. Unfortunately, some people still see the HPV vaccine as controversial since it protects against a disease that is sexually transmitted and because the recommendations suggest girls and boys get it as young as 9 to ensure that they’ve received all three doses before they become sexually active.