American Social Health Association

Experimental HIV Vaccine Prevents Infection in Nearly 1/3 of Subjects
Researchers optimistic, but questions remain

On Thursday, September 24, 2009, The Surgeon General of the U.S. Army released results from the Thai Phase III HIV vaccine study that demonstrated modest results in preventing HIV infection among participants in the clinical trial. The study found the vaccine regimen to be safe and 31 percent effective in preventing HIV infection.

The potential breakthrough comes after several failed vaccine trials; many scientists believed an HIV vaccine might not be possible. For the first time, however, the Thai Phase III study used the combination of two vaccines, Sanofi Pasteur's ALVAC vaccine and the AIDSVAX B/E vaccine, dev elope d by Vaxgen Inc. and licensed to the nonprofit Global Solutions for Infectious Diseases (GSID) in 2008. The research was sponsored jointly by the U.S. Army and the National Institute of Allergy and Infectious Diseases (NIAID), along with Sanofi Pasteur and GSID.

The study, conducted in two Thai provinces, began in October 2003 and involved approximately 16,402 HIV-negative subjects ages 18-30 at various levels of risk for HIV infection. Trial participants were evenly divided into groups and received either the vaccine or placebo upon enrollment in the study and again after 1 month, 3 months, and 6 months. Participants were counseled on HIV risk reduction strategies and tested for the virus twice a year for three years. Among the 8,197 subjects who received the combination of vaccines, 51 contracted HIV during the study. This compares to 74 of the 8,198 participants in the placebo group who became infected with the virus. Those who became HIV-positive during the study have been offered treatment at no cost.

In a press release, Anthony S Fauci, M.D. and Director of the National Institute of Allergy and Infectious Diseases, acknowledges these new findings as “an important step forward in HIV vaccine research,” but cautions that “additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection.”

The United Nations Joint Programme on HIV/AIDS estimates that 7,000 people worldwide are newly infected with HIV everyday; 2 million people died of AIDS in 2007. There is much to consider regarding future HIV vaccine research. Yet, after more than two decades, the search for a safe, effective vaccine that protects against HIV infection has made an encouraging advance.

A girl's attempt to gain U.S. citizenship may be derailed by refusal to have the human papillomavirus (HPV) vaccine . Simone Davis, a 17-year-old girl born in Britain, seeks to become a U.S. citizen but is confronted by immigration laws mandating that she receive the HPV vaccine that protects against the sexually transmitted human papillomavirus commonly attributed to cervical cancer.

This vaccine requirement stems from the 1996 Immigration and Nationality Act, which mandates that prior to being granted permanent resident status, immigrants must receive all vaccines recommended by the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP). In 2008, however, the U.S. Citizenship and Immigration Services (USCIS) updated the list of vaccines required of immigrants to include HPV, a move criticized by a number of advocacy groups who say the mandate places undue burden on those seeking to enter the U.S., and in particular, to women and girls.

Some organizations and advocate groups that focus on immigrant rights and women's health have questioned the necessity of forcing individuals to receive the vaccine considering that HPV isn't communicable in public settings. Of the 14 required vaccines, 13 of which aim to prevent infectious diseases considered highly contagious, Gardasil alone targets a sexually transmissible virus. Another worry is that cost may pose unfair financial burden placed on women, possibly acting as a significant financial barrier to seeking citizenship (the vaccine costs $360, plus clinic fees).

Simone protests the HPV vaccine for several reasons; her story reported by abcnews.com. As a devout Christian, Simone has taken a virginity pledge and doesn't understand she why she should be required to take the vaccine when she doesn't believe herself to be at risk. Her guardian and paternal grandmother, whom Simone calls “Nanny,” was also upset by this mandate and filed a waiver to the U.S. Citizenship and Immigration Services on moral and religious grounds but was rejected. Now facing the possibility of being separated from her Nanny, with only 30 days to appeal the decision before she must reapply as an adult (which requires a five year wait to become eligible for citizenship), Simone questions why none of her American classmates were required to take the HPV vaccine. Simone's Nanny claims the issue is not simply about religion, and instead highlights their desire to have the same rights of any U.S. citizen.

Deborah Arrindell, ASHA's vice-president of health policy, says “This vaccine has enormous potential to protect women's health, no one's debating that. What's troubling is the requirement extends only to immigrants, and doesn't apply to U.S. citizens. One has to question just how much public health is advanced by requiring the vaccine for a such a narrow segment of the population.” Jon Abramson, chairman of the CDC's Advisory Committee for Immunization Practices when the body recommended the vaccine for U.S. citizens last year, further purports that this policy is “not a good idea.”

There are some indications, however, that the HPV vaccine requirement may be reconsidered. Within the month CDC is expected to release new criteria to determine which vaccines should be mandated for U.S. immigrants. Whether this new criteria will affect Simone Davis' situation, or the lives of other female immigrants, has yet to seen.