Lessons learned from past HIV vaccine trials and recent technological as well as scientific advancements in the fields of HIV biology, immunology, and vaccinology allow us to conceive of a forthcoming effective HIV vaccine. Nevertheless, persisting “non-vaccine challenges” demand continued global attention in other areas, such as healthcare policy, reproductive health and HIV education programs to enhance public awareness, especially in low-to-middle income countries (Fauci & Marston, 2014; MacLennan, 2013). In particular, public knowledge about clinical trial and vaccination is important to establish public trust and ensure a streamline clinical trial, future dissemination, and acceptance of the vaccine once it becomes licensable (Newman et al., 2004). Therefore, in addition to research scientists, policymakers and public health officials play an important role in educating the public and strengthening trust for current development and future inclusion of the HIV vaccine in public health programs.
The most important consideration in establishing public trust is to enhance transparency in public communication and avoid false promises. Previously, scientists predicted that an HIV vaccine would be developed within years after the first reported cases of AIDS in 1981 (McCluskey et al., 2005; Goldman et al., 2014). However, over thirty years into the pandemic, this prediction has proven to be an underestimation of the complexity of HIV pathogenesis and the constant evolutionary race between host and pathogen. Into the bargain, socio-cultural and political challenges, including HIV-related stigma, gender-based violence against people living with HIV/AIDS, AIDS denialism and anti-vaccine movements, as well as sodomy laws further impede the progress. Therefore, it may be necessary to reemphasize the fact that HIV/AIDS, despite its recent advancement in treatment and/as prevention, is not over (Phillips et al., 2013; Deeks et al., 2013). Additionally, public health professionals must make it clear that typical vaccine development may take decades, and that effective HIV vaccine development may take even longer both due to its scientific and socio-cultural barriers (Newman et al., 2004).
Public mistrust in the developmental process of an HIV vaccine steams from past history of bad science, irresponsible publication, mis-representation, and interpretation of related scientific information in the media, such as those of the inherent risk for clinical trial participants and safety of vaccines. Most infamously was the publication by Andrew Wakefield in 1998 on The Lancet journal, wrongly challenging the link between measles, mumps, and rubella (MMR) vaccine and autism (Dyer, 2010). Despite its retraction over twelve years later in 2010, the resulting crisis of public confidence in general vaccination remains internationally until now. As demonstrated by a survey conducted by the National Institute of Allergy and Infectious Diseases (NIAID), most people strongly agreed that an HIV vaccine was being kept secret, or that participating in a clinical trial for an HIV vaccine candidate could cause them to contract HIV (McCluskey et al., 2005; Newman et al., 2004). Therefore, it’s important to ensure that participants in clinical trials understand their rights, associated risks, and the reasons behind the presented facts or conditions (Zielinski et al., 2014). For example, participants should understand that an experimental HIV vaccine does not contain sufficient genetic materials to cause productive infection of HIV (McCluskey et al., 2005). Furthermore, it’s also an ethical obligation to inform participants in clinical trials that their future HIV tests are more likely to yield false positive results because the antibodies made in response to the vaccine agent may remain in their body and get detected by HIV antibody tests (McCluskey et al., 2005; Bayer, 2000). This again is not because they are infected with HIV. Therefore, policymakers should ensure that, in addition to the prioritized accessibility of safe and FDA-approved vaccines to all participants in the trials, participants are protected from disqualification from services due to false positive HIV test results, such as blood donations, health insurance, international traveling, and certain employments (Bayer, 2000).
Fundamental knowledge—e.g. the differences between a vaccine, a treatment, and a cure—should be publicly disseminated. For instance, a vaccine is different from a cure because most vaccines do not necessarily confer sterilizing immunity, which is the short-lived complete prevention against infection (Andre et al., 2008; McCluskey et al., 2005). Rather, vaccination protects against developing a disease. In addition, treatment is also different from a cure because effective treatment may not provide complete clearance of infection without potential relapse, exemplified as the HIV latency in patients despite of pro-longed antiretroviral treatments (Marsden & Zack, 2015). In conclusion, a vaccine may not be taken as a replacement for a treatment nor a cure because an HIV vaccine is important in preventing future cases of HIV infection, but it cannot revert the damages of the AIDS pandemic (McCluskey et al., 2005). Consequently, for a complete HIV prevention, a vaccine must be recommended in condition of other preventative measures, such as the “ABC” method – “Abstinence, Be faithful, and use Condoms,” or the antiretroviral prophylaxis, especially in most vulnerable populations (Newman et al., 2012; McCluskey et al., 2005). Of note, just as a vaccine is different from a cure, a treatment should not also be taken as same as a vaccine regardless of its current application in treatment as prevention strategy against HIV. Lastly, policies insuring access to immediate and affordable care for people who are currently living or recently diagnosed with HIV/AIDS, e.g. recent expansion of Affordable Care Act and the Ryan White CARE Act, must also not be ignored to prevent further transmission (Goldman et al., 2014; Bayer, 2000).
Furthermore, alongside its biological complexity, HIV/AIDS is a unique socio-economic illness that requires a “social vaccine” targeting the most at risk populations, including African American men and women as well as men having sex with men (McCluskey et al., 2005; Goldman et al., 2014; Newman et al., 2012). As a result, willingness among the general public to participate in HIV clinical trials decreases while the stigmatization against such participants remains elevated. Moreover, general attitudes about future HIV vaccination also differ among various ethnic communities both in developing and developed countries (Newman et al., 2014).
Since effective vaccine development programs require a large number of healthy volunteers in clinical trials, policymakers and healthcare professionals play a critical role in ensuring ethical consideration of such trials and properly educating the general public about potential issues, especially in communities of color and areas where clinical trials are typically conducted, e.g. WHO African Region (Zielinski et al., 2014). Policymakers and healthcare professionals should not only focus on informing the public about current understandings of HIV transmission, prevention and treatment, but also educating them about the inherent challenges of developing an effective HIV vaccine and its future expectations. Furthermore, policymakers at an international level are also charged with developing new regulations and guidelines while reevaluating existing policies, such as anti-homosexuality, compulsory vaccination, home HIV testing policies, or those that involve parental consents to allow participation of adolescents in clinical trials (McCluskey et al., 2005; Newman et al., 2014; Thrun et al., 2013; MacLennan, 2013). Such policies may also extend to the inclusion of infants in clinical trials as infants’ immune response against HIV has been shown to differ from that of immunized adults (Gray & Corey, 2015). Indeed, an effective vaccine that is not sufficiently trusted by the general public remains an ineffective vaccine. Therefore, public mistrust of the process of developing a vaccine and its safety must be addressed to avert HIV-related stigma, foster a well-informed population of volunteers for clinical vaccine trials, and promote public acceptance as well as ensure appropriate dissemination of such proven effective vaccines in the future.
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