Dear Editor, One of the limitations in conducting phase 1 preventive HIV vaccine trials in a resource-rich country is the difficulty in recruiting volunteers. There are currently 34 million people living with HIV and each year 2.7 million people become newly infected and 1.8 million people die of AIDS. Preventive HIV vaccine investigation is a critical path in developing a long-term strategy to control the worldwide HIV epidemic. Research efforts over the last two decades to develop a preventive HIV vaccine have showed that this is a particularly difficult objective. To date, over 200 phase 1–3 HIV vaccine trials have been conducted or are ongoing but only 3 have reached phase 3. Only one HIV vaccine in a phase 3 study demonstrated a modest efficacy when compared with placebo. Therefore, multiple trials are needed to find an effective HIV vaccine and greater efforts for any promising immunogen to reach phase 1 clinical trials has been proposed. It is estimated that over 35,000 volunteers will be required per year for phase 1–3 HIV vaccine trials worldwide to achieve this goal. Several studies have focused on the hypothetical willingness-to-participate or enrollment efficiency and have identified the most frequent reasons cited for declining HIV trial enrollment. Despite the growing literature on this issue, there are few data on barriers to participation in low risk volunteers willing to participate in phase 1 preventive HIV vaccine. The first phase 1 HIV vaccine clinical trial conducted in Spain, RISVAC-02, needed to recruit 30 HIV-uninfected volunteers in Spain. RISVAC-02 was a double-blinded, randomized placebocontrolled phase 1 HIV vaccine trial conducted in two Spanish clinical centers in Madrid and Barcelona. The study was approved by the institutional ethical review board and by the Spanish Regulatory Authorities. Details of the design of the study are published elsewhere. Inclusion criteria were age between 18 and 55 years, being at low risk of HIV-1 infection, agreeing to use an effective method of contraception from 14 days prior to the first vaccination until 4 months after the last immunization, and consent to HIV and sexually transmitted disease (STD) testing. The exclusion criteria were pregnancy or lactation, serious clinical problems, receiving a live attenuated vaccine 60 days before or any vaccine 14 days before screening, receiving any blood product or gamma-globulins 4 months before screening, participating in any other clinical trial 30 days before enrollment, history of several local or systemic vaccine reactions, and HIV/hepatitis B virus (HBV)/ hepatitis C virus (HCV)/syphilis infection. We analyzed demographics, recruitment source, sexuality, motivation to participate, or discontinuation of all healthy volunteers from the first contact with us to the baseline RISVAC-02 study. Different strategies and various approaches for recruitment of potential volunteers were used. Advertisements in mass media such as national and local newspapers, medical journals, HIV-related magazines, and TV interviews were conducted. E-mails were sent to different organizations: HIV/ AIDS NGOs, gay community associations, universities, hospitals, and others social networks. Informative posters were distributed in the cities of Madrid and Barcelona. Individuals who responded and provided a telephone number or an e-mail address were contacted and given further information. If they were interested we invited them to participate in a prescreening interview were they answered a survey that was conducted by trained nursing staff in a personal interview. Demographics, clinical history, lifestyle and risk factors, how they found out about the study and reasons for participating were obtained through an open/closed-ended questionnaire. If individuals were eligible and interested in participating, they were booked for a screening appointment. Informed consent was obtained from all the subjects. Those patients who agreed and fulfilled the inclusion criteria were enrolled. SPSS version 17 (SPSS, Inc., Chicago, IL) was used for analysis. Descriptive statistics and cross-tabulations were generated for all the variables of interest. Continuous variables were compared between groups with the Student’s t test or the non-parametric Mann-Whitney U test. Categorical variables were compared between groups with the v or Fisher’s exact tests. p value of £ 0.05 was considered significant. A total of 356 volunteers who responded to our campaign and sent a telephone number or an e-mail address were contacted and invited to a first interview. Seventy-five subjects
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Open Access
Dec 16, 2014
Patrick W Brady + 9
