Adolescents and HIV Vaccine Trials
Identifieur interne : 004327 ( Istex/Corpus ); précédent : 004326; suivant : 004328Adolescents and HIV Vaccine Trials
Auteurs : Linda-Gail Bekker ; Heather Jaspan ; James Mcintyre ; Robin Wood ; Glenda GraySource :
- Journal of the International Association of Providers of AIDS Care [ 1545-1097 ] ; 2005-10.
English descriptors
- KwdEn :
- Actuarial society, Adolescent, Adolescent care, Adolescent participants, Adolescent studies, Adult trial, Assoc physicians aids care, Bekker, Cape town, Clinical trial, Clinical trials, Demographic impact, Desmond tutu, Efficacy trials, Health care, Healthy volunteers, High risk, Infectious disease, Legal guardian, Molecular medicine, National indicators, Operational issues, Other hand, Participant, Pivotal assessment, Preventive vaccine trials, Public transportation, School students, Separate trial, Sexual behaviour, Sexual risk, Sexual risk behavior, Social implications, Trial design, Vaccine, Vaccine efficacy, Vaccine products, Vaccine trials, Young people.
- Teeft :
- Actuarial society, Adolescent, Adolescent care, Adolescent participants, Adolescent studies, Adult trial, Assoc physicians aids care, Bekker, Cape town, Clinical trial, Clinical trials, Demographic impact, Desmond tutu, Efficacy trials, Health care, Healthy volunteers, High risk, Infectious disease, Legal guardian, Molecular medicine, National indicators, Operational issues, Other hand, Participant, Pivotal assessment, Preventive vaccine trials, Public transportation, School students, Separate trial, Sexual behaviour, Sexual risk, Sexual risk behavior, Social implications, Trial design, Vaccine, Vaccine efficacy, Vaccine products, Vaccine trials, Young people.
Abstract
Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.
Url:
DOI: 10.1177/1545109705284836
Links to Exploration step
ISTEX:CE8C27B86B710FEAFA36926E6EEBB556D6F04142Le document en format XML
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However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. 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type="degree">MBChB, FCP, PhD</roleName><email>linda-gail.bekker@hiv-research.org.za</email><affiliation>The Desmond Tutu HIV Centre, The Institute of Infectious Disease and Molecular Medicine, University of Cape Town Faculty of Health Sciences, Werhner and Beit Building, North Anzio Road, Mowbray, Cape Town 7925, South Africa;</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Heather</forename><surname>Jaspan</surname></persName><roleName type="degree">MD, PhD, FAAP</roleName><affiliation>Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa</affiliation></author><author xml:id="author-0002"><persName><forename type="first">James</forename><surname>McIntyre</surname></persName><roleName type="degree">MBChB, MRCOG</roleName><affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa</affiliation></author><author xml:id="author-0003"><persName><forename type="first">Robin</forename><surname>Wood</surname></persName><roleName type="degree">BSc, BM, DTMLM, MMED, FCP(SA)</roleName><affiliation>Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa</affiliation></author><author xml:id="author-0004"><persName><forename type="first">Glenda</forename><surname>Gray</surname></persName><roleName type="degree">MBBCh, FCPaed(SA)</roleName><affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa</affiliation></author><idno type="istex">CE8C27B86B710FEAFA36926E6EEBB556D6F04142</idno><idno type="ark">ark:/67375/M70-BZ6G7SPG-T</idno><idno type="DOI">10.1177/1545109705284836</idno><idno type="article-id">10.1177_1545109705284836</idno></analytic><monogr><title level="j">Journal of the International Association of Providers of AIDS Care</title><idno type="pISSN">1545-1097</idno><idno type="eISSN">2325-9582</idno><idno type="publisher-id">JIA</idno><idno type="PublisherID-hwp">spjia</idno><imprint><publisher>Sage Publications</publisher><pubPlace>Sage CA: Thousand Oaks, CA</pubPlace><date type="published" when="2005-10"></date><biblScope unit="volume">4</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="93">93</biblScope><biblScope unit="page" to="97">97</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2005</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>adolescents</term></item><item><term>HIV vaccine clinical trials</term></item><item><term>operational issues</term></item><item><term>trial design</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2005-10">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/CE8C27B86B710FEAFA36926E6EEBB556D6F04142/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus sage not found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article" dtd-version="2.3" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="hwp">spjia</journal-id><journal-id journal-id-type="publisher-id">JIA</journal-id><journal-title>Journal of the International Association of Physicians in AIDS Care</journal-title><issn pub-type="ppub">1545-1097</issn><publisher><publisher-name>Sage Publications</publisher-name><publisher-loc>Sage CA: Thousand Oaks, CA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1177/1545109705284836</article-id><article-id pub-id-type="publisher-id">10.1177_1545109705284836</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject></subj-group></article-categories><title-group><article-title>Adolescents and HIV Vaccine Trials</article-title><subtitle>What Are the Clinical Trial Site Issues?</subtitle></title-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Bekker</surname><given-names>Linda-Gail</given-names></name><degrees>MBChB, FCP, PhD</degrees><aff>The Desmond Tutu HIV Centre, The Institute of Infectious Disease and Molecular Medicine, University of Cape Town Faculty of Health Sciences, Werhner and Beit Building, North Anzio Road, Mowbray, Cape Town 7925, South Africa; <email xlink:type="simple">linda-gail.bekker@hiv-research.org.za</email></aff></contrib></contrib-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Jaspan</surname><given-names>Heather</given-names></name><degrees>MD, PhD, FAAP</degrees><aff>Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa</aff></contrib></contrib-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>McIntyre</surname><given-names>James</given-names></name><degrees>MBChB, MRCOG</degrees><aff>Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa</aff></contrib></contrib-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Wood</surname><given-names>Robin</given-names></name><degrees>BSc, BM, DTMLM, MMED, FCP(SA)</degrees><aff>Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa</aff></contrib></contrib-group>
<contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Gray</surname><given-names>Glenda</given-names></name><degrees>MBBCh, FCPaed(SA)</degrees><aff>Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa</aff></contrib></contrib-group>
<pub-date pub-type="ppub"><month>10</month><year>2005</year></pub-date><volume>4</volume><issue>4</issue><fpage>93</fpage><lpage>97</lpage><abstract>
<p>Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.</p>
</abstract><kwd-group><kwd>adolescents</kwd><kwd>HIV vaccine clinical trials</kwd><kwd>operational issues</kwd><kwd>trial design</kwd></kwd-group><custom-meta-wrap><custom-meta xlink:type="simple"><meta-name>sagemeta-type</meta-name><meta-value>Journal Article</meta-value></custom-meta><custom-meta xlink:type="simple"><meta-name>search-text</meta-name><meta-value> 10.1177/1545109705284836Bekker et alAdolescents and HIV Vaccine Trials Adolescents and HIV Vaccine Trials What Are the Clinical Trial Site Issues? Linda-Gail Bekker, MBChB, FCP, PhD, Heather Jaspan, MD, PhD, FAAP, James McIntyre, MBChB, MRCOG, Robin Wood, BSc, BM, DTMLM, MMED, FCP(SA), and Glenda Gray, MBBCh, FCPaed(SA) Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, en- rollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining ado- lescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of edu- cation materials that target both youth and their parents. Be- cause these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials. Keywords: adolescents; HIV vaccine clinical trials; operational issues; trial design There are at least 2 good reasons to conduct HIV preven- tive vaccine trials in adolescents and children. First, the US Food and Drug Administration and other interna- tional licensing bodies are likely to require safety and immunogenicity data in this age group if the product is to be licensed for use in youth. 1 Secondly, in developing countries young people are at high risk for acquisition of HIV infection. Adolescents and preadolescents could benefit greatly from a preventive vaccine and would be good candidates for efficacy trials. On the other hand, young people younger than the age of majority are con- sidered a potentially vulnerable group, and many reasons have been put forward to exclude them from nontherapeutic trials. 2 A recent survey conducted by the Reproductive Health Research Unit 3 at the University of Witwatersrand reported an HIV prevalence rate of 10.2% for 15- to 24- year-olds. In the 15-to-19 age group, 7.3% of females and 2.5% of males tested positive for HIV antibodies.4 A review of unsafe sexual behavior has demonstrated that South African teenagers put themselves at risk for HIV infection through unprotected sex.3 Research conducted among Cape Town high school students has demon- strated that sexual initiation begins at age 13, with a 15% annual incidence of sexual debut, and that half of these encounters are without condom protection.3,5,6 In addi- tion, some of this adolescent sexual experience is coer- cive, particularly among adolescent girls 4 ; and even within stable relationships, rape, violence, and assault are not uncommon. 7 The Centre for Actuarial Science, University of Cape Town, has been modeling the HIV epidemic for a num- ber of years. 8 Future trends in HIV prevalence have been predicted using the Actuarial Society of South Africa model and are shown in Figure 1. These data have impor- tant implications for prevention and vaccination pro- grams: because the majority of new infections occurring in South Africa currently occur between the ages of 15 Adolescents and HIV Vaccine Trials J INT ASSOC PHYSICIANS AIDS CARE 4(4); 2005 pp. 93-97 93 DOI: 10.1177/1545109705284836 © 2005 Sage Publications Please visit the Journal at http://jiapac.sagepub.com From the Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa (Bekker, Jaspan, and Wood) and the Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa (McIntyre and Gray). Correspondence: Linda-Gail Bekker, MBChB, FCP, PhD, The Desmond Tutu HIV Centre, The Institute of Infectious Disease and Mo- lecular Medicine, University of Cape Town Faculty of Health Sciences, Werhner and Beit Building, North Anzio Road, Mowbray, Cape Town 7925, South Africa; e-mail: linda-gail.bekker@hiv-research.org.za. and 24 years, that is where we need to focus our preven- tion and vaccination campaigns. Vaccinating adolescents before the onset of behavior that puts them at risk for HIV acquisition may be one of the most effective ways of curbing future growth of the South African HIV epidemic. Since 1988, an increasing number of candidate HIV vaccines have been studied in phase I and II trials involving healthy adult volunteers, and in the next few years, it is expected that large-scale efficacy trials of the more promising products will be per- formed. In contrast, no vaccine trials have been con- ducted in adolescents, and only 2 have been conducted in HIV-exposed infants.9 There are a number of barriers that must be addressed to successfully perform HIV vaccine trials with adolescents. Some psychosocial, legal, ethical, and sociocultural issues are specific to HIV vaccine trials, but many issues are common to all research involving adoles- cent subjects. These issues are addressed in this journal by Swartz et al, and elsewhere.2 In addition, there are management issues stemming from adolescents' vulner- ability such as their legal minority and social and emo- tional developmental phase10 in which antiestablishment culture and distrust of authoritarian or hierarchical structures are common.11 However, for the same reasons, adolescents are often passionate about specific causes. Other logistic barriers to trial enrollment inherent to adolescence exist. Teenagers are often very mobile and less predictable with regard to medium-term plans. Because of age and resources, teenagers are more often reliant on public transportation, and school and college hours may restrict availability for clinic visits. Eliciting sexual risk information is often difficult and may lead to unreliable data. Finally, for purposes of legal informed consent, adolescents need the consent of a parent or guardian to participate in trials. However, adolescents often test the limits of dependence and experiment with a range of life experiences.12 Therefore, the concerns of the parent need to be considered. Oftentimes, parents of teenagers feel excluded from youth culture and lack of influence on their adolescent offspring. The impact of all these components is critical to the clinical and practi- cal aspects that must be considered. Any clinical trial site will need to address these logistic aspects before embarking on HIV vaccine trials with adolescent participants. This article will expand on some of these issues. Phases of Vaccine Development All vaccine products must pass through 3 phases of hu- man clinical trials. These trials are usually random, double-blinded, placebo-controlled trials. Phase I stud- ies involve small numbers (fewer than 100 participants) of relatively low-risk, healthy volunteers and primarily in- vestigate the safety of the product. Phase II trials include larger numbers of healthy volunteers (more than 100 participants) and investigate dosing levels and safety, as well as some immunogenicity. Only promising products will go on to larger, more expensive phase III trials, which are conducted in thousands of high-risk individuals to in- vestigate efficacy of the product. Adolescents may need to be involved in all 3 phases of product testing. Operational Issues Pertinent to All Phases of Trials Recruitment and Retention Recruiting and retaining adolescents to participate in re- search is challenging. Legislation requires that each ado- lescent be accompanied by a legal guardian, so the adolescent-guardian pair must be considered for recruit- Bekker et al 94 J INT ASSOC PHYSICIANS AIDS CARE 4(4); 2005 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 15-24 25-34 35+ 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 15-24 25-34 35+ Women Men Figure 1 The first graph shows the number of new female infections in each year by age category. In the early years of the epi- demic, there were dramatic increases in new infections in all age categories. The vast majority of new HIV infections in women currently occur in those younger than 25 years of age. The reason for this finding is that most of the women engaging in sexual risk behavior at an older age have already been infected, so the new infections now occur mostly among the young women who have recently joined the sexually active population. The second graph shows a similar pattern for males.Currently the 15-to-24 age band is the category in which the most new male infections occur. *Dorrington R, Bradshaw D, Johnson L, Budlender D. The demo- graphic impact of HIV/AIDS in South Africa. National indicators for 2004. Cape Town: CARe, SA MRC and Actuarial Society of South Africa, 2004. ment in any trial. Recruitment is more problematic when the vaccine product is new and experimental (early phase trials) and biomedical science is viewed with suspi- cion, especially in communities where HIV is still associ- ated with stigmatization and fears of discrimination. South Africa has at least 4 vaccine field sites currently preparing or already actively recruiting adults for clinical trials. Expediency may dictate simply using the same strategies, staff, sites, and protocols in the implementa- tion of adolescent studies, which may be counterproduc- tive in the successful recruitment and retention of youn- ger age groups. Evaluations of adolescent voluntary counseling services have given some insights into key requirements for both recruitment and retention of young people.12 Youth-friendly, comfortable surround- ings that are accessible by public transportation and also cater to after-school hours are essential. Confidentiality must be ensured with adequate privacy, as well as age- appropriate and culturally relevant education and coun- seling. Creating the right environment may require involving peer adolescent consultants who can advise on settings, advertisements, campaigns, language for con- sents, and sexual risk assessments. In setting an appropri- ately youth-friendly tone to attract adolescents, the trial site must also consider the legal guardian, usually an older adult and often a parent, who will need to be assured of professionalism, confidentiality, and expertise. Education Often the concerns about a product or protocol raised by adolescents are quite different from those raised by adult participants. Hence, youth-specific materials and strate- gies need to be developed for youth trials. Again, peer ad- olescent input is invaluable to ensure appropriateness. Material generated also needs to be reviewed frequently because what may be considered fashionably "hip" and thus appealing may fall out of favor with time. The infor- mation sheets for informed consent for parents and for children need to address age-specific concerns to ensure truly informed consent. Adolescent representatives, es- pecially if from the target communities, can act as liai- sons between researchers and youth, ensuring that the voice and feelings of the community are heard. Educa- tion must be adequately provided. Knowledge often may be poor, and information may be incorrect. Sufficient time and a variety of inputs may be necessary to totally allay fears and to ensure meaningful participation and thus retention. Community Involvement Assessing where the community is in terms of participa- tion of adolescents in clinical trials is important. Commu- nity "buy in" is a vital initial step in adolescent trial partici- pation. The community will, quite correctly, see the need to protect their youth from exploitation and may be cau- tious and distrustful. Engaging both representative pa- rental and youth liaisons in a community advisory capacity is advisable. As in all clinical research, keeping the community informed on progress, outcomes, safety issues, and other relevant aspects will do much to enhance the researcher-community relationship for future studies. Services The South African primary health care services for youth can sometimes be inadequate, particularly in the socially deprived areas where HIV prevalence is highest and thus HIV research is more likely to occur. Experience has shown that research is much more likely to succeed when basic services are provided and people's immediate needs are met.12 There is a need to instill fundamental re- quirements, such as respect for privacy and opinion, as well as basic infrastructure and services, such as counsel- ing, sexually transmitted infection management, contra- ceptive services, and other primary health care. Without these services, researchers may find a level of distrust from individuals and a lack of community cooperation. Provision of these support structures may also assist in comprehensive follow-up required as part of these clinical trials. Poststudy Vaccine-Induced HIV Seropositivity The fear of social implications of possible vaccine- induced HIV seropositivity is often a deterrent to partici- pation. Guardians and adolescents may have different causes for concern. A guardian may consider social im- plications and future risk behavior. The young person may be concerned about social stigma and what their seropositivity would mean for sexual partners. Adoles- cents may have problems with insurance applications; al- though this issue has been addressed in South Africa, where the life insurance industry has agreed to viral ge- nome testing in all vaccine trial participants, socially mo- bile young people may find themselves being tested outside of South Africa. In addition, there may be impli- cations for job applications and other opportunities such as travel. Phase-Specific Issues Sexual Risk Assessment Phase I and II trials, which assess safety and immuno- genicity of a candidate vaccine, often require partici- pants who have low risk of HIV acquisition, as HIV infections acquired during a trial may be misunderstood Adolescents and HIV Vaccine Trials J INT ASSOC PHYSICIANS AIDS CARE 4(4); 2005 95 by the media and communities. However, excluding those who have high-risk profiles may be stigmatizing. To overcome this stigmatization, it is necessary to make it clear that exclusion from trials can be for a variety of rea- sons; therefore, those with high-risk profiles can be ex- cluded without revealing their sexual risk. On the other hand, efficacy trials require participa- tion of volunteers at risk for acquisition of HIV. In South Africa, because the most common manner of transmis- sion is sexual, sexual activity is implied; thus, participa- tion in a clinical trial, in turn, implies tacit disclosure to a guardian and guardian acceptance of sexual risk. A more acceptable strategy may be to conduct the studies in com- munities where the level of HIV prevalence is high, implying a high-risk community and thus negating the need for individual assessment. Trial Design and Protocols The vaccine products chosen for adolescent testing and timing of adolescent participation in the development of a vaccine should be carefully considered. Consensus should be reached among South African researchers in the context of global networks. When possible, study pro- tocols should be tailored to adolescent lifestyles; e.g., they may need to consider teenage mobility and make follow-up as short as possible with the minimal number of vaccinations and blood draws, as physical pain may be a significant barrier to participation. It is likely that the initial phase I trial(s) will need to be completed in an adult cohort initially. After reasonable safety data is available and the product appears suitable, adolescents may be included in phase I and II studies. A number of approaches are being considered in develop- ing the kind of information about vaccine efficacy in ado- lescents that regulatory bodies may require to license vaccine products for use in this group (S. Self, personal communication). One strategy that reduces the size and time and therefore the cost of a trial in adolescents would be a bridging trial based on immunogenicity. In this strat- egy, a moderate number of adolescents would be ran- domized as a subgroup of an adult trial or a separate trial. Vaccine immunogenicity data in adolescents would be compared with adults to assess equivalence of immuno- genicity profiles and also to provide adolescent safety data. The problem with this approach is that it relies on the existence of measurable immune responses that accurately correlate with vaccine-induced protection. These correlates are not yet available in HIV vaccinology. The second possibility is to use a screen assessment of efficacy. In this method, a larger number of adolescents is randomly enrolled, providing an adolescent-specific, direct, screening-type assessment of vaccine efficacy (a phase IIb trial) to augment the assessment in adults, either as a stratum of the adult trial or as a separate trial using similar protocols. This strategy is not dependent on immune correlates of protection, is less costly than a full-scale efficacy trial, and gives independent adolescent data. The longer follow-up requires that the adult and adolescent studies be reasonably contemporaneous. The third kind of trial would be to conduct a full-scale pivotal assessment of efficacy by enrolling large numbers of ado- lescents randomly into a trial with longer follow-up. The objective of this design would be to provide an adolescent-specific, direct, pivotal assessment of vaccine efficacy that would stand alone and be independent of the results in adults. This strategy completely separates the scientific questions of safety and efficacy in adult and adolescent populations and addresses them independently. Willingness to Participate With all these concerns, one may ask whether it is feasible to recruit young people to HIV preventive clinical trials. In an adolescent, cross-sectional, community, HIV preva- lence study performed in South Africa, 256 participants with a mean age of 14.3 years, a mean level of education of seventh grade, and 7% HIV prevalence were asked their willingness to participate in an HIV vaccine trial (H. Jaspan and L-G. Bekker, unpublished data). Fifty-three percent of participants stated that they would definitely participate in an HIV vaccine study. Willingness to partic- ipate was independent of gender or sexual risk behavior but was strongly associated with both increasing age and school grade. The most common reason for HIV vaccine trial participation was hope that the study vaccine might prevent HIV, and the most commonly perceived barriers to participation were fear of unknown side effects, fear of HIV infection, or fear of needles. Other studies such as the Reaching for Excellence in Adolescent Care and Health study enrolled nearly 500 young people aged 12 to 18 years in the United States. The participants were both HIV-infected and uninfected youth who had quar- terly blood draws, biannual gynecologic and urologic ex- ams, annual anal exams, and a variety of questionnaires and still had a 90% retention rate and a high rate of will- ingness to participate in future trials.13 HIV vaccine clinical trials can be conducted in adoles- cents. Overcoming the associated challenges will need a concerted community approach based on strong community-researcher relationships. This includes sound feasibility assessment and community prepared- ness, appropriate education, peer support, and adequate counseling, as well as clinical infrastructure and services before and after the clinical trial. Waiting until all required adult testing is complete may result in unreasonable delays in adolescent implementation. Bekker et al 96 J INT ASSOC PHYSICIANS AIDS CARE 4(4); 2005 References 1. Rules and Regulations. Fed Regist December 2, 1998;63(231): 66631-66672. Available from: wais.access.gpo.gov. 2. McClure CA, Gray G, Rybczyk GK, Wright PF. Challenges to con- ducting HIV preventive vaccine trials with adolescents. J Acquir Immune Defic Syndr. 2004;36:726733. 3. Eaton L, Flisher AJ, Aaro LE. Unsafe sexual behaviour in South African youth. Soc Sci Med. 2003;56:149-165. 4. Pettifor A, Rees H, Steffenson A, et al. HIV and Sexual Behaviour Among Youth South Africans: A National Survey of 15-24 Year Olds. Johannesburg, South Africa: Reproductive Health Research Unit, University of the Witwatersrand; 2004. 5. Kaaya SF, Flisher AJ, Mbwambo JK, Schaalma H, Aaro LE, Klepp KI. A review of studies of sexual behaviour of school students in sub-Saharan Africa. Scand J Public Health. 2002;30:148-160. 6. Flisher AJ, Reddy P, Muller M, Lombard C. Sexual behaviour of Cape Town high-school students. S Afr Med J. 2003;93:537541. 7. Wood K, Jewkes R. Violence, rape, and sexual coercion: everyday love in a South African township. Gend Dev. 1997;5:4146. 8. Dorrington R, Bradshaw D, Johnson L, Budlender D. The demo- graphic impact of HIV/AIDS in South Africa: national indicators for 2004. Centre for Actuarial Research and South African Medi- cal Research; 2004. Available at: http://www.commerce.uct.ac .za/care/RESEARCH/PAPERS/IndicatorsASSA2002.pdf. 9. Safrit JT. HIV vaccines in infants and children: past trials, present plans and future perspectives. Curr Mol Med. 2003;3:303-312. Available at: www.library.uow.edu.au/adt-NWU/uploads/ approved/adt-NWU20031001.162858/public/05Chapter3.pdf. 10. Jasso NK, Wolkon GH. Drug use, attitudes, and behaviors of youth in an urban free clinic. Int J Addict. 1978;13:317-326. 11. Erikson EH. Identity Youth and Crisis. New York, NY: W. W. Norton; 1968. 12. Boswell D, Baggaley R. Voluntary Counseling and Testing (VCT) and Young People: A Summary Overview. Research Triangle Park, NC: Family Health International; 2002. Available at: http:// www.etharc.org/vct/vctyouth.pdf. 13. 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</ref-list></back></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Adolescents and HIV Vaccine Trials</title><subTitle>What Are the Clinical Trial Site Issues?</subTitle></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Adolescents and HIV Vaccine Trials</title><subTitle>What Are the Clinical Trial Site Issues?</subTitle></titleInfo><name type="personal"><namePart type="given">Linda-Gail</namePart><namePart type="family">Bekker</namePart><namePart type="termsOfAddress">MBChB, FCP, PhD</namePart><affiliation>The Desmond Tutu HIV Centre, The Institute of Infectious Disease and Molecular Medicine, University of Cape Town Faculty of Health Sciences, Werhner and Beit Building, North Anzio Road, Mowbray, Cape Town 7925, South Africa;</affiliation><affiliation>E-mail: linda-gail.bekker@hiv-research.org.za</affiliation></name><name type="personal"><namePart type="given">Heather</namePart><namePart type="family">Jaspan</namePart><namePart type="termsOfAddress">MD, PhD, FAAP</namePart><affiliation>Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa</affiliation></name><name type="personal"><namePart type="given">James</namePart><namePart type="family">McIntyre</namePart><namePart type="termsOfAddress">MBChB, MRCOG</namePart><affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa</affiliation></name><name type="personal"><namePart type="given">Robin</namePart><namePart type="family">Wood</namePart><namePart type="termsOfAddress">BSc, BM, DTMLM, MMED, FCP(SA)</namePart><affiliation>Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa</affiliation></name><name type="personal"><namePart type="given">Glenda</namePart><namePart type="family">Gray</namePart><namePart type="termsOfAddress">MBBCh, FCPaed(SA)</namePart><affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa</affiliation></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>Sage Publications</publisher><place><placeTerm type="text">Sage CA: Thousand Oaks, CA</placeTerm></place><dateIssued encoding="w3cdtf">2005-10</dateIssued><copyrightDate encoding="w3cdtf">2005</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract lang="en">Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.</abstract><subject><genre>keywords</genre><topic>adolescents</topic><topic>HIV vaccine clinical trials</topic><topic>operational issues</topic><topic>trial design</topic></subject><relatedItem type="host"><titleInfo><title>Journal of the International Association of Providers of AIDS Care</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">1545-1097</identifier><identifier type="eISSN">2325-9582</identifier><identifier type="PublisherID">JIA</identifier><identifier type="PublisherID-hwp">spjia</identifier><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>4</number></detail><detail type="issue"><caption>no.</caption><number>4</number></detail><extent unit="pages"><start>93</start><end>97</end></extent></part></relatedItem><identifier type="istex">CE8C27B86B710FEAFA36926E6EEBB556D6F04142</identifier><identifier type="ark">ark:/67375/M70-BZ6G7SPG-T</identifier><identifier type="DOI">10.1177/1545109705284836</identifier><identifier type="ArticleID">10.1177_1545109705284836</identifier><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-0J1N7DQT-B">sage</recordContentSource></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/CE8C27B86B710FEAFA36926E6EEBB556D6F04142/metadata/json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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