Showing papers on "Vaccine trial published in 2000"
TL;DR: It was found no evidence that two doses of ALM plus BCG offered significant protective immunity against visceral leishmaniasis compared with BCG alone, andLeishmanin skin conversion with an induration of 5 mm or more in either group was associated with protection from the disease.
225 citations
TL;DR: The results suggest that the formulation tested in this trial did not generate immune responses that were strong enough to reduce parasite growth in naive volunteers.
137 citations
TL;DR: It is argued that mass vaccination of 70% of the children with the cold-adapted influenza vaccine could provide substantial protection to the community at large.
111 citations
TL;DR: Current data from experimental models and studies of patients with pulmonary tuberculosis and their household contacts indicate that Mycobacterium tuberculosis-stimulated whole-blood production of interferon-gamma, although imperfect, is the best available correlate.
Abstract: Correlates of protective immunity to Mycobacterium tuberculosis in humans are desirable for identifying protective antigens, demonstrating the immunogenicity of a vaccine candidate and its potential efficacy, and permitting optimization of the dose, vehicle, adjuvant, and schedule of immunization. Potential correlates can be proposed on the basis of animal models and ex vivo/in vitro studies in humans. Most critical is their validation; ultimate validation will require correlation with protection in a phase III efficacy trial of an effective vaccine. Other approaches, however, can allow selection of the most promising correlates for inclusion in phase I and II and, ultimately, phase III vaccine trials. Current data from experimental models and studies of patients with pulmonary tuberculosis and their household contacts indicate that Mycobacterium tuberculosis-stimulated whole-blood production of interferon-gamma, although imperfect, is the best available correlate. Nonetheless, further refinement of this assay and additional studies of more complex assays that model M. tuberculosis killing and cytotoxic T lymphocyte activity are warranted. During planning of a vaccine trial, the best available correlates of immunity can be selected for inclusion.
86 citations
TL;DR: Contin educational efforts at the community and individual level are needed to address certain vaccine trial concepts and to increase knowledge levels in all potential study populations.
Abstract: Longitudinal data were analyzed to determine changes in willingness to participate in HIV vaccine efficacy trials and knowledge of vaccine trial concepts among populations at high risk of HIV-1 infection. Gay men (MSM), male and female injection drug users, and non-injecting women at heterosexual risk were recruited (n = 4892). Follow-up visits occurred every 6 months up to 18 months. Willingness was significantly lower at follow-up visits compared with at baseline. Knowledge levels increased for all study populations. Problematic concepts were possible effects of the vaccine on the immune system and lack of knowledge about efficacy of a vaccine before the start of a trial. For concepts concerning safety, blinding, and guarantees of future participation in trials, MSM men had significant increases in knowledge, but little to no change occurred for the other populations. An increase in knowledge was associated with becoming not willing, particularly among MSM with low knowledge levels. At least half of high-risk participants were consistently willing to participate in future vaccine efficacy trials and with basic vaccine education, knowledge levels increased. Continued educational efforts at the community and individual level are needed to address certain vaccine trial concepts and to increase knowledge levels in all potential study populations.
71 citations
TL;DR: Despite the presence of broad cross-clade recognition, the CTL responses to the infecting viral clade were highest in most people, lending justification to the use of clade B-based immunogens in the current phase 1 vaccine trial in Uganda.
Abstract: The first prophylactic human immunodeficiency virus type 1 (HIV-1) vaccine trial in Africa, with a clade B immunogen, is currently under way in Uganda, in a region where clades A and D are endemic. The use of a B clade vaccine is based on anticipated cross-recognition of endemic strains of HIV-1 in Uganda, but, in fact, little is known about the cytotoxic T lymphocyte (CTL) responses in that region. Seventeen HIV-1-infected volunteers from Kampala, Uganda, were studied to determine the immune responses elicited by natural infection with local HIV-1 strains. Despite the presence of broad cross-clade recognition, the CTL responses to the infecting viral clade were highest in most people. Recognition of nonendemic clade B antigens was similar to that of the coendemic local clade, and, in some instances, cross-recognition of clade B was greater. Nevertheless, the degree of cross-clade cellular responses we observed lends justification to the use of clade B-based immunogens in the current phase 1 vaccine trial in Uganda.
71 citations
TL;DR: Willingness to participate in HIV-1 vaccine trials and associated factors was somewhat greater than in other investigations of non-injection drug user (IDU) cohorts in Thailand, with fewer concerns expressed about physical harm.
Abstract: Objectives: Willingness to participate in HIV-1 vaccine trials and associated factors were investigated in a sample of 2670 Royal Thai Army conscripted recruits.
Methods: Self administered questionnaires were used. Data were collected during the final visit of a longitudinal cohort study of HIV-1 epidemiology. Cross sectional analysis of data from this visit was performed.
Results: 32% of the respondents reported they would "definitely" join an HIV-1 vaccine trial. Greater willingness was associated with perceived risk of HIV-1 infection and a desire to help Thai society, although tangible incentives and intentions to reduce condom use in a vaccine trial also were associated with increased willingness. Concerns about physical harm and anticipated social pressure from family not to join were the most substantial impediments to willingness. Concerns about "social harm" (for example, participation would give appearance of having AIDS virus, a partner might refuse sex) also appeared to inhibit interest in joining trials and approached significance.
Conclusions: Willingness to participate was somewhat greater than in other investigations of non-injection drug user (IDU) cohorts in Thailand, with fewer concerns expressed about physical harm. Motivations appear to involve tradeoffs among perceived risk, anticipated social pressure, altruism, and tangible rewards. The absence of significant problems associated with vaccine trials to date, along with the presence of educational interventions in the study may help explain the lower level of concerns here relative to other Thai studies.
Key Words: HIV; vaccine; Thailand
63 citations
TL;DR: Contin educational efforts at the community and individual level are needed to address certain vaccine trial concepts and to increase knowledge levels in all potential study populations.
Abstract: Longitudinal data were analyzed to determine changes in willingness to participate in HIV vaccine efficacy trials and knowledge of vaccine trial concepts among populations at high risk of HIV-1 infection. Gay men (MSM), male and female injection drug users, and non-injecting women at heterosexual risk were recruited (n = 4892). Follow-up visits occurred every 6 months up to 18 months. Willingness was significantly lower at follow-up visits compared with at baseline. Knowledge levels increased for all study populations. Problematic concepts were possible effects of the vaccine on the immune system and lack of knowledge about efficacy of a vaccine before the start of a trial. For concepts concerning safety, blinding, and guarantees of future participation in trials, MSM men had significant increases in knowledge, but little to no change occurred for the other populations. An increase in knowledge was associated with becoming not willing, particularly among MSM with low knowledge levels. At least half of high-risk participants were consistently willing to participate in future vaccine efficacy trials and with basic vaccine education, knowledge levels increased. Continued educational efforts at the community and individual level are needed to address certain vaccine trial concepts and to increase knowledge levels in all potential study populations.
56 citations
TL;DR: Investigation of the willingness to participate in HIV vaccine trials of initially HIV‐seronegative homosexual men enrolled in an HIV seroincidence cohort study demonstrates that this high‐risk homosexual male cohort has a high willingness to participants.
Abstract: Evaluation of HIV vaccines requires high-risk individuals willing to participate in a vaccine trial. We investigated the willingness to participate in HIV vaccine trials of initially HIV-seronegative homosexual men enrolled in an HIV seroincidence cohort study. Of 815 initially HIV-seronegative participants, 569 (69.8%) reported willingness to participate in an HIV vaccine trial. Altruism was the primary reason given for wanting to participate. Fear of HIV infection from the study's immunizations and a vaccine-induced positive HIV test result were the main reasons for not wanting to participate. Of the 34 study subjects who eventually had HIV seroconversion, 29 (85%) had indicated a willingness to participate. In a univariate analysis, factors associated with willingness to participate included HIV seroconversion during follow-up (odds ratio [OR]. 2.6; p =.04), low educational level (OR, 1.6; p =.005), low family income (p =.02), and exchanging sex for housing, food, or clothing (OR 6.1; p =.005). Students were less likely to be willing to participate in a trial (OR, 0.7; p = .03), as well as those who reported sex at the first encounter (OR, 0.7; p = .05). In a multivariate analysis, low education level, infection with Condyloma, and exchanging sex for housing, food, or clothing were positively associated with willingness to participate, whereas being a student and reporting sex at first encounter were negatively associated. In general, factors indicative of high-risk of HIV infection were associated with a higher willingness. These data demonstrate that this high-risk homosexual male cohort has a high willingness to participate in HIV vaccine trials.
46 citations
TL;DR: The results suggest that early immunization against Hib may reduce the incidence of childhood leukaemia, but confirmatory studies are needed.
Abstract: Incidence of childhood leukaemia was studied among subjects of a trial comparing administration of several doses of a conjugate vaccine against Haemophilus influenzae type b (Hib) starting at an early age (three months) with a single dose given at the age of two years. Among 114 000 subjects, a total of 77 cases of childhood leukaemia were detected. The incidence of childhood leukaemia was lower in the early vaccination arm (relative risk 0.72, 95% confidence interval 0.46–1.13) than late vaccination arm, but the difference did not reach statistical significance. Our results suggest that early immunization against Hib may reduce the incidence of childhood leukaemia, but confirmatory studies are needed. © 2000 Cancer Research Campaign
32 citations
TL;DR: Theoretical considerations, a cholera vaccine trial example, and an extensive simulation study of a human immunodeficiency virus type 1 (HIV-1) vaccine trial show that information about failure times does not appreciably improve estimation or testing unless the pathogen has a high attack rate and the relative prevalence of pathogen strains shifts substantially during the trial follow-up period.
Abstract: In a preventive vaccine efficacy trial of a vaccine for a genotypically and phenotypically diverse pathogen, it is important to assess if and how vaccine protection against infection or disease varies with characteristics of the exposing pathogen. Gilbert, Self and Ashby developed statistical methods for this problem when the outcome data are counts of the number of vaccinated and unvaccinated trial participants infected by each pathogen strain. However, in many vaccine trials time-to-case information is available, and the extent to which this information improves investigation of differential vaccine protection is unclear. We describe how cause-specific proportional hazards models and other popular competing risks failure time techniques can be applied to this problem. This includes new results on the assumptions required for these methods to give valid inferences about strain-specific vaccine efficacy, and a comparison of theoretical and finite-sample properties between these methods and the time-independent methods. Theoretical considerations, a cholera vaccine trial example, and an extensive simulation study of a human immunodeficiency virus type 1 (HIV-1) vaccine trial show that information about failure times does not appreciably improve estimation or testing unless the pathogen has a high attack rate and the relative prevalence of pathogen strains shifts substantially during the trial follow-up period. An important implication is that practically optimal evaluation of strain-specific vaccine efficacy in HIV-1 vaccine trials will not require knowledge of infection times.
TL;DR: Both HPV vaccine trial acceptability and compliance rates at routine visits of the general Finnish female population are going to be high based on a pilot study, suggesting prerequisites for large scale field trials on HPV vaccination are fulfilled in Finland.
TL;DR: The results obtained up to this moment confirm the feasibility of following this type of cohort for an extended period estimating HIV incidence rate and evaluating counseling for safe sexual practices in preparation for clinical trials with candidate HIV vaccines in Brazil.
Abstract: Project Horizonte an open cohort of homosexual and bisexual HIV-1-negative men is a component of the Minas Gerais AIDS Vaccine Program of the Federal University of Minas Gerais Belo Horizonte Brazil. Its objectives included the evaluation of seroincidence of HIV to ascertain the role of counseling on behavior modification and to assess their willingness to participate in future HIV vaccine trials. Various means of recruitment were used including pamphlets notices in community newspapers radio and television at anonymous testing centers and by word of mouth. From October 1994 to May 1999 470 volunteers were enrolled. Their mean age was 26 years and over 70% of them had high school or college education. During the follow-up they were seen every 6 months when they received counseling and condoms and when HIV testing was done. 18 seroconversions were observed and the incidence rate estimates were 1.75/100 and 1.99/100 person-years for 36 and 48 months of follow-up respectively. During the entire period 139 volunteers were lost to follow-up. Among them 59 (42.4%) never returned after the initial visit and 51 (36.7) came only once after their initial visit. No losses were observed for those observed during follow-up for more than 3 years. At enrollment 50% of participants said they would participate in a vaccine trial and 30% said they might participate. The results obtained up to this moment confirm the feasibility of following this type of cohort for an extended period estimating HIV incidence rate and evaluating counseling for safe sexual practices in preparation for clinical trials with candidate HIV vaccines in Brazil. (authors)
TL;DR: A field trial compared a modified Pasteurella haemolytica biotype A serotype 1 leukotoxin vaccine to a commercial vaccine during March-July 1995 in a Natal Midlands, South African, feedlot and highlighted the importance of reducing sub-clinical lesions in a feedlot.
10 Dec 2000
TL;DR: Monte Carlo simulation analyses conducted with HIVSIM indicate that the RPT design is able to produce vaccine effect estimates with acceptably small bias, high precision and excellent statistical power under plausible HIV vaccine trial conditions.
Abstract: The field of infectious disease epidemiology has increasingly adopted stochastic simulation technologies to simulate complex infectious disease transmission systems. Such simulations have both increased the scientific understanding of infectious disease transmission dynamics and served as important tools for evaluating epidemiologic study designs and statistical methods. This paper reports on a discrete-event simulation to analyze the recently developed Retrospective Partner Trials (RPT) HIV vaccine trial design. A specially designed simulation system, HIVSIM, was used to simulate data resulting from the RPT design vaccine trials. HIVSIM explicitly models complex HIV transmission dynamics (e.g., sexual partner mixing patterns and concurrent sexual partnerships) and vaccine trial design characteristics. Monte Carlo simulation analyses conducted with HIVSIM indicate that the RPT design is able to produce vaccine effect estimates with acceptably small bias, high precision and excellent statistical power under plausible HIV vaccine trial conditions. Additionally, the explicit simulation of HIV transmission dynamics permits investigations into the common, but unwarranted, statistical independence assumptions routinely used in the estimation of vaccine effects.
TL;DR: The effectiveness of the current recommended adult booster immunisation of a single, low dose diphtheria vaccine is evaluated in Belgium, where 95% of children are covered.
Abstract: The diphtheria epidemic in eastern Europe and the worldwide increase in diphtheria morbidity have sparked discussion on whether people in western Europe are adequately protected.1 2 In western Europe, the effectiveness of long term protection afforded by immunisation programmes is under debate.
In Belgium, the national immunisation programme against diphtheria was introduced in 1959. Vaccination was recommended for all infants, and a catch up programme for children up to the age of 15 years was also instituted. The programme comprises four doses of toxoid, given at age 3, 4, 5, and 15 months. The vaccine is a combination of diphtheria, pertussis, and tetanus toxins, and 95% of children are covered.3 We evaluated the effectiveness of the current recommended adult booster immunisation of a single, low dose diphtheria vaccine.
Altogether 176 …
TL;DR: It is suggested that negative attitudes regarding vaccination to control STDs may not be a significant barrier to use and that both groups supported vaccination for most diseases.
Abstract: The purpose of this study was to examine, among 2 groups of individuals with different risk profiles, the similarity of their attitudes towards vaccines for sexually transmitted diseases (STDs) and non-STDs. Subjects were recruited from an undergraduate psychology class at an urban university (n=518) or were participants in genital herpes vaccine trials (n=87). The participants were asked to complete a questionnaire regarding their attitudes about vaccines for selected diseases. The results of this study revealed that, in general, both groups supported vaccination for most diseases. There were differences, however, between groups regarding 3 diseases: measles, genital warts, and chlamydia. The vaccine trial participants were more likely to accept vaccines for measles and the college students were more likely to accept vaccines for chlamydia and genital warts. The results of this study suggest that negative attitudes regarding vaccination to control STDs may not be a significant barrier to use.
TL;DR: The results suggest that early vaccination against Hib may reduce the incidence of childhood leukaemia, but confirmatory studies are needed.
TL;DR: Assessment of whether and how investigators are monitoring adverse events following immunization (AEFI) in vaccine trials using evidence from the WHO Vaccine Trial Registry indicates that only few investigators included detailed AEFI monitoring in their study reports and publications.
Abstract: This article assesses whether and how investigators are monitoring adverse events following immunization (AEFI) in vaccine trials using evidence from the WHO Vaccine Trial Registry. It is noted that the Registry includes all vaccine trials sponsored since 1987 by the WHO Expanded Programme on Immunization Global Programme for Vaccines and Immunization and Department of Vaccines and Biologicals. For each trial records include internal documents reports of visits to trial sites and publications. Based on the records from 68 trials completed or in progress analysis indicates that only few investigators included detailed AEFI monitoring in their study reports and publications. However an increasing trend to include AEFI monitoring in vaccine clinical trials was noted. Since many vaccine trials are conducted by independent investigators and AEFI monitoring methods and results deserve to be included in any publication along with vaccine efficacy methods and results it should be the responsibility of the study investigators rather than of the vaccine manufacturer and the national control authority as suggested. Several practical points for monitoring AEFIs in vaccine clinical trials are cited.
TL;DR: This article summarizes material on statistical issues in the design of HIV-1 preventive vaccine trials and antiretroviralAIDS treatment trials that was presented at the first school on Modern Statistical Methods in Medical Research, held at the International Centre for Theoretical Physics in Trieste, in September 1999.
Abstract: This article summarizes material on statistical issues in the design of HIV-1 preventive vaccine trials and antiretroviral HIV-1 treatment trials that was presented at the first school on Modern Statistical Methods in Medical Research, held at the International Centre for Theoretical Physics in Trieste, in September 1999. Design issues for the two trial types are discussed separately and are compared, which highlights the relative complexity of vaccine trials. Vaccine trial designs for assessing various vaccine effects are considered, including classical double-blind individual-randomized designs for evaluating biological vaccine effects on susceptibility to infection, and augmented partners, cluster-randomized, and infant designs for evaluating biological vaccine effects on infectiousness as well as on susceptibility. Within these designs, covered topics include surrogate endpoints for measuring vaccine effects on secondary transmission and on HIV-1 disease progression, and exploratory and confirmatory m...
TL;DR: Recombinant gp120s derived from CM244 and HIV-MN strains are components of a vaccine that is undergoing phase III efficacy testing, begun in March 1999, among Bangkok area IDUs, and will be important in the evaluation of any breakthrough HIV-1 infections occurring among vaccinees during the vaccine trial.
Abstract: Complete gp120 sequence information was obtained from eight persons with incident HIV-1 infections (four subtype E and four subtype B) who were part of a prospective injecting drug user (IDU) cohort in Bangkok, Thailand, during 1996–1998. The incident subtype E strains were similar to the prototype subtype E strain CM244 isolated in 1992 in northern Thailand. The incident subtype B strains displayed divergence, in both overall genetic distance and other significant gp120 characteristics, from the prototype North American subtype B strain HIV-MN. Recombinant gp120s derived from CM244 and HIV-MN strains are components of a vaccine that is undergoing phase III efficacy testing, begun in March 1999, among Bangkok area IDUs. The information presented here will be important in the evaluation of any breakthrough HIV-1 infections occurring among vaccinees during the vaccine trial and in ongoing vaccine development efforts in Thailand.
TL;DR: Concerns about the impact of local conditions on the implementation of ethical standards and countries and organizations that gain knowledge and advance their own interests by conducting research in less developed countries may not recognize any explicit obligation to support their hosts' research sustainability.
Abstract: T he global distribution of AIDS has highlighted the stark differences in social and economic realities across the world. Multicenter AIDS vaccine trials are most efficient where the rates of HIV infection are high; hence the importance of vaccine trial sites in less developed countries in Africa, Asia, and Latin America. Ethical concerns about exploitation arise because the conduct of such trials in less developed countries often depends on both funds and vaccines from developed countries.
One area of concern is that vaccines selected for clinical trials in less developed countries may include those already judged unacceptable or of low priority in developed countries. Conversely, vaccines that may be useful in less developed countries may not reach them because those vaccines are considered low priority for development and testing by developed countries. A lack of concordance between the vaccine candidate and the prevalent viral clades of the host country may be a serious concern in countries such as South Africa. In most host countries, institutional review boards (IRBs) and regulatory authorities for drug licensing usually review vaccine trial applications. However, if regulatory authorities and IRBs are not well developed and independent, political influence or economic interests can determine which vaccines proceed in human trials. An example of this type of political patronage that is reminiscent of the colonial era is the recent offer from a U.S.-based company to the president of South Africa of a free license to test its vaccine after the company failed to secure the support of local AIDS researchers to conduct the trials. International agencies such as UNAIDS, international research organizations, and local researchers need to intensify their efforts to support and strengthen local IRBs and regulatory authorities.
A second concern is the impact of local conditions on the implementation of ethical standards. As was determined in one South African study,[*][1] a prime factor in the decision to participate in clinical trials can be the belief among those eligible that participation will result in better medical treatment, despite assurances by researchers to the contrary. Language creates additional constraints, such as when there are no local words for “placebo” and “randomization.” One way of enhancing informed participation in AIDS vaccine trials is through researcher-community partnership. In rural Hlabisa, South Africa, HIV researchers undertook an extensive process of community consultation that culminated in the establishment of a Community Advisory Board. The board has taken the initiative to employ eight local people as community educators, to develop educational materials, consult with and inform the community about each new research project, and provide advice to researchers about local needs for the ethical conduct of research. To achieve and sustain such a community-based approach at AIDS vaccine testing sites, funding agencies need to be made cognizant of such models and to set aside funds for this purpose.
Another concern is that countries and organizations that gain knowledge and advance their own interests by conducting research in less developed countries may not recognize any explicit obligation to support their hosts' research sustainability. Within less developed countries, however, most would consider it a fundamental ethical obligation to redress the global inequity in research. For less developed countries to move beyond serving merely as field sites to become full research partners, there must be a commitment to building local research capacity. The Fogarty Center's AIDS training programs in southern Africa provide models that deserve emulation for this purpose.
Finally, concerns about adequate post-trial access to a successful HIV vaccine at an affordable level must be addressed. Approaches are being developed by organizations such as the International AIDS Vaccine Initiative.[†][2] These efforts, which include commitments by pharmaceutical companies to a vaccine price of cost plus 10% for developing countries in return for financial investments in R&D, deserve support.
[1]: #fn-1
[2]: #fn-2
TL;DR: This study randomised children to receive either the heptavalent pneumococcal vaccine or an experimental vaccine of meningococcal C at 2, 4, 6, and 12 to 15 months of age, and followed for up to 24 months after vaccination.
Abstract: In February 2000, the Food and Drug Administration approved the new heptavalent pneumococcal conjugate vaccine (Prevnar) for use in the USA. This approval was based on a number of studies, the most prominent of which was the Northern Kaiser Permanente Vaccine trial involving 37 868 children.1 In this study, children were randomised to receive either the heptavalent pneumococcal vaccine or an experimental vaccine of meningococcal C at 2, 4, 6, and 12 to 15 months of age. Children were followed for up to 24 months after vaccination. There were …
01 Jan 2000
TL;DR: In this article, the authors investigated the willingness to participate in HIV-1 vaccine trials and associated factors in a sample of 2670 Royal Thai Army conscripted recruits in Thailand.
Abstract: Objectives: Willingness to participate in HIV-1 vaccine trials and associated factors were investigated in a sample of 2670 Royal Thai Army conscripted recruits. Methods: Self administered questionnaires were used. Data were collected during the final visit of a longitudinal cohort study of HIV-1 epidemiology. Cross sectional analysis of data from this visit was performed. Results: 32% of the respondents reported they would “definitely” join an HIV-1 vaccine trial. Greater willingness was associated with perceived risk of HIV-1 infection and a desire to help Thai society, although tangible incentives and intentions to reduce condom use in a vaccine trial also were associated with increased willingness. Concerns about physical harm and anticipated social pressure from family not to join were the most substantial impediments to willingness. Concerns about “social harm” (for example, participation would give appearance of having AIDS virus, a partner might refuse sex) also appeared to inhibit interest in joining trials and approached significance. Conclusions: Willingness to participate was somewhat greater than in other investigations of non-injection drug user (IDU) cohorts in Thailand, with fewer concerns expressed about physical harm. Motivations appear to involve tradeoVs among perceived risk, anticipated social pressure, altruism, and tangible rewards. The absence of significant problems associated with vaccine trials to date, along with the presence of educational interventions in the study may help explain the lower level of concerns here relative to other Thai studies. (Sex Transm Inf 2000;76:386‐392)
TL;DR: The first phase of a new vaccine trial was launched in Oxford last week in a bid to boost international efforts to find a vaccine against HIV.
Abstract: The first phase of a new vaccine trial was launched in Oxford last week in a bid to boost international efforts to find a vaccine against HIV. The trials are sponsored by the International AIDS Vaccine Initiative, and conducted under the auspices of the Medical Research Council's human immunology unit.
Eighteen volunteers, including Dr Evan Harris, MP for Oxford West and Abingdon, are taking part in the trials, which are being conducted at the Churchill Hospital in Oxford.
Dr Seth Berkley, president of the International AIDS Vaccine Initiative, …
Journal Article•
01 Jan 2000
TL;DR: Potts’ proposal is unlikely to hold sway, but UNAIDS vaccine trial ethics guidance document does make clear thatropriate risk-reduction counselling and access to prevention method must be provided to all vaccine trial partici-pants.
Abstract: cal trials, has not yielded an effective product.This assumption puts the theoretical saving oflives in the future over the certain saving oftrial participants’ lives in the present. Whatwill Potts say to the participants in an unsuc-cessful microbicide trial, conducted withoutcondoms or counseling, who become HIV-positive?Fortunately, Potts’ proposal is unlikely tohold sway. Although we find the UNAIDSvaccine trial ethics guidance document to bedeeply flawed (see our critique at http://www.citizen.org/hrg/publications/1508.htm), it doesmake clear that “[a]ppropriate risk-reductioncounselling and access to prevention methodsshould be provided to all vaccine trial partici-pants, with new methods being added as theyare discovered and validated.”