Psychological Outcomes of 12-15-Year-Olds with Gender Dysphoria Receiving Pubertal Suppression in the UK: Assessing Reliable and Clinically Significant Change.

The evidence base for psychological benefits of GnRHA for adolescents with gender dysphoria (GD) was deemed "low quality" by the UK National Institute of Health and Care Excellence. Limitations identified include inattention to clinical importance of findings. This secondary analysis of UK clinical study data uses Reliable and Clinically Significant Change approaches to address this gap. The original uncontrolled study collected data within a specialist GD service. Participants were 44 12-15-year-olds with GD. Puberty was suppressed using "triptorelin"; participants were followed-up for 36 months. Secondary analysis used data from parent-report Child Behavior Checklists and Youth Self-Report forms. Reliable change results: 15-34% of participants reliably deteriorated depending on the subscale, time point and parent versus child report. Clinically significant change results: 27-58% were in the borderline (subclinical) or clinical range at baseline (depending on subscale and parent or child report). Rates of clinically significant change ranged from 0 to 35%, decreasing over time toward zero on both self-report and parent-report. The approach offers an established complementary method to analyze individual level change and to examine who might benefit or otherwise from treatment in a field where research designs have been challenged by lack of control groups and low sample sizes.

Conflict and antagonism within global psychiatry: A discourse analysis of organisational responses to the UN reports on rights-based approaches in mental health.

Between 2017 and 2020, the UN Special Rapporteur (SR) Dainius Puras published three reports that called for significant changes to organisation, funding and service provision in mental health care in ways that emphasise inclusive, rights-oriented, democratic and sustainable community health services. This article aims to examine formal organisational responses to the UN mental health reports and consider the underlying arguments that either support or delegitimise the SR stance on the need for a paradigmatic shift towards a human rights-based approach to mental health. By combining several different search strategies to identify organisational responses across the web, a total of 13 organisational responses were included in the analysis. Given the political nature of the responses, concepts from discourse theory were used to analyse the responses. The analysis showed how the responses articulated two binary positions and contesting articulations of good mental health care, which formed a backdrop for rejecting the SR reports in defence of psychiatry. The discussion elucidates how the responses tend to resemble previous ways in which critique has been dealt with mainly by 'biological psychiatry', but that the counter-critical nature of the medical and psychiatric organisational responses remains in contrast to the broader reception within the UN community.

Prevalence of personality disorders in adults with binge eating disorder-A systematic review and Bayesian meta-analysis.

Binge eating disorder (BED) is a complex mental health problem entailing high risk for obesity, overweight, and other psychiatric disorders. However, there is still unclear evidence of the prevalence of personality disorders (PDs) in BED patients. We conducted a systematic review and a Bayesian meta-analysis for studies examining the prevalence of any PD in adult BED patients. Data sources included PubMed, Cochrane library, EBSCO, PsycINFO, and Science Direct. A Bayesian meta-analysis was conducted to estimate effect sizes for the prevalence of any PD in BED patients. Twenty eligible articles were examined with a total of 2945 BED patients. Borderline personality disorder and "Cluster C" PD, particularly obsessive-compulsive and avoidant PD, were the most frequent PD found in BED patients. BED diagnosis was associated with 28% probability of a comorbid diagnosis of any PD (0.279, 95%CrI: [0.22, 0.34]), with high levels of between-study heterogeneity (τ = 0.61, 95% CrI [0.40, 0.90]). Sensitivity analysis suggested effect sizes ranging from 0.27 to 0.28. The high comorbidity of PDs in BED patients draws attention to the potential complexity of BED clinical presentations, including those that might also be comorbid with obesity. Clinical practice should address this complexity to improve care for BED and obesity patients.

The relatives of people with depression: A systematic review and methodological critique of qualitative studies.

Being a close relative of a person with depression can take a heavy toll on the former, but these relatives are increasingly made responsible for taking on extensive carer roles. Research on relatives of people with depression is currently dominated by a focus on "carer burden" and although such a focus can explain many relatives' experiences and daily lives, it provides very limited insight into the everyday life of a person living with someone with depression. Therefore, we scoped qualitative research on people who are relatives of people living with depression and identified knowledge gaps caused by explicit or implicit theoretical or methodological assumptions. We conducted an exhaustive literature search in CINAHL, PubMed, PsycINFO, Sociological Abstracts, and Eric. In total, 34 publications were included, their quality evaluated and their findings mapped and summarized. We identified four interrelated and overlapping themes that dominated the findings of the publications: (a) recognition of "depression", (b) emotional responses, (c) interruptions of relationships, and (d) a staged psychosocial process. The vast majority of studies presented de-contextualized and underinterpreted analyses assuming a homogeneity of (illness) experiences and disregarded the important influence of social contributors to social relationships, connectedness, and mental health problems.

Experiences of adults from a Black ethnic background detained as inpatients under the Mental Health Act (1983).

OBJECTIVE: People from a Black ethnic (BE) background in England and Wales are disproportionately detained as inpatients under the United Kingdom's Mental Health Act (MHA). Qualitative research into the lived experiences of this group is sparse. This study, therefore, aims to explore the experiences of people from a BE background detained under the MHA. METHOD: Semistructured interviews were conducted with 12 self-identified adults from a BE background who were currently detained as inpatients under the MHA. Thematic analysis was used to identify themes across the interviews. RESULTS: Four themes emerged from the interviews: "Help is decided by others, not tailored to me"; "I am not a person-I am a Black patient"; "Mistreated or neglected instead of cared for"; and "Sectioning can be a space for sanctuary and support." CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: People from a BE background report inpatient detention to be a racist and racialized experience, inseparable from a wider context of systemic racism and inequality. Experiences of detention were also discussed in terms of stigma within BE families and communities, as well as social support that appeared to be lacking outside of the hospital. Systemic racism must be addressed across mental health care, led by the lived experiences of BE people. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Quality-of-life measurement in depression trials: A consumerist relic.

Quality-of-life measurement in depression is advocated as a patient-centred indicator of recovery, but may instead enhance the mimetic authority of randomised controlled trials (RCTs) which have been roundly critiqued in mental health. In this paper we draw on the social life of methods approach to extend the well-developed critique of RCTs into the field of quality-of-life measurement. We accomplish this through consideration and critique of the conceptual and epistemological development of quality-of-life measurement in depression, including the role of psychometrics in its development. Examining conceptual developments from the 1970s onwards, we consider how the scientific literature on quality-of-life in depression aligns with behavioural economics and consumerism but falls short of engaging with genuinely patient-centred approaches to recovery. We argue that quality-of-life measures in depression were developed within a consumerist model of healthcare in which the medical model was a central pillar and 'choice' a rhetorical device only. While quality-of-life instrument development was largely funded by industry, psychometrics provided no coherent solution to the 'affective fallacy' (high correlations between quality-of-life and depressive symptoms). Industry has largely abandoned the measures, while psychotherapy research has increasingly endorsed them. We argue that in their design and implementation, quality-of-life measures for depression remain based on a commercial model of healthcare, are conceptually flawed and do not support concepts of patient-centred healthcare.

Psychological treatments for persistent depression: A systematic review and meta-analysis of quality of life and functioning outcomes.

[Correction Notice: An Erratum for this article was reported in Vol 59(3) of Psychotherapy (see record 2022-94545-001). In the article, there were errors in the abstract. The confidence interval in the sentence Quality of life at follow-up: pooled g = 0.21 should appear as follows: 95% CI, 0.10-0.32. In the sentence The psychological interventions were associated with improvements in patients' functioning at end-of-treatment, the pooled g should appear as g = 0.35. The confidence interval in the sentence Functioning at follow-up resulted in: pooled g = 0.33 should appear as follows: 95% CI, 0.15-0.51. Figure 5 also has been corrected. All versions of this article have been corrected.] To date it is unclear whether psychological therapies have potential to improve quality of life and functioning in patients with persistent depression. This meta-analysis examines the effect of psychological therapies for improving quality of life and functioning in patients with persistent forms of depression. Data sources include Medline and Meta-Analytic Psychotherapy Database (METAPSY), searched 07/2021. Eligible studies were randomized controlled trials where participants had major depressive disorder on entry and met criteria for a persistent form of depression, for example, chronic, treatment resistant or recurrent depression. Standardized mean differences (Hedge's g) were calculated in random-effects meta-analyses. Fourteen studies met inclusion criteria (N = 1898). Psychological interventions were associated with improvements in patients' quality of life at the end of treatment: pooled g = 0.24 (95% confidence intervals [CIs] 0.13-0.34); low to moderate levels of heterogeneity (I² = 0% [95% CI 0%-41.2%]). Quality of life at follow-up: pooled g = 0.21 (95% CI 0.01-0.32); low to high levels of heterogeneity considering the wide CI for I² (I² = 10.36% [95% CI 0%-77.5%]). The psychological interventions were associated with improvements in patients' functioning at end of treatment: pooled g = 0.34 (95% CI 0.21-0.48); low to high levels of heterogeneity considering the wide CI for I² (I² = 0% [95% CI 0%-81.7%]). Functioning at follow-up resulted in: pooled g = 0.33 (95% CI 0.15-0.50); low to high levels of heterogeneity considering the wide CI for I² (I² = 0% [95% CI 0%-86.2%]). This meta-analysis highlights the potential benefits of psychological therapies for improving quality of life and functioning in patients with persistent depression, with strongest long-term effects for mindfulness-based cognitive therapy, interpersonal therapy in combination with antidepression medication, and long-term psychoanalytic psychotherapy. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

War of conscience: antivaccination and the battle for medical freedom during World War I.

The nineteenth century British antivaccination movement attracted popular and parliamentary support and ultimately saw the 1853 law which had made smallpox vaccination compulsory nullified by the 1898 'conscientious objector' clause. In keeping with popular public health discourse of the time, the movement had employed rhetoric associated with sanitary science and liberalism. In the early twentieth century new discoveries in bacteriology were fuelling advances in vaccination and the medical establishment was increasingly pushing for public health to move towards more interventionist medical approaches. With the onset of war in 1914, the medical establishment hoped to persuade the government to introduce compulsory typhoid inoculation for soldiers. This article analyses antivaccination literature, mainstream newspapers and medical press along with parliamentary debates to examine how the British antivaccination movement engaged with this new threat of compulsion by expanding the rhetoric of 'conscience' and emphasising medical freedom while also asserting scientific critique concerning the effectiveness of vaccines and the new laboratory based diagnostic practices. In spite of 'conscience' fitting well with an emerging public health discourse of individual subjectivity, the mainstream press ridiculed the idea of working-class soldiers having a conscience, coalescing around the idea that 'conscientious objection' be reserved for spiritual, philosophical and educated men who objected to military service. Moreover, in spite of engaging in reasoned scientific critique, parliament and press consorted in the demarcation of scientific knowledge as exclusive to medical scientists, reflecting a growing allegiance between the state and the medical establishment during the war. Any scientific arguments critical of medical orthodoxy were subjugated, labelled as 'crank' or 'faddist' as well as unpatriotic. The antivaccination narratives around conscience contributed to or were part of an evolving discourse on consent and ethics in medicine. Potential parallels are drawn with current and likely future debates around vaccination and counterhegemonic scientific approaches.

Depression in disabling medical conditions - current perspectives.

Chronic diseases commonly entail disability and are highly comorbid with mental health problems, particularly depression. Prevalence of depression across different disabling conditions affecting adult patients, as well as risk factors for depression in these patient groups are reviewed in the current work, with a particular focus on the literature published in the past 5 years. The prevalence of depression in disabling conditions is higher than in the general population and is associated with different factors. Examples of disease-specific factors include neurological implications of stoke, diabetic related conditions (e.g. amputation), limitations imposed by vision loss caused by age-related eye diseases, fatigue in rheumatoid arthritis, and pain in cancer. Common factors identified across different conditions include pre-morbid depression, history of mental health problems, poor social support, disease-related disability, multi-morbidity, and less adaptive coping strategies. We also reviewed studies suggesting a potential bidirectional relationship between depression and chronic disease, particularly for stroke, cardiovascular disease, diabetes, and potential factors mediating that relationship. Current findings suggested that long-term depression might be associated with an increased risk of subsequent physical health problems, although the nature of that relationship and its underlying mechanisms are still unclear.

InterOrganizational practice committee guidance/recommendation for models of care during the novel coronavirus pandemic.

Objective: The Inter Organizational Practice Committee (IOPC) convened a workgroup to develop guidance on models to provide neuropsychological (NP) care during the COVID-19 pandemic while minimizing risks of novel coronavirus transmission as lockdown orders are lifted and ambulatory clinical services resume.Method: A collaborative panel of experts from major professional organizations developed provisional guidance for models of neuropsychological practice during the pandemic. The stakeholders included the American Academy of Clinical Neuropsychology/American Board of Clinical Neuropsychology, the National Academy of Neuropsychology, Society of Clinical neuropsychology (Division 40) of the American Psychological Association, the American Board of Professional Neuropsychology, and the American Psychological Association Services, Inc.Results: This guidance reviews the risks and benefits of conducting NP exams in several ways, including standard in-person, mitigated in-person, in-clinic teleneuropsychology (TeleNP), and in-home TeleNP. Strategies are provided for selecting the most appropriate model for a given patient, taking into account four levels of patient risk stratification, level of community risk and the concept of stepped models of care. Links are provided to governmental agency and professional organization resources as well as an outline and discussion of essential infection mitigation processes based on commonalities across recommendations from diverse federal, state, local, and professional organization recommendations.Conclusion: This document provides recommendations and guidance with analysis of the risks relative to the benefits of various models of neuropsychological care during the COVID-19 pandemic. These recommendations may be revised as circumstances evolve, with updates posted continuously on the IOPC website (https://iopc.online/).

Inter Organizational Practice Committee Guidance/Recommendation for Models of Care During the Novel Coronavirus Pandemic.

OBJECTIVE: The Inter Organizational Practice Committee (IOPC) convened a workgroup to develop guidance on models to provide neuropsychological (NP) care during the COVID-19 pandemic while minimizing risks of novel coronavirus transmission as lockdown orders are lifted and ambulatory clinical services resume. METHOD: A collaborative panel of experts from major professional organizations developed provisional guidance for models of neuropsychological practice during the pandemic. The stakeholders included the American Academy of Clinical Neuropsychology/American Board of Clinical Neuropsychology, the National Academy of Neuropsychology, Society of Clinical neuropsychology (Division 40) of the American Psychological Association, the American Board of Professional Neuropsychology, and the American Psychological Association Services, Inc. RESULTS: This guidance reviews the risks and benefits of conducting NP exams in several ways, including standard in-person, mitigated in-person, in-clinic teleneuropsychology (TeleNP), and in-home TeleNP. Strategies are provided for selecting the most appropriate model for a given patient, taking into account four levels of patient risk stratification, level of community risk, and the concept of stepped models of care. Links are provided to governmental agency and professional organization resources as well as an outline and discussion of essential infection mitigation processes based on commonalities across recommendations from diverse federal, state, local, and professional organization recommendations. CONCLUSION: This document provides recommendations and guidance with analysis of the risks relative to the benefits of various models of NP care during the COVID-19 pandemic. These recommendations may be revised as circumstances evolve, with updates posted continuously on the IOPC website (https://iopc.online/).

Patient experiences of psychological therapy for depression: a qualitative metasynthesis.

BACKGROUND: Globally, national guidelines for depression have prioritised evidence from randomised controlled trials and quantitative meta-analyses, omitting qualitative research concerning patient experience of treatments. A review of patient experience research can provide a comprehensive overview of this important form of evidence and thus enable the voices and subjectivities of those affected by depression to have an impact on the treatments and services they are offered. This review aims to seek a comprehensive understanding of patient experiences of psychological therapies for depression using a systematic and rigorous approach to review and synthesis of qualitative research. METHOD: PsychINFO, PsychARTICLES, MEDLINE, and CINAHL were searched for published articles using a qualitative approach to examine experiences of psychological therapies for depression. All types of psychological therapy were included irrespective of model or modes of delivery (e.g. remote or in person; group or individual). Each article was assessed following guidance provided by the Critical Appraisal Skill Programme tool. Articles were entered in full into NVIVO and themes were extracted and synthesized following inductive thematic analysis. RESULTS: Thirty-seven studies, representing 671 patients were included. Three main themes are described; the role of therapy features and setting; therapy processes and how they impact on outcomes; and therapy outcomes (benefits and limitations). Subthemes are described within these themes and include discussion of what works and what's unhelpful; issues integrating therapy with real life; patient preferences and individual difference; challenges of undertaking therapy; influence of the therapist; benefits of therapy; limits of therapy and what happens when therapy ends. CONCLUSIONS: Findings point to the importance of common factors in psychotherapies; highlight the need to assess negative outcomes; and indicate the need for patients to be more involved in discussions and decisions about therapy, including tailoring therapy to individual needs and taking social and cultural contexts into account.

Non-strategic ignorance: Considering the potential for a paradigm shift in evidence-based mental health.

Randomised controlled trials form a central building block within the prevailing evidence-based mental health paradigm. Both methodology and paradigm have been widely problematised since their emergence in the mid-late twentieth century. We draw on the concept of 'strategic ignorance' to understand why the paradigm still prevails. We present focus group data gathered from 37 participants (service users, public, carers, general practitioners, commissioners) concerning the way they made sense of a randomised controlled trial of psychotherapy for treatment-resistant depression. Thematic analysis of the findings revealed an overall critique of randomised controlled trial methods which we refer to as 'non-strategic ignorance'. Specifically, participants problematised the construct of depression, unseating the premise of the randomised controlled trial; they were sceptical about the purpose and highlighted its failure to show how therapy works or who might benefit; the randomised controlled trial was seen as inadequate for informing decisions about how to select a therapy. Participants assumed the treatment would be cost-effective given the client group and nature of the therapy, irrespective of any randomised controlled trial findings. Each area of lay ('non-strategic') critique has an analogous form within the methodological expert domain. We argue that 'expert' critiques have generally failed to have paradigmatic impact because they represent strategic ignorance. Yet parallel non-strategic critiques have common sense appeal, highlighting the potential power of lay voices. The discussion considers whether the evidence-based mental health paradigm is faced with epistemological problems of such complexity that the conditions exist for a new paradigm in which service user views are central and randomised controlled trials peripheral.

To support and not to cure: general practitioner management of loneliness.

Loneliness is associated with numerous detrimental effects on physical health, mental health, cognition and lifestyle. Older adults are one of the groups at highest risk of loneliness, and indeed about 46% of older adults in England feel lonely. Those experiencing loneliness visit their general practitioner (GP) more frequently than those who are not, which has the capacity to put a strain on GPs and primary care waiting lists and costs. This study's aim was to explore GPs' views and experiences of loneliness within their older adult patients, and to understand GPs' awareness and feelings of agency within this. Nineteen UK GPs were recruited using purposive sampling and snowballing techniques. Individual semi-structured interviews were conducted either in person or over the telephone. Data were analysed using thematic analysis. Four overarching themes were identified from the data: Whose responsibility is it anyway?, Pandora's box of shame; Keeping distance; and Community responsibility. Themes emphasise that GPs tend to hold a medicalised and individualistic view of loneliness. This intensifies stigma which in turn creates barriers to raising the topic. GPs felt powerless in their ability to fix the 'problem' and tended to believe that the solution had to lie in the community, the individual or in social care rather than in primary care. The findings are discussed in the context of literature on GP management of other social problems which give rise to similar issues concerning the restrictions of the medical model and the need for joined-up approaches in which the GP is one part of a wider social support structure. It is suggested that it might be useful for training and support for GPs to address management of social problems jointly rather than training specific to loneliness which GPs tend to see as peripheral to their core remit.

The Dobson-Rawlins pact and the National Institute for Health and Care Excellence: impact of political independence on scientific and legal accountability.

This analysis considers whether the independence of the National Institute for Health and Care Excellence (NICE), while safeguarding guidelines from commercial lobbying, may render NICE legally and scientifically unaccountable. The analysis examines the role of judicial reviews and stakeholder consultations in place of peer review in light of current debates concerning the depression guideline.

A NICE game of Minecraft: philosophical flaws underpinning UK depression guideline nosology.

Categorising mental disorders for purposes of diagnosis, research and practice has historically been justified on philosophical terms as a pragmatic activity; categories which have been subject to wide-ranging philosophical critique have been defended on the grounds that they serve as heuristic devices providing loose representations of shared experiences, not labels for real structures. In acknowledgement of this, there has been increasing recognition that subclassifying multiple discrete forms of persistent depression moves too far away from the notion of a heuristic and that attempts to create more precise categories become less clinically useful. Hence the most recent Diagnostic and Statistical Manual of Mental Disorders (V.5) and International Classification of Diseases (V.11) both group persistent forms of depression together. However, the UK National Institute for Health and Care Excellence has delineated certain subclassifications of persistent depression in its new guideline, which grossly distorts the phenomenology of depression. This approach commits a fundamental philosophical error in conflating absence of knowledge with knowledge of absence. In this sense, the new guideline appears to be engaging in an activity akin to the digital game Minecraft, in which the craft of building structures from units of construction is largely divorced from the laws of physics. The risk of ignoring these philosophical errors and making false claims about scientific plausibility is that the guideline recommendations inevitably represent a highly distorted phenomenology of depression and will be of very little value to patients or practitioners looking for guidance on best possible treatment options.

Long-term outcomes of trials in the National Institute for Health and Care Excellence depression guideline.

The forthcoming National Institute for Health and Care Excellence depression guideline reviews short-term outcomes for long-term depression. We present effect sizes for long-term outcomes in trials that report these data. Psychological therapies become more effective, whereas antidepressants become less effective over the long term. We review other forms of longitudinal research that support these findings.

"I'm Still Fighting for the Two of Us": How Partners of UK Veterans Construct Their Experience of Living with Combat-Related Trauma.

There has been little qualitative research into the experiences of UK partners of veterans with PTSD. This study therefore aimed to explore how partners constructed their experiences of living with the condition. Fifteen female partners of male UK veterans were recruited and interviewed. Using a social constructionist thematic analysis, five themes were constructed: the women's need to subdue own emotional and behavioral responses; dilemmas about whether the veteran was unwell or 'bad'; attempts at negotiating multiple roles; challenging the narrative of veterans as heroes; and the relational struggle with the transition to nonmilitary life. This study highlighted the importance of considering the veteran as existing within a relational and cultural context, and the need to include partners in therapeutic interventions.

Risk assessment practice within primary mental health care: A logics perspective.

From the 1980s onwards, discourses of risk have continued to grow, almost in ubiquity. Ideas and practices of risk and risk aversion have extended to UK mental health care where services are expected to assess and manage risks, and high-quality clinical assessment has been revised to incorporate risk assessment. This article problematises practices of risk assessment in mental health provision, focussing on the base-rate problem. It presents an analysis of audio recordings of risk assessments completed within a primary care mental health service. The analysis is informed by a critical logics approach which, using ideas from discourse theory as well as Lacanian psychoanalysis, involves developing a set of logics to describe, analyse and explain social phenomena. We characterise the assessments as functioning according to social logics of well-oiled administration and preservation, whereby bureaucratic processes are prioritised, contingency ironed out or ignored, and a need to manage potential risks to the service are the dominant operational frames. These logics are considered in terms of their beatific and horrific fantasmatic dimensions, whereby risk assessment is enacted as infallible (beatific) until clients become threats (horrific), creating a range of potential false negatives, false positives and so forth. These processes function to obscure or background problems with risk assessment, by generating practices that favour and offer protection to assessors, at the expense of those being assessed, thus presenting a challenge to the stated aim of risk assessment practice.

A safety and immunogenicity study of immunization with hVEGF26-104/RFASE in cynomolgus monkeys.

INTRODUCTION: Vascular endothelial growth factor (VEGF) is pivotal in tumor angiogenesis and therapies targeting the VEGF axis are widely used in the clinic for the treatment of cancer. We have developed a therapeutic vaccine targeting human (h)VEGF165. hVEGF26-104/RFASE is based on the truncated protein hVEGF26-104 as antigen formulated in an oil-in-water emulsion containing the sulpholipopolysaccharide RFASE as adjuvant. Here we describe the toxicity and immunogenicity of this therapeutic vaccine in cynomolgus monkeys. METHODS: In total 54 cynomolgus monkeys were used and divided in 7 groups. Groups 1-3 were control groups, either receiving PBS alone (group 1), RFASE alone (group 2) or hVEGF26-104 alone (group 3). Animals allocated to groups 4-7 received hVEGF26-104 together with RFASE, but with varying doses of the antigen or the adjuvant. All animals were immunized four times with 2-week intervals and safety and immunogenicity were monitored until 3 days after the final immunization. RESULTS: Immunization induced an RFASE adjuvant dependent acute phase response. High titers of antibodies against hVEGF26-104 and cross-reactive with hVEGF165, were found in monkey sera, 28 days after primer immunization. These antibodies were able to inhibit the binding of the monoclonal antibody bevacizumab with hVEGF165 in a competition ELISA. Moreover, the biological activity of hVEGF165 could be inhibited by the addition of immunized monkey serum in a VEGF specific bioassay. Importantly, no adverse events commonly observed with VEGF neutralization were observed throughout the study. CONCLUSION: These data show that hVEGF26-104/RFASE can be safely administered in cynomolgus monkeys, induces the desired immune response and therefore support the clinical development of this vaccine.