ArticleVaccine2011
"Once Bitten, Twice Shy": participant perspectives in the aftermath of an early HIV vaccine trial termination.
Article in Vaccine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Descriptions of risks and benefits of HIV vaccine trials in low-and middle-income countries (LMICs): an integrative review.BMC medical ethics · 2025Pooled it
- Ethical Considerations for Engaging Children and Adolescents Living with HIV in Research in African Countries: A Systematic Review.Journal of empirical research on human research ethics : JERHRE · 2023Pooled it
- Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence.Journal of the International AIDS Society · 2018Pooled it
- Perception of potential harm and benefits of HIV vaccine trial participation: A qualitative study from urban Tanzania.PloS one · 2019Trial
- Expectation of volunteers towards the vaccine efficacy of the prime-boost HIV vaccine phase III trial during unblinding.AIDS research and human retroviruses · 2014Trial
- Occurrence and management of premature clinical trial termination: a survey of UK healthcare professionals.Trials · 2026Article
- Characterising concerns and misinformation shaping global HIV vaccine confidence and demand: a structured literature search and content analysis.BMJ global health · 2026Review
- UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination.Clinical trials (London, England) · 2025Review
- Exploring views of South African research ethics committees on pandemic preparedness and response during COVID-19.Research ethics · 2024Article
- Article
- Factors that impact on recruitment to vaccine trials in the context of a pandemic or epidemic: a qualitative evidence synthesis.The Cochrane database of systematic reviews · 2023Review
- Early termination of pivotal trials in Alzheimer's disease-Preserving optimal value for participants and science.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2022Article
- Perceived enablers and barriers of community engagement for vaccination in India: Using socioecological analysis.PloS one · 2021Article
- Innovations in HIV-1 Vaccine Design.Clinical therapeutics · 2020Review
- "Why Don't You Go Into Suburbs? Why Are You Targeting Us?": Trust and Mistrust in HIV Vaccine Trials in South Africa.Journal of empirical research on human research ethics : JERHRE · 2018Article
- Bridging the divide: HIV prevention research and Black men who have sex with men.American journal of public health · 2014Article
- "If It's Not Working, Why Would They Be Testing It?": mental models of HIV vaccine trials and preventive misconception among men who have sex with men in India.BMC public health · 2013Article
- Article
- Conceptual framework for behavioral and social science in HIV vaccine clinical research.Vaccine · 2011Article
- "Speaking the dialect": understanding public discourse in the aftermath of an HIV vaccine trial shutdown.American journal of public health · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
Abstract
The Step Study phase IIb HIV-1 vaccine trial was terminated early due to futility; subsequent analyses revealed increased susceptibility to HIV infection among a subset of test vaccine recipients. We conducted a mixed methods investigation, including a brief, self-administered baseline questionnaire and in-depth, semi-structured, 1-h interviews after unblinding, to explore experiences and perspectives among trial participants and key informants. Interviews were digitally recorded, transcribed, and analyzed using NVivo and thematic techniques. Forty-eight trial participants (46 gay/bisexual men) completed baseline surveys; 15 (14 gay/bisexual men) engaged in post-trial interviews. Participants indicated surprise and disappointment about the early trial termination and unexpected risks. Some articulated understanding the uncertainties of clinical trials, steadfast support and willingness to participate in the future; others reported greater risks than they deemed acceptable and unlikelihood of volunteering again. A few indicated mistrust of trial sponsors and ethics. Participants' most profound criticism was not about unexpected results, but perceived delays in unblinding and gaps in post-trial dissemination of information. Future HIV vaccine trials may benefit from increased emphasis on: (1) communication mechanisms among participants, investigators and trial sponsors, and (2) post-trial dissemination of information and psychosocial support.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.