Dataset Information

Vaccines for COVID-19: learning from ten phase II trials to inform clinical and public health vaccination programmes.

ABSTRACT: Public health professionals and clinicians, in many countries, are immersed in the ongoing and upcoming vaccination programmes for COVID-19. Published information from vaccine trials is complex. There are important and helpful insights about the nature of the available and forthcoming vaccines, immune responses and side-effects from phase II trials. We have systematically summarised information from 10 such trials on the nature of the vaccines, exclusions from the trials, immunological effects and side-effects. Some important information within these trial reports is not available in the phase III trial articles, so a complete picture requires examination of phase II and phase III trials for each vaccine. We recommend our systematic approach for the examination of other upcoming COVID-19 vaccine phase II and III trials.

SUBMITTER: Bhopal SS

PROVIDER: S-EPMC7846205 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Vaccines for COVID-19: learning from ten phase II trials to inform clinical and public health vaccination programmes.

Bhopal Sunil S SS Olabi Bayanne B Bhopal Raj R

Public health 20210129

Public health professionals and clinicians, in many countries, are immersed in the ongoing and upcoming vaccination programmes for COVID-19. Published information from vaccine trials is complex. There are important and helpful insights about the nature of the available and forthcoming vaccines, immune responses and side-effects from phase II trials. We have systematically summarised information from 10 such trials on the nature of the vaccines, exclusions from the trials, immunological effects a ...[more]

PMID: 33743214

Similar Datasets

Project description:BackgroundGonorrhea is the second most common sexually transmitted disease notified in Singapore in 2023. Evidence suggests that the 4CMenB vaccine designed to protect against Neisseria meningitidis infection may offer partial cross-protection against gonorrhea. This generated interest in using 4CMenB for the purpose of staving gonorrhea transmission. We explored the efficacy of potential gonorrhea vaccination strategies in the context of historically declining gonorrhea incidence.Methods and findingsWe employed an integrated transmission-dynamic model, calibrated using Bayesian methods to local surveillance data to understand the potential public health impact of 4CMenB in reducing gonorrhea acquisition and transmission in men who have sex with men (MSM) in Singapore. We explored the efficacy of implementing six vaccination programmes: (1) offering vaccination to all male adolescents in schools (vaccination before entry [VbE]), (2) offering vaccination to individuals attending sexual health clinics for testing (vaccination on attendance [VoA]), (3) offering vaccination to individuals attending sexual health clinics and who were diagnosed with gonorrhea (vaccination on diagnosis [VoD]), or (4) vaccination according to risk (VaR), by offering vaccination to patients who were diagnosed with gonorrhea plus individuals who tested negative, but report having more than five sexual partners per year. We further examined how altering (5) VoA and (6) VoD strategies changed if the strategies only targeted high risk groups (VoA(H),VoD(H)). We assessed efficacy by examining vaccination impact relative to no vaccination and when behavioral parameters were held constant. We further ascertained the effects of varying vaccine uptake (10%, 33%, 100%), vaccine efficacy (22%, 31%, 47%), and duration of protection (1.5, 4, 7.5 years) on the effectiveness of each vaccination strategy. For a hypothetical 10-year vaccination programme, VbE had 14.18% of MSM gonorrhea cases averted over the time the programme was implemented. VoA had the highest protective impact on the MSM population with 40.26% averted cases (95% credible interval (CrI): 18.32%-52.57%), but required more vaccine doses than any other strategy. VoD had a smaller impact (12.04% averted cases (95% CrI: 7.12%-15.00%)), but was three times more efficient than VoA in terms of averted cases per dose. VoA(H) and VoD(H) improved the efficiency of VoA and VoD strategies by increasing averted cases per dose to 0.22 and 0.24 respectively, but conferred similar protective effects as VoA (VoA(H): 40.10% averted cases (95% CrI: 18.14%-52.55%)) and VoD (VoD(H): 12.04% averted cases (95% CrI: 7.12%-15.00%)), respectively. VaR (40.10% averted cases (95% CrI: 18.14%-52.55%)) had almost the same impact as VoA, but was more efficient by requiring administration of fewer doses than VoA, with 0.21 (95% CrI: 0.12-0.27) averted cases per dose. Sensitivity analyses indicated that VaR had the greatest public health impact with the highest number of averted cases per dose for vaccines of any efficacy or duration of protection (or both), although VoD and VoD(H) saved more vaccine resource and had the highest number averted MSM cases per dose for highly protective vaccines of long protection.ConclusionsVaccination of MSM against gonorrhea, according to risk in sexual health clinics in Singapore, can be considered to reduce gonorrhea acquisition and transmission. Development of gonorrhea-specific vaccines which focuses on protective efficacy and the implementation of efficient vaccination programmes can maximize public health impact.

Project description:BackgroundDecisions regarding which vaccines are funded in the United Kingdom (UK) are increasingly informed by cost-effectiveness analyses. Such analyses use Quality Adjusted Life Years (QALYs) as a measure of effectiveness and assume that QALYs are equal regardless of where and in whom they occur in the population. However, there is increasing debate about whether this QALY approach is appropriate and whether societal preferences for childhood vaccinations should be used to help inform childhood immunisation policy.ObjectiveTo gauge the general public's preferences for prioritising certain characteristics of childhood vaccination, to help inform future policy making decisions in the UK.DesignQualitative design using individual face-to-face interviews, with data analysed using an inductive thematic framework approach.SettingTwo counties in England, UK.PopulationAdult members of the general public were recruited using the Bristol and South Gloucestershire open electoral registers, using gender and deprivation quotas for each area.Participants21 members of the public participated in qualitative interviews.ResultsThe qualitative research identified three major themes and several key attributes that influences participant's opinions about priority setting for childhood vaccinations: (1) population segment (i.e. age group, carer impact and social group), (2) vaccine preventable diseases preferences (i.e. disease severity, disease incidence and declining infection) and (3) risks and benefits associated with childhood vaccinations (i.e. vaccine associated side-effects, herd protection and peace of mind).ConclusionEvidence from this qualitative study suggests that some members of the UK general public have more nuanced views than the health-maximisation approach when considering how childhood vaccines should be prioritised. This is not necessarily captured by the current economic approaches for assessing the benefits from childhood vaccinations in the UK, but is an important area for future research to ensure appropriate decision making.

Dataset Information

Vaccines for COVID-19: learning from ten phase II trials to inform clinical and public health vaccination programmes.

Publications

Vaccines for COVID-19: learning from ten phase II trials to inform clinical and public health vaccination programmes.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets