Vaccine Clinical Development

2021 ◽  
Author(s):  
Stephen Lockhart ◽  
William Gruber
Keyword(s):  
Vaccine Development ◽  
Vaccine Candidate ◽  
Phase 1 ◽  
Target Population ◽  
Clinical Development ◽  
Marketing Approval ◽  
Policy Makers ◽  
Care Workers ◽  
Target Disease ◽  
Study Participants

Vaccine Clinical Development is an integrated part of the overall process of vaccine development, which involves clinical trials in which study participants are usually prospectively and randomly allocated to receive the vaccine candidate or a control vaccine. Participants are then actively monitored to generate information on safety, and often immune responses and/or cases of the target disease. Clinical development starts with small phase 1 studies in tens or hundreds of volunteers. In phase 2, volunteers in the target population are studied for safety and evidence of a desired effect, often an immune response. In phase 3, pivotal studies will generally examine prevention of the target disease with at least 3000 participants receiving the vaccine candidate. The key outputs are reports for regulatory agencies, policy makers and health care workers to support marketing approval and appropriate ways to use the vaccine. Clinical trial designs and results are made public through registries and peer-reviewed publications.

scholarly journals Gamma-irradiated SARS-CoV-2 vaccine candidate, OZG-38.61.3, confers protection from SARS-CoV-2 challenge in human ACEII-transgenic mice

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Raife Dilek Turan ◽  
Cihan Tastan ◽  
Derya Dilek Kancagi ◽  
Bulut Yurtsever ◽  
Gozde Sir Karakus ◽  
...  
Keyword(s):  
Transgenic Mice ◽  
Neutralizing Antibodies ◽  
Vaccine Development ◽  
Vaccine Candidate ◽  
Protective Efficacy ◽  
Phase 1 ◽  
Challenge Test ◽  
Viral Rna ◽  
Viral Vaccine ◽  
Gamma Irradiated

AbstractThe SARS-CoV-2 virus caused the most severe pandemic around the world, and vaccine development for urgent use became a crucial issue. Inactivated virus formulated vaccines such as Hepatitis A and smallpox proved to be reliable approaches for immunization for prolonged periods. In this study, a gamma-irradiated inactivated virus vaccine does not require an extra purification process, unlike the chemically inactivated vaccines. Hence, the novelty of our vaccine candidate (OZG-38.61.3) is that it is a non-adjuvant added, gamma-irradiated, and intradermally applied inactive viral vaccine. Efficiency and safety dose (either 1013 or 1014 viral RNA copy per dose) of OZG-38.61.3 was initially determined in BALB/c mice. This was followed by testing the immunogenicity and protective efficacy of the vaccine. Human ACE2-encoding transgenic mice were immunized and then infected with the SARS-CoV-2 virus for the challenge test. This study shows that vaccinated mice have lowered SARS-CoV-2 viral RNA copy numbers both in oropharyngeal specimens and in the histological analysis of the lung tissues along with humoral and cellular immune responses, including the neutralizing antibodies similar to those shown in BALB/c mice without substantial toxicity. Subsequently, plans are being made for the commencement of Phase 1 clinical trial of the OZG-38.61.3 vaccine for the COVID-19 pandemic.

scholarly journals Perspectives on non-clinical health care workers’ moral obligation to report for work during virulent epidemics: an exploration in Guinea

2019 ◽  
Vol 25 (2) ◽  
pp. 115-121
Author(s):  
Lonzozou Kpanake ◽  
Vissého Adjiwanou ◽  
Paul Clay Sorum ◽  
Etienne Mullet
Keyword(s):  
Health Care ◽  
Working Conditions ◽  
Health Care Workers ◽  
Moral Obligation ◽  
Moral Dilemmas ◽  
Family Status ◽  
Policy Makers ◽  
Lay People ◽  
Care Workers ◽  
Study Participants

Objectives To examine the views of non-clinical health care workers (NCHW) and lay people in Guinea on NCHWs’ moral obligation to work during epidemics. Methods NCHWs ( N = 227) and lay people ( N = 253) were presented with theoretical vignettes of NCHWs who refused to work during a virulent epidemic and invited to rate the extent to which such decision was acceptable. Vignettes varied in four factors: level of risk of getting infected; the nature of the infection (Ebola, influenza, tuberculosis); working conditions and the NCHW’s family status. Results Three general qualitatively different positions were identified: (a) NCHWs have an unlimited moral obligation to work, irrespective of circumstances (10% of study participants); (b) NCHWs do not have a moral obligation to work (12%), and (c) the moral obligation to work depends entirely on circumstances (58%), while 19% of participants did not express any position. Conclusions Only a small proportion of NCHWs and lay people in Guinea considered that NCHWs’ refusal to work during an epidemic is always unacceptable. Policy makers planning for future epidemics need to take account of NCHWs’ moral dilemmas in deciding whether to report to work during epidemics and provide appropriate working conditions.

scholarly journals Nationwide Seroprevalence of SARS-CoV-2 IgG Antibodies among Four Groups of Primary Health-Care Workers and Their Household Contacts 6 Months after the Initiation of the COVID-19 Vaccination Campaign in France: SeroPRIM Study Protocol

Pathogens ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 911
Author(s):  
Marie Pouquet ◽  
Dorine Decarreaux ◽  
Pol Prévot-Monsacré ◽  
Corentin Hervé ◽  
Andréas Werner ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Health Care Workers ◽  
Phase 1 ◽  
Vaccination Campaign ◽  
Igg Antibodies ◽  
Household Contacts ◽  
Primary Health ◽  
Care Workers ◽  
Natural Protection

Background: The protocol study will focus on the seroprevalence of IgG antibodies to SARS-CoV-2 achieved by vaccination and/or natural protection as well as the history, symptoms, and risk factors for SARS-CoV-2 in four primary health-care workers (PHCWs) and their household contacts in metropolitan France. Methods: Here, we propose a protocol for a nationwide survey to determine the seroprevalence of IgG antibodies to SARS-CoV-2 achieved by vaccination and/or natural protection in four PHCW populations (general practitioners, pediatricians, pharmacists and assistants, and dentists and assistants) and their household contacts. Participants will be included from June to July 2021 (Phase 1) among PHCW populations located throughout metropolitan France. They will be asked to provide a range of demographic and behavioral information since the first SARS-CoV-2 wave and a self-sampled dried blood spot. Phase 1 will involve also a questionnaire and serological study of PHCWs’ household contacts. Seroprevalence will be estimated using two ELISAs designed to detect specific IgG antibodies to SARS-CoV-2 in humoral fluid, and these results will be confirmed using a virus neutralization test. This study will be repeated from November to December 2021 (Phase 2) to evaluate the evolution of immune status achieved by vaccination and/or natural protection of PHCWs and to describe the history of exposure to SARS-CoV-2.

Towards an AIDS-free generation by 2030: how are South African children, adolescents, caregivers and health care workers coping with HIV?

2021 ◽  
pp. 008124632199217
Author(s):  
Yogan Pillay
Keyword(s):  
Health Care ◽  
Children And Adolescents ◽  
South African ◽  
Health Care Workers ◽  
Policy Makers ◽  
Number Of Children ◽  
Key Stakeholders ◽  
Care Workers ◽  
Free Generation ◽  
Living With Hiv

We are committed to an AIDS free generation by 2030 – nine short years away. This article reflects on the global and South African data on new infections, total number of children and adolescents living with HIV as well as data on vertical transmission. The article includes the voices of key stakeholders in the quest to end HIV in children so that lessons from their experiences can be used by policy makers in strengthening services.

scholarly journals Safety and immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2

2021 ◽  
Author(s):  
Peter G. Kremsner ◽  
Philipp Mann ◽  
Arne Kroidl ◽  
Isabel Leroux-Roels ◽  
Christoph Schindler ◽  
...  
Keyword(s):  
Immune Responses ◽  
Vaccine Candidate ◽  
Phase 1 ◽  
Lipid Nanoparticles ◽  
Enzyme Linked Immunosorbent Assay ◽  
Receptor Binding Domain ◽  
Igg Antibodies ◽  
Phase 1 Study ◽  
S Protein ◽  
Dosage Escalation

Summary Background We used the RNActive® technology platform (CureVac N.V., Tübingen, Germany) to prepare CVnCoV, a COVID-19 vaccine containing sequence-optimized mRNA coding for a stabilized form of SARS-CoV‑2 spike (S) protein encapsulated in lipid nanoparticles (LNP). Methods This is an interim analysis of a dosage escalation phase 1 study in healthy 18–60-year-old volunteers in Hannover, Munich and Tübingen, Germany, and Ghent, Belgium. After giving 2 intramuscular doses of CVnCoV or placebo 28 days apart we assessed solicited local and systemic adverse events (AE) for 7 days and unsolicited AEs for 28 days after each vaccination. Immunogenicity was measured as enzyme-linked immunosorbent assay (ELISA) IgG antibodies to SARS-CoV‑2 S‑protein and receptor binding domain (RBD), and SARS-CoV‑2 neutralizing titers (MN50). Results In 245 volunteers who received 2 CVnCoV vaccinations (2 μg, n = 47, 4 μg, n = 48, 6 μg, n = 46, 8 μg, n = 44, 12 μg, n = 28) or placebo (n = 32) there were no vaccine-related serious AEs. Dosage-dependent increases in frequency and severity of solicited systemic AEs, and to a lesser extent local AEs, were mainly mild or moderate and transient in duration. Dosage-dependent increases in IgG antibodies to S‑protein and RBD and MN50 were evident in all groups 2 weeks after the second dose when 100% (23/23) seroconverted to S‑protein or RBD, and 83% (19/23) seroconverted for MN50 in the 12 μg group. Responses to 12 μg were comparable to those observed in convalescent sera from known COVID-19 patients. Conclusion In this study 2 CVnCoV doses were safe, with acceptable reactogenicity and 12 μg dosages elicited levels of immune responses that overlapped those observed in convalescent sera.

scholarly journals Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults

2019 ◽  
Vol 222 (4) ◽  
pp. 572-582 ◽  
Author(s):  
Louis Fries ◽  
Iksung Cho ◽  
Verena Krähling ◽  
Sarah K Fehling ◽  
Thomas Strecker ◽  
...  
Keyword(s):  
Public Health ◽  
Immune Response ◽  
Ebola Virus ◽  
Vaccine Development ◽  
Phase 1 ◽  
Healthy Adults ◽  
Wild Type ◽  
Dose Ranging ◽  
Further Development ◽  
Human Vaccine

Abstract Background Ebola virus (EBOV) epidemics pose a major public health risk. There currently is no licensed human vaccine against EBOV. The safety and immunogenicity of a recombinant EBOV glycoprotein (GP) nanoparticle vaccine formulated with or without Matrix-M adjuvant were evaluated to support vaccine development. Methods A phase 1, placebo-controlled, dose-escalation trial was conducted in 230 healthy adults to evaluate 4 EBOV GP antigen doses as single- or 2-dose regimens with or without adjuvant. Safety and immunogenicity were assessed through 1-year postdosing. Results All EBOV GP vaccine formulations were well tolerated. Receipt of 2 doses of EBOV GP with adjuvant showed a rapid increase in anti-EBOV GP immunoglobulin G titers with peak titers observed on Day 35 representing 498- to 754-fold increases from baseline; no evidence of an antigen dose response was observed. Serum EBOV-neutralizing and binding antibodies using wild-type Zaire EBOV (ZEBOV) or pseudovirion assays were 3- to 9-fold higher among recipients of 2-dose EBOV GP with adjuvant, compared with placebo on Day 35, which persisted through 1 year. Conclusions Ebola virus GP vaccine with Matrix-M adjuvant is well tolerated and elicits a robust and persistent immune response. These data suggest that further development of this candidate vaccine for prevention of EBOV disease is warranted.

scholarly journals A Phase 1/2 Clinical Trial Evaluating Safety and Immunogenicity of a Varicella Zoster Glycoprotein E Subunit Vaccine Candidate in Young and Older Adults

2012 ◽  
Vol 206 (8) ◽  
pp. 1280-1290 ◽  
Author(s):  
Isabel Leroux-Roels ◽  
Geert Leroux-Roels ◽  
Frédéric Clement ◽  
Pierre Vandepapelière ◽  
Ventzislav Vassilev ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Subunit Vaccine ◽  
Vaccine Candidate ◽  
Phase 1 ◽  
Glycoprotein E ◽  
Varicella Zoster

scholarly journals A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel® with CPG 7909, using two different formulations and dosing intervals

Vaccine ◽  
2009 ◽  
Vol 27 (31) ◽  
pp. 4104-4109 ◽  
Author(s):  
Ruth D. Ellis ◽  
Gregory E.D. Mullen ◽  
Mark Pierce ◽  
Laura B. Martin ◽  
Kazutoyo Miura ◽  
...  
Keyword(s):  
Malaria Vaccine ◽  
Vaccine Candidate ◽  
Phase 1 ◽  
Blood Stage ◽  
Phase 1 Study ◽  
Malaria Vaccine Candidate ◽  
Dosing Intervals ◽  
Blood Stage Malaria

scholarly journals Pharmacists in advanced clinical practice roles in emergency departments (PARED)

2021 ◽  
Author(s):  
David Terry ◽  
Shalini Ganasan ◽  
Matthew Aiello ◽  
Chi Huynh ◽  
Veronica Wilkie ◽  
...  
Keyword(s):  
Emergency Departments ◽  
Phase 1 ◽  
Career Transition ◽  
Support Service ◽  
Clinical Activity ◽  
X Rays ◽  
Structured Interviews ◽  
Clinical Supervisors ◽  
Practitioner Training ◽  
Study Participants

AbstractBackground Following evidence published in the Pharmacists in Emergency Departments (PIED 2016) study Health Education England funded novel advanced clinical practitioner training for pharmacists (ACP-p), to support service delivery.Objective To explore experiences and clinical activity of trainee ACP-p, and opinions and recommendations of both trainees and clinical supervisors.Setting Five Urgent/Emergency Care Departments in London UK.Method Longitudinal mixed-methods study in three phases of registered UK pharmacists appointed as trainee ACP-p. Phase 1 (May-July 2019) – early semi-structured interviews and focus group using an experiences, opinions and recommendations (EOR) framework, Phase 2 (January-December 2019) – prospective recording of trainee clinical activity, standardised using bespoke spreadsheet, Phase 3 (November-December 2019) – as Phase 1 but at conclusion of training.Main outcome measure Experiences, clinical activity, opinions and recommendations of study participants.Results Twelve (92 %) eligible trainee ACP-p and five supervisors were recruited. Identified themes were: trainee personality, educational components, length of programme, support/supervision, career transition, university and placement training alignment, recommendations. Success was dependent on effective support and supervision. Clinical supervisors should be allocated adequate supervision time. Trainees, their supervisors and emergency department staff should be given a clear brief. Study participants agreed that the programme could be successful. Trainee ACP-p reported that they could manage 82 % of 713 pre-selected clinical presentations. Additional training needs include: ECGs, X-rays and CT scans.Conclusions Pharmacists can successfully train as ACP-p in this setting over a two-year period. This career transition needs careful management and clear structures. Training ACP-p is a useful way of enhancing skills and supporting clinical services to large numbers of patients.

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