protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04111965 | 7.5.1.2 | Visit 1 | 7.5.1.2 Visit 1 - Vital signs: See [above](#page-41-3) - Evaluation of concomitant medications: Se[e above](#page-41-3) - MAVC: Ve[r 7.4.4.3](#page-38-0) - TRPL: Se[e 7.4.4.4](#page-39-1) - Ocular surface stains: See [7.4.4.5a](#page-39-0)nd [7.4.4.6](#page-40-0) - Ophthalmological evaluation: Se[e 7.4.4.2](#page-38-1)... | [] |
NCT04111965 | 7.5.1.3 | Final Visit | 7.5.1.3 Final Visit - Vital signs: See [above](#page-41-3) - OSDI Score: See [7.4.4.1](#page-37-2) - Evaluation of concomitant medications: Se[e above7](#page-41-3).5.1.1 - Urine pregnancy test: Se[e above7](#page-41-3).5.1.1 - MAVC: Ve[r 7.4.4.3](#page-38-0) - TRPL: Se[e 7.4.4.4](#page-39-1) - Ocular surface stains: S... | [] |
NCT04111965 | 7.5.2 | Unscheduled follow-up visits | 7.5.2 Unscheduled follow-up visits At the request of the patient or any other individual involved in the study, unscheduled follow-up visits may be conducted to report adverse events. During these visits, all relevant data on reported adverse events must be collected, and an appropriate management plan must be establis... | [] |
NCT04111965 | 7.6 | Data collection | 7.6 Data collection | [] |
NCT04111965 | 7.6.1 | Source documents | 7.6.1 Source documents Source documents are all written or printed records derived from automated processes (for example, printouts of laboratory results issued by automated analysis equipment) where information is first recorded and which become part of the patient's permanent record. Examples of source documents incl... | [] |
NCT04111965 | 7.6.2 | Electronic forms of data collection | 7.6.2 Electronic forms of data collection All protocol-related data will be captured via an electronic case report form (ECF) by research team personnel. Protocol-related data should NOT be captured directly into the ECF; rather, they should be transcribed from the corresponding source document. This procedure allows f... | [] |
NCT04111965 | 7.6.3 | Archive | 7.6.3 Archive The data collected in this database is anonymous (only the patient number is stored along with other relevant information). The software used for data capture and storage meets the traceability requirements necessary for conducting clinical studies. The collected data will be stored by the sponsor or desi... | [] |
NCT04111965 | 8 | Evaluation and management of adverse events | 8. Evaluation and management of adverse events | [] |
NCT04111965 | 8.1 | Regulation and standards on adverse events | 8.1 Regulation and standards on adverse events The registration and reporting of adverse events will be carried out in accordance with the guidelines established in NOM-220-SSA1-2016, which is in accordance with the international ICH E6 guidelines. | [] |
NCT04111965 | 8.2 | Definition of adverse event | 8.2 Definition of adverse event According to the International Conference on Harmonization (ICH), an adverse event (AE) is any unfavorable medical occurrence in a patient undergoing clinical research who is administered a pharmaceutical product, regardless of causal attribution. Therefore, an AE may be any of the follo... | [] |
NCT04111965 | 8.3 | Definitions relevant to the classification of adverse events | 8.3 Definitions relevant to the classification of adverse events Severity (serious/non-serious), also called seriousness (serious/non-serious). A serious event is defined as any event that: results in death, threatens life, requires hospitalization or prolongs hospitalization, causes permanent or significant disability... | [] |
NCT04111965 | 8.4 | Researcher Responsibilities | 8.4 Researcher Responsibilities The investigator is responsible for verifying the AE by conducting a questioning, reviewing the information recorded in the subject's diary, conducting a relevant physical examination, assessing progress, and providing appropriate medical and pharmacological management. The investigator ... | [
"Figure 5Adverse [event care](#page-48-2))."
] |
NCT04111965 | 8.4.1 | Recording of adverse events in the electronic case report form | 8.4.1 Recording of adverse events in the electronic case report form
The EA registry considers: - − Subject identification information such as: subject number, age, sex, and if applicable, specify the eye. - − Information about the causality of the AE, its relationship to the PI, or to another studyrelated drug, as ap... | [
"The EA registry considers:"
] |
NCT04111965 | 8.4.2 | Monitoring of adverse events | 8.4.2 Monitoring of adverse events The IP will provide care and follow-up to the AE presented by the participant until its outcome, in accordance with the provisions of the following section. | [] |
NCT04111965 | 8.4.3 | Procedures for a serious adverse event | 8.4.3 Procedures for a serious adverse event The EA care process considers the following stages:  Figure 5Adverse event care During the development and conduct of this study, undesirable adverse events or adverse reactions of medical significance may occur in the research subject, which are not n... | [] |
NCT04111965 | 8.4.4 | Assessment of causality | 8.4.4 Assessment of causality Causality assessment is the methodology used to estimate the probability of attributing an observed adverse event to a medication. It considers probabilistic categories according to the available evidence and the quality of the information, based on national pharmacovigilance regulations. ... | [
"Table 3Karch and Lasagna algorithm modified by Naranjo"
] |
NCT04111965 | 8.5 | Unanticipated problems | 8.5 Unanticipated problems Unanticipated problems (ANP) are considered situations that pose risks to the participating subjects, generally any incident, experience or result that meets all of the following criteria: - Unexpected in terms of its nature, severity, or frequency in relation to: 1) study-related documents s... | [] |
NCT04111965 | 8.5.1 | PNAs Report | 8.5.1 PNAs Report The PI will be responsible for reporting PNAs to the sponsor, the IC, and the IEC. The report should contain the following information: - Study identification: protocol title and number, name of the PI and, where applicable, the center. - Detailed description of the event, incident, experience or outc... | [] |
NCT04111965 | 9 | Study monitoring | 9. Study monitoring The study sponsor is responsible for monitoring the study. Monitoring activities include, but are not limited to: general safety monitoring, general study quality monitoring, study site monitoring, adverse event detection monitoring, reporting and follow-up, monitoring to resolve data entry discrepa... | [] |
NCT04111965 | 9.1 | Monitoring of study centers | 9.1 Monitoring of study centers The research centers participating in the study will be monitored. At least one initial visit and one closing visit must be conducted for each center, although one or more follow-up visits may be required between these two mandatory visits. The initial visit must be conducted before the ... | [] |
NCT04111965 | 9.2 | Audit and quality control | 9.2 Audit and quality control To ensure compliance with GCPs and all applicable regulatory requirements, Laboratorios Sophia, SA de CV may conduct quality assurance audits. Regulatory agencies may also conduct a regulatory inspection of this study. Details of the audit process are set out separately in an Audit Plan. D... | [] |
NCT04111965 | 9.2.1 | Pre-study audit | 9.2.1 Pre-study audit The study centers included in the study will be subject to a feasibility visit prior to center selection, where they will be verified to meet the minimum requirements indicated by the sponsor. | [] |
NCT04111965 | 9.2.2 | Audit during the conduct of the study | 9.2.2 Audit during the conduct of the study They may take place at any time before, during, or after the conclusion of the study. If an audit or inspection is conducted, the investigator and the institution must agree to allow the auditor/inspector direct access to all relevant documents and must allocate their time an... | [] |
NCT04111965 | 10 | Statistical analysis | 10. Statistical analysis | [] |
NCT04111965 | 10.1 | Data analysis | 10.1 Data analysis | [] |
NCT04111965 | 10.1.1 | Statistical analysis | 10.1.1 Statistical analysis Statistical analysis will be performed by staff of Laboratorios Sophia, SA de CV. The statistical program SPSS version 19.0 (IBM Corporation, Armonk, NY, USA) will be used. The designated personnel will be blinded to the intervention groups. Coding will be performed using consecutive numbers... | [] |
NCT04111965 | 10.1.2 | Data interpretation | 10.1.2 Data interpretation The Kolmogorov-Smirnov and Shapiro-Wilk tests will be performed, as applicable, to determine whether the distribution is normal in the results obtained in each study group. The results of continuous quantitative variables will be presented in measures of central tendency: mean, standard devia... | [] |
NCT04111965 | 10.1.3 | Procedure for handling missing data | 10.1.3 Procedure for handling missing data Safety: The safety assessment will include in the analysis all subjects (both eyes) who have been exposed at least once to any of the interventions. Subjects enrolled in the efficacy phase will be included in the safety analysis for this phase, regardless of the visit at which... | [] |
NCT04111965 | 10.1.4 | Deviations from the statistical analysis plan | 10.1.4 Deviations from the statistical analysis plan According to the sample size calculation to meet the efficacy objective, 102 evaluable subjects (51 subjects per arm) are required. If this number is not met due to a loss of subjects exceeding the 20% threshold established in this protocol (loss to follow-up or with... | [] |
NCT04111965 | 10.1.5 | Subjects included in the analysis | 10.1.5 Subjects included in the analysis A preliminary safety analysis will be performed upon completion of follow-up of subject 12 in the Nanodrop® group (Phase I). If fewer than 20% of unexpected drug-related AEs occur in the Nanodrop® group, enrollment for the efficacy analysis (Phase II) will be completed. Otherwis... | [] |
NCT04111965 | 10.2 | Sample size calculation | 10.2 Sample size calculation | [] |
NCT04111965 | 10.2.1 | Number of subjects calculated | 10.2.1 Number of subjects calculated n= 126 evaluable subjects (both eyes) 63 subjects per arm. December-2018 An estimated 63 subjects (both eyes) are enrolled per treatment arm. During the safety phase, 24 subjects (12 from each group) will be recruited, and 102 will be recruited during the final phase, completing the... | [] |
NCT04111965 | 10.2.2 | Justification of the sample calculation | 10.2.2 Justification of the sample calculation For the sample size calculation, studies with ocular lubricants in patients with dry eye were considered, in which changes in the OSDI score were the primary outcome variable. Nanodrop® is expected to be non-inferior to its comparator (Systane® Balance), based on the follo... | [] |
NCT04111965 | 11 | Ethical considerations | 11. Ethical considerations | [] |
NCT04111965 | 11.1 | Approval of the committees | 11.1 Approval of the committees This study will be conducted in accordance with the standards of the Declaration of Helsinki, World Medical Association 2013. Nuremberg Code; Nuremberg Judgment by the International Tribunal of Nuremberg, 1947. Belmont Report, National Commission for the Protection of Subjects of Biomedi... | [] |
NCT04111965 | 11.2 | Amendments to the protocol | 11.2 Amendments to the protocol The amendment process will be relevant when there is a need to make any changes to a document that is part of the research project or protocol, due to changes in the methodological structure, replacement of the principal investigator, or the identification of risks to the research subjec... | [] |
NCT04111965 | 11.3 | Early termination of study | 11.3 Early termination of study The study may be temporarily suspended or terminated prematurely if there is sufficiently reasonable cause. Written notification documenting the reason for the suspension or early termination must be provided by the party executing the suspension. The PI must promptly inform the study pa... | [] |
NCT04111965 | 11.4 | Informed consent | 11.4 Informed consent The informed consent letter contains complete and understandable information about the study and the investigational product, in accordance with current applicable regulations and Good Clinical Practices. The informed consent letter will be considered a source document and will be filed as such. T... | [] |
NCT04111965 | 11.4.1 | Obtaining | 11.4.1 Obtaining Informed consent must be obtained before the subject undergoes any procedure indicated in the protocol. For this purpose, the informed consent form must be signed. Written consent documents will incorporate the elements of informed consent described in the Declaration of Helsinki and the ICH Guidelines... | [] |
NCT04111965 | 11.4.2 | Special considerations | 11.4.2 Special considerations The procedures that will be performed during the conduct of the study do not pose any additional risk that should be considered apart from the procedures listed in the informed consent. | [] |
NCT04111965 | 11.4.3 | Modifications to informed consent | 11.4.3 Modifications to informed consent Any change to the "informed consent" constitutes an amendment to this document and must be submitted for approval to the Research Ethics Committees and, if applicable, to the Competent Authorities. Such amendments may be implemented only after obtaining written approval from the... | [] |
NCT04111965 | 11.5 | Confidentiality | 11.5 Confidentiality All documents and information provided to the research center by the sponsor are strictly confidential. The PI expressly agrees that the data regarding his or her professional and clinical experience, provided to the sponsor in paper form and stored electronically, are solely for use in connection ... | [] |
NCT04111965 | 11.6 | Conflict of interest | 11.6 Conflict of interest The independence of the study's conduct and results from any actual or perceived external influences is critical. Therefore, any current conflict of interest of any person playing a role in the design, conduct, analysis, publication, or any other aspect of this study will be declared. Furtherm... | [] |
NCT04111965 | 11.6.1 | Declaration of interests | 11.6.1 Declaration of interests The IP undertakes to make a declaration of financial interests, as well as conflict of interests prior to the start of the study. | [] |
NCT04111965 | 11.7 | Access to information | 11.7 Access to information The final study database will be the property of Laboratorios Sophia, SA de CV, and access to it will be restricted. The PI will not have access to it except with prior written authorization from the sponsor. Any information obtained that is relevant to the safety of the subjects participatin... | [] |
NCT04111965 | 11.8 | Ancillary and post-study care | 11.8 Ancillary and post-study care Once the study is completed and adverse events are closed according to sectio[n 8,](#page-45-0) the sponsor will not extend care to the research subject. | [] |
NCT04111965 | 12 | Biosecurity aspects | 12.Biosecurity aspects
NO BIOSECURITY IMPLICATIONS This protocol, with title: " Phase I-II clinical study to compare the safety and efficacy of Nanodrop® versus Systane® Balance in the treatment of patients with dry eye", and number: SOPH176-1218/I-IIDOES NOT HAVE BIOSECURITY IMPLICATIONS, since infectious-contagious ... | [
"NO BIOSECURITY IMPLICATIONS"
] |
NCT04111965 | 13 | Publication Policy | 13.Publication Policy | [] |
NCT04111965 | 13.1 | Final report | 13.1 Final report Once the statistical analysis is completed, the final report will be written with the results obtained, by the Clinical Team of the Clinical Operations Department of Laboratorios Sophia, SA de CV. This report will be prepared following the recommendations of the ICH E3 Step 4 Guide. | [] |
NCT04111965 | 13.2 | Communication of results | 13.2 Communication of results Regardless of the results of the study, Laboratorios Sophia, SA de CV, is committed to communicating the final study report to the principal investigators and COFEPRIS. These results will also be shared with the research committee and the IEC. The PI will be responsible for communicating t... | [] |
NCT04111965 | 13.3 | Publication of the results | 13.3 Publication of the results Laboratorios Sophia, SA de CV, acting as the sponsor of the study, assumes full responsibility for its role and retains exclusive ownership rights to the study results, which it may use as it sees fit. The PI agrees not to publish or communicate data collected from the study, unless prio... | [] |
NCT04111965 | 14 | Financing and insurance | 14. Financing and insurance | [] |
NCT04111965 | 14.1 | Compensation to study participants | 14.1 Compensation to study participants Subjects participating in the study will not receive financial compensation for their participation. However, randomized subjects will receive financial support in the form of travel expenses for each scheduled visit they attend on time. This support, as well as the amount, will ... | [] |
NCT04111965 | 14.2 | Insurance for study participants | 14.2 Insurance for study participants Subjects participating in the study will sign the informed consent form, which specifies that Laboratorios Sophia, SA de CV agrees to pay for immediate treatment resulting from injuries or illnesses caused by the investigational products until resolved, in accordance with medical j... | [] |
NCT04111965 | 15 | Annexes | 15.Annexes | [] |
NCT04111965 | 15.1 | OSDI | 15.1 OSDI | Ficha de identificación | | | |--------------------------------------|--------------------|---| | SOPH176-1218/I-IINo. de estudio: | /Fecha: | / | | Iniciales del sujeto: | No. de sujeto: 176 | | | | | |
Indicaciones: El test OSDI e s u n test sencillo creado para establecer una gravedad/ clasificación del... | [
"Indicaciones:"
] |
NCT04111965 | 15.2 | SICCA CTO format | 15.2 SICCA CTO format
Formato de Calificación de Tinción Ocular del SICCA | OD | OS | |--------------------------------------|-------------------------| | Iniciales del sujeto: | No. de sujeto: 176- | | SOPH176-1218/I-IINo. de estudio: | //Fecha: | | Ficha de identificación | | Verde lisamina (solo conjuntiva) | Grado... | [
"Formato de Calificación de Tinción Ocular del SICCA"
] |
NCT04297917 | 1 | BACKGROUND | 1 BACKGROUND | [] |
NCT04297917 | 1.1 | Disease Review | 1.1 Disease Review Hepatitis B virus (HBV) is a complex, small deoxyribonucleic acid (DNA) virus that goes through a ribonucleic acid (RNA) intermediate life cycle requiring reverse transcription. After transmission through infected blood, contaminated body fluids or through perinatal transfer, the virus infects the li... | [] |
NCT04297917 | 1.2 | Treatment Review | 1.2 Treatment Review Highly effective prophylactic vaccines were implemented in the early 1980's; however, these vaccines are ineffective once infection is established [\[2\]](#page-80-2). Despite the wide use of prophylactic vaccines, there are an estimated 240 million CHB carriers and over 686,000 related deaths per ... | [] |
NCT04297917 | 1.3 | Summary of Non-clinical Studies | 1.3 Summary of Non-clinical Studies Immunogen design: 1,447 HBV genotype C nucleotide sequences (HBV database) were aligned, and an HBV genotype C consensus sequence was generated. Then, a patient's HBV genotype C sequence (accession number: KP017269.1 HBV isolate JP-02) that had maximum similarity to the consensus was... | [] |
NCT04297917 | 1.4 | Summary of Clinical Experience | 1.4 Summary of Clinical Experience ChAdOx1 has been administered to over 200 participants (MERS, malaria, influenza and prostate cancer) and as the prime for an MVA boost in the malaria, influenza and prostate cancer studies (NCT03399578, NCT03203421, NCT01818362, NCT01623518 and NCT03815942). In all of those studies, ... | [] |
NCT04297917 | 1.5 | Study Rationale | 1.5 Study Rationale Chronic hepatitis B virus infection is a global public health challenge on the same scale as TB, HIV and malaria. The current prophylactic vaccine has no effect on established chronic infection. Available treatments suppress viral replication, but they are not curative, largely due to the persistenc... | [] |
NCT04297917 | 1.5.1 | Rationale for Investigation of Dosing Interval With Respect to COVID-19 Vaccines | 1.5.1 Rationale for Investigation of Dosing Interval With Respect to COVID-19 Vaccines There are concerns that the prior use of a vectored vaccine may result in anti-vector responses, which would decrease the response to a subsequent use of the same vector. Specifically, there have been concerns raised that the use of ... | [] |
NCT04297917 | 2 | STUDY OBJECTIVES AND ENDPOINTS | 2 STUDY OBJECTIVES AND ENDPOINTS
Objectives Endpoints
Primary Determine the safety and tolerability of different doses of a single vaccination of ChAdOx1-HBV in healthy participants and in participants with CHB infection and virally suppressed with oral antiviral medication.
Secondary • Determine the immunogenicity ... | [
"Objectives Endpoints",
"Primary",
"Secondary",
"Exploratory",
"Primary",
"Secondary",
"Exploratory"
] |
NCT04297917 | 3 | STUDY OVERVIEW | 3 STUDY OVERVIEW | [] |
NCT04297917 | 3.1 | Overall Study Design and Methodology | 3.1 Overall Study Design and Methodology | [] |
NCT04297917 | 3.1.1 | Study Design | 3.1.1 Study Design This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non-randomised dose escalation study comparing the safety, tolerability and im... | [] |
NCT04297917 | 3.1.2 | Study Methodology | 3.1.2 Study Methodology Participants will be screened in the period Day -42 to Day -1. Informed consent will be obtained before any study specific procedures are performed. Eligible participants will then attend the clinic to receive study vaccine on Day 0. Participants will be enrolled sequentially. The study will inv... | [] |
NCT04297917 | 3.1.3 | Study Stopping Criteria/Holding Criteria/Dose Escalation Process | 3.1.3 Study Stopping Criteria/Holding Criteria/Dose Escalation Process There will be a review of the study data by the DMC when there is a reasonable possibility that the investigational vaccine caused any of the listed following adverse events based on the assessment of the Investigator in one or more participants at ... | [] |
NCT04297917 | 3.1.4 | Duration of Study | 3.1.4 Duration of Study
Duration for Each Participant Cohorts 1-4: Up to 8 months (up to 1.5 months for screening and 6.5 months on the study with study vaccine given on Day 0). Cohorts 5 and 6: Up to 4.5 months (up to 1.5 months for screening and 3 months on the study with study vaccine given on Day 0).
Duration of ... | [
"Duration for Each Participant",
"Duration of Study"
] |
NCT04297917 | 3.2 | Discussion of Study Design | 3.2 Discussion of Study Design This is a first in human study of the ChAdOx1 vaccine and is designed to assess the safety in both healthy adults, as well as in the target CHB population. As T cell responses to natural infection are blunted or exhausted in participants with CHB, it will be important to determine how res... | [] |
NCT04297917 | 3.3 | Benefit Risk Assessment | 3.3 Benefit Risk Assessment There are potential known and unknown risks associated with vaccination. With any vaccine, including those that are licensed, there is a rare risk of anaphylaxis which can be fatal. All participants will be observed in the clinic for at least 30 minutes post-vaccination. Intramuscular inject... | [] |
NCT04297917 | 4 | STUDY POPULATION | 4 STUDY POPULATION | [] |
NCT04297917 | 4.1 | Number of Participants | 4.1 Number of Participants It is planned that 40 healthy participants and 12 participants with CHB infection and virally suppressed with oral antiviral medication will be enrolled in the study. Chronic HBV participants will be recruited/deemed eligible by hepatologists, infectious disease specialists or physicians expe... | [] |
NCT04297917 | 4.2 | Inclusion Criteria | 4.2 Inclusion Criteria Participants must meet all the following criteria to be eligible for the study: - 1. Adult males or females aged ≥18 to ≤65 years at screening - 2. Body Mass Index ≤30 kg/m2 - 3. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and... | [
"Healthy participants (cohorts 1 and 2):",
"Participants with well controlled CHB (cohorts 3 and 4):",
"Healthy participants (cohort 5):",
"Healthy participants (cohort 6):"
] |
NCT04297917 | 4.3 | Exclusion Criteria | 4.3 Exclusion Criteria - 1. Presence of any significant acute or chronic, uncontrolled medical/psychiatric illness - 2. Hepatitis C virus (HCV) antibody positive. - 3. HIV antibody positive - 4. History or evidence of autoimmune disease or known immunodeficiency of any cause - 5. Prolonged therapy with immunomodulators... | [] |
NCT04297917 | 4.3.1 | Removal of Participants from Vaccination or Assessment | 4.3.1 Removal of Participants from Vaccination or Assessment
Contraindications to Vaccination The following events constitute contraindications to administration of study vaccine at that point in time; if any one of these events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later... | [
"Contraindications to Vaccination",
"Study Discontinuation"
] |
NCT04297917 | 4.3.2 | Study Termination | 4.3.2 Study Termination The study may be terminated, either at one centre or all centres for the following reasons: - The discovery of an unexpected, serious or unacceptable risk to participants enrolled in the study - The decision on the part of the Sponsor to suspend or discontinue testing, evaluation or development ... | [] |
NCT04297917 | 5 | STUDY VACCINE | 5 STUDY VACCINE The Investigator must ensure that study vaccine is handled only by study team members who have been appropriately trained for the conduct of this clinical study and that dosing is only performed by study team members who fully understand the procedures outlined in this section, the Investigator's Brochu... | [] |
NCT04297917 | 5.1 | Study Vaccines Administered | 5.1 Study Vaccines Administered ChAdOx1-HBV is a non-replicating viral vector encoding HBV consensus sequences from a group C genotype. It will be given by intramuscular injection into the deltoid muscle in the non-dominant arm. The study vaccine to be given in each treatment group are shown in [Table 1.](#page-41-3) T... | [] |
NCT04297917 | 5.2 | Identity of Study Vaccine | 5.2 Identity of Study Vaccine ChAdOx1-HBV will be manufactured to Good Manufacturing Practice, labelled according to local regulations, including Annex 13 of the Good Manufacturing Practice Directive [\[35\]](#page-82-2) as detailed in the IP Handling Manual. ChAdOx1-HBV is formulated in an A438 buffer comprising of 10... | [] |
NCT04297917 | 5.3 | Labelling, Packaging and Shipping | 5.3 Labelling, Packaging and Shipping Study vaccine will be shipped by Catalent Pharma Solutions to the study centres on dry ice with a continuous temperature monitoring device. Upon receipt, the pharmacist or designee must immediately inspect all vials for damage. Any damage or discrepancies from the packing list must... | [] |
NCT04297917 | 5.4 | Storage | 5.4 Storage Vials of study vaccine in the outer carton (to protect from light) must be stored in a continuously monitored freezer at ≤-65°C. All study vaccine must be kept in a secured location with no access for unauthorised personnel. | [] |
NCT04297917 | 5.5 | Accountability | 5.5 Accountability The pharmacist or designee is required to maintain accurate accountability records for the study vaccine. Instructions and forms to be completed and kept for accountability will be provided to the pharmacist or designee. If the pharmacist or designee wishes to use study centre-specific accountability... | [] |
NCT04297917 | 5.6 | Destruction or Disposal | 5.6 Destruction or Disposal The Sponsor will provide instructions for the return of unused ChAdOx1-HBV. Genetically modified organism (GMO) waste, including empty vials after full study vaccine accountability has been conducted, will be destroyed by appropriately licensed vendors. This destruction will be recorded with... | [] |
NCT04297917 | 5.7 | Method of Assigning Participants to Treatment Groups | 5.7 Method of Assigning Participants to Treatment Groups At the screening visit, participants will be sequentially allocated a participant number once written, informed consent has been obtained. They will be identified by this number throughout the study. In cohorts 1-4, the healthy and CHB participants will be alloca... | [] |
NCT04297917 | 5.8 | Selection of Doses, Dosing Schedule and Administration | 5.8 Selection of Doses, Dosing Schedule and Administration | [] |
NCT04297917 | 5.8.1 | Selection of Doses in the Study | 5.8.1 Selection of Doses in the Study The doses of adenoviruses have been taken from historical context of innumerable previous adenovirus vaccine studies. A review of the adenoviral pre-clinical and clinical literature reveals that the overall T cell response may vary for CD4 and CD8+ T cells, and a number of studies ... | [] |
NCT04297917 | 5.8.2 | Selection and Timing of Dose for each Participant | 5.8.2 Selection and Timing of Dose for each Participant
Dosing Schedule The healthy and CHB participants will be allocated to low dose or high dose treatment depending on the assignment. Vaccination will be performed on Day 0 after eligibility has been re-confirmed. There are no restrictions in the time of day that th... | [
"Dosing Schedule",
"Study Vaccine Preparation and Administration",
"Dose and Schedule Modifications"
] |
NCT04297917 | 5.9 | Prior and Concomitant Vaccines and Medications | 5.9 Prior and Concomitant Vaccines and Medications Prior (within the previous 28 days) and concomitant medications include prescription and non-prescription drugs or other treatments, and any vaccines other than the study vaccine. Recently used and ongoing medications will be reviewed and recorded during screening. Con... | [] |
NCT04297917 | 5.10 | Treatment Compliance | 5.10 Treatment Compliance Vaccine administration will take place at the study centre and will be performed by a suitably qualified healthcare professional. The precise date and time of vaccination shall be documented in the source documents and eCRF. The study will be monitored by a Study Monitor approved by the Sponso... | [] |
NCT04297917 | 5.11 | Post-study Vaccine | 5.11 Post-study Vaccine The Sponsor does not intend to provide ChAdOx1-HBV after the end of the study or after any early participant withdrawal, as there is currently no clinical data supporting their efficacy. These participants will remain under the care of their healthcare professionals and treated according to stan... | [] |
NCT04297917 | 6 | STUDY PROCEDURES AT EACH VISIT/SCHEDULE OF ASSESSMENTS | 6 STUDY PROCEDURES AT EACH VISIT/SCHEDULE OF ASSESSMENTS The study consists of the following: - A 42-day screening period before the start of the study period - A study period of 168 days, consisting of a vaccination day on Day 0, a follow-up telephone call on Day 1 and follow-up visits on Days 7, 14, 28, 56. Participa... | [] |
NCT04297917 | 6.1 | Screening and Baseline Pre-Dose Assessments | 6.1 Screening and Baseline Pre-Dose Assessments Written informed consent for participation in the study must be obtained before performing any study specific screening tests or evaluations according to the process in Section [13.4.](#page-75-4) Unsolicited adverse events will be recorded from the date the informed cons... | [] |
NCT04297917 | 6.2 | Treatment Day Assessments (Day 0) | 6.2 Treatment Day Assessments (Day 0) The following will be performed pre-vaccination: - Re-check of eligibility criteria - A urine pregnancy test will be performed - Blood samples will be taken for haematology (including PT/INR and aPTT), biochemistry and LFTs Vaccitech Ltd CONFIDENTIAL Page 49 of 118  will be measured - Blood samples will be taken for haematology (including PT/INR and aPTT), biochemistry and LFTs | [] |
NCT04297917 | 6.3.3 | Clinic Visit: Day 14 | 6.3.3 Clinic Visit: Day 14 - A symptom-directed physical examination will be performed if required - Vital signs (pulse rate, blood pressure and temperature) will be measured - Blood samples will be taken for haematology (including PT/INR and aPTT), biochemistry and LFTs - Blood samples will be taken for immunogenicity... | [] |
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