scholarly journals Algorithm for the support of non-related (serious) adverse events in an Ebola vaccine trial in the Democratic Republic of the Congo

2021 ◽  
Vol 6 (6) ◽  
pp. e005726
Author(s):  
Gwen Lemey ◽  
Ynke Larivière ◽  
Trésor Matuvanga Zola ◽  
Vivi Maketa ◽  
Junior Matangila ◽  
...  
Keyword(s):  
Adverse Events ◽  
Democratic Republic ◽  
Vaccine Trial ◽  
Well Being ◽  
Serious Adverse Events ◽  
Response Options ◽  
Low Middle Income Countries ◽  
Republic Of The Congo ◽  
Pharmaceutical Industries ◽  
Ancillary Care

Implementing an Ebola vaccine trial in a remote area in the Democratic Republic of the Congo (DRC), and being confronted with a dysfunctional health care system and acute unmet health needs of participants, ethical considerations were made regarding the ancillary care obligations of the sponsor and researchers. Spurred by the occurrence of non-related (serious) adverse events (NR-SAEs), the Universities of Antwerp and Kinshasa jointly developed an algorithm, accompanied by an algorithm policy. The algorithm consists of a set of consecutive questions with binary response options, leading to structured, non-arbitrary and consistent support and management for each NR-SAE. It is the result of dialogue and collaboration between the sponsor (University of Antwerp) and the principal investigator (University of Kinshasa), consultation of literature, and input of research ethics and social sciences experts. The characteristics of the project and its budgetary framework were taken into account, as well as the local socioeconomic and healthcare situation. The algorithm and related policy have been approved by the relevant ethics committee (EC), so field implementation will begin when the study activities resume in November 2021. Lessons learnt will be shared with the relevant stakeholders within and outside DRC.If NR-SAEs are not covered by a functioning social welfare system, sponsors and researchers should develop a feasible, standardised and transparent approach to the provision of ancillary care. National legislation and contextualised requirements are therefore needed, particularly in low/middle-income countries, to guide researchers and sponsors in this process. Protocols, particularly of clinical trials conducted in areas with ‘access to care’ constraints, should include adequate ancillary care arrangements. Furthermore, it is essential that local ECs systematically require ancillary care provisions to enhance the well-being and protection of the rights of research participants. This project was funded by the European Union’s Horizon 2020 research and innovation programme, European Federation of Pharmaceutical Industries and Associations, and the Coalition for Epidemic Preparedness Innovations.

scholarly journals Open-label, randomised, clinical trial to evaluate the immunogenicity and safety of a prophylactic vaccination of healthcare providers by administration of a heterologous vaccine regimen against Ebola in the Democratic Republic of the Congo: the study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046835
Author(s):  
Ynke Larivière ◽  
Trésor Zola ◽  
Elke Stoppie ◽  
Vivi Maketa ◽  
Junior Matangila ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Democratic Republic ◽  
Healthcare Providers ◽  
Vaccine Trial ◽  
Booster Vaccination ◽  
Open Label ◽  
Serious Adverse Events ◽  
Vaccine Regimen ◽  
Republic Of The Congo

IntroductionThis article describes the protocol of an Ebola vaccine clinical trial which investigates the safety and immunogenicity of a two-dose prophylactic Ebola vaccine regimen comprised of two Ebola vaccines (Ad26.ZEBOV and MVA-BN-Filo) administered 56 days apart, followed by a booster vaccination with Ad26.ZEBOV offered at either 1 year or 2 years (randomisation 1:1) after the first dose. This clinical trial is part of the EBOVAC3 project (an Innovative Medicines Initiative 2 Joint Undertaking), and is the first to evaluate the safety and immunogenicity of two different booster vaccination arms in a large cohort of adults.Methods and analysisThis study is an open-label, monocentric, phase 2, randomised vaccine trial. A total of 700 healthcare providers and frontliners are planned to be recruited from the Tshuapa province in the Democratic Republic of the Congo (DRC). The primary and secondary objectives of the study assess the immunogenicity of the first (Ad26.ZEBOV), second (MVA-BN-Filo) and booster (Ad26.ZEBOV) dose. Immunogenicity is assessed through the evaluation of EBOV glycoprotein binding antibody responses after vaccination. Safety is assessed through the collection of serious adverse events from the first dose until 6 months post booster vaccination and the collection of solicited and unsolicited adverse events for 1 week after the booster dose.Ethics and disseminationThe protocol was approved by the National Ethics Committee of the Ministry of Health of the DRC (n°121/CNES/BN/PMMF/2019). The clinical trial was registered on 4 December 2019 on ClinicalTrials.gov. Trial activities are planned to finish in October 2022. All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.Trial registration numberNCT04186000; Pre-results.

scholarly journals Comparison of Safety and Tolerability of Deutetrabenazine During Titration and Maintenance in Patients with Tardive Dyskinesia

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 164-180
Author(s):  
Amanda Wilhelm ◽  
Karen E. Anderson ◽  
Hubert H. Fernandez ◽  
Hadas Barkay ◽  
Nayla Chaijale ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Adverse Events ◽  
Tardive Dyskinesia ◽  
Dry Mouth ◽  
Fixed Dose ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Extension ◽  
Pharmaceutical Industries ◽  
Flexible Dose

AbstractBackgroundDeutetrabenazine is approved to treat tardive dyskinesia (TD) in adults and is titrated weekly by 6 mg/day, from 12 to 48 mg/day, based on dyskinesia control and tolerability. This analysis compared the safety of deutetrabenazine during titration versus maintenance.MethodsSafety was assessed during titration versus maintenance using integrated data from two 12-week placebo-controlled studies (ARM-TD and AIM-TD) and the open-label extension study. Rates were compared for overall and serious adverse events (AEs), AEs leading to discontinuation, treatment-related AEs, common AEs (≥4%), and specific AEs (parkinsonism, suicidal ideation, akathisia, restlessness).ResultsIn titration versus maintenance, AE rates with placebo (n=130) were: overall, 43.1% vs 25.4%; serious, 4.6% vs 2.3%; leading to discontinuation, 3.1% vs 0; treatment-related, 26.9% vs 10.0%. For placebo, common AEs during titration were somnolence, headache, nausea, fatigue, and dry mouth; none occurred during maintenance. In titration versus maintenance, AE rates in fixed-dose deutetrabenazine 12–36 mg (n=216) were: overall, 33.3–38.9% vs 22.2–29.2%; serious, 2.8–6.9% vs 0–1.4%; leading to discontinuation, 2.8–5.6% vs 0; treatment-related, 8.3–16.7% vs 8.3–13.9%. For fixed-dose deutetrabenazine, common AEs during titration were headache, diarrhea, nasopharyngitis, depression, hypertension, and dry mouth; headache was the only common AE during maintenance. In titration versus maintenance, AE rates with flexible-dose deutetrabenazine (n=168) were: overall, 49.4% vs 32.7%; serious, 3.6% vs 2.4%; leading to discontinuation, 2.4% vs 0.6%. For flexible-dose deutetrabenazine, the only common AE during titration was somnolence; none occurred during maintenance. Rates of parkinsonism, suicidal ideation, akathisia, and restlessness were low and comparable in titration and maintenance.ConclusionsDeutetrabenazine was well-tolerated, with AE rates similar to placebo during both phases; AE rates were higher during titration and decreased during maintenance.FundingTeva Pharmaceutical Industries Ltd., Petach Tikva, Israel

scholarly journals Violence, Well-Being and Level of Participation in Formal Education among Adolescent Girls in Eastern Democratic Republic of the Congo: The Role of Child Marriage

2018 ◽  
Vol 12 (2) ◽  
pp. 273-290 ◽  
Author(s):  
Debbie Landis ◽  
Kathryn Falb ◽  
Ilaria Michelis ◽  
Theresita Bakomere ◽  
Lindsay Stark
Keyword(s):  
Formal Education ◽  
Democratic Republic ◽  
Well Being ◽  
Child Marriage ◽  
Safety Education ◽  
Logistic Regression Models ◽  
Increased Risk ◽  
Negative Effect ◽  
Republic Of The Congo

Child marriage is a well-recognized barrier to education, and exposes girls to an increased risk of violence along with other negative health and developmental outcomes. A quantitative survey was conducted with girls selected from 14 communities in South Kivu, Democratic Republic of the Congo (DRC). Data from 350 girls (ages 13-14) were analyzed using mixed effects logistic regression models. Findings revealed that child marriage was associated with lower levels of participation in formal education as well as higher rates of physical, sexual and emotional violence. In particular, when adjusting for age and girls’ level of participation in formal education, being married was associated with more than a three-fold (OR: 3.23) increased risk of experiencing sexual violence (p<0.001). Married girls were also significantly more likely to affirm the belief that they would be forced to marry their perpetrator in the event that they were raped (p=0.017), suggesting that a portion of girls within this sample may have experienced this occurrence. Although higher levels of participation in formal education were associated with a reduced risk of violence among non-married girls, these differences were not observed for girls who were married. Findings reveal that child marriage has a significantly negative effect on the relationship between girls’ level of participation in formal education and experiences with violence. Taken cumulatively, findings from this study suggest an overall harmful relationship between child marriage and girls’ safety, education and well-being, and that efforts to prevent its occurrence in the DRC and beyond are urgently needed.

scholarly journals OC 8582 A PHASE IA/B STUDY TO ASSESS SAFETY AND IMMUNOGENICITY OF PLACENTAL MALARIA VACCINE CANDIDATE: PRELIMINARY RESULTS OF THE PRIMALVAC TRIAL

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A14.3-A15
Author(s):  
Amadou Konate ◽  
Laura Richert ◽  
Arnaud Chêne ◽  
Jean-Philippe Semblat ◽  
Gwenaelle Roguet ◽  
...  
Keyword(s):  
Adverse Events ◽  
Burkina Faso ◽  
Malaria Vaccine ◽  
Clinical Laboratory ◽  
Placental Malaria ◽  
Safety Data ◽  
Vaccine Trial ◽  
Adult Women ◽  
Serious Adverse Events ◽  
Double Blind

BackgroundAdhesion of P. falciparum-infected erythrocytes (PEs) to placental chondroitin-4-sulfate (CSA) has been linked to severe placental malaria (PM) outcomes. Evidence strongly supports the VAR2CSA variant surface antigen mediating PEs CSA-binding phenotype as the leading candidate for a PM vaccine. This study was conducted to assess the safety and immunogenicity of 3 different dosages (20 µg, 50 µg and 100 µg) of the recombinant VAR2CSA protein (PRIMVAC), formulated with Alhydrogel or GLA-SE administered at days 0, 28 and 56.MethodsA randomised double-blind phase Ia/Ib dose-escalation vaccine trial was conducted in healthy adult women. Within 4 sequential cohorts, volunteers were randomised to 2 arms (PRIMVAC adjuvanted with Alhydrogel or GLA-SE) in the first phase conducted in France and then to 3 arms (PRIMVAC with Alhydrogel or GLA-SE or placebo) in Burkina Faso. Enrolled volunteers were observed for at least 1 hour following each vaccination then seen at 1 day and 7 days later for safety evaluations. Serious adverse events (SAE) were recorded throughout the study duration. Routine clinical laboratory safety analyses were performed prior to first injection and at each subsequent visit.ResultsA total of 68 subjects were recruited in the four study cohorts. No SAE was reported in any of the cohort A volunteers and enrolment in cohort B was started. A Data Safety Monitoring Board (DSMB) reviewed the safety data for cohorts A (20 µg) and B (50 µg) before the trial was initiated in Burkina Faso. The DSMB also reviewed the safety data in Burkina to authorise the progression from the cohort C (50 µg) to cohort D (100 µg). The last vaccination of the last subject occurred in September 2017.ConclusionThis was the first placental malaria vaccine phase Ia/b clinical trial conducted in France and Burkina Faso. No serious adverse events have been recorded. Preliminary safety and immunogenicity results will be presented.

scholarly journals Cumulative Risk and Teacher Well-Being in the Democratic Republic of the Congo

2015 ◽  
Vol 59 (4) ◽  
pp. 717-742 ◽  
Author(s):  
Sharon Wolf ◽  
Catalina Torrente ◽  
Marissa McCoy ◽  
Damira Rasheed ◽  
J. Lawrence Aber
Keyword(s):  
Democratic Republic ◽  
Cumulative Risk ◽  
Well Being ◽  
Republic Of The Congo

scholarly journals Use of iris scanning as a method of biometric recognition of healthy adults participating in an Ebola vaccine trial in the Democratic Republic of the Congo. (Preprint)

2021 ◽  
Author(s):  
Trésor Zola Matuvanga ◽  
Ginger Johnson ◽  
Ynke Larivière ◽  
Emmanuel Esanga ◽  
Junior Matangila-Rika ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Democratic Republic ◽  
Vaccine Trial ◽  
Group Discussions ◽  
Republic Of The Congo ◽  
The Right ◽  
High Level ◽  
The University ◽  
Iris Scanning

BACKGROUND As part of an Ebola outbreak preparedness initiative, a partnership between the University of Antwerp and the University of Kinshasa, through an Innovative Medicines Initiative-European Union (project ‘EBOVAC 3’), implemented a clinical trial on an Ebola vaccine regimen to be administered to health care provider participants (HCP-P) in Tshuapa Province (Democratic Republic of the Congo). The EBOVAC3 clinical trial used iris scan technology to identify all HCP-P participating in the vaccine trial so the right participant received the right vaccine at the right visit. OBJECTIVE To assess the acceptability, accuracy and feasibility of iris scan technology as an identification method within a population of HCP-P in a vaccine trial in a remote setting. METHODS A mixed-method study was utilized. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and assessed at enrolment. Feasibility and accuracy research was conducted using a longitudinal trial study design where iris scanning was compared to the unique study ID card to identify HCP-P at enrolment, and at their follow-up visits. RESULTS During the FGDs, main concerns raised by HCP-P about the iris scan technology were that it may cause physical problems to their eyes or expose them to spiritual problems through sorcery. Though, 99.1% (95%CI: 97.1;100.0) of HCP-P in the FGDs agreed to be identified by the iris scan. Also, at enrolment 99.0% (95%CI:98.3; 99.7) HCP-P accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (95%CI:91.2; 95.0) of the participants returning for scheduled follow-up visits. Iris scanning operation lasted no more than 2 minutes 30 seconds for 96.0% (95%CI: 99.0;100.0) and one attempt was enough to identify the majority of study volunteers [69.5% (95% CI:66.1;73.0)]. CONCLUSIONS Iris scan is highly acceptable as an identification tool in a clinical trial in HCP-Ps. Its operationalization during the trial demonstrated a high-level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but it requires a trained operator in order to reduce the duration and the number of attempts to identify a participant.

scholarly journals Review of the National Program for Onchocerciasis Control in the Democratic Republic of the Congo

2019 ◽  
Vol 4 (2) ◽  
pp. 92 ◽  
Author(s):  
Jean-Claude Makenga Bof ◽  
Fortunat Ntumba Tshitoka ◽  
Daniel Muteba ◽  
Paul Mansiangi ◽  
Yves Coppieters
Keyword(s):  
Democratic Republic ◽  
Neglected Tropical Diseases ◽  
Rapid Assessment ◽  
Mass Treatment ◽  
National Program ◽  
Preventive Chemotherapy ◽  
Serious Adverse Events ◽  
Republic Of The Congo ◽  
History Of ◽  
Onchocerciasis Control

Here, we review all data available at the Ministry of Public Health in order to describe the history of the National Program for Onchocerciasis Control (NPOC) in the Democratic Republic of the Congo (DRC). Discovered in 1903, the disease is endemic in all provinces. Ivermectin was introduced in 1987 as clinical treatment, then as mass treatment in 1989. Created in 1996, the NPOC is based on community-directed treatment with ivermectin (CDTI). In 1999, rapid epidemiological mapping for onchocerciasis surveys were launched to determine the mass treatment areas called “CDTI Projects”. CDTI started in 2001 and certain projects were stopped in 2005 following the occurrence of serious adverse events. Surveys coupled with rapid assessment procedures for loiasis and onchocerciasis rapid epidemiological assessment were launched to identify the areas of treatment for onchocerciasis and loiasis. In 2006, CDTI began again until closure of the activities of African Program for Onchocerciasis Control (APOC) in 2015. In 2016, the National Program for Neglected Tropical Diseases Control using Preventive Chemotherapy (PNMTN-CP) was launched to replace NPOC. Onchocerciasis and CDTI are little known by the population. The objective of eliminating onchocerciasis by 2025 will not be achieved due to the poor results of the NPOC. The reform of strategies for eliminating this disease is strongly recommended.

Preliminary impacts of the “Learning to Read in a Healing Classroom” intervention on teacher well-being in the Democratic Republic of the Congo

2015 ◽  
Vol 52 ◽  
pp. 24-36 ◽  
Author(s):  
Sharon Wolf ◽  
Catalina Torrente ◽  
Paul Frisoli ◽  
Nina Weisenhorn ◽  
Anjuli Shivshanker ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Well Being ◽  
Classroom Intervention ◽  
Learning To Read ◽  
Republic Of The Congo

Anaesthetic practices in the gynaecology and obstetric department in the principal health facilities of Butembo city, Eastern of the Democratic Republic of the Congo

2020 ◽  
Vol 6 (5) ◽  
pp. 233-242
Author(s):  
Moise Muhindo Valimungighe ◽  
◽  
Larrey Kasereka Kamabu ◽  
Rodriguez Mbusa Baraka ◽  
Kambale Mayalunga ◽  
...  
Keyword(s):  
Adverse Events ◽  
General Anaesthesia ◽  
Spinal Anaesthesia ◽  
Well Being ◽  
Health Facilities ◽  
Team Work ◽  
Continuous Training ◽  
Republic Of The Congo ◽  
Obstetric Department ◽  
Safe Anaesthesia

Background: The practice of anaesthesia should be team work involving Obstetrician and Anesthesiologist to determine the anaesthetic and surgical needs of the patient in order to have a successful plan for the baby and mother. The aim of this survey was to evaluate the practice of anesthesia in obstetric and gynaecology department in the principal health facilities of Butembo city. Methods: A prospective and observational descriptive study was done in four health facilities of Butembo city, from January 1st, 2015 to December 31st, 2019. Results: 64.86% of obstetrical and gynaecological procedures were done under spinal anaesthesia. General anaesthesia with an endotracheal tube was performed in 2.97% of the cases, the laryngeal mask in 0.10% and intra venous anaesthesia without any airway support in 96.93% of the cases. 100% of the cases had benefited from a pre-anaesthetic consultation; 77.75% anaesthesia was administered by anaesthetic officers. 53,27% of the patients were classified as ASA I and 77.25% of cases were electives. Caesareans accounted for 87.83% of emergency cases and 70.73% of elective cases. The pre-medication consisted of atropine and diazepam in 31,02%. Bupivacaine was used for spine anaesthesia in 66.87%. Maintenance during general anaesthesia with ketamine was done in 98.72%. Pethidine was the analgesic used in intraoperative in 48.00%. Tramadol was the most used drugs for pain management in post operative period. Adverse events were recorded in 2.94% of the patients; hypotension was noted in 39,27%. 24 maternal deaths were recorded. Fifteen among them died due to complication related to anaesthesia. There is a dependency between the accidents and complications and qualification of anaesthetists. Conclusion: Anaesthesia is commonly used in the gynaecology and obstetric department. It is important to promote continuous training of Non Physician Anaesthetists as well as Consultants Anaesthesiologists in order to practice safe anaesthesia for the well being of our patients. Spinal anaesthesia was the common used predominantly with few adverse events to the mother and foetus.

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