Navrongo Health Research Centre

Health and Demographic Surveillance Site

Navrongo Health Research Centre

Health and Demographic Surveillance Site

Navrongo Health Research Centre

Health and Demographic Surveillance Site

CLINICAL SCIENCE DEPT- PROJECTS

ONGOING


Name of Project Objective(s)
A prospective study to evaluate the safety, effectiveness and impact of the RTS, S/ASO1E vaccine in young children in sub- Saharan Africa.

(EPI-MAL 003)
  • To estimate the incidence of aetiology- confirmed meningitis in children vaccinated with RTS,S/AS01E.

  • To estimate the incidence of adverse events of special interest (AESI), and of other adverse events (AE) leading to hospitalization or death, in children vaccinated with RTS,S/AS01E.
An epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two studies pre- and post-RTS, S/AS01E introduction (EPI-MAL- 002 and EPI-MAL-003) to assess, in field conditions, vaccine benefit: risk in children in Sub-Saharan Africa.

(EPI-MAL 005)
  • To obtain longitudinal estimates of P. falciparum parasite prevalence in order to characterize malaria transmission intensity in a standardized way at sites conducting the EPI- MAL-002 and EPI-MAL-003 studies before and after the introduction of the malaria vaccine RTS,S/AS01E in sub-Saharan Africa.

  • To obtain longitudinal estimates of the use of malaria control interventions in sites conducting the EPI-MAL-002 and EPI-MAL- 003 studies before and after the introduction of the malaria vaccine RTS,S/AS01E in sub-Saharan Africa.
Temporal Strain Structure and Responses to Interventions in a High Endemicity Region of Plasmodium Falciparum.

MRS-CMRS (BONGO MALARIA)
  • Characterize diversity of P. falciparum reservoir using malariometrics and molecular diagnostic methods.
  • Investigate immune selected markers, ADR Markers and Neutrally Evolving Markers (microsatellites)

  • To extend longitudinal study in Bongo to monitor and evaluate malaria control programmes.

  • To combine theory with field and lab methodologies to generate new understandings of the reservoir of P. falciparum and its resilience to elimination.

  • Examine interactions between host genetic traits and how these influence susceptibilities and affect immune responses to P. falciparum.
“A parallel-group, Phase III, multi-stage, modified double- blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older as a primary series and open-label extension to assess immunogenicity, safety, efficacy of a monovalent booster dose of SARS-CoV2 Adjuvanted Recombinant Protein Vaccine”

(Sanofi VAT00008 Study)
  • Assess efficacy of the vaccines against the SARS-CoV-2-induced coronavirus infection compared to placebo.

  • Assess tolerability and safety of the vaccines against the SARS-CoV-2-induced coronavirus infection compared to placebo.

  • Assess immunogenicity of the vaccines against the SARS-CoV-2-induced coronavirus infection compared to placebo.
A Phase 1 Randomized, Blinded, Placebo-Controlled, Dose- Escalation and Dosing Regimen Selection Study to Evaluate the Safety and Immunogenicity of rVSV Vectored Lassa Virus Vaccine in Healthy Adults at Multiple Sites in West Africa.

(LASSA Fever study)
  • To evaluate safety and tolerability of increasing dose levels of EBS-LASV vaccine To evaluate humoral immune responses to EBS-LASV vaccine (i.e., LASV nAb and LASV-GP-specific IgG) at various dose levels and dosing schedules for the purpose of selecting two regimens (dose and schedule) for further evaluation in a Phase 2 study.
Integrating Point of Care Testing (POCT) Technology into Primary Care Settings to Advance the Diagnosis of Care of Children with Sickle Cell Disease.

(Sickle Cell Disease study)
  • To assess the feasibility and acceptability of integrating Gazelle for routine screening of newborns and toddlers in CHPS compounds and Immunization clinics.
YET TO COMMENCE
Name of Project Objective(s)
(PLATINUM): A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability, and pharmacokinetics of anti-malarial agents administered as monotherapy and/or combination therapy in patients with uncomplicated plasmodium falciparum Malaria. (PLATINUM Study)
  • To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria.
  • To assess the 28-day cure rate of an anti-malarial agent administered orally as a combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19. (Atea Study)
  • To evaluate the efficacy of bemnifosbuvir (BEM) compared with placebo in reducing all-cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care.
To evaluate the efficacy of bemnifosbuvir (BEM) compared with placebo in reducing all-cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care. (KALUMA Study)
  • To confirm the efficacy of KLU156 in adults and children ≥5 Kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P. falciparum (with or without other Plasmodium spp. Co-infection) by demonstrating that KLU156 is non-inferior to Coartem.
Phase III, randomized, observer-blind, placebo-controlled, multi-centre, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers.
A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19. (ACTIV 2D STUDY)
  • To determine if S-217622 will reduce the time to sustained symptom resolution through Day 29.
  • To determine the effect of S-217622 compared with placebo on the change from baseline in quantitative log10 SARS-CoV-2 RNA levels by PCR on NP swab on Day 4.
  • To determine whether S-217622 reduces COVID-19-related hospitalization (adjudicated) and all deaths regardless of occurrence outside of the hospital or during hospitalization (not adjudicated) through Day 29.
  • To determine if S-217622 will decrease the proportion of participants with detectable SARS-CoV-2 viral culture on NP swab on Day 4.