NHRCIRB

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.