Partnership of Clinical Research in Guinea (PREGUI)

PREGUI is a collaborative biomedical research partnership established in 2015 between the National Institute of Allergy and Infectious Diseases (NIAID) and the Ministry of Health of the Republic of Guinea. The mission of PREGUI is to improve the health and welfare of the Guinean people and people worldwide by conducting and implementing a national and international high-quality research program while building and developing sustainable research capacity in-country.

The Partnership's primary goal is to build a sustainable and clinical research program in Guinea that leverages externally funded research collaborations and generates interest within the research community. The Partnership strives to identify and prioritize research topics and publish and disseminate knowledge that influences public health in Guinea. The Partnership has built a supportive environment that provides research training and development opportunities to clinicians and researchers to enhance the research capacity within Guinea.

Conakry, Guinea’s capital, and Maferinyah, a rural town in the Forecariah prefecture, were chosen as the sites for PREGUI operations. To support research implementation and conduct, core infrastructure and capacities were built at the existing Maferinyah Training and Research Center in Rural Health, including a clinical research unit, pharmacy, participant flow area, laboratory, training and conference rooms, and biorepository, as well as facilities (water, waste, electricity, storage) management, information management capabilities.

Assessments and discussions are underway with the network's leadership to evaluate the strategic plan and determine the best approaches to support PREGUI’s growth in its next phase.

Main Areas of Focus

The mission of the partnership is to conduct and implement a program of national and international, high-quality research on public health priorities in Guinea and build and develop sustainable research capacity.

Clinical Studies

PREVAIL II (NCT02363322): A 2015-2017, phase1/2, multicenter randomized safety and efficacy study of putative investigational therapeutics in treating patients with known Ebola infection, which enrolled 12 adults.

PREVAC (NCT02876328): A 2017-2023 randomized placebo-controlled study to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease events in children and adults that enrolled 1212 adults and 1115 children in Guinea.

PREVAIL IV (NCT02818582): A 2018-2020, phase 2, double-blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen

D2EFT (NCT03017872): A 2019-2023 multinational study that included 8 randomized adults with HIV seen at Maferinyah.

InVITE (NCT02876328A): 2021-2024 multinational study of COVID-19 vaccine immunogenicity and durability that enrolled 500 adults in Guinea.

Malaria Transmission (EDTCP) (NCT04969913): A 2022-2023 observational study dynamics of malaria transmission by estimating the rate of blood smear-positive people by month and season. The study enrolled 400 adults in Maferiyah.

Malaria Burden (NCT04105855): A 2020-2023 Observational study of Plasmodium and Other Parasites in Pregnant Women and Infants Around Maferinyah, Guinea, which enrolled 2000 adults and 1392 children.

DeTACT-Africa (NCT03923725): A 2020-2024, phase 3, partially blinded randomized controlled non-inferiority study comparing the efficacy, tolerability, and safety of four different antimalarial treatment combinations for the treatment of uncomplicated Plasmodium falciparum malaria that enrolled 420 children living in Maferinyah.

Measles West Africa 01 (NCT06153979): An ongoing observational study investigating the effects of measles virus (MeV) infection on pre-existing immunity, vaccine response, and susceptibility to subsequent illness in children aged 1-15 with or without acute MeV infection.

Publications

SARS-CoV-2 seroprevalence in vaccine-naïve participants from the Democratic Republic of Congo, Guinea, Liberia, and Mali, International Journal of Infectious Diseases, 2024

Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults, Clinical Infectious Diseases, 2024

Long-term cellular immunity of vaccines for Zaire Ebola Virus Diseases, Nature Portfolio, 2024

Challenges of conducting an international observational study to assess immunogenicity of multiple COVID-19 vaccines, PLoS Global Public Health, 2023

Immune response of a two-dose heterologous Ebola vaccine regimen: summary of three African clinical trials using a single validated Filovirus Animal Nonclinical Group enzyme-linked immunosorbent assay in a single accredited laboratory, eBioMedicine, 2023

Adaption of an ongoing clinical trial to quickly respond to gaps in changing international recommendations: the experience of D2EFT, HIV Research & Clinical Practice, 2022

Randomized Trial of Vaccines for Zaire Ebola Virus Disease, The New England Journal of Medicine, 2022

Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE), PLoS One, 2022

PREVAIL IV: A Randomized, Double-Blind, 2-Phase, Phase 2 Trial of Remdesivir vs Placebo for Reduction of Ebola Virus RNA in the Semen of Male Survivors, Clinical Infectious Diseases, 2021

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries, Trials, 2021

A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection, New England Journal of Medicine, 2016

Contact Information

For more information about PREGUI and the Collaborative Clinical Research Branch (CCRB), please email CCRB_INFO@niaid.nih.gov.

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