Clinical trials

The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali. This first-in-human study is intended to obtain initial data on the safety of the adjuvanted IP-QSV vaccine and its effect on immune responses in a Shigella-endemic region.

This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.

The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine/Dukoral®. The participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination. The study is funded by Wellcome Trust, grant number : 226726/Z/22/Z.

This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.

The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.

This Phase I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.

This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC. This study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out: * Community engagement * Enhanced health facility-based mpox disease surveillance * Vaccination using the LC16m8 vaccine * Safety monitoring following immunization * LC16m8 Vaccine effectiveness evaluation using a TND Study Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.

This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals

This is Phase I, randomized, open-label, active-controlled study to evaluate the safety, tolerability, and immunogenicity of a hepatitis B vaccine administered trans-dermally via microneedle array patch (MAP) compared to the intra-muscular (IM) hepatitis B vaccine (Euvax B™), administered at Day (D) 0, Week (W) 4, W26 among healthy adults aged 19 to 40 years in the Republic of Korea.

This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.