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Search / Trial NCT06266754

The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau

Launched by BANDIM HEALTH PROJECT · Feb 11, 2024

Trial Information

Current as of November 08, 2025

Enrolling by invitation

Keywords

Oral Polio Vaccine Trained Immunity

ClinConnect Summary

This study is a randomized, double-blind trial to see if a single dose of oral polio vaccine (OPV) given to men aged 50 and older in Guinea-Bissau can have non-specific, or broader, benefits for the immune system. Researchers want to know if OPV can “train” the innate immune system (a kind of general immune readiness), lower levels of inflammatory markers in the body, and cause changes in immune cells’ genes and activity. There are two small sub-studies using blood tests to explore these immune changes one month after vaccination.

Participation is limited to men 50 or older who live in the Bandim Health Project area near Bissau, have a visible BCG scar, and have no history of adverse reactions to OPV or signs of an active infection. Participants will be randomly assigned to receive either OPV or a saline placebo (2 drops on a sugar lump) in a process kept blind to participants and some study staff. About 80 people are planned to enroll, with follow-up blood tests about a month after the dose to measure immune responses. The study is being conducted in Guinea-Bissau, with results not yet available.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Male.
  • Living in a household which had a Bandim Health Project census visit conducted after 1 January 2017.
  • Age above 50.
  • Has a visible BCG scar.
  • Exclusion Criteria:
  • Previous adverse events to OPV
  • Suspicion of active viral/bacterial/HIV infection.

About Bandim Health Project

The Bandim Health Project is a leading research initiative based in Guinea-Bissau, dedicated to improving public health outcomes through rigorous scientific investigation. Established in collaboration with local health authorities and international partners, the project focuses on a wide range of health issues, including disease prevention, maternal and child health, and infectious diseases. With a commitment to evidence-based practices, the Bandim Health Project conducts clinical trials and observational studies to inform healthcare policies and interventions, ultimately aiming to enhance health services and promote well-being in the region. Through its innovative research and community engagement, the project plays a crucial role in advancing global health knowledge and practices.

Locations

Bissau, Guinea Bissau

Patients applied

0 patients applied

Trial Officials

Anne Marie R Madsen, MD, PhD

Principal Investigator

Bandim Health Project

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported