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Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine

NCT05409261 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-27

No results posted yet for this study

Summary

Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.

Conditions

  • COVID-19
  • Vaccine Reaction
  • SARS CoV 2 Infection
  • Vaccine Adverse Reaction

Interventions

BIOLOGICAL

Ad26.COV2.S

Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein

Sponsors & Collaborators

  • CEPI

    collaborator OTHER

  • Innovative clinical research network in vaccinology (IREIVAC)

    collaborator UNKNOWN

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • APHP

    collaborator OTHER

  • Center for Vaccine Development - Mali

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Odile Launay · Innovative clinical research network in vaccinology (I-REIVAC)

  • Samba Sow · Center for Vaccine Development-Mali (CVD-Mali)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2022-09-25
Completion
2025-03-31

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05409261 on ClinicalTrials.gov