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Phase IIb Trial of Recombinant Novel Coronavirus Vaccine (Ad5-nCoV) in Adults 18 Years of Age and Older, Living With HIV

NCT05005156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2025-06-25

No results posted yet for this study

Summary

A randomized, double-blind, placebo -controlled, phase IIb clinical trial to evaluate the efficacy, safety and immunogenicity of one or two doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years of age and older, living with HIV, on stable treatment, and virologically suppressed for at least 6 months

Protocol number: FH-58

Conditions

  • Covid19

Interventions

BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)

All participants will receive two doses vaccine and will be followed to monitor vaccine candidate safety, immunogenicity, and efficacy for a duration of 52 weeks. Fifty four days after the first vaccination, all participants will receive a second injection.

Sponsors & Collaborators

  • Canadian Center for Vaccinology

    collaborator OTHER

  • CanSino Biologics Inc.

    collaborator INDUSTRY

  • Hospital Fernandez

    collaborator OTHER

  • Fundación Huésped

    lead OTHER

Principal Investigators

  • Pedro Cahn, MD:PhD · fundacion huesped

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2023-01-13
Completion
2023-01-13

Countries

  • Argentina

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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 NCT05005156 on ClinicalTrials.gov