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Phase IIB Study of Recombinant Novel Coronavirus Vaccine

NCT05293223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-06-25

No results posted yet for this study

Summary

This is an open-label and non-randomized study to demonstrate the immunogenicity and safety profile in adults that received the Ad5-nCoV vaccine at least 21 days but no later than 90 days after the first dose of Sputnik V.

The non-inferiority hypothesis is used for the evaluation of the exploratory objective. The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.

It is assumed to enroll about 100 subjects for each group. Additionally, 45 participants will be selected from Group A (to enter the immunogenicity subgroup for cellular immune response analysis. According to the above, considering extra subjects for compensating about 10% dropouts, the sample size of Group A is designed to be 450, for Group B is 200. Participants enrolled in Group A (1st dose of Sputnik V plus 1 dose of Ad5-nCoV) must have only received the 1st dose of Sputnik V and the interval between the previous injection (1st dose of Sputnik V) and the day of vaccination with Ad5-nCoV should be between 21 and 90 days. The comparator (Group B) will be the samples stored at the immunology lab of the Buenos Aires University Medical School, corresponding to individuals vaccinated with 2 doses of Sputnik V.

UPDATE : It's worth noting that enrollment number during the study was lower than the originallyplanned. According to the Protocol Group A sample size was designed to be 450. A low enrollment rate due to a fast vaccination rate (second dose) through the national COVID vaccination campaign for the entire population of Argentina resulted in difficulties in reaching the sample size planned. (the final number of participants enrolled and vaccinated in the study was 86 in arm A ).The enrollment period was affected due to the fast expansion of the National Vaccination Plan and the opportunity for potential participants to access it. Therefore, it was not possible to achieve the number of enrolled participants that was planned at the beginning of the study (450).

Conditions

  • COVID-19 Vaccine

Interventions

BIOLOGICAL

Ad5-nCov

Participants enrolled in Group A with only the 1st dose of Sputnik V will receive Ad5-nCoV vaccine at least 21 days but no more than 180 days after the first dose. They will be followed to evaluate the immunogenicity and safety of Ad5-nCoV vaccine during 6 months

Sponsors & Collaborators

  • Dalhousie University

    collaborator OTHER

  • CanSino Biologics Inc.

    collaborator INDUSTRY

  • Fundación Huésped

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-11-15
Completion
2023-12-15

Countries

  • Argentina

Study Locations

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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 NCT05293223 on ClinicalTrials.gov