NCT04916886

A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.

Completed NA Last updated 8 February 2023

What this trial tests

NA trial testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml in COVID-19 in 2,021 participants. Completed in 31 July 2022.

Timeline

3 June 2021

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	CanSino Biologics Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	2,021
Start date	3 June 2021
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across China

Drugs / interventions tested

• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml — full drug profile →
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

CanSino Biologics Inc. — full company profile →

Who can join

Adults 6 to 59, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
2. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
   Luxi N, Giovanazzi A, Capuano A, Crisafulli S, et al · · 2021 · cited 98× · PMID 34739716 · DOI 10.1007/s40264-021-01131-6
3. Current advances and challenges in COVID-19 vaccine development: from conventional vaccines to next-generation vaccine platforms.
   Jafari A, Danesh Pouya F, Niknam Z, Abdollahpour-Alitappeh M, et al · · 2022 · cited 27× · PMID 35235159 · DOI 10.1007/s11033-022-07132-7
4. COVID-19: Clinical status of vaccine development to date.
   Kumar S, Basu M, Ghosh P, Ansari A, et al · · 2023 · cited 17× · PMID 36184710 · DOI 10.1111/bcp.15552
5. Antiviral fungal metabolites and some insights into their contribution to the current COVID-19 pandemic.
   Takahashi JA, Barbosa BVR, Lima MTNS, Cardoso PG, et al · · 2021 · cited 9× · PMID 34438338 · DOI 10.1016/j.bmc.2021.116366
6. Pooled Analysis of the Effect of Pre-Existing Ad5 Neutralizing Antibodies on the Immunogenicity of Adenovirus Type 5 Vector-Based COVID-19 Vaccine from Eight Clinical Trials.
   Liu W, Li Y, Li X, Wang F, et al · · 2025 · cited 1× · PMID 40266233 · DOI 10.3390/vaccines13030333
7. Immunogenicity, Safety, and Immune Persistence of One Dose of SARS-CoV-2 Recombinant Adenovirus Type-5 Vectored Vaccine in Children and Adolescents Aged 6-17 Years: An Immunobridging Trial.
   Han X, Wei M, Zheng X, Wan P, et al · · 2024 · cited 1× · PMID 38932412 · DOI 10.3390/vaccines12060683