Sinopharm-SOBERANA COVID-Cienfuegos

Immunogenicity evaluation of the heterologous combination of two doses of SINOPHARM and one dose of SOBERANA Plus: a post-authorization study for emergency use (COVID-19) - Sinopharm-SOBERANA COVID-Cienfuegos

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000408

Enrollment

202

Registered

2022-08-30

Start date

2021-09-14

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Vaccine SINOPHARM (6.5 U/dose of antigens from the inactivated virus SARS-CoV-2), Intramuscular (IM), 0.5 mL, 0 – 21 days + vaccine SOBERANA Plus (50 µg of d-RBD+ Gel of alumine hydroxide, IM, 0.5 mL)

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

SOBERANA Plus SINOPHARM

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.- Subjects with 19 years or more, who were eligible for vaccination with SINOPHARM and SOBERANA Plus in the province of Cienfuegos. 2.- Subjects who give informed consent for blood extraction at the scheduled times.

Exclusion criteria

Exclusion criteria: 1.- Pregnancy, puerperium or lactation. 2.- Subjects with a history of having suffered from COVID-19

Design outcomes

Primary

Measure	Time frame
Concentration of specific anti-RBD IgG antibodies. Measurement time: Day 42, 63	—

Secondary

Measure	Time frame
% ACE2-RBD inhibition: Measurement time: Day 42, 63 Neutralizing antibody titer: Measurement time: Day 42, 63 (sample subset).	—

Countries

Cuba

Contacts

Public ContactMaria Toledo Romani

"Pedro Kouri" Institute of Tropical Medicine

mariaeugenia@ipk.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026