NCT05409300

Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea

Phase II Trial Evaluating the Immunogenicity and Safety of BBIBP-CorV Vaccine in Adults in Guinea

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.

Detailed description

The main objective of this phase II trial is to evaluate the humoral immune response induced by the BBIBP-CorV vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, comparing younger (up to 45 years old) and elderly (55+ years old) populations. 200 participants will be included. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines. Participants will receive two doses of BBIBP-CorV at 28 days interval. Vaccines will be administered intramuscular (0.5mL per injection) Humoral vaccine immune responses, induced by BBIBP-CorV will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

Conditions

• COVID-19
• Vaccine Adverse Reaction
• Sars-CoV-2 Infection
• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	BBIBP-CorV	Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide

Timeline

• Start date: 2022-04-25
• Primary completion: 2023-08-03
• Completion: 2025-02-01
• First posted: 2022-06-08
• Last updated: 2024-03-27

Locations

2 sites across 1 country: Guinea