Trials / Unknown
UnknownNCT05409261
Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine
Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali
- 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, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
Detailed description
The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations. 200 participants will be included, 200 participants for each vacine. 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. Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL. Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.COV2.S | Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein |
Timeline
- Start date
- 2022-06-02
- Primary completion
- 2022-09-25
- Completion
- 2025-03-01
- First posted
- 2022-06-08
- Last updated
- 2024-03-27
Locations
1 site across 1 country: Mali
Source: ClinicalTrials.gov record NCT05409261. Inclusion in this directory is not an endorsement.