Solidarity trial of candidate vaccines against COVID-19

Phase 3

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN15779782
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-08
• Last Update Posted: 5 August 2024
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

1. Male or female participants between the ages of 16 and above at randomization
2. Living in the area and planning to reside in the area for at least 6 months
3. Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent as described in SOP-03
4. Healthy participants who are determined by the clinical judgment of the investigator to be eligible for inclusion in the study
5. Participants who are willing and able to comply with all scheduled visits, vaccination plans, laboratory tests (if randomised and consent given, lifestyle considerations, and other study procedures

Exclusion Criteria

1. Previous laboratory-confirmed diagnosis of COVID 19.
2. Previous vaccination with any COVID-19 vaccine.
3. Receipt of medications intended to prevent COVID 19.
4. Participation in other studies involving a study intervention within 28 days prior to study entry and/or during study participation.
5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
6. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
8. Women who are pregnant or breastfeeding will be informed that there is no data on the safety of these vaccines among these groups and will be given the opportunity to decide if they are willing to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virologically confirmed COVID-19 disease, through SARS-CoV2 RNA isolation and RRT-PCR amplification in oro-nasopharyngeal specimen, regardless of disease severity, at 14, 180, 365 days after the last dose.

Secondary Outcome Measures

Name	Time	Method
Measured at dose 1, dose 2, 7, 180, and 365 days after dose 2:<br>1. Serious adverse events (SAEs), adverse events of special interest (AESIs) as requested, collected for all participants throughout the study.<br>2. Severe COVID-19 (as per WHO classification) and death with recently confirmed COVID-19.<br>3. COVID-19 and severe COVID-19 diagnosed starting 14 days after the final dose through the final study visit.<br>4. SARS-CoV-2-specific neutralization antibody, binding antibody, and T-cell immune responses measured using blood test in a subset of participants at selected sites.<br>5. COVID-19 viral load and other disease progression biomarkers measured using blood test.