Solidarity trial of candidate vaccines against COVID-19
| ISRCTN | ISRCTN15779782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15779782 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | World Health Organization |
| Funder | World Health Organization |
- Submission date
- 03/08/2021
- Registration date
- 08/10/2021
- Last edited
- 25/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This large, international, randomized controlled clinical trial is designed to enable an expeditious, agile, and concurrent evaluation of the benefits and risks of multiple candidate preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. The trial is designed to provide sufficient evidence of safety and vaccine efficacy against COVID-19 to support decision-making about global vaccine deployment, which may include licensure and/or WHO pre-qualification. Final decisions about COVID-19 deployment will be made in each jurisdiction.
Simplicity of procedures: Within each country, the investigator invites selected sites and helps them get ethical and regulatory approval and study vaccines, then volunteers’ recruitment can begin. To facilitate collaboration, volunteer enrolment and randomisation (via a cloud-based GCP-compliant platform) and all other trial procedures are greatly simplified, and no paperwork is required. Once consent has been obtained, electronic entry of anonymised details of a few key characteristics of each volunteer takes only a few minutes. At the end of a patient's entry, a random vaccine allocation is generated.
Who can participate?
Adults (age ≥ 16 years), capable of giving personal signed informed consent, healthy participants who are determined by the clinical judgment of the investigator to be eligible for inclusion in the study.
What does the study involve?
Trial entry, randomization: Once electronic data collection has been completed the volunteer automatically enters the trial and a random allocation of their trial vaccine is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study vaccines and its placebos) and displayed. The volunteers will be randomly allocated either to placebo or to one of the study vaccines.
Follow-up: Each participant will be contacted weekly for 52 weeks for information as to whether any potentially relevant symptoms have arisen, with laboratory testing triggered if the report suggests COVID-19.
What are the possible benefits and risks of participating?
Safety: Evaluation of COVID-19 vaccine safety is one of the primary objectives of this trial. All sites will monitor and report serious adverse events (SAEs) at any time after vaccination, by baseline SARS-CoV-2 serostatus where available.
Where is the study run from?
World Health Organization (Switzerland)
When is the study starting and how long is it expected to run for?
August 2021 to September 2023
Who is funding the study?
World Health Organization (Switzerland)
Who is the main contact?
Dr Ana Maria Henao Restrepo, henaorestrepoa@who.int
Contact information
Scientific
Medical Officer
HQ/RDB R&D Blue Print
(HQ/HEO/RDB)
World Health Organization HQ
Geneva
1211
Switzerland
 ORCID ID |
0000-0001-9910-7999 |
|---|---|
| Phone | +41 795130039 |
| henaorestrepoa@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | An international randomised trial of candidate vaccines against COVID-19 |
| Study acronym | SOLIDARITY Vaccine Trial |
| Study objectives | This large, international, randomized controlled clinical trial is designed to enable an expeditious, agile, and concurrent evaluation of the benefits and risks of multiple preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. The trial is designed to provide sufficient evidence of safety and vaccine efficacy against COVID-19 to support decision-making about global vaccine deployment, which may include licensure and/or WHO pre-qualification. Final decisions about COVID-19 deployment will be made in each jurisdiction. |
| Ethics approval(s) | Approved 01/06/2022, WHO Ad Hoc COVID-19 Research Ethics Review Committee (World Health Organization, 20, Avenue Appia, Geneva 1211, Switzerland; +41 (0)22 791 2174; ersec@who.int, mumforde@who.int), ref: not applicable |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Four vaccine candidates selected for evaluation. Candidate vaccines are selected on a rolling basis by the WHO Working Group on vaccine prioritization Trial entry, randomization: Once electronic data collection has been completed the volunteer automatically enters the trial and a random allocation of their trial vaccine is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study vaccines and its placebos) and displayed. The volunteers will be randomly allocated either to placebo or to one of the study vaccines. Follow-up: Each participant will be contacted weekly for 52 weeks for information as to whether any potentially relevant symptoms have arisen, with laboratory testing triggered if the report suggests COVID-19. Adaptive design: A global Data Monitoring Committee will keep the accumulating safety results and major outcome results under regular review. Different candidate vaccines may be available or suitable to enter the trial at different times; for each candidate vaccine, the primary efficacy results are expected within 3-6 months of the vaccine entering the trial. By using a shared placebo/control group and a common Core protocol to evaluate multiple candidate vaccines in the trial, resources allocated to the evaluation of each candidate vaccine are judiciously saved while a high standard of scientific rigor and efficiency is ensured. Add-on studies: Particular countries, or particular groups of sites, may want to collaborate in making further measurements or observations. These could be thought of as Phase 2b trials that are being conducted concurrently with the Phase 3 trial. However, while well-organised additional research studies of additional secondary and supportive endpoints, for which monitoring is valuable but optional at each study site include infection with SARS-CoV-2, trans-mission of SARS-CoV-2, and possible immunological markers as correlates of risk could well be valuable, they are not core requirements in every site. |
| Intervention type | Biological/Vaccine |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Candidate Vaccines |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Measured at dose 1, dose 2, 7, 180, and 365 days after dose 2: |
| Completion date | 30/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 80000 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/08/2023 |
Locations
Countries of recruitment
- Colombia
- Kenya
- Mali
- Philippines
- Sierra Leone
- Switzerland
Study participating centre
1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. After the trial has ended and its results have been reported, anonymized data sharing will occur as per the Policy Statement on Data Sharing by the World Health Organization (https://www.who.int/ihr/procedures/SPG_data_sharing.pdf?ua=1&ua=1) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2.0 | 14/06/2021 | 16/09/2021 | No | No |
| Protocol file | version 4.1 | 20/05/2022 | 12/09/2022 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40252 WHO COVID-2019_SolidarityVaccineTrial_Protocol_v2.0_14June2021.pdf
- Protocol file
- ISRCTN15779782_PROTOCOL_V4.1_20May22.pdf
- Protocol file
Editorial Notes
25/07/2024: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2023 to 30/10/2024.
2. The countries of recruitment Colombia, Kenya, Mali, Philippines, Sierra Leone were added.
12/09/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer reviewed).
2. Ethics approval details added.
3. The recruitment end date was changed from 01/09/2023 to 01/08/2023.
08/09/2022: Trial website added. The recruitment end date was changed from 01/09/2022 to 01/09/2023.
18/07/2022: The intention to publish date was changed from 01/07/2022 to 31/01/2023.
21/10/2021: The participant information sheet was removed.
16/09/2021: Trial's existence confirmed by World Health Organization
