COVID-19NCT05124509
Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection, Solid Organ Transplant
- What is being tested?
- Three doses of SARS-CoV-2 BNT162b2 vaccine (observational) and Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)
- Type of treatment
- Vaccines
- How many people
- 147 participants
- Where
- 1 siteChile
- Study dates
- 6 Oct 2021to 3 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
Who may be able to join
- Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccines, followed by a booster dose (3d dose) of BNT162b2 vaccine administered in the previous 8-12 weeks.
Who cannot join
- Previous SARS-CoV-2 infection
- Booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment
- Intravenous immunoglobulin therapy 60 days before enrolment
- Previous SARS-CoV-2 vaccine different from CoronaVac or BNT162b2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients.
This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines.
- Being tested
- Three doses of SARS-CoV-2 BNT162b2 vaccine (observational), Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three doses of SARS-CoV-2 BNT162b2 vaccine (observational)Biological
Two doses of SARS-CoV-2 BNT162b2 mRNA vaccine, followed by a booster (3rd) dose of SARS-CoV-2 BNT162b2 mRNA vaccine.
Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)Biological
Two doses of CoronaVac SARS-CoV-2 inactivated vaccine, followed by a booster (3rd) dose of BNT162b2 mRNA vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Three doses of BNT162b2 vaccine | Solid organ transplant patients who received three doses of BNT162b2 Receives: Biological: Three doses of SARS-CoV-2 BNT162b2 vaccine (observational) | |
| Two doses of Coronavac and one of BNT162b2 vaccine | Solid organ transplant patients who received two doses of CoronaVac and one dose of BNT162b2 Receives: Biological: Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.
Measured: 8-12 weeks after booster vaccine
Secondary outcomes (2)
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.
Measured: 8-12 weeks after booster vaccine
Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.
Measured: 8-12 weeks after booster vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start6 Oct 2021
- Primary completion13 Dec 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124509
- Sponsor's protocol ID
- 210405014E
- Status last verified
- Jan 2022
- First submitted
- 15 Nov 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized IPD may be shared under institutional request if IRB requirements are met.
Publications
Dib M, Le Corre N, Ortiz C, Garcia D, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ojeda MJ, Espinoza MA, Jara A, Arab JP, Rabagliati R, Vizcaya C, Ceballos ME, Sarmiento M, Mondaca S, Vinuela M, Pastore A, Szwarcfiter V, Galdames E, Barrera A, Castro P, Galvez NM, Soto JA, Bueno SM, Kalergis AM, Nervi B, Balcells ME. SARS-CoV-2 vaccine booster in solid organ transplant recipients previously immunised with inactivated versus mRNA vaccines: A prospective cohort study. Lancet Reg Health Am. 2022 Dec;16:100371. doi: 10.1016/j.lana.2022.100371. Epub 2022 Sep 23.
PubMed 36185969
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT05124509
- Acronym / sponsor ID
- 210405014E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients.
This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three doses of BNT162b2 vaccine | – | Biological: Three doses of SARS-CoV-2 BNT162b2 vaccine (observational)Solid organ transplant patients who received three doses of BNT162b2 |
| Two doses of Coronavac and one of BNT162b2 vaccine | – | Biological: Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)Solid organ transplant patients who received two doses of CoronaVac and one dose of BNT162b2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
Key inclusion criteria (2 listed)
- Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccines, followed by a booster dose (3d dose) of BNT162b2 vaccine administered in the previous 8-12 weeks.
Key exclusion criteria (4 listed)
- Previous SARS-CoV-2 infection
- Booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment
- Intravenous immunoglobulin therapy 60 days before enrolment
- Previous SARS-CoV-2 vaccine different from CoronaVac or BNT162b2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three doses of SARS-CoV-2 BNT162b2 vaccine (observational)Two doses of SARS-CoV-2 BNT162b2 mRNA vaccine, followed by a booster (3rd) dose of SARS-CoV-2 BNT162b2 mRNA vaccine. | Biological | Three doses of BNT162b2 vaccine |
| Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)Two doses of CoronaVac SARS-CoV-2 inactivated vaccine, followed by a booster (3rd) dose of BNT162b2 mRNA vaccine. | Biological | Two doses of Coronavac and one of BNT162b2 vaccine |
Primary outcome
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.
Time frame: 8-12 weeks after booster vaccine
2 secondary outcomes
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.
Time frame: 8-12 weeks after booster vaccine
Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.
Time frame: 8-12 weeks after booster vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 36185969Dib M, Le Corre N, Ortiz C, Garcia D, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ojeda MJ, Espinoza MA, Jara A, Arab JP, Rabagliati R, Vizcaya C, Ceballos ME, Sarmiento M, Mondaca S, Vinuela M, Pastore A, Szwarcfiter V, Galdames E, Barrera A, Castro P, Galvez NM, Soto JA, Bueno SM, Kalergis AM, Nervi B, Balcells ME. SARS-CoV-2 vaccine booster in solid organ transplant recipients previously immunised with inactivated versus mRNA vaccines: A prospective cohort study. Lancet Reg Health Am. 2022 Dec;16:100371. doi: 10.1016/j.lana.2022.100371. Epub 2022 Sep 23.
- Individual participant dataSharing planned: Undecided. Anonymized IPD may be shared under institutional request if IRB requirements are met.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine. (time frame: 8-12 weeks after booster vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.