Covid19Phase 2COVACNCT04800133
Covid-19 Vaccination in Adolescents and Children
A Phase 2 study testing Tozinameran, CoronaVac and CoronaVac, intradermal in people with Covid19, run by The University of Hong Kong at 1 site in China.
Trial summary
Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity… Read more about this study
- Who is it for?
- Ages 0 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Tozinameran, CoronaVac and CoronaVac, intradermal
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,018 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2021to 31 Mar 2025
- Phase
- Phase 2
- 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 0 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- informed consent from the parents or a legally acceptable representative for an underage participant
- biological parents of students enrolled in the trial or unrelated healthy adults
- ability to adhere to the follow-up schedules
- willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively
- willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)
- good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders
- prior COVID-19 (for COVID-19 survivor subgroup)
Who cannot join
- 1. reported pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Reactogenicity and Immunogenicity of Recommended COVID-19 Vaccines in Young Adolescents and Children in Hong Kong
Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.
Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.
Read more
Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)
Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.
Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route
Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.
- Conditions
- Covid19
- Being tested
- Tozinameran, CoronaVac, CoronaVac, intradermal
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TozinameranBiological
Also called BNT162b2
mRNA vaccine developed by BioNTech against COVID-19
CoronaVacBiological
Inactivated virus vaccine developed by SinoVac against COVID-19, intramuscular
CoronaVac, intradermalBiological
Inactivated virus vaccine developed by SinoVac against COVID-19, intradermal
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2 (adult/adolescent) | Experimental | BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (or intradermal for immunocompromised patients; or by graded challenge with history of non-severe allergy to PEG-containing drugs) 30ug/0.3ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19 Receives: Biological: Tozinameran |
| CoronaVac (intramuscular) | Experimental | CoronaVac by SinoVac Intramuscular injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19 Receives: Biological: CoronaVac |
| CoronaVac (intradermal) | Experimental | CoronaVac by SinoVac Intradermal injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19 Receives: Biological: CoronaVac, intradermal |
| BNT162b2 (paediatric) | Experimental | BNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (for immunocompromised patients only) 10ug/0.1ml per dose 4 doses for immunocompromised patients Receives: Biological: Tozinameran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions
Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days
Measured: 7 days post-doses 1, 2 and 3 (and 4)
Binding antibody response
Geometric mean levels of SARS-CoV2 S and S-RBD-specific binding antibody and related markers as determined by Enzyme-linked Immunosorbent Assay
Measured: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Neutralizing antibody response
Geometric mean levels and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay and surrogate assays
Measured: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
T cell response
Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S (and N and M) protein
Measured: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Secondary outcomes (3)
Vaccine breakthrough
Incidence of COVID-19 in participants throughout study period as self-reported or as determined by Luciferase Immunoprecipitation Systems assay/ELISA
Measured: Throughout the study period, until 36 months post-dose 3/4
Adverse events
Percentage of occurrence, types, duration and severity of adverse events and severe adverse events throughout study period
Measured: Throughout the study period, until 36 months post-dose 3/4
Binding anti-N antibody response
Geometric mean levels and geometric mean fold rise of SARS-CoV2 N-specific binding antibody as determined by Enzyme-linked Immunosorbent Assay in Arm C participants receiving CoronaVac
Measured: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start8 May 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
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 Covid19Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Lung Lau, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800133
- Sponsor's protocol ID
- COVAC01
- Acronym
- COVAC
- Status last verified
- Dec 2023
- First submitted
- 1 Mar 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosa Duque JS, Wang X, Leung D, Cheng SMS, Cohen CA, Mu X, Hachim A, Zhang Y, Chan SM, Chaothai S, Kwan KKH, Chan KCK, Li JKC, Luk LLH, Tsang LCH, Wong WHS, Cheang CH, Hung TK, Lam JHY, Chua GT, Tso WWY, Ip P, Mori M, Kavian N, Leung WH, Valkenburg S, Peiris M, Tu W, Lau YL. Immunogenicity and reactogenicity of SARS-CoV-2 vaccines BNT162b2 and CoronaVac in healthy adolescents. Nat Commun. 2022 Jun 28;13(1):3700. doi: 10.1038/s41467-022-31485-z.
PubMed 35764637
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Reactogenicity and Immunogenicity of Recommended COVID-19 Vaccines in Young Adolescents and Children in Hong Kong
- ClinicalTrials.gov ID
- NCT04800133
- Acronym / sponsor ID
- COVAC / COVAC01
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 8 May 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Mar 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.
Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.
Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.
Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)
Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.
Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route
Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BNT162b2 (adult/adolescent) | Experimental | Biological: TozinameranBNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (or intradermal for immunocompromised patients; or by graded challenge with history of non-severe allergy to PEG-containing drugs) 30ug/0.3ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19 |
| CoronaVac (intramuscular) | Experimental | Biological: CoronaVacCoronaVac by SinoVac Intramuscular injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19 |
| CoronaVac (intradermal) | Experimental | Biological: CoronaVac, intradermalCoronaVac by SinoVac Intradermal injection 3ug/0.5ml per dose 3 doses, or 4 for immunocompromised patients; or 1/2 dose for patients with prior COVID-19 |
| BNT162b2 (paediatric) | Experimental | Biological: TozinameranBNT162b2, tozinameran by Fosun/BioNTech Intramuscular injection (for immunocompromised patients only) 10ug/0.1ml per dose 4 doses for immunocompromised patients |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- informed consent from the parents or a legally acceptable representative for an underage participant
- biological parents of students enrolled in the trial or unrelated healthy adults
- ability to adhere to the follow-up schedules
- willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively
- willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable)
Key exclusion criteria (1 listed)
- 1. reported pregnancy or breastfeeding
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 |
|---|---|---|
| TozinameranAlso: BNT162b2mRNA vaccine developed by BioNTech against COVID-19 | Biological | BNT162b2 (adult/adolescent), BNT162b2 (paediatric) |
| CoronaVacInactivated virus vaccine developed by SinoVac against COVID-19, intramuscular | Biological | CoronaVac (intramuscular) |
| CoronaVac, intradermalInactivated virus vaccine developed by SinoVac against COVID-19, intradermal | Biological | CoronaVac (intradermal) |
Primary outcome
Adverse reactions
Time frame: 7 days post-doses 1, 2 and 3 (and 4)
Percentage of occurrence, types, duration and severity of adverse reactions occurring within 7 days
Binding antibody response
Time frame: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Geometric mean levels of SARS-CoV2 S and S-RBD-specific binding antibody and related markers as determined by Enzyme-linked Immunosorbent Assay
Neutralizing antibody response
Time frame: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Geometric mean levels and geometric mean fold rise of SARS-CoV2 neutralizing antibodies as determined by plaque reduction neutralization assay and surrogate assays
T cell response
Time frame: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Geometric mean percentage of CD4 and CD8 T cells specific to SARS-CoV2 S (and N and M) protein
3 secondary outcomes
Vaccine breakthrough
Time frame: Throughout the study period, until 36 months post-dose 3/4
Adverse events
Time frame: Throughout the study period, until 36 months post-dose 3/4
Binding anti-N antibody response
Time frame: 1 month post-dose 1, and 1, 6, 18, and 36 months post-dose 3 (and 2 weeks after dose 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 35764637Rosa Duque JS, Wang X, Leung D, Cheng SMS, Cohen CA, Mu X, Hachim A, Zhang Y, Chan SM, Chaothai S, Kwan KKH, Chan KCK, Li JKC, Luk LLH, Tsang LCH, Wong WHS, Cheang CH, Hung TK, Lam JHY, Chua GT, Tso WWY, Ip P, Mori M, Kavian N, Leung WH, Valkenburg S, Peiris M, Tu W, Lau YL. Immunogenicity and reactogenicity of SARS-CoV-2 vaccines BNT162b2 and CoronaVac in healthy adolescents. Nat Commun. 2022 Jun 28;13(1):3700. doi: 10.1038/s41467-022-31485-z.
- Individual participant dataSharing planned: No
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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.
Yu Lung Lau, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tozinameran, CoronaVac and CoronaVac, intradermal in people with Covid19, run by The University of Hong Kong at 1 site in China.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Adverse reactions (time frame: 7 days post-doses 1, 2 and 3 (and 4)). The study lists 4 primary outcomes in all. 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 NCT04800133, 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 16 Jan 2024.