COVID-19Phase 3CurumimNCT05225285
Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents
A Phase 3 study testing Inactivated Coronavac/Butantan vaccine and BNT162b2 (Pfizer) in people with COVID-19, run by Federal University of Espirito Santo at 1 site in Brazil.
Trial summary
To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2. Read more about this study
- Who is it for?
- Ages 3 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Inactivated Coronavac/Butantan vaccine and BNT162b2 (Pfizer)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jan 2022to 21 Mar 2023
- Phase
- Phase 3
- 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 3 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 3 and 17 years old (VACC and BNTC groups)
- Age between 18 and 49 years old (ADU group)
Who cannot join
- Pregnant teenagers;
- History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine;
- Have previously received a vaccine against COVID-19;
- Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C);
- Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Valéria Valim
Vitória, Espírito Santo, 29041-295
Valeria Valim, PhD, +55 27 3315-7899, val.valim@gmail.com
Carolina SE Gadelha, MSc, +55 27 99309-7010, carolina.pneumoped@gmail.com
About this study
Official title: Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project
To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.
Read the detailed description
Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC, N=320). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU, N=160). The main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by RT-PCR, the cellular immune response and frequency of adverse events. Outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. The study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received Coronavac and compared to children vaccinated with the immunizing BNT162b2 (Pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.
- Conditions
- COVID-19
- Being tested
- Inactivated Coronavac/Butantan vaccine, BNT162b2 (Pfizer)
- Keywords
- covid-19, Vaccine, Children, Coronavac, Vero Cell
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Coronavac/Butantan vaccineBiological
Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart
BNT162b2 (Pfizer)Biological
BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| VACC | Experimental | This group will receive the inactivated Coronavac/Butantan vaccine. Receives: Biological: Inactivated Coronavac/Butantan vaccine |
| BNTC | Active comparator | This group will receive the immunizing BNT162b2 (Pfizer). Receives: Biological: BNT162b2 (Pfizer) |
| ADU | Active comparator | This group of adults participants will receive the inactivated Coronavac/Butantan vaccine. Receives: Biological: Inactivated Coronavac/Butantan vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral neutralization assay
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive.
Measured: 3 months
Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S)
Results are expressed in AU/mL and data interpretation will be as follows: <50 AU/mL = negative; ≥50 U/mL = positive.
Measured: 3 months
Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2
Results will be expressed as fluorescence intensity or pg/mL. The cutoff is 1.4 and <1.4 = negative; ≥1.4 = positive.
Measured: 3 months
Dosage of systemic soluble factors
Chemokines, cytokines and growth factors - biomarkers of humoral and cellular response. Results will be expressed in pg/mL.
Measured: 12 months
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Measured: 2 months
T lymphocytes
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Measured: 12 months
B lymphocytes
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Measured: 12 months
intracytoplasmic cytokines
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Measured: 12 months
Secondary outcomes (2)
RT-PCR confirmed cases
Cases confirmed by RT-PCR, whose signs/symptoms have started 15 days after the second dose of vaccine, over 6 months after receiving the vaccine.
Measured: 6 months
Adverse events
Surveillance of adverse post-vaccine events (PVAE) and adverse events of special interest (EAIE) will be carried out.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start21 Jan 2022
- Primary completion21 Jun 2022 (estimated)
- Study completion21 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto René Rachou (IRR), Butantan Institute, Secretaria de Estado da Saúde do Espírito Santo - SESA
- Responsible party
- Principal investigator, Valéria Valim, Federal University of Espirito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225285
- Sponsor's protocol ID
- FUES04
- Acronym
- Curumim
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project
- ClinicalTrials.gov ID
- NCT05225285
- Acronym / sponsor ID
- Curumim / FUES04
- Conditions
- COVID-19
- Keywords
- covid-19, Vaccine, Children, Coronavac, Vero Cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Collaborators
- Instituto René Rachou (IRR), Butantan Institute, Secretaria de Estado da Saúde do Espírito Santo - SESA
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 21 Jun 2022 (estimated)
- Study completion
- 21 Mar 2023 (estimated)
- First posted
- 4 Feb 2022 (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.
To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.
Detailed description
Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC, N=320). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU, N=160). The main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by RT-PCR, the cellular immune response and frequency of adverse events. Outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. The study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received Coronavac and compared to children vaccinated with the immunizing BNT162b2 (Pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU).
| Arm | Type | Receives |
|---|---|---|
| VACC | Experimental | Biological: Inactivated Coronavac/Butantan vaccineThis group will receive the inactivated Coronavac/Butantan vaccine. |
| BNTC | Active comparator | Biological: BNT162b2 (Pfizer)This group will receive the immunizing BNT162b2 (Pfizer). |
| ADU | Active comparator | Biological: Inactivated Coronavac/Butantan vaccineThis group of adults participants will receive the inactivated Coronavac/Butantan vaccine. |
Who may qualify
- Ages
- 3 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 3 and 17 years old (VACC and BNTC groups)
- Age between 18 and 49 years old (ADU group)
Key exclusion criteria (5 listed)
- Pregnant teenagers;
- History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine;
- Have previously received a vaccine against COVID-19;
- Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C);
- Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).
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 |
|---|---|---|
| Inactivated Coronavac/Butantan vaccineInactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart | Biological | ADU, VACC |
| BNT162b2 (Pfizer)BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart | Biological | BNTC |
Primary outcome
Viral neutralization assay
Time frame: 3 months
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive.
Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S)
Time frame: 3 months
Results are expressed in AU/mL and data interpretation will be as follows: <50 AU/mL = negative; ≥50 U/mL = positive.
Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2
Time frame: 3 months
Results will be expressed as fluorescence intensity or pg/mL. The cutoff is 1.4 and <1.4 = negative; ≥1.4 = positive.
Dosage of systemic soluble factors
Time frame: 12 months
Chemokines, cytokines and growth factors - biomarkers of humoral and cellular response. Results will be expressed in pg/mL.
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro
Time frame: 2 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
T lymphocytes
Time frame: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
B lymphocytes
Time frame: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
intracytoplasmic cytokines
Time frame: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
2 secondary outcomes
RT-PCR confirmed cases
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated Coronavac/Butantan vaccine and BNT162b2 (Pfizer) in people with COVID-19, run by Federal University of Espirito Santo at 1 site in Brazil.
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 5 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 4 Feb 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral neutralization assay (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2022.