Coronavirus InfectionsPhase 2/3ButanvacNCT05354024

Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine

A Phase 2/3 study testing NDV-HXP-S 10μg and BNT162b2 30μg in people with Coronavirus Infections and Healthy, run by Butantan Institute at 6 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing Spike (S) protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Coronavirus Infections, Healthy
What is being tested?: NDV-HXP-S 10μg and BNT162b2 30μg
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,400 participants
Where: 6 sitesBrazil
Study dates: 28 Feb 2023to 25 Sep 2024
Phase: Phase 2/3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥ 18 years, of which 50% and 20% were aged ≥60 years in Phase II and Phase III studies, respectively, regardless of previous SARS-CoV-2 infection status, with proof of four doses of any monovalent vaccine against COVID-19, of which the last dose administered at least 120 days to 540 days ago.
If pre-existing medical conditions: be in a stable condition that does not require hospitalization or significant changes in therapy during the three months prior to enrollment.
Agree to regular contact by phone, electronic means, and/or home visits.
Intention to participate in the study, documented by the Informed Consent Form.

Who cannot join

Administration of a vaccine of active or inactivated virus not provided for in the study regimen up to 30 days before the dose of the study vaccine.
Use of other COVID-19 vaccination regimen other than the one contemplated in item a. of the inclusion criteria.
Angioedema or anaphylactic reaction to previous immunizations.
Allergy to egg or chicken.
Severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine.
Suspected or confirmed fever within 24 hours prior to vaccination or an axillary temperature greater than 37.8°C* on the day of vaccination (inclusion may be delayed until the subject is fever-free for 24 hours), as well as confirmation of SARS-CoV-2 infection (enrollment should be deferred until the participant has completed 24 hours without fever or until the participant resolves the SARS-CoV-2 infection documented by two negative RT-PCR tests).

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Evidence of uncontrolled active neurological, cardiac, pulmonary, liver or kidney disease. Significant treatment changes or hospitalizations for worsening the condition in the last three months are indicators of uncontrolled disease.
Bleeding disorders (e.g., clotting factor deficiency, coagulopathy, platelet dysfunction), or previous history of significant bleeding or bruising after intramuscular injection or venipuncture.
Neoplastic diseases (except basal cell carcinoma and cervical carcinoma in situ) diagnosed or under investigation.
Suspected or confirmed immune compromising diseases including congenital or acquired immunodeficiencies and autoimmune diseases not under control according to the medical history or physical examination, including asplenia. Significant treatment changes or hospitalizations for worsening the condition in the last three months are indicators of uncontrolled disease.
Use of immunosuppressive therapies six months prior to study inclusion or scheduled to be of service within two years of inclusion. The dose of corticosteroid considered immunosuppressive is the equivalent of prednisone at a dose of 20 mg/day for adults for more than 14 days. Continued use of topical or nasal corticosteroids and other topical immunomodulators or immunosuppressants will not be considered immunosuppressive. The following are considered immunosuppressive therapies: antineoplastic chemotherapy, radiotherapy, immunosuppressants to induce transplant tolerance, immunosuppressive and immunobiological treatments in patients with autoimmune rheumatic diseases, among others.
Use of blood products (transfusions or immunoglobulins) within the last three months prior to study inclusion or scheduled blood product or immunoglobulin administration within six months of study inclusion.
Alcohol or drug abuse in the past 12 months prior to the subject's inclusion.
Behavioral, cognitive, or psychiatric illness that affects the subject's ability to understand and cooperate with the study protocol requirements.
Being team member conducting the study or having a dependent relationship with one of the study team members.
Any other condition that may jeopardize the safety or rights of a potential participant or prevent him/her from complying with this protocol.
Abnormalities in screening laboratory tests are considered to be excludable in the opinion of the principal investigator or his/her medical representative. If any changes in the tests are considered temporary, the tests may be repeated up to three times during the screening period (Phase II only)
Positive serology tests for human immunodeficiency virus (anti-HIV1/2 ELISA); Hepatitis B (HbsAg or Anti-HBc) or Hepatitis C (total Anti-HCV ELISA).
Any other findings that the investigator expect to would increase the risk of adverse outcomes from study participation.
For women of childbearing potential:
Pregnancy (confirmed by positive β-hCG test), being a breastfeeding, and/or manifest intention to have sexual practices with reproductive potential without the use of a contraceptive method (abstinence, sterilization, intrauterine or implantable contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive gel, cream, or foam) within 30 days before and 28 days after vaccination.
Note: * The temperature measured with a temporal scanner skin thermometer is considered equivalent to the axillary temperature.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Brazil6 sites

Instituto Aggeu Magalhães - Fundação Osvaldo Cruz - Pernambuco
Recife, Pernambuco, 50670-420
Instituto Brasil de Pesquisa Clínica (IBPClin)
Rio de Janeiro, 20241-180
Universidade Municipal de São Caetano do Sul
São Caetano do Sul, São Paulo, 09530-905
Centro de Pesquisa Clínica S
Serrana, São Paulo, 14150-000
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo, 13271-130
Instituto Lóbus
Volta Redonda, São Paulo, 27258-000

Other trials in Brazil

About this study

Official title: Phase II/III Double-blind, Randomized Clinical Trial With Active Vaccine Control to Evaluate the Safety, Immunogenicity, and Consistency of the Lots of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine in Adults in Brazil

This vaccine was successfully tested in non-clinical and clinical studies with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.

Read the detailed description

The present protocol of Phase II/III studies.The Phase II study consists in a randomized (1:1) controlled double-blinded trial that aims to evaluate the safety and immunogenicity of NDV-HXP-S 10μg as a dose of booster in comparison to the vaccine against COVID-19 BNT162b2 30μg in a population of 400 adult subjects (50% with age ≥ 60 years), regardless of past of infection by COVID-19, with proof of two or more doses of COVID-19, of which the last dose administered at least 120 days ago.

The Phase III study consists in a randomized (3:1) controlled double-blinded trial that aims to evaluate the safety, immunogenicity and consistency of three consecutive batches of NDV-HXP-S 10μg as a dose of booster in comparison to the vaccine against COVID-19 BNT162b2 30μg in a population of 4000 adult subjects (20% with age ≥ 60 years), with similar characteristics as the population of Phase II.

Conditions: Coronavirus Infections, Healthy
Being tested: NDV-HXP-S 10μg, BNT162b2 30μg
Keywords: Vaccine, SARS-CoV-2, COVID-19
Medical subject headings: Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NDV-HXP-S 10μgBiological
NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), 1 dose (booster)
BNT162b2 30μgBiological
Vaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), 1 dose (booster)

Study groups in NCT05354024
Study group	Role	What they receive
NDV-HXP-S 10μg (Phase II)	Experimental	In the Phase III, 200 adult subjects will be assigned to receive NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety and immunogenicity. Receives: Biological: NDV-HXP-S 10μg
BNT162b2 30μg (Phase II)	Active comparator	In the Phase III, 200 adult subjects will be assigned to receive vaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety and immunogenicity. Receives: Biological: BNT162b2 30μg
NDV-HXP-S 10μg batch 1 (Phase III)	Experimental	In the Phase III, 1000 adult subjects will be assigned to receive the first consecutive batch of NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity and consistency of batches. Receives: Biological: NDV-HXP-S 10μg
NDV-HXP-S 10μg batch 2 (Phase III)	Experimental	In the Phase III, 1000 adult subjects will be assigned to receive the second consecutive batch of NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity and consistency of batches. Receives: Biological: NDV-HXP-S 10μg
NDV-HXP-S 10μg batch 3 (Phase III)	Experimental	In the Phase III, 1000 adult subjects will be assigned to receive the third consecutive batch of NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity and consistency of batches. Receives: Biological: NDV-HXP-S 10μg
BNT162b2 30μg (Phase III)	Active comparator	In the Phase III, 1000 adult subjects will be assigned to receive the vaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity only. Receives: Biological: BNT162b2 30μg

What is being measured

The primary outcome is the main question the study is designed to answer.

Solicited and unsolicited adverse reactions
Frequency and intensity of local and systemic solicited and unsolicited adverse reactions.
Measured: Within to 7 days after vaccination booster dose
Unsolicited adverse reactions
Frequency and intensity of all unsolicited grade ≥2 adverse reactions.
Measured: Within 28 days after vaccination booster dose
Severe adverse events
Frequency, intensity and relatedness of severe adverse events.
Measured: Within 28 days after vaccination booster dose
Neutralization GMTR SARS-CoV-2 pseudovirus
Neutralization of Geometric mean titer ratio (GMTR) SARS-CoV-2 pseudovirus.
Measured: Up to 28 days after vaccination booster dose
Seroconversion Neutralization GMT SARS-CoV-2 pseudovirus
Percentage of subjects with Seroconversion Neutralization GMT SARS-CoV-2 pseudovirus.
Measured: Up to 28 days after vaccination booster dose

Secondary outcomes (14)

GMT SARS-CoV-2 pseudovirus
Neutralization of Geometric mean titer (GMT) SARS-CoV-2 pseudovirus.
Measured: Up to 28 days after vaccination booster dose
Neutralization GMFR SARS-CoV-2 pseudovirus
Neutralization Geometric mean fold rise ratio (GMFR) SARS-CoV-2 pseudovirus.
Measured: Up to 28 days after vaccination booster dose
GMTR against SARS-CoV-2 (ELISA)
Geometric mean titer ratio (GMTR) of Anti-SARS-CoV-2-S IgG antibodies (ELISA).
Measured: Up to 28 days after vaccination booster dose
Seroconversion anti-SARS-CoV-2 ELISA
Percentage of subjects with seroconversion of Anti-SARS-CoV-2 S IgG antibodies (ELISA).
Measured: Up to 28 days after vaccination booster dose
GMFR against SARS-CoV-2 (ELISA)
Geometric mean fold rise ratio (GMFR) of Anti-SARS-CoV-2-S IgG titers (ELISA).
Measured: Up to 28 days after vaccination booster dose
GMT against SARS-CoV-2 (ELISA)
Geometric mean titer (GMT) of Anti-SARS-CoV-2-S IgG antibodies (ELISA).
Measured: Up to 28 days after vaccination booster dose
GMT against SARS-CoV-2 (ELISA)
Geometric mean titer (GMT) of Anti-SARS-CoV-2-S IgG antibodies (ELISA).
Measured: Up to 3 and 12 months after vaccine booster dose
Neutralization GMT against SARS-CoV-2 pseudovirus (variants of concern)
Neutralization of Geometric mean titer (GMT) against SARS-CoV-2 pseudovirus (variants of concern)
Measured: Up to 28 days after vaccination booster dose
T cell-mediated response against SARS-CoV-2
Vaccine-induced T cell immune response against SARS-CoV-2 (parental and variants of concern) by AIM (Activation-Induced Marker) and electrochemiluminescence Meso Scale Discovery® (MSD) V-PLEX Human Biomarker.
Measured: Up to 12 months after vaccine booster dose
Serious adverse events
Frequency, intensity and relatedness of serious adverse events.
Measured: Up to 12 months after vaccine booster dose
Adverse events of special interest
Frequency, intensity and relatedness of adverse events of special interest.
Measured: Up to 12 months after vaccine booster dose
Unsolicited adverse events
Frequency and intensity of all unsolicited adverse events.
Measured: Up to12 months after vaccine booster dose
Hematologic and biochemical assessments (Phase II)
Frequency, severity and relatedness of hematologic (hemoglobin, white blood cells and platelets) and biochemical (AST, ALT, bilirubins and creatinine) out of reference values.
Measured: Up to 7 days after vaccine booster dose
Adverse events with medical attention
Frequency, intensity and relatedness of adverse events with medical attention.
Measured: Up to 12 months after vaccine booster dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202325 Sep 2024

First posted29 Apr 2022
Study start28 Feb 2023
Primary completion5 Oct 2023
Study completion25 Sep 2024

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 Coronavirus InfectionsStudies 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment in Phase II (1:1), that aims to evaluate safety and immunogenicity in 400 subjects. Phase III (3:1), that aims to evaluate safety in total population (n=4.000, 3000 in arm of NDV-HXP-S 10μg, 1000 subjects per each consecutive batch, and 1000 subjects in the active control arm), immunogenicity in a subcohort (n=1000) and consistency of three consecutive batches in part of the subcohort of immunogenicity correspondent only to the NDV-HXP-S 10μg arms (n=750).
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 4,400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05354024
Sponsor's protocol ID: NCV-02-IB
Acronym: Butanvac
Status last verified: Feb 2024
First submitted: 27 Apr 2022
Last updated: 6 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
PubMed 36435633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II/III Double-blind, Randomized Clinical Trial With Active Vaccine Control to Evaluate the Safety, Immunogenicity, and Consistency of the Lots of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine in Adults in Brazil
ClinicalTrials.gov ID: NCT05354024
Acronym / sponsor ID: Butanvac / NCV-02-IB
Conditions: Coronavirus Infections, Healthy
Keywords: Vaccine, SARS-CoV-2, COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,400 participants (actual)
Lead sponsor: Butantan InstituteOther government
Study start: 28 Feb 2023 (actual)
Primary completion: 5 Oct 2023 (actual)
Study completion: 25 Sep 2024 (actual)
First posted: 29 Apr 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6
Model description: Parallel Assignment in Phase II (1:1), that aims to evaluate safety and immunogenicity in 400 subjects. Phase III (3:1), that aims to evaluate safety in total population (n=4.000, 3000 in arm of NDV-HXP-S 10μg, 1000 subjects per each consecutive batch, and 1000 subjects in the active control arm), immunogenicity in a subcohort (n=1000) and consistency of three consecutive batches in part of the subcohort of immunogenicity correspondent only to the NDV-HXP-S 10μg arms (n=750).

Arm	Type	Receives
NDV-HXP-S 10μg (Phase II)	Experimental	Biological: NDV-HXP-S 10μgIn the Phase III, 200 adult subjects will be assigned to receive NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety and immunogenicity.
BNT162b2 30μg (Phase II)	Active comparator	Biological: BNT162b2 30μgIn the Phase III, 200 adult subjects will be assigned to receive vaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety and immunogenicity.
NDV-HXP-S 10μg batch 1 (Phase III)	Experimental	Biological: NDV-HXP-S 10μgIn the Phase III, 1000 adult subjects will be assigned to receive the first consecutive batch of NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity and consistency of batches.
NDV-HXP-S 10μg batch 2 (Phase III)	Experimental	Biological: NDV-HXP-S 10μgIn the Phase III, 1000 adult subjects will be assigned to receive the second consecutive batch of NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity and consistency of batches.
NDV-HXP-S 10μg batch 3 (Phase III)	Experimental	Biological: NDV-HXP-S 10μgIn the Phase III, 1000 adult subjects will be assigned to receive the third consecutive batch of NDV-HXP-S 10μg/0.5mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity and consistency of batches.
BNT162b2 30μg (Phase III)	Active comparator	Biological: BNT162b2 30μgIn the Phase III, 1000 adult subjects will be assigned to receive the vaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), booster, 1 dose. All the population will be evaluated for safety. Of them, 250 will be evaluated for immunogenicity only.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18 years, of which 50% and 20% were aged ≥60 years in Phase II and Phase III studies, respectively, regardless of previous SARS-CoV-2 infection status, with proof of four doses of any monovalent vaccine against COVID-19, of which the last dose administered at least 120 days to 540 days ago.
If pre-existing medical conditions: be in a stable condition that does not require hospitalization or significant changes in therapy during the three months prior to enrollment.
Agree to regular contact by phone, electronic means, and/or home visits.
Intention to participate in the study, documented by the Informed Consent Form.

Key exclusion criteria (22 listed)

Administration of a vaccine of active or inactivated virus not provided for in the study regimen up to 30 days before the dose of the study vaccine.
Use of other COVID-19 vaccination regimen other than the one contemplated in item a. of the inclusion criteria.
Angioedema or anaphylactic reaction to previous immunizations.
Allergy to egg or chicken.
Severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine.

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
NDV-HXP-S 10μgNDV-HXP-S 10μg/0.5mL intramuscular (deltoid), 1 dose (booster)	Biological	NDV-HXP-S 10μg (Phase II), NDV-HXP-S 10μg batch 1 (Phase III), NDV-HXP-S 10μg batch 2 (Phase III), NDV-HXP-S 10μg batch 3 (Phase III)
BNT162b2 30μgVaccine against COVID-19 BNT162b2 30μg/0.3mL intramuscular (deltoid), 1 dose (booster)	Biological	BNT162b2 30μg (Phase II), BNT162b2 30μg (Phase III)

Primary outcome

Solicited and unsolicited adverse reactions
Time frame: Within to 7 days after vaccination booster dose
Frequency and intensity of local and systemic solicited and unsolicited adverse reactions.
Unsolicited adverse reactions
Time frame: Within 28 days after vaccination booster dose
Frequency and intensity of all unsolicited grade ≥2 adverse reactions.
Severe adverse events
Time frame: Within 28 days after vaccination booster dose
Frequency, intensity and relatedness of severe adverse events.
Neutralization GMTR SARS-CoV-2 pseudovirus
Time frame: Up to 28 days after vaccination booster dose
Neutralization of Geometric mean titer ratio (GMTR) SARS-CoV-2 pseudovirus.
Seroconversion Neutralization GMT SARS-CoV-2 pseudovirus
Time frame: Up to 28 days after vaccination booster dose
Percentage of subjects with Seroconversion Neutralization GMT SARS-CoV-2 pseudovirus.

14 secondary outcomes

GMT SARS-CoV-2 pseudovirus
Time frame: Up to 28 days after vaccination booster dose
Neutralization GMFR SARS-CoV-2 pseudovirus
Time frame: Up to 28 days after vaccination booster dose
GMTR against SARS-CoV-2 (ELISA)
Time frame: Up to 28 days after vaccination booster dose
Seroconversion anti-SARS-CoV-2 ELISA
Time frame: Up to 28 days after vaccination booster dose
GMFR against SARS-CoV-2 (ELISA)
Time frame: Up to 28 days after vaccination booster dose
GMT against SARS-CoV-2 (ELISA)
Time frame: Up to 28 days after vaccination booster dose
GMT against SARS-CoV-2 (ELISA)
Time frame: Up to 3 and 12 months after vaccine booster dose
Neutralization GMT against SARS-CoV-2 pseudovirus (variants of concern)
Time frame: Up to 28 days after vaccination booster dose
T cell-mediated response against SARS-CoV-2
Time frame: Up to 12 months after vaccine booster dose
Serious adverse events
Time frame: Up to 12 months after vaccine booster dose
Adverse events of special interest
Time frame: Up to 12 months after vaccine booster dose
Unsolicited adverse events
Time frame: Up to12 months after vaccine booster dose
Hematologic and biochemical assessments (Phase II)
Time frame: Up to 7 days after vaccine booster dose
Adverse events with medical attention
Time frame: Up to 12 months after vaccine booster dose

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 6 Feb 2025.
Derived from this study: PubMed 36435633Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.

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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.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing NDV-HXP-S 10μg and BNT162b2 30μg in people with Coronavirus Infections and Healthy, run by Butantan Institute at 6 sites 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 4 inclusion and 22 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 combined 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.

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?

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?

Solicited and unsolicited adverse reactions (time frame: Within to 7 days after vaccination booster dose). The study lists 5 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 NCT05354024, 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 6 Feb 2025.