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Coronavirus InfectionsPhase 1ADAPTCOVNCT04993209

Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil

A Phase 1 study testing NDV-HXP-S 1μg, NDV-HXP-S 3μg and NDV-HXP-S 10μg in people with Coronavirus Infections and Healthy, run by Butantan Institute at 1 site in Brazil.

Completed

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

Official record
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Trial summary

NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing 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 1μg, NDV-HXP-S 3μg and NDV-HXP-S 10μg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteBrazil
Study dates
9 Jul 2021to 4 Nov 2022
Phase
Phase 1
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

  • Adults aged between 18 and 59 years at the time of consent;
  • Agree to periodical contacts via phone, electronic means and home visits;
  • Good health conditions (absence of a clinically significant medical condition, acute or chronic, determined by medical history, physical examination, and clinical evaluation by the investigator);
  • Body Mass Index (BMI) of 17 to 40 kg/m² at the time of screening;
  • Intention of participating in the study by signing the Informed Consent Form;
  • A negative result for antibody testing against SARS-CoV-2 by CLIA performed within 7 days prior to study immunization;
  • No history of COVID-19 diagnosed by RT-PCR or antigen testing at screening visit and therefore within 72 hours prior to study enrollment;
  • No history of vaccination against COVID-19.

Who cannot join

  • Use any product under investigation within 90 days prior to randomization or plan to use a product during the period of participation in the study;
  • Have received vaccine in the last 28 days prior to inclusion in the study, or have immunization scheduled throughout the study period;
  • Evidences of uncontrolled active neurological, cardiac, pulmonary, hepatic or renal disease, according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
  • Have a history of severe allergic reaction or anaphylaxis to the vaccine or study vaccine components;
  • History of being allergic to chicken or eggs;
  • History of angioedema or anaphylactic reaction;
Show all 22Show fewer
  • Have suspected or confirmed fever within 72 hours prior to vaccination or an axillary temperature above 37.8°C* on the day of vaccination (inclusion may be delayed until participant completes 72 hours without fever);
  • Altered vital signs, clinically relevant in the opinion of the principal investigator;
  • Neoplastic diseases (except basal cell carcinoma and cervical carcinoma in situ);
  • Suspected or confirmed diseases with compromised immune system including: congenital or acquired immunodeficiencies and uncontrolled autoimmune diseases according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
  • Make use of immunosuppressive therapies six months prior to inclusion in the study or schedule use of immunosuppressants within two years of inclusion in the study. The dose of corticosteroids considered immunosuppressive is the equivalent to prednisone at a dose of 2,0 mg/kg/day for adults, for more than a week. The continuous use of topical or nasal corticosteroids is not considered immunosuppressive. The following therapies are considered immunosuppressive: antineoplastic drugs, radiotherapy, immunosuppressants to induce tolerance to transplants, among others.
  • Have received blood products (transfusions or immunoglobulins) in the last three months prior to inclusion in the study, or schedule administration of blood products or immunoglobulins within two years of inclusion in the study.
  • Have a history of bleeding disorders (e.g., clotting factor deficiency, coagulopathy, platelet dysfunction), or prior history of significant bleeding or bruising after IM injection or venipuncture;
  • Have a history of any alcohol or drug abuse in the last 12 months prior to inclusion in the study that has caused medical, professional or family problems, as indicated by the clinical history;
  • Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or medical representative, affects the participant's ability to understand and collaborate with the requirements of the study protocol;
  • The participant is a member of the team conducting the study or is in a dependent relationship with one of the members of the team conducting the study. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents), as well as employees or students who are directly dependent on the Researcher or local personnel conducting the study;
  • Any other condition that, in the opinion of the principal investigator or medical representative, may jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol.
  • Abnormalities in screening laboratory tests considered to be exclusionary in the opinion of the principal investigator or medical representative. Grade 1 alterations are considered non-significant unless the principal investigator or medical representative indicates otherwise. If any alteration in the tests is considered temporary, the tests may be repeated in up to three opportunities during the screening period;
  • Positive serological tests for the human immunodeficiency virus (ELISA anti-HIV1/2); Hepatitis B (HbsAg or Anti-HBc) or Hepatitis C (total ELISA anti-HCV);
  • For females:
  • Pregnancy (confirmed by a positive β-hCG test), breastfeeding and/or expressing intention to engage in sexual practices with reproductive potential without using a contraceptive method in the three months following vaccination
  • The temperature measured with a temporal thermometer is considered equivalent to the axillary temperature.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    Ribeirão Preto, São Paulo, 14015-069

Other trials in Brazil

About this study

Official title: Double-blind, Randomized, With an Active Control Vaccine, Phase I Clinical Trial for Evaluation of Safety and Immunogenicity of a Recombinant Inactivated COVID-19 Vaccine in Adults in Brazil - ADAPTCOV

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

This vaccine was successfully tested in non-clinical study 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 aims, to respond to several regulatory requirements to advance the clinical development of the product through a dose-escalation, controlled, randomized, adult clinical trial. The results of the Phase I (former Stage A), allow us to base the decision to evaluate the safety and immunogenicity of three doses of HDV-HXP-S (1μg, 3μg or 10μg).

Being tested
NDV-HXP-S 1μg, NDV-HXP-S 3μg, NDV-HXP-S 10μg, Adsorbed inactivated COVID-19 vaccine (CoronaVac)
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 1μgBiological

    NDV-HXP-S 1μg 0.5mL 2 doses intramuscular (deltoid) 28 days apart

  • NDV-HXP-S 3μgBiological

    NDV-HXP-S 3μg 0.5mL 2 doses intramuscular (deltoid) 28 days apart

  • NDV-HXP-S 10μgBiological

    NDV-HXP-S 10μg 0.5mL 2 doses intramuscular (deltoid) 28 days apart

  • Adsorbed inactivated COVID-19 vaccine (CoronaVac)Other

    Adsorbed inactivated COVID-19 vaccine 600 SU/0.5 mL 2 doses intramuscular (deltoid) 28 days apart

Study groups in NCT04993209
Study groupRoleWhat they receive
NDV-HXP-S 1μgExperimentalNDV-HXP-S 1μg with an interval of 28 days apart. A dose escalation will be performed with an interval of two days between each dose in a blinded form. The aim is to verify the product safety and support the decision on the dose selection among three alternatives, 1 μg, 3 μg and 10 μg, based on the immune response evaluation. These results will also explore the response against two variants of concern in SARS-CoV-2: γ and β. The Phase I (former stage A) is designed as a non-inferiority test comparing the three different doses.
Receives: Biological: NDV-HXP-S 1μg
NDV-HXP-S 3μgExperimentalNDV-HXP-S 3μg with an interval of 28 days apart. A dose escalation will be performed with an interval of two days between each dose in a blinded form. The aim is to verify the product safety and support the decision on the dose selection among three alternatives, 1 μg, 3 μg and 10 μg, based on the immune response evaluation. These results will also explore the response against two variants of concern in SARS-CoV-2: γ and β. The Phase I (former stage A) is designed as a non-inferiority test comparing the three different doses.
Receives: Biological: NDV-HXP-S 3μg
NDV-HXP-S 10μgExperimentalNDV-HXP-S 10μg/0.5mL intramuscularly, with an interval of 28 days apart. A dose escalation will be performed with an interval of two days between each dose in a blinded form. The aim is to verify the product safety and support the decision on the dose selection among three alternatives, 1 μg, 3 μg and 10 μg, based on the immune response evaluation. These results will also explore the response against two variants of concern in SARS-CoV-2: γ and β. The Phase I (former stage A) is designed as a non-inferiority test comparing the three different doses.
Receives: Biological: NDV-HXP-S 10μg
Adsorbed inactivated COVID-19 vaccine (CoronaVac)Active comparatorAdsorbed inactivated COVID-19 vaccine 600 SU dose (0.5 mL) with an interval of 28 days apart Intramuscular (deltoid). In the original version of protocol, the control arm consisted in placebo use. There was a changing post hoc to Adsorbed inactivated COVID-19 vaccine (CoronaVac) due to decision of Data and Safety Monitoring Board, when 219 (50% of original sample) subjects have already included in the study. Therefore, those who received a placebo at the first vaccine visit started to receive active control vaccine and those who were included from that moment forward received two doses of active control vaccine. The original study protocol provided for the inclusion of the placebo arm (10% of population of study), in order to serve as a control for safety evaluations and to assess the attack rate of natural infection to which participants will be exposed during the study.
Receives: Other: Adsorbed inactivated COVID-19 vaccine (CoronaVac)

What is being measured

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

  1. Safety: Adverse reactions.

    Number and intensity of solicited local and systemic adverse reactions.

    Measured: 7 days after each vaccination.

  2. Safety: Laboratory evaluations

    Number, severity and summary of clinically significant changes of hematological (hemoglobin [g/dL], white blood cells [cells/mm³] and platelets [count per mm³]) and biochemical evaluations (creatinine [mg/dL], AST [U/L], ALT [U/L], and total bilirubin [mg/dL]) since the baseline within 7 days after each vaccination.

    Measured: 7 days after each vaccination.

  3. Immunogenicity: Percentage of seroconversion.

    Percentage of positive SARS-CoV-2 pseudovirus neutralization assay in a participant with a baseline negative result (Wuhan strain).

    Measured: 42(+7) days after the first dose.

  4. Immunogenicity: Neutralization GMT SARS-CoV-2 pseudovirus.

    Neutralization GMT against SARS-CoV-2 pseudovirus (Wuhan strain)

    Measured: 28 days after the first vaccination.

  5. Immunogenicity: Neutralization GMT SARS-CoV-2 pseudovirus.

    Neutralization GMT against SARS-CoV-2 pseudovirus (Wuhan strain)

    Measured: 14 days after the second vaccination.

  6. Immunogenicity: Neutralization GMT SARS-CoV-2 pseudovirus.

    Neutralization GMT against SARS-CoV-2 pseudovirus (beta and gamma strains)

    Measured: 42(+7) days after the first dose.

Secondary outcomes (8)

  1. Safety: all unsolicited adverse reactions.

    Number, intensity, and relatedness of all unsolicited adverse reactions.

    Measured: 28 days after each vaccination.

  2. Safety: serious and medically-attended adverse reactions.

    Number, intensity, and relatedness of serious adverse reactions

    Measured: Throughout the entire study period.

  3. Safety: events of special interest.

    Number, intensity, and relatedness of events of special interest.

    Measured: Throughout the entire study period.

  4. Immunogenicity: Levels of antibodies.

    Levels of antibodies against SARS-CoV-2 Nucleocapsid protein and RBD

    Measured: At baseline, 28 days after the first vaccination, and 14 days after the second vaccination, and 3, 6, 9, and 12 months after first vaccination.

  5. Immunogenicity: Neutralization GMT of SARS-CoV-2 pseudovirus.

    Neutralization GMT against SARS-CoV-2 pseudovirus per age group

    Measured: 28 days after the first vaccination, and 14 days after the second vaccination.

  6. Exploratory Endpoints: Levels of antibodies.

    Levels of antibodies against SARS-CoV-2 Nucleocapsid protein and RBD.

    Measured: At baseline, 28 days after the first vaccination, and 14 days after the second vaccination, and 3 months, 6 months, 9 months, and 12 months after first vaccination.

  7. Exploratory Endpoints: Neutralization GMT of SARS-CoV-2 pseudovirus.

    Neutralization GMT against SARS-CoV-2 pseudovirus at 3 months, 6 months, 9 months, and 12 months after first vaccination in subjects.

    Measured: at 3 months, 6 months, 9 months, and 12 months after first vaccination in subjects.

  8. Exploratory Endpoints - COVID-19 cases.

    Number and intensity of COVID-19 cases diagnosed.

    Measured: 14 days after first and second vaccination.

Timeline

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

  1. First posted6 Aug 2021
  2. Study start9 Jul 2021
  3. Primary completion10 Dec 2021
  4. Study completion4 Nov 2022

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stage A (blinding form) will verify the product safety and support the decision on the dose selection among 1 μg, 3 μg and 10 μg, based on the immune response assessment. These results will also explore the response against 2 variants of concern in SARS-CoV-2: γ and β.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993209
Sponsor's protocol ID
NCV-01-IB
Acronym
ADAPTCOV
Status last verified
Aug 2023
First submitted
3 Aug 2021
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Peixoto de Miranda EJF, Calado RT, Boulos FC, de Sousa Moreira JA, Machado FF, Almeida MAALDS, Da Rocha MCO, Infante V, Mercer LD, Hjorth R, Scharf R, White J, Polyak C, Raghunandan R, Garcia-Sastre A, Sun W, Palese P, Krammer F, Innis B, Pereira CG, Kallas EG. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Results of a randomized vaccine-controlled phase I ADAPTCOV trial in Brazil. Vaccine. 2025 Apr 11;52:126680. doi: 10.1016/j.vaccine.2024.126680. Epub 2025 Mar 3.

    PubMed 40037239

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NDV-HXP-S 1μg, NDV-HXP-S 3μg and NDV-HXP-S 10μg in people with Coronavirus Infections and Healthy, run by Butantan Institute 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 8 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 21 Aug 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety: Adverse reactions. (time frame: 7 days after each vaccination.). The study lists 6 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 NCT04993209, 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 21 Aug 2023.

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