InfluenzaPhase 1NCT05252338
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVSQIV in Healthy Adults
A Phase 1 study testing CVSQIV in people with Influenza, run by CureVac at 3 sites in Panama.
Trial summary
This study aims to evaluate the safety and reactogenicity profile of CVSQIV at different dose levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CVSQIV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesPanama
- Study dates
- 7 Feb 2022to 27 Sep 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
- Healthy male or female subjects between the ages of 18 and 55 years, inclusive, at enrollment (Younger Adults groups) or aged ≥65 years at enrollment (Older Adults groups). A healthy subject is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered stable and well controlled with treatment according to the discretion of the Investigator.
- Signed informed consent obtained before any trial procedures.
- Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned contact.
- Physical examination without clinically significant findings according to the Investigator's assessment.
- Body mass index (BMI) ≥18.0 and ≤32.0kg/m2.
- Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if serum pregnancy test was performed more than 3 days before). Note: Women that are postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to enrollment without an alternative medical cause) or permanently sterilized will be considered as not having reproductive potential.
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- Females of childbearing potential must use highly effective methods of birth control from 1 month before until 3 months after the trial vaccine administration. The following methods of birth control are considered highly effective when used consistently and correctly:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
- Intrauterine devices;
- Intrauterine hormone-releasing systems;
- Bilateral tubal occlusion;
- Vasectomized partner;
- Same sex relationships.
- Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal) are not acceptable methods.
Who cannot join
- Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the trial vaccine administration, or planned use during the trial.
- Receipt of any influenza vaccine within 90 days of enrollment.
- Receipt of any mRNA vaccine within 2 months of enrollment.
- Receipt of any other vaccines within 28 days prior to enrollment or planned receipt of any vaccine within 28 days of trial vaccine administration.
- Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for >14 days total within 6 months prior to the trial vaccine administration or planned use during the trial, with the exception of inhaled or topically-applied steroids. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection.
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- Chronic hepatitis B virus infection and chronic hepatitis C virus infection.
- History of pIMD
- History of angioedema.
- History of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
- History of allergy to any component of CVSQIV, or to aminoglycoside or beta-lactam antibiotics.
- History of any severe allergic reaction or anaphylactic reaction.
- History of or current alcohol and/or drug abuse.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the trial vaccine administration.
- Presence or evidence of significant acute or chronic medical or psychiatric illness.
- Current or past malignancy, unless completely resolved without sequelae for >5 years.
- For females: pregnancy or lactation.
- Subjects with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated.
- Subjects employed by the Sponsor, Investigator or trial site, or relatives of research staff working on this trial.
Trial locations and contacts
3 sites in 1 country.
Panama3 sites
International Vaccination and Research Center (CEVAXIN) Avenida Mexico, 33 Street
Panama City, Calidonia, Panama City
International Vaccination and Research Center (CEVAXIN) Panama Clinic, Ramon H Jurado Street, Pacific Center, Level 12
Panama City
Unidad de Investigación Clínica INDICASAT AIP / Hospital Paitilla
Panama City
About this study
Official title: A Phase 1, Open-label, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational Seasonal Quadrivalent Influenza mRNA Vaccine CVSQIV Administered Intramuscularly in Healthy Younger and Older Adults
This study aims to evaluate the safety and reactogenicity profile of CVSQIV at different dose levels.
Read the detailed description
This is a Phase 1, open-label, dose-escalation FIH trial to evaluate the safety, reactogenicity and immunogenicity of different dose levels of CVSQIV using an adaptive dose-finding design.
- Conditions
- Influenza
- Being tested
- CVSQIV
- Keywords
- Safety, Reactogenicity, Immunogenicity, Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVSQIVBiological
Participants will receive an intramuscular injection by needle in the deltoid area.
| Study group | Role | What they receive |
|---|---|---|
| Younger Adults group aged 18-55 years | Experimental | Subjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1. Receives: Biological: CVSQIV |
| Adults group aged ≥65 years | Experimental | Subjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1. Receives: Biological: CVSQIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequencies of Grade 3 ARs and any SAR within at least 20 hours after the trial vaccine administration by dose level, for decisions on subsequent vaccination of additional sentinel subjects with the same dose level.
Measured: up to day 2
The frequencies of Grade 3 ARs and any SAR within at least 60 hours after the trial vaccine administration by dose level, for decisions on dose escalation as well as continuation of enrollment at the same dose level.
Measured: up to day 3
The frequencies, intensities and duration of solicited local ARs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
Measured: up to day 8
The frequencies, intensities, duration and relationship to trial vaccination of solicited systemic AEs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
Measured: up to day 8
The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on the day of vaccination and the following 28 days by dose level, for the characterization of the safety and reactogenicity profile.
Measured: up to day 29
The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial, for the characterization of the safety and reactogenicity profile.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
For each antigen, the proportion of subjects with antigen-specific serum HAI assay titers.
Measured: On Day 22 and Day 183
For each antigen, geometric mean titers (GMTs) of antigen-specific HAI antibody titers.
Measured: On Day 22 and Day 183
For each antigen, the proportion of subjects with antigen-specific seroconversion measured by HAI assay.
Measured: On Day 22 and Day 183
For each antigen, the percentage of subjects with a post-vaccination HAI antibody titer ≥1:20, ≥1:40 and ≥1:80.
Measured: On Day 22 and Day 183
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start7 Feb 2022
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252338
- Sponsor's protocol ID
- CV-SQIV-001
- Status last verified
- Mar 2022
- First submitted
- 26 Jan 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational Seasonal Quadrivalent Influenza mRNA Vaccine CVSQIV Administered Intramuscularly in Healthy Younger and Older Adults
- ClinicalTrials.gov ID
- NCT05252338
- Acronym / sponsor ID
- CV-SQIV-001
- Conditions
- Influenza
- Keywords
- Safety, Reactogenicity, Immunogenicity, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- CureVacIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 23 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.
This study aims to evaluate the safety and reactogenicity profile of CVSQIV at different dose levels.
Detailed description
This is a Phase 1, open-label, dose-escalation FIH trial to evaluate the safety, reactogenicity and immunogenicity of different dose levels of CVSQIV using an adaptive dose-finding design.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger Adults group aged 18-55 years | Experimental | Biological: CVSQIVSubjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1. |
| Adults group aged ≥65 years | Experimental | Biological: CVSQIVSubjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy male or female subjects between the ages of 18 and 55 years, inclusive, at enrollment (Younger Adults groups) or aged ≥65 years at enrollment (Older Adults groups). A healthy subject is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered stable and well controlled with treatment according to the discretion of the Investigator.
- Signed informed consent obtained before any trial procedures.
- Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned contact.
- Physical examination without clinically significant findings according to the Investigator's assessment.
- Body mass index (BMI) ≥18.0 and ≤32.0kg/m2.
Key exclusion criteria (19 listed)
- Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the trial vaccine administration, or planned use during the trial.
- Receipt of any influenza vaccine within 90 days of enrollment.
- Receipt of any mRNA vaccine within 2 months of enrollment.
- Receipt of any other vaccines within 28 days prior to enrollment or planned receipt of any vaccine within 28 days of trial vaccine administration.
- Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for >14 days total within 6 months prior to the trial vaccine administration or planned use during the trial, with the exception of inhaled or topically-applied steroids. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more.
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 |
|---|---|---|
| CVSQIVParticipants will receive an intramuscular injection by needle in the deltoid area. | Biological | Adults group aged ≥65 years, Younger Adults group aged 18-55 years |
Primary outcome
The frequencies of Grade 3 ARs and any SAR within at least 20 hours after the trial vaccine administration by dose level, for decisions on subsequent vaccination of additional sentinel subjects with the same dose level.
Time frame: up to day 2
The frequencies of Grade 3 ARs and any SAR within at least 60 hours after the trial vaccine administration by dose level, for decisions on dose escalation as well as continuation of enrollment at the same dose level.
Time frame: up to day 3
The frequencies, intensities and duration of solicited local ARs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
Time frame: up to day 8
The frequencies, intensities, duration and relationship to trial vaccination of solicited systemic AEs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
Time frame: up to day 8
The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on the day of vaccination and the following 28 days by dose level, for the characterization of the safety and reactogenicity profile.
Time frame: up to day 29
The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial, for the characterization of the safety and reactogenicity profile.
Time frame: through study completion, an average of 6 months
4 secondary outcomes
For each antigen, the proportion of subjects with antigen-specific serum HAI assay titers.
Time frame: On Day 22 and Day 183
For each antigen, geometric mean titers (GMTs) of antigen-specific HAI antibody titers.
Time frame: On Day 22 and Day 183
For each antigen, the proportion of subjects with antigen-specific seroconversion measured by HAI assay.
Time frame: On Day 22 and Day 183
For each antigen, the percentage of subjects with a post-vaccination HAI antibody titer ≥1:20, ≥1:40 and ≥1:80.
Time frame: On Day 22 and Day 183
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 Jun 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVSQIV in people with Influenza, run by CureVac at 3 sites in Panama.
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 15 inclusion and 19 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Panama. 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?
The frequencies of Grade 3 ARs and any SAR within at least 20 hours after the trial vaccine administration by dose level, for decisions on subsequent vaccination of additional sentinel subjects with the same dose level. (time frame: up to day 2). 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?
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 Jun 2023.