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COVID-19Phase 1COVID-19-101NCT04497298

Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine

A Phase 1 study testing Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose, Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose and One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose in people with COVID-19, run by Institut Pasteur at 2 sites in 2 countries.

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

This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose, Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose and One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesin 2 countries
Study dates
10 Aug 2020to 12 May 2021
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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and females between the ages of 18 and 55 years (at the time of consent).
  • Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments
  • Participant with a body mass index (BMI) <30.0 kg/m2
  • Provide written informed consent before initiation of any study procedures.
  • A female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at V1 (1st injection), or breast feeding and 1 of the following:
  • Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
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  • Of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (D210).
  • Highly effective methods of contraception include 1 or more of the following:
  • male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant;
  • hormonal (oral, intravaginal, transdermal, implantable or injectable);
  • an intrauterine hormone-releasing system (IUS);
  • an intrauterine device (IUD) with a documented failure rate of < 1%.
  • A female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (D210);
  • A male participant who is sexually active is eligible if he is willing to :
  • use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (D210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception;
  • not donate sperm from the screening visit up to 6 months after the last injection (D210);
  • not plan to father a child from the screening visit up to 6 months after the last injection (D210).
  • Negative HIV 1/2 antibody/antigen test, Hepatitis B surface antigen (HBsAg), and Hepatitis C virus (HCV) antibody.
  • Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
  • Willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study.
  • Affiliated to a social security system, (except state medical aid) (Only for France).
  • Volunteer registered in the French Health Ministry computerized file and authorized to participate in a clinical trial (only for France).

Who cannot join

  • Subjects actively or previously infected by SARS-CoV-2, as determined by a positive RT-PCR and positive serology test.
  • Subject currently working with high risk of exposure to SARS-CoV-2 (e.g. health care worker, emergency response personnel, etc.) or considered at the investigator's discretion to be at increased risk to acquire SARS-CoV-2 for any other reason.
  • Previous vaccination with an investigational COVID-19 vaccine.
  • History of presence of pulmonary disorders (e.g. COPD, etc.) or asthma.
  • History or present of thrombocytopenia and/or bleeding disorders.
  • A positive serum pregnancy test at screening or urine pregnancy test prior to study injection, women who are planning to become pregnant during the study, or women who are breastfeeding.
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  • Clinically relevant history of or current renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, autoimmune, central nervous system or neurological diseases or clinically relevant abnormal laboratory values.
  • Use of immunosuppressive drugs like e.g. corticosteroids (excluding topical preparations and inhalers) within 3 months prior to the first vaccination or 6 months for chemotherapies and all along the study.
  • A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt.
  • A history of treatment for any other psychiatric disorder in the past 3 years that increases the risk to the subject in the opinion of the investigator.
  • Received immunoglobulin or other blood product within 3 months prior to enrollment or planned receipt of immunoglobulin or a blood product through study completion.
  • Vaccination within 4 weeks prior to first injection or planning to receive a licensed vaccine before D56 (e.g. Inactivated influenza vaccine).
  • Received measles-containing vaccine within 3 months prior to enrollment.
  • History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the COVID-19 vaccine.
  • Participation in another investigational clinical study within four weeks before the screening visit or planned before the study completion.
  • Individuals who are living and/or working with severely immunocompromised people, pregnant women, lactating women, children under 12 months old, or any other individual that, in the judgment of the investigator, might be at increased risk.
  • Any condition that, in the opinion of the investigator, may interfere with the aim of the study or the safety or wellbeing of the subject.
  • Subjects with any condition associated with, or that might be associated with, an increased risk of severe illness from COVID-19 according to US CDC definition .
  • Subjects with confirmed or suspected immunodeficiency.
  • Exposure to an individual with confirmed COVID-19 or SARS-CoV-2 infection within the past 2 weeks prior to enrollment.
  • Subject with an acute disease and/or fever (body temperature ≥ 38°C) at the time of the 1st vaccination visit.
  • History of confirmed SARS-CoV or MERS-CoV infection.
  • Current heavy smoker defined as smoking at least 20 cigarettes (1 pack, or equivalent) per day or former heavy smoker who was an active heavy smoker within the last year prior to the screening visit or has a total smoking history of ≥ 1 pack per day for 10 years or more.
  • Current or history of alcohol or drug abuse during the previous 3 years.
  • Presence of tattoos that, in the opinion of the investigator, would preclude evaluation of the injection site.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • SGS Life Sciences, Clinical Pharmacology Unit

    Antwerp, 2060

Other trials in Belgium

France1 site

  • CIC Cochin - Pasteur

    Paris, 75014

Other trials in France

About this study

Official title: A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083/V-591).

Read the detailed description

This is a prospective, interventional, randomized, Phase I trial comparing two different dose levels and immunization regimen of a novel COVID-19 vaccine candidate (TMV-083/V-591) against SARS-CoV-2 infection, consisting of two phases, an unblinded dose escalation and a double-blind treatment phase, to assess the safety, tolerability and immunogenicity.

90 subjects will be enrolled, 30 per cohort in three cohorts, each cohort comprising 24 vaccinees and 6 placebo recipients. Subjects will either receive two immunizations with a low dosage vaccine (Cohort A), two immunization with a high dosage vaccine (Cohort B), a single immunization with the high dosage vaccine (Cohort C) or placebo (randomized to all three cohorts).

As safety precaution, the study will begin with the enrolment of a small group of 6 sentinel subjects (2 Sentinel Groups, three subjects each of cohorts A and B) each of whom will receive the vaccine on days 0 and 28 in an unblinded and non-randomized manner.

Thereafter, 84 remaining participants will be enrolled in a double-blinded, randomized manner into one of the three cohorts (A, B or C). Placebo will be applied to blind the different regimen.

After the screening visit, participants will be expected to return to the investigational clinical site for 8 visits (9 for the sentinel groups) up to day 91 for immunogenicity sample collection and up to day 210 for safety assessments.

Samples for measles shedding will be collected from subjects of the Sentinel Groups (unblinded regiment in cohort A and B). Body fluids including saliva, nasal swab, urine and whole blood will be collected from day 0 up to day 42.

The investigator and site personnel assessing Adverse Events (AEs), all participants, as well as the sponsor's representatives involved in the monitoring and conduct of the study will be unblinded to which vaccine was administered within the unblinded treatment phase. Only the site personnel performing randomization, preparation and administration of Investigational Medicinal Product (IMP) will be unblinded within the randomized double-blinded treatment phase.

Conditions
COVID-19
Being tested
Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose, Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose, One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose, Placebo
Keywords
SARS-CoV-2, Vaccine, Prevention
Medical subject headings
COVID-19

What participants receive

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

  • Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low doseBiological

    Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2)

  • Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High doseBiological

    Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2)

  • One COVID-19 vaccine candidate (TMV-083/V-591) administration - High doseBiological

    Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2) and placebo

  • PlaceboOther

    Physiological saline solution (0.9% NaCl)

Study groups in NCT04497298
Study groupRoleWhat they receive
COVID-19 vaccine candidate (TMV-083/V-591) - Low doseExperimentalVolunteers will receive two administrations of the low dose COVID-19 vaccine candidate by intramuscular (i.m.) injection on day 0 and 28
Receives: Biological: Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose
COVID-19 vaccine candidate (TMV-083/V-591) - High doseExperimentalVolunteers will receive two administrations of the high dose COVID-19 vaccine candidate by intramuscular (i.m.) injection on day 0 and 28.
Receives: Biological: Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose
One COVID-19 vaccine candidate (TMV-083/V-591) - High and placeboExperimentalVolunteers will receive one administration of the high dose COVID-19 vaccine candidate on day 0 by intramuscular (i.m.) injection and one administration of the placebo on day 28 by intramuscular (i.m.) injection.
Receives: Biological: One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose; Other: Placebo
PlaceboPlacebo comparatorVolunteers will receive physiological saline solution (0.9% NaCl), administered by intra muscular (i.m.) injection
Receives: Other: Placebo

What is being measured

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

  1. To assess the safety and tolerability of the COVID-19 vaccine following one or two consecutive intramuscular injections in healthy volunteers

    Rate of solicited Adverse Event up to 14 days after each injection. Rate of unsolicited AE up to 28 days after the last injection. Rate of serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) all along the study period (up to Day 210).

    Measured: up to Day 210

Secondary outcomes (4)

  1. To assess induction of SARS-CoV-2 spike protein-binding antibodies upon one or two administrations of the COVID-19 vaccine by means of ELISA up to study day 56

    SARS-CoV-2 specific antibodies up to study day 56 as measured by spike protein-specific ELISA and serum neutralization assay

    Measured: Day 56

  2. To assess induction of SARS-CoV-2 neutralizing antibodies upon one or two administrations of the COVID-19 vaccine by means of serum neutralization assay up to study day 91

    SARS-CoV-2 specific antibodies up to study day 91 for each cohort as measured by spike protein-specific ELISA and serum neutralization assay

    Measured: Day 91

  3. To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses up to study day 91, induced by one or two doses of vaccine, by means of intracellular staining and flow cytometry.

    SARS-CoV-2 spike protein-specific cell-mediated immune response up to study day 91 induced by one or two doses as measured by intracellular staining and flow cytometry

    Measured: up to Day 91

  4. To assess potential measles virus shedding by means of RT-qPCR of saliva, nasal swab, urine, or blood samples in sentinel groups on day 0 and up to day 42

    Occurrence of measles virus shedding as evidenced by a positive RT-PCR for saliva, nasal swab, urine, or blood sample in sentinel groups.

    Measured: up to Day 42

Timeline

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

  1. First posted4 Aug 2020
  2. Study start10 Aug 2020
  3. Primary completion12 May 2021
  4. Study completion12 May 2021

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
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497298
Sponsor's protocol ID
2020-016
Other IDs
2020-002973-89
Acronym
COVID-19-101
Status last verified
Jul 2021
First submitted
31 Jul 2020
Last updated
18 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Launay O, Artaud C, Lachatre M, Ait-Ahmed M, Klein J, Luong Nguyen LB, Durier C, Jansen B, Tomberger Y, Jolly N, Grossmann A, Tabbal H, Brunet J, Gransagne M, Choucha Z, Batalie D, Delgado A, Mullner M, Tschismarov R, Berghmans PJ, Martin A, Ramsauer K, Escriou N, Gerke C. Safety and immunogenicity of a measles-vectored SARS-CoV-2 vaccine candidate, V591 / TMV-083, in healthy adults: results of a randomized, placebo-controlled Phase I study. EBioMedicine. 2022 Jan;75:103810. doi: 10.1016/j.ebiom.2021.103810. Epub 2022 Jan 16.

    PubMed 35045362

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose, Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose and One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose in people with COVID-19, run by Institut Pasteur at 2 sites in 2 countries.

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 22 inclusion and 25 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 18 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 2 sites in Belgium, France. 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. Some participants in this study may receive a placebo. 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?

To assess the safety and tolerability of the COVID-19 vaccine following one or two consecutive intramuscular injections in healthy volunteers (time frame: up to Day 210). 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 NCT04497298, 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 18 Feb 2022.

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