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SARS-CoV2 InfectionPhase 2HeVaccNCT04907331

Heterologous SARS-CoV-2 Vaccination With ChAdOx-1 and BNT162b2

A Phase 2 study testing Vaxzevria and Comirnaty in people with SARS-CoV2 Infection, run by Medical University Innsbruck at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will analyze the safety and efficacy of the heterologous vaccination with Vaxzevria followed by Comirnaty. As a control individuals will be vaccinated with Comirnaty or Vaxzevria twice. Each arm will involve 1000 individuals. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV2 Infection
What is being tested?
Vaxzevria and Comirnaty
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteAustria
Study dates
10 May 2021to 30 Dec 2021
Phase
Phase 2
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject provides written informed consent
  • Participant is ≥ 18 and ≤ 65 years of age on the day of signing the ICF
  • Individuals that are eligible for vaccination according to the Austrian vaccination plan.
  • Participants that have been vaccinated with either ChAdOx1-S prime within the last 12 weeks or BNT162b2 prime within the last 3 - 6 weeks
  • Subject understands and agrees to comply with study procedures
  • Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
Show all 16Show fewer
  • Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
  • has a negative urine pregnancy test at screening
  • has agreed to practice adequate contraception from providing consent until 3 months after administration of study vaccine
  • is not currently breastfeeding Adequate female contraception is defined as consistent and correct use of an approved contraceptive method, for example:
  • Barrier method (condoms, diaphragm, cervical cap) used in conjunction with spermicide
  • Prescription hormonal contraceptive taken administered via oral (pill), transdermal (patch), subdermal or IM route
  • Intrauterine device
  • Sterilization of a female participant's monogamous male partner prior to study inclusion Cave: periodical abstinence (eg calendar, ovulation, symptothermal,...) and withdrawal are not acceptable methods of contraception.
  • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as: surgically sterile (history of bilateral dubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (amenorrhea for 12 consecutive months prior to Screening without an alternative medical cause).
  • Participants agrees to not donate bone marrow, blood and blood products from the study vaccine administration until 3 months after receiving the study vaccine

Who cannot join

  • Participant has already received full vaccination against SARS- CoV-2 2. Prior administration of an investigational coronavirus (SARS- CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19 3. Participant has received/plans to receive a non-study vaccine within 14 days prior to or after any dose of IP 4. Participant has a contraindication to IM injections and blood draws (eg, bleeding disorders) 5. Participants has a known or suspected allergy or history of anaphylaxis, urticaria or other significant adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine; refer to the IB) 6. Subjects with previous positive PCR-test result for SARS-CoV-2 or positive anti-SARS-CoV-2 N protein antibody test 7. History of leukemia, lymphoma, or underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant. 8. Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment. 9. Has participated in an interventional clinical study within 30 days prior to study inclusion

Trial locations and contacts

1 site in 1 country.

Dorothee von Laer, MD/PhD contact

+4366473333617

dorothee.von-laer@i-med.ac.at

Austria1 site, 1 recruiting

  • Medical University of Innsbruck

    Innsbruck, Tyrol, 6020

    Dorothee von Laer, MD/PhD, +4366473333617, dorothee.von-laer@i-med.ac.at

    Janine Kimpel, PhD, Janine.kimpel@i-med.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Comparison of Heterologous Vaccination With an Vaxzevria (ChAdOx1-S) Prime and a Comirnaty (BNT162b2) Boost to Homolog Vaccination

This study will analyze the safety and efficacy of the heterologous vaccination with Vaxzevria followed by Comirnaty. As a control individuals will be vaccinated with Comirnaty or Vaxzevria twice. Each arm will involve 1000 individuals. Endpoints will be the level of antibody and T cell response as well as frequency of vaccine failures.

Read the detailed description

The immune escape variants are spreading worldwide. Local transmission of the B.1.351 is observed in several European regions while P1 cases are mostly still travel associated. In Austria, there is local transmission of the Czech variant B.1.258 in several regions, while the P1 variant from Brazil plays no role yet. However, B.1.351 local transmission is observed in Tyrol, where 20-30% of SARS-CoV-2 infections were caused by this immune escape variant in January/February 2021, but then controlled but not eliminated by intensive testing. In March and April the largest world-wide outbreak of B.1.1.7 + E484K, also an immune escape variant, was observed in Tyrol. Although, some of the diagnosed cases seemed to be false positive for the E484K mutation, still several hundred have currently already been confirmed, a number that is internationally still unprecedented. It is expected that until the winter infection season, that is likely to hit Europe after a phase of low-level infections in summer, the immune escape variants will make up a substantial portion of SARS-CoV-2 infections in the countries with high seroprevalence after the vaccine campaigns such as Austria. Therefore, the vaccine programs must build up an effective immunity against the wild-type virus as well as the immune escape variants. ChAdOx1-S contributes considerably to the arsenal of vaccines purchased by the European Community. The investigators propose to test whether this vaccine could still be used to build up a cross-protective immunity in the population, when combined with a heterologous boost with the mRNA vaccine BNT162b2. Heterologous prime - boost vaccine regimen including vector vaccines have been broadly used and are generally more effective than homologous vector prime-boost regimen. If ChAdOx1-S followed by BNT162b2 builds up the same or even higher level of cross-neutralizing antibodies as BNT162b2 prime-boost, which is highly likely, the vector vaccine could potentially be included in the program for building a substantial level of cross-immunity against the immune escape variants in the population. Therefore, this study compares the level of cross-neutralizing antibodies induced by classical BNT162b2 and ChAdOx1-S vaccinations with the heterologous prime and boost with ChAdOx1-S followed by BNT162b2, respectively

Being tested
Vaxzevria, Comirnaty
Medical subject headings
COVID-19

What participants receive

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

  • VaxzevriaBiological

    The participants either receive homologous vaccination with Comirnaty or Vaxzevria as approved or the new heterologous vaccination with Vaxzevria followed by Comirnaty

  • ComirnatyBiological

    The participants either receive homologous vaccination with Comirnaty or Vaxzevria as approved or the new heterologous vaccination with Vaxzevria

Study groups in NCT04907331
Study groupRoleWhat they receive
Corminaty twiceActive comparatorThe participants receive Comirnaty twice 3-7 weeks apart
Receives: Biological: Comirnaty
Vaxzevria twiceActive comparatorThe participants receive Vaxzevria twice 12 weeks apart.
Receives: Biological: Vaxzevria
HeterologousExperimentalThe recipients receive Vaxzevria followed by Comirnaty 12 weeks apart
Receives: Biological: Vaxzevria; Biological: Comirnaty

What is being measured

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

  1. Neutralizing antibodies

    in the heterologous arm the levels of neutralizing antibodies are at least as high as in the homologous arms

    Measured: 10 to 180 days

  2. T cells

    The level of T cell responses to SARS-CoV-2 S protein epitopes is at leas as high in the heterologous are than in the homologous arms

    Measured: 10-180 days

  3. vaccine failures

    Vaccine failures are not more frequent in the heterologous arm than in the homologous arms.

    Measured: 180 days post intervention

Timeline

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

  1. First posted28 May 2021
  2. Study start10 May 2021
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907331
Sponsor's protocol ID
2021-002171-19
Acronym
HeVacc
Status last verified
May 2021
First submitted
25 May 2021
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Banki Z, Mateus J, Rossler A, Schafer H, Bante D, Riepler L, Grifoni A, Sette A, Simon V, Falkensammer B, Ulmer H, Neurauter B, Borena W; HEVACC Study Group; Krammer F, von Laer D, Weiskopf D, Kimpel J. Heterologous ChAdOx1/BNT162b2 vaccination induces stronger immune response than homologous ChAdOx1 vaccination: The pragmatic, multi-center, three-arm, partially randomized HEVACC trial. EBioMedicine. 2022 Jun;80:104073. doi: 10.1016/j.ebiom.2022.104073. Epub 2022 May 23.

    PubMed 35617826

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaxzevria and Comirnaty in people with SARS-CoV2 Infection, run by Medical University Innsbruck at 1 site in Austria.

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 16 inclusion and 1 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 10 Sep 2021. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Dorothee von Laer, MD/PhD (+4366473333617, dorothee.von-laer@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutralizing antibodies (time frame: 10 to 180 days). The study lists 3 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 NCT04907331, 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 10 Sep 2021.

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