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

NCT04907331 | Unknown Phase 2 DMC

• 1 other identifier: 2021-002171-19
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. Endpoints will be the level of antibody and T cell response as well as frequency of vaccine failures.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (3)

• Neutralizing antibodies

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

  10 to 180 days

• 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

  10-180 days

• vaccine failures

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

  180 days post intervention

Study Arms (3)

Corminaty twice

ACTIVE COMPARATOR

The participants receive Comirnaty twice 3-7 weeks apart

Biological: Comirnaty

Vaxzevria twice

ACTIVE COMPARATOR

The participants receive Vaxzevria twice 12 weeks apart.

Biological: Vaxzevria

Heterologous

EXPERIMENTAL

The recipients receive Vaxzevria followed by Comirnaty 12 weeks apart

Biological: Vaxzevria; Biological: Comirnaty

Interventions

Vaxzevria BIOLOGICAL

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

Heterologous; Vaxzevria twice

Comirnaty BIOLOGICAL

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

Corminaty twice; Heterologous

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Medical University of Graz: collaborator
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 35617826 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; mRNA Vaccines; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Dorothee von Laer, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorothee von Laer, MD/PhD

CONTACT

+4366473333617; dorothee.von-laer@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: May 10, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)