ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects

NCT05077267 | Completed Phase 2 Results DMC

• 1 other identifier: ABNCoV2-01
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 2

Brief Summary

An open label phase 2 trial to evaluate safety, tolerability and immunogenicity of the ABNCoV2 vaccine after intramuscular (IM) application. The trial will evaluate a homologous prime-boost regimen with 100 µg ABNCoV2 in initially seronegative adult subjects (Group 1), as determined by a qualitative test for SARS-CoV-2 antibodies, compared to a single boost vaccination with 100 µg (Group 2) or 50 µg (Group 3) ABNCoV2 in initially seropositive subjects, as defined by a positive qualitative test for SARS-CoV-2 antibodies and a history of SARS-CoV-2 vaccination or previous COVID-19 disease at least 90 days prior to planned trial vaccination.

Conditions

COVID-19 Disease

Outcome Measures

Primary Outcomes (1)

• Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV)-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination

  The primary endpoint was SARS-CoV-2 index virus neutralizing antibody titers by pseudovirus assay at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3), for subjects in the Immunogenicity Analysis Set.

  2 weeks after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3)

Secondary Outcomes (2)

• Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

  Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.

• Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

  Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.

Study Arms (3)

ABNCoV2 100ug single dose

EXPERIMENTAL

ABNCoV2 100ug single dose. Intervention type: Biological/Vaccine

Biological: ABNCoV2 100ug

ABNCoV2 50ug single dose

EXPERIMENTAL

ABNCoV2 50ug single dose. Intervention type: Biological/Vaccine

Biological: ABNCoV2 50ug

ABNCoV2 100ug two doses

EXPERIMENTAL

ABNCoV2 100ug two doses 4 weeks apart. Intervention type: Biological/Vaccine

Biological: ABNCoV2 100ug

Interventions

ABNCoV2 100ug BIOLOGICAL

IM injection 100ug dose

ABNCoV2 100ug single dose; ABNCoV2 100ug two doses

ABNCoV2 50ug BIOLOGICAL

IM injection 50ug dose

ABNCoV2 50ug single dose

Eligibility Criteria

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

You may qualify if:

• Seronegative (Group 1): negative qualitative test for SARS-CoV-2 antibodies at SCR.
• Seropositive (Group 2 and Group 3): Previous COVID-19 disease or previously completed vaccination regimen with an authorized SARS-CoV-2 vaccine at least 90 days before planned trial vaccination and a positive qualitative test for SARS-CoV-2 antibodies at SCR. "Authorized" SARS-CoV-2 vaccine refers to authorization status at SCR, i.e., subjects can be eligible if the subject previously received investigational vaccines that have since been authorized for emergency use or granted full market licensure. Receipt of a single dose of an authorized COVID-19 vaccine regimen in subjects with a previous diagnosis of COVID-19 or a mix/match series of 2 doses of any authorized COVID-19 vaccine will be considered as a completed vaccination.
• General good health, without acute medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
• Body mass index (BMI) ≥18.5 and \<40.
• Female subjects of childbearing potential (WOCBP) must agree to the use of an effective method of birth control from at least 30 days prior to administration of the vaccine until 30 days after the vaccination. Male subjects who are sexually active with a WOCBP must agree to the use of an effective method of birth control from the day of administration of the vaccine until 30 days after the vaccination.
• Negative human immunodeficiency virus antibody test (anti HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus (HCV).

You may not qualify if:

• Group 1 only: History of COVID-19 infection or previous vaccination with a licensed or candidate SARS-CoV-2 vaccine, or positive qualitative test for SARS-CoV-2 antibodies at SCR.
• Groups 2 and 3 only: History of COVID-19 infection and subsequent receipt of more than one licensed or candidate SARS-CoV-2 vaccine.
• Positive test for SARS-CoV-2 infection at SCR.
• Pregnant or breastfeeding women.
• Subject has an acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses.
• History of or active autoimmune disease. History of Guillain-Barré syndrome or Reye's syndrome. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
• Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome.
• History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to SCR that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site.
• Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase (AST), alanine amino transferase (ALT), alkaline phosphokinase (AP), bilirubin, or creatinine values), pulse rate, blood pressure, or electrocardiogram (ECG) outside normal range at SCR and deemed clinically relevant by the investigator.
• Clinically significant mental disorder not adequately controlled by medical treatment.
• Active or recent history (within 6 months before SCR) of chronic alcohol abuse, intravenous drug abuse, or nasal drug abuse.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of anaphylaxis or severe allergic reaction to any vaccine.
• Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
• Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (2)

Emovis GmbH

Berlin, 10629, Germany

Location

Velocity Clinical Research Hamburg

Hamburg, 22143, Germany

Location

MeSH Terms

Interventions

ABNCoV2 vaccine

Results Point of Contact

• Title: Bavarian Nordic Call Center
• Organization: Bavarian Nordic A/S

medical.information_us@bavarian-nordic.com

+1-844-422-8274

Study Officials

• Christine Grigat, MD

  Velocity Clinical Research Hamburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 14, 2021
• Study Start: August 19, 2021
• Primary Completion: February 2, 2022
• Study Completion: October 31, 2023
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-06

Locations

DE (2)