A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

NCT05389319 | Suspended Phase 1 DMC

• 1 other identifier: PRiME2_21_1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV\_Beta in healthy participants who had received the full course of vaccination, including booster vaccination (i.e., having received 3 doses) with the Pfizer/BioNTech-BNT162b2 vaccine (Comirnaty).

Conditions

COVID-19

Keywords

COVID-19; vaccine; Orf virus; SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

• Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study

  All safety data will be summarized descriptively overall and by cohort. TEAEs will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.

  Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)

• Proportion of participants with solicited local adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): pain at injection site, redness, induration, and swelling.

  Solicited local adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).

  Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)

• Proportion of participants with solicited systemic adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): fever, fatigue, headache, chills, vomiting, nausea, diarrhea, new or worsened muscle pain, new or worsened joint pain.

  Solicited systemic adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).

  Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)

• Proportion of participants with unsolicited treatment-emergent adverse events throughout the study

  All unsolicited adverse events which occur after the first administration of investigational product are defined as treatment-emergent adverse events. Treatment-emergent adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.

  Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)

Secondary Outcomes (6)

• Level of neutralizing antibody titers versus SARS CoV-2 (Wuhan wild type) at each post-booster vaccination assessment

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

• Geometric mean fold rise (GMFR) of neutralizing antibodies (versus Wuhan wild type) from Baseline to each post-booster vaccination assessment

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

• IgG antibody titer versus SARS-CoV-2 receptor-binding protein

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

• Geometric mean titers (GMT) of receptor-binding protein-specific IgG antibodies

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

• Geometric mean fold rise of receptor-binding protein-specific IgG antibodies from Baseline

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

Other Outcomes (10)

• IgG antibody titer versus SARS-CoV-2 S1 protein

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

• Geometric mean titers of IgG S1-specific antibodies

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

• Geometric mean fold rise of IgG S1-specific antibodies from Baseline

  Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)

Study Arms (5)

Cohort 1

EXPERIMENTAL

Prime-2-CoV\_Beta, dose: 30 000 PFUs

Biological: Prime-2-CoV_Beta

Cohort 2

EXPERIMENTAL

Prime-2-CoV\_Beta, dose: 300 000 PFUs

Biological: Prime-2-CoV_Beta

Cohort 3

EXPERIMENTAL

Prime-2-CoV\_Beta, dose: 3 000 000 PFUs

Biological: Prime-2-CoV_Beta

Cohort 4

EXPERIMENTAL

Prime-2-CoV\_Beta, dose: 150 000 000 PFUs

Biological: Prime-2-CoV_Beta

Cohort 5

EXPERIMENTAL

Prime-2-CoV\_Beta, dose: 30 000 000 PFUs

Biological: Prime-2-CoV_Beta

Interventions

Prime-2-CoV_Beta BIOLOGICAL

1 intramuscular injection (1.0 mL each) into the deltoid muscle on Day 1

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult men or women aged 18 to 55 years
• Full course of vaccination, including booster vaccination (i.e., having received 3 doses) with Comirnaty, with the booster dose being administered at least 10 weeks before Day 1 as documented in a respective vaccination certificate
• Able to understand the participant information and providing written informed consent
• Body mass index of 18.5 to 30.0 kg/m² and weight \> 50 kg at Screening
• Women of childbearing potential must:
• have a negative pregnancy test at Screening (blood) and at Day 1 (urine)
• agree to use, and be able to comply with, highly effective measures of contraception without interruption, from 14 days before Prime-2-CoV\_Beta booster vaccination until the end of the study.
• A highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and correctly) for this study: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence or vasectomized sexual partner. Abstinence is only acceptable as true abstinence when this is in line with the preferred and usual lifestyle of the participant (abstinent on a long-term and persistent basis). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal\] are not acceptable methods of contraception.) Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy or bilateral oophorectomy) may be enrolled.
• Male participants must agree not to intend to father a child or to donate sperm starting at Screening, throughout the clinical study. Male participants must also
• abstain from sexual intercourse with a female partner (acceptable only if it is the participant's usual form of birth control/lifestyle choice: abstinent on a long-term and persistent basis). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant or
• use adequate barrier contraception (male condom) during treatment with the investigational product until the end of the study, and
• use condoms during the entire study if they have a pregnant partner, to avoid exposure of the fetus to the investigational product
• Willing and able to comply with all study procedures based on the investigator's judgment

You may not qualify if:

• Previous and concomitant therapy:
• Receipt of any vaccine (licensed or investigational) from 4 weeks before Prime-2-CoV\_Beta booster vaccination or anticipated vaccination during the study until 6 weeks after the Prime-2-CoV\_Beta booster vaccination
• Previous vaccination against COVID-19 with vaccines (licensed or investigational) other than Comirnaty
• Current or previous treatment with another investigational drug and/or medical device (within 30 days of enrollment or 5 half-lives of that investigational drug)
• Administration of immunoglobulins or any blood products within 2 months of Prime-2-CoV\_Beta booster vaccination
• Chronic administration of medication associated with impaired immune responsiveness as judged by the investigator (including, but not limited to: immunosuppressive therapy, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy shots for hypo-sensitization, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs) within 2 months before the Prime-2-CoV\_Beta booster vaccination (Day 1). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Previous and concomitant medical condition:
• Active SARS-CoV-2 infection, confirmed by a commercially available SARS-CoV-2 rapid antigen test at Day 1, or currently on quarantine
• Confirmed (by real-time quantitative polymerase chain reaction) SARS-CoV-2 infection after 2nd vaccination with Comirnaty
• Known history of severe adverse reactions to any vaccine and/or severe allergic reactions to any component of the study vaccine, to any drug, or to any other exposure
• Known history of angioedema
• Pregnant or lactating women
• Any confirmed or suspected immunosuppressive or immunodeficient condition
• Known history of Guillain-Barré Syndrome
• Known infection with human immunodeficiency virus, hepatitis C virus or hepatitis B virus

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• FGK Clinical Research GmbH: collaborator
• VisMederi srl: collaborator
• Staburo GmbH: collaborator
• Viedoc Technologies AB: collaborator

Study Sites (2)

University Hospital Tübingen, Institute of Tropical Medicine

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

Bernhard-Nocht-Institut für Tropenmedizin

Hamburg, Hamburg, 20359, Germany

Location

Related Publications (1)

• Esen M, Fischer-Herr J, Gabor JJ, Gaile JM, Fleischmann WA, Smeenk GW, de Moraes RA, Belard S, Calle CL, Woldearegai TG, Egger-Adam D, Haug V, Metz C, Reguzova A, Loffler MW, Balode B, Matthies LC, Ramharter M, Amann R, Kremsner PG. First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster. Vaccines (Basel). 2024 Nov 18;12(11):1288. doi: 10.3390/vaccines12111288.

  PMID: 39591190 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

PRIME-2-CoV_Beta COVID-19 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

Study Officials

• Meral Esen, Dr.

  University Hospital Tübingen, Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohorts 1 to 5 will include a safety lead with 1 sentinel participant. If no safety issues occurred within the on-site monitoring period as assessed by the investigator and solicited during telephone visits, the next 2 participants in that dose cohort will be vaccinated. After an 48-hour observation period and assuming no safety issues were identified in these 2 participants, an additional 4 participants will be vaccinated. After a 48-hour observation period, and assuming that no safety problems were noted in these 4 participants, the remaining participants in the dosing group will be vaccinated. Each participant will be observed for at least 4 hours at the study center after Prime-2-CoV\_Beta booster vaccination. After the last participant of each of the Cohorts 1 to 4 has completed 7 days of follow up after the Prime-2-CoV\_Beta booster vaccination, all safety data will be reviewed by the safety review committee.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 25, 2022
• Study Start: June 24, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)