Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells

NCT07199569 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: POX-MVA-046
• Study Type: interventional
• Target: 970
• Locations: 1 country
• Sites: 10

Brief Summary

Randomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults

Conditions

Monkeypox (Mpox)

Outcome Measures

Primary Outcomes (8)

• Immunogenicity of 2 doses of MVA-BN

  Titer of serum neutralizing antibodies against vaccinia virus as measured by plaque reduction neutralization tests (PRNTs)

  2 weeks after the second MVA-BN vaccination

• Number of Participants with Serious Adverse Events (SAE)

  Number and percentage of study participants reporting any serious adverse events at any time during the trial period

  From vaccination through study termination, up to 7 months

• Number of Participants with Adverse Events of Special Interest (AESI)

  Number and percentage of study participants reporting any Adverse Events of Special Interest (AESI)

  From vaccination through study termination, up to 7 months

• Number of Participants with Medically Attended Adverse Events (MAAE)

  Number and percentage of study participants reporting any Medically Attended Adverse Events (MAAE)

  From vaccination through study termination, up to 7 months

• Number of Participants with a Grade 3 or higher adverse event (AE)

  Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse event (AE) assessed as related to trial vaccine

  The day of or within 28 days after either vaccination

• Number of Participants with Solicited Local AE

  Number and percentage of study participants reporting any solicited local AE (pain, swelling, pruritus, erythema, induration)

  The day of or within 7 days after either vaccination

• Number of Participants with Solicited Systemic AE (body temperature, headache, fatigue, myalgia, nausea, chills)

  Number and percentage of study participants reporting any solicited systemic AE (body temperature, headache, fatigue, myalgia, nausea, chills)

  The day of or within 7 days after either vaccination

• Number of Participants with Unsolicited AE

  Number and percentage of study participants reporting any unsolicited AE

  The day of or within 28 days after either vaccination

Secondary Outcomes (4)

• Titer of Serum Neutralizing Antibodies against Vaccinia Virus

  4 weeks after the first MVA-BN vaccination and 6 months after the last MVA-BN vaccination

• Seroconversion in Neutralizing Antibodies

  4 weeks after the first MVA-BN vaccination, 2 weeks and 6 months after the second MVA-BN vaccination

• Titer of Total Antibodies against Vaccinia Virus

  4 weeks after the first MVA-BN vaccination, 2 weeks and 6 months after the second MVA-BN vaccination

• Seroconversion in Total Antibodies against Vaccinia Virus

  4 weeks after the first MVA-BN vaccination, 2 weeks and 6 months after the second MVA-BN vaccination

Study Arms (2)

Group 1

ACTIVE COMPARATOR

MVA-BN (CEF)

Biological: Jynneos

Group 2

EXPERIMENTAL

MVA-BN (Quail)

Biological: MVA-BN (Quail)

Interventions

Jynneos BIOLOGICAL

MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29).

Group 1

MVA-BN (Quail) BIOLOGICAL

MVA-BN manufactured in CCX.E10 quail cell line. Vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U. and is a LF suspension to be administered subcutaneously into the deltoid muscle of the upper arm (preferably the nondominant arm). Participant will receive 2 doses 4 weeks apart (Day 1 and Day 29).

Group 2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 49 years of age
• Informed consent form (ICF) signed and dated by the participant after reading the form and being advised of the risks and benefits of the trial in a language understood by the participant and before performance of any trial-specific procedures
• General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator that would interfere with the trial
• Body mass index (BMI) ≥18.5 and ≤35 (calculated as \[body weight in kg\]/\[body height in m\]2 )
• Agreement by female participants of childbearing potential and male participants who are sexually active with a female partner of childbearing potential to use a highly effective method of birth control from at least 30 days prior to administration of the MVA-BN vaccine until 30 days after last vaccination
• Medically acceptable methods of contraception that may be used by the participant and/or partner include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined use of 2 barrier birth control methods (male condom with female diaphragm, male condom with cervical cap), bilateral tubal occlusion, vasectomy, or abstinence (acceptable only if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of the MVA-BN vaccine until 30 days after last vaccination
• Female participants or partners are not considered to be of childbearing potential if they are at least 1 year postmenopausal

You may not qualify if:

• Pregnancy or breastfeeding
• Acute or chronic condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of responses including, but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immunosuppressive conditions
• Known immunodeficiency syndrome or known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, or moderate to severe kidney impairment; HIV infection under stable HAART regimen (no change within the last 3 months) and CD4 count is \>500/µL is not considered immunodeficient
• Known or reported previous smallpox vaccination or vaccination with any licensed or investigational poxvirus-based vaccine
• History of monkeypox, cowpox, or vaccinia infection
• Close contact in the 3 weeks prior to signing the ICF with anyone known to have mpox
• History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure
• Clinically significant mental disorder not adequately controlled by medical treatment
• Active or recent (within 6 months before screening) chronic alcohol abuse and/or intravenous and/or nasal drug abuse
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, eg, tris(hydroxymethyl)-amino methane, including history of allergic asthma
• Known allergy to aminoglycosides or quinolones
• History of anaphylaxis or severe allergic reaction to any vaccine
• Receipt of or plans to receive any licensed live vaccine from 30 days prior to the trial vaccination until 30 days after last trial vaccination
• Receipt of or plans to receive any licensed nonlive vaccine from 14 days prior to the trial vaccination until 14 days after last trial vaccination
• Use of any investigational or nonregistered agent within 30 days prior to vaccination or plans to receive an investigational agent during the trial

Sponsors & Collaborators

• Bavarian Nordic: lead
• ICON plc: collaborator

Study Sites (10)

Accellacare and McFarland Clinic

Ames, Iowa, 50010, United States

Location

Johnson County ClinTrials, LLC

Lenexa, Kansas, 66219, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Accellacare of Cary - Cary Medical Group

Cary, North Carolina, 27518, United States

Location

Accellacare Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Accellacare of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Accellacare - Knoxville

Knoxville, Tennessee, 37938, United States

Location

Avacare

Austin, Texas, 78705, United States

Location

Avacare

Fort Worth, Texas, 76135, United States

Location

Velocity Clinical Research

Suffolk, Virginia, 23435, United States

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (10)