Health TrialsbyHealthPanel

mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults

ConditionEBV
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-25
SponsorVaccine Company, Inc.

About this trial

This is an adaptive design Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 25 years, inclusive

Healthy per medical assessment based on self-reported medical history, physical examination, vital signs, and laboratory assessment

Disqualifiers

Self-reported or medically-documented significant medical or psychiatric condition that per medical assessment could interfere with study participation

Likely or confirmed myocarditis or pericarditis

Prior receipt of an investigational EBV vaccine

Prior receipt of a licensed vaccine within 56 days prior to Day 1

Trial design

Design model

Sequential

Treatments tested in this trial

  • VXCO-102

    Biological/Vaccine

    Sterile liquid for injection

  • Placebo

    Biological/Vaccine

    0.9% sodium chloride (BP grade)

Treatment groups

45 Participants
are divided into 4 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Solicited Local and Systemic Reactions

Time frame
7 days after each product administration
2

Number of Participants with Unsolicited Adverse Events

Time frame
Up to 28 days after each product administration
3

Number of Participants with Serious Adverse Events (SAEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events of Special Interest (AESIs)

Time frame
Day 1 to end of study (Day 357)

Secondary outcomes

1

Rate of neutralizing antibody response

Time frame
Day 1 and 85

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vaccine Company, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: