Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 Against Crimean Congo Hemorrha… (NCT06684431) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 Against Crimean Congo Hemorrhagic Fever
Sweden15 participantsStarted 2024-11-12
Plain-language summary
This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Men and women between the ages of 18 and 60 years (at the time of consent).
✓. Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments.
✓. No clinically significant laboratory abnormalities as determined by the investigator at screening.
✓. Negative HIV 1/2 antibody/antigen test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
✓. Participant with a body mass index (BMI) 20-30.0 kg/m2.
✓. Provide written informed consent before initiation of any study procedures.
✓. A female participant is eligible for this study if she is one of the following:
✓. male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject;
Exclusion criteria
✕. History of presence of pulmonary disorders (chronic obstructive pulmonary lung disease etc) or asthma (exception of allergic asthma, which is allowed).
✕. History or presence of thrombocytopenia and/or bleeding disorders.
✕. A positive serum pregnancy test at screening or urine pregnancy test prior to study injection, women who are planning to become pregnant during the study, or women who are breastfeeding.
What they're measuring
1
Local reactions
Timeframe: For up to 7 days after each vaccine dose
2
Visual analogue scale (VAS) score
Timeframe: At vaccination (0 minutes), and after 5, 15, 30 and 60 minutes post-EP
3
Systemic events
Timeframe: For 7 days after each vaccine dose
4
Unsolicited AEs
Timeframe: From the first study dose to 28 days after the last vaccination
✕. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune, central nervous system or neurological diseases.
✕. Use of immunosuppressive drugs as e.g. corticosteroids (excluding topical preparations and inhalers) within 3 months prior to vaccination or 6 months for chemotherapies and all along the study.
✕. Vaccination within 2 weeks prior to vaccination or planning to receive a licensed vaccine before month 3 (e.g. inactivated influenza vaccine).
✕. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the Investigational vaccine.
✕. Participation in another investigational clinical study within four weeks before the screening visit or planned before the study completion.