A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine (NCT05685953) | Clinical Trial Compass
CompletedPhase 1
A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine
Sweden16 participantsStarted 2023-02-08
Plain-language summary
This is a randomized, placebo-controlled, double-blinded phase I study, designed to evaluate the safety including reactogenicity and immunogenicity of this investigational DNA vaccine delivered intramuscularly by in vivo EP in human adults. The vaccine doses will be given to healthy adults aged 18 to 60 years, who have been previously vaccinated against COVID-19 with 3 doses of either Comirnaty® or Spikevax®, or both in any combination ≥3 months ago.
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).
✓. All study subjects have received three doses of registered mRNA vaccine/s, the last dose given ≥ 3 months before inclusion in this study.
✓. 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:
Exclusion criteria
✕. Previous vaccination with investigational or registered non-mRNA vaccines against COVID-19.
✕. 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.
✕
What they're measuring
1
Local reactions after the vaccine/placebo dose
Timeframe: Up to 7 days after the vaccine/placebo dose
2
Visual analogue scale pain rating scale score
Timeframe: At 0, 5, 15, 30 and 60 minutes post-EP.
3
Systemic events for 7 days after each vaccine/placebo dose.
Timeframe: For 7 days after each vaccine/placebo dose.
4
Unsolicited AEs
Timeframe: From the study dose to 28 days after vaccination.
5
Serious Adverse Events (SAEs)/SUSARs
Timeframe: From the study dose until the study end at 3 months after vaccination.
. 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.
✕. 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.