Status:
NOT_YET_RECRUITING
Safety and Immunogenicity of PCV-LITE, a Low-dose of Pneumococcal Conjugate Vaccine With LiteVax Adjuvant
Lead Sponsor:
LiteVax BV
Conditions:
Vaccine Reaction
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Streptococcus pneumoniae is a common bacteria and major cause of serious infections like bloodstream infections, pneumonia, and meningitis. These infections are most common in children under 2 years o...
Detailed Description
The objectives are to evaluate the safety and the immunogenicity of a single intramuscular (IM) injection of a standard dose of PCV20 and a low dose of PCV20 (1/5th) with or without 1 mg of LVA immuno...
Eligibility Criteria
Inclusion
- Written signed informed consent obtained before any study-related activities.
- Aged 18 to 50 years inclusive, at the time of signing the ICF.
- Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination (PE) and laboratory tests within 21 days prior to enrolment.
- Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
- Women who are not pregnant or breastfeeding, and one of the following conditions applies:
- Women of non-childbearing potential (WONCBP) OR
- WOCBP and using a highly effective contraceptive method (with a failure rate of less than 1 % per year). Appendices from at least 1 month prior to study vaccination and for 3 months post-vaccination. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to study vaccination. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. The participant should commit to abstinence for at least 1 month prior to study vaccination and for 3 months post-vaccination. If the participant will not maintain abstinence and changes her status, the participant must first commit to another highly effective method of contraception, which should be discussed with the investigator prior to terminating sexual abstinence as contraceptive method.
- WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination at Day 1. The investigator is responsible for review of medical history and menstrual history to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Participants who are willing and able to comply with the study procedures and are in the view of the investigator capable of completing the study.
Exclusion
- Medical Conditions
- History of laboratory confirmed pneumococcal infection in the past 36 months prior to the day of study vaccination.
- Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
- Past or current history of immune-mediated and/or autoimmune diseases as indicated by the investigator, e.g. diabetes mellitus type I and thyroid disease.
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.
- Clinical conditions representing a contraindication for IM administration, as judged by the investigator, e.g. history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM administration or blood draws.
- History of confirmed hypersensitivity, allergy and/or anaphylaxis to diphtheria toxoid or to squalene-based adjuvants, or other components of the study vaccine (aluminum phosphate, succinic acid, Polysorbate 80).
- Current history of uncontrolled medical illness (unstable for the past 3 months) as judged by investigator, e.g. hypertension, diabetes mellitus type 2.
- Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and seizure disorder other than: 1) childhood febrile seizures, or 2) seizures that have not required treatment within the last 3 years.
- History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- Active malignancy or malignancy within the past 5 years, except basocellular carcinoma (single lesion) that has been fully removed.
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years or that is expected to require the use of oral or intravenous corticosteroids.
- History of hereditary angioedema, acquired angioedema or idiopathic forms of angioedema.
- History of idiopathic urticaria within the past year.
- Current or recent (\< 2 years ago) heavy smoking (\> 20 cigarettes per day) or heavy vaping (\> 2 mL e-liquid daily, which correspond with 20 cigarettes; reference ). If candidate stopped smoking or vaping \> 2 years ago, the investigator would make an individual judgement based on the total packs or use per year and the candidate's overall health status. Drug - or alcohol abuse/addiction (including alcohol dependence), or psychiatric condition (e.g., past or present psychoses; disorder requiring lithium; or within 5 years prior to administration of study vaccine, a history of suicide plan or attempt), which in the investigator's opinion could compromise the participant's safety and/or compliance with the protocol.
- A rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06986239
Start Date
July 1 2025
End Date
July 1 2026
Last Update
May 22 2025
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