Safety and Immunogenicity of PCV-LITE, a Low-dose of Pneumococcal Conjugate Vaccine With LiteVax Adjuvant

Launched by LITEVAX BV · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new version of the pneumococcal vaccine called PCV-LITE. Pneumococcal bacteria can cause serious infections like pneumonia and meningitis, especially in young children and older adults. The trial will test whether a lower dose of this vaccine, combined with a special ingredient called LiteVax Adjuvant, can still provide strong protection while making the vaccine more affordable and accessible, particularly for older adults in low- and middle-income countries. Researchers want to see if this new approach can create a better immune response and confirm that the vaccine is safe for healthy adults.

To participate in this study, individuals must be between 18 and 50 years old, in good general health, and meet certain health criteria. Participants will receive either the standard or low dose of the vaccine during the study and will be closely monitored for safety and effectiveness. Importantly, women who are pregnant or breastfeeding cannot participate. If you are interested in joining the trial, you'll need to sign a consent form and undergo some health checks to ensure it's safe for you. Overall, this research aims to improve vaccine options for everyone, especially those who need it most.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria: 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.
• • Exclusion Criteria: Prior/Concomitant Therapy
• • Prior receipt of an investigational or licensed pneumococcal vaccine in the 36 months before administration of study vaccine or planning to receive a pneumococcal vaccination during the study period.
• • Prior receipt of a live attenuated vaccine in the 28 days prior to administration of study vaccine or within 14 days for subunit or inactivated vaccines other than pneumococcal vaccination.
• • Planning to receive a vaccine during the first 28 days following the administration of study vaccine.
• • Currently participating in another clinical study or planning to participate in another study during the study period, or administration of any investigational drug, vaccine or medical device in the 4 weeks prior to study vaccination.
• • Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months prior to administration of study vaccine or planning to receipt such product during the study period.
• • Chronic administration (defined as 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to vaccination or planned administration during the study (excluding topical, inhaled and intranasal preparations and intra-articular injections). For corticosteroids, this is prednisone \>= 20 mg/day, or equivalent.
• • Current intake of more than 1 anticoagulant medication (coumarin derivatives, low molecular weight heparin, DOAC) or 1 anticoagulant medication in combination with anti-aggregation medication.
• • Current anti-tuberculosis prophylaxis or therapy.
• • Elective surgery planned in the first 14 days following study vaccination.
• • Exclusion Criteria:Others
• • WOCBP who are pregnant, breast-feeding or planning to become pregnant during the study.
• • Participants with history of any medical conditions that, in opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants due to participation in the study.