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

NCT06986239 | Not Yet Recruiting Phase 1

• 1 other identifier: 2024-515972-11-00
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 old and adults over 65 years of age and dangerous for all age groups. Current vaccines, which contain parts of the bacteria, have significantly reduced the incidence of invasive pneumococcal disease (IPD). To broaden protection more serotypes are added to the vaccines over the years, which results in lower immune responses to the serotype-specific polysaccharides while a stronger vaccine is desired for older people and people with a weakened immune system. In addition, these complex vaccines are hardly affordable for the growing group of older adults in low- and middle-income countries (LMICs). To address these challenges, a new potent adjuvant called 'LiteVax Adjuvant' was developed. It has been shown to improve the efficacy of vaccines, even at low doses of antigen. A lower antigen dose reduces the costs of vaccines and promotes accessibility in LMICs. By testing a standard and a low dose of a commercial pneumococcal conjugate vaccine combined with LiteVax Adjuvant in healthy volunteers, we aim to determine whether the adjuvant enhances the immune response and if a lower vaccine dose is effective. At the same time, the safety of the vaccines is being investigated.

Conditions

Vaccine Reaction

Keywords

Vaccine adjuvant; LiteVax Adjuvant; Pneumococcal polysaccharide conjugate vaccine

Outcome Measures

Primary Outcomes (1)

• Solicited and non-solicited local and systemic adverse events after a single administration of Prevenar 20 with or without LiteVax adjuvant

  To evaluate the safety and tolerability of a single administration of 1/5th-dose of Prevenar 20 + 1 mg LVA (PCV-LITE), 1/5th-dose of Prevenar 20 without LVA, and a full-dose of Prevenar 20 + 1 mg LVA in comparison to a full-dose of Prevenar 20 without LVA, in healthy participants (18-50 years) * Occurrence of solicited local and systemic adverse events (AEs) for 14 days, unsolicited AEs for 28 days, and serious adverse events (SAEs), potential immune-mediated diseases (pIMDs), and adverse events of special interest (AESIs) for 180 days after vaccination. * Occurrence of clinically abnormal haematology and serum biochemistry laboratory values 1 day, 7 days, and 28 days, after vaccination versus baseline (Day 0, pre-vaccination).

  Solicited AEs 14 days, non-solicited AEs 28 days and SAEs/pIMD/AESIs 180 days post-vaccination

Secondary Outcomes (2)

• Humoral immune responses to a single administration of Prevenar 20 with or without LiteVax Adjuvant by multiplex immune assay (MIA)

  Pre-vaccination (Day 0) and 28 and 180 days post-vaccination

• Humoral immune response to a single administration of Prevenar 20 with or without LiteVax Adjuvant measured by opsonophagocytic activity assay (OPA)

  Pre-vaccination (Day 0), 28 days and optionally 180 days post-vaccination

Other Outcomes (2)

• Functional serum antibody responses

  Pre-vaccination (Day 0), and 28 and optionally 180 days post-vaccination and pre-vaccination

• Mucosal antibody response

  Pre-vaccination (Day 0), and 28 days and optionally 180 days post-vaccination

Study Arms (4)

Fractional dose of PCV20

EXPERIMENTAL

A single intramuscular injection of 0.5 mL comprising 1/5th dose of Prevenar20 without LiteVax Adjuvant (LVA)

Biological: PCV-LITE

Fractional dose of PCV20 plus LVA

EXPERIMENTAL

A single intramuscular injection of 0.5 mL comprising 1/5th dose of Prevenar20 with 1 mg of LiteVax Adjuvant (LVA)

Biological: PCV-LITE+LVA

Standard dose of PCV20 without LVA

ACTIVE COMPARATOR

A single intramuscular injection of 0.5 mL comprising a full dose of Prevenar20 without LiteVax Adjuvant

Biological: PCV20

Standard dose of PCV20 plus 1 mg LiteVax Adjuvant

EXPERIMENTAL

A single intramuscular injection of 0.5 mL comprising a full dose of Prevenar20 with LiteVax Adjuvant

Biological: PCV20+LVA

Interventions

PCV-LITE BIOLOGICAL

Fractional dose of pneumococcal polysaccharide conjugate vaccine without LiteVax Adjuvant (LVA)

Fractional dose of PCV20

PCV-LITE+LVA BIOLOGICAL

Fractional dose of pneumococcal polysaccharide conjugate vaccine with 1 mg of LiteVax Adjuvant (LVA)

Fractional dose of PCV20 plus LVA

PCV20 BIOLOGICAL

Standard (full) dose of pneumococcal polysaccharide conjugate vaccine without LiteVax Adjuvant (LVA)

Standard dose of PCV20 without LVA

PCV20+LVA BIOLOGICAL

Standard (full) dose of pneumococcal polysaccharide conjugate vaccine with LiteVax Adjuvant (LVA)

Standard dose of PCV20 plus 1 mg LiteVax Adjuvant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LiteVax BV: lead

Related Publications (1)

• van Beek LF, van der Gaast-de Jongh C, Platenburg PP, Hilgers L, de Jonge MI. Improving the immunogenicity of the pneumococcal conjugate vaccine using a synthetic carbohydrate fatty acid monosulphate squalane-in-water adjuvant. Vaccine. 2025 Apr 2;51:126893. doi: 10.1016/j.vaccine.2025.126893. Epub 2025 Feb 20.

  PMID: 39983540 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: May 22, 2025
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share