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

NCT06986239 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

PCV-LITE

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

BIOLOGICAL

PCV-LITE+LVA

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

BIOLOGICAL

PCV20

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

BIOLOGICAL

PCV20+LVA

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

Sponsors & Collaborators

  • LiteVax BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-04-01
Completion
2026-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06986239 on ClinicalTrials.gov