AFX3772 Vaccine for Pneumococcal Infections

Recruiting at 58 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Corticosteroids, Immunoglobulins, others

Disqualifiers: Immunodeficiency, Allergies, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

472 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new vaccine called AFX3772 in healthy infants to prevent pneumococcal disease. The vaccine aims to help their immune systems recognize and fight off the bacteria that cause this disease.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, infants who have received systemic corticosteroids for more than 14 days must have completed the treatment at least 30 days before the study vaccine.

What data supports the effectiveness of the AFX3772 treatment for pneumococcal infections?

The AFX3772 vaccine is similar to other pneumococcal vaccines like PCV13 and PPSV23, which have shown effectiveness in preventing pneumococcal diseases. For example, PCV13 has been reported to be 75% effective against certain types of invasive pneumococcal disease and 45% effective against pneumococcal pneumonia. ^{1 2 3 4 5}

Is the AFX3772 vaccine for pneumococcal infections safe for humans?

The AFX3772 vaccine, also known as a pneumococcal vaccine, has been studied for safety in various forms. In general, these vaccines are well-tolerated, with most side effects being mild, such as fever, irritability, and redness at the injection site. Serious side effects are rare and usually resolve on their own. ^{2 3 6 7 8}

How is the AFX3772 vaccine different from other treatments for pneumococcal infections?

The AFX3772 vaccine is unique because it is a 24-valent pneumococcal vaccine, meaning it targets 24 different strains of the bacteria, which is more than many existing vaccines. It uses a novel method of combining proteins and polysaccharides to enhance the immune response, potentially offering broader protection against pneumococcal infections. ^{2 3 9 10 11}

Eligibility Criteria

This trial is for healthy, full-term infants around 2 months old without prior pneumococcal vaccines or immunoglobulins. Infants with fevers, bleeding issues, allergies to vaccine components, immune deficiencies, or whose mothers have HIV/hepatitis B can't participate.

Inclusion Criteria

My baby is about 2 months old and was born at full term.

Exclusion Criteria

I have received a pneumococcal vaccine before.

I have a bleeding condition that makes injections unsafe for me.

I have received immunoglobulin treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part 1)

Infants are randomized in sequential cohorts to receive increasing doses of AFX3772 or PCV13, with safety and tolerability data reviewed by the Data Monitoring Committee

12 months

4 visits (in-person)

Randomized Treatment (Part 2)

Additional infants are enrolled and randomized to receive either PCV20 or AFX3772 at approved dose levels

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• AFX3772
• Prevnar 13

Trial Overview The study compares the safety and immune response of a new vaccine AFX3772 against Prevnar 13 in preventing pneumonia. Infants receive four doses over up to 21 months. The first part tests escalating doses; the second expands to more infants at approved levels.

Participant Groups

Group I: Group 3 Experimental Treatment 1 Intervention

5 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 \& Part 2 of the study.

Group II: Group 2 Experimental Treatment 1 Intervention

2 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 \& Part 2 of the study.

Group III: Group 1 Experimental Treatment 1 Intervention

1 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 of the study.

Group IV: Group 5 Active Control 1 Intervention

PCV20 administered intramuscularly 4 times within 12 months in Part 2 of the study.

Group V: Group 4 Active Control 1 Intervention

PCV13 administered intramuscularly 4 times within 12 months in Part 1 of the study.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Affinivax, Inc.

Industry Sponsor

Trials

4

Recruited

1,300+

Findings from Research

The new pneumococcal conjugate vaccines, PCV15 and PCV20, have been shown to be safe and immunogenic in adults, providing a promising alternative to the previously recommended PCV13 and PPSV23 vaccines.

PCV13 demonstrated efficacy rates of 75% against PCV13-type invasive pneumococcal disease (IPD) and 45% against pneumococcal pneumonia (PP), while PPSV23 showed lower effectiveness of 45% against PPSV23-type IPD and only 18% against PPSV23-type PP, indicating that PCV13 offers better protection in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of the Efficacy and Effectiveness of Pneumococcal Vaccines in Adults. Farrar, JL., Childs, L., Ouattara, M., et al.[2023]

The 13-valent pneumococcal conjugate vaccine is shown to be as safe and effective as the 7-valent vaccine in infants, with both vaccines well tolerated and most reactions being mild or moderate.

The 13-valent vaccine not only protects against the seven common serotypes but also offers expanded protection against six additional serotypes, achieving high immunogenicity with at least 89% of infants reaching protective antibody levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: a meta-analysis. Ruiz-Aragón, J., Márquez Peláez, S., Molina-Linde, JM., et al.[2015]

The 20-valent pneumococcal conjugate vaccine (PCV20) significantly reduces the incidence and mortality of pneumococcal diseases in Danish adults compared to the 23-valent pneumococcal polysaccharide vaccine (PPV23), leading to substantial health benefits.

Vaccination with PCV20 is a cost-effective strategy, potentially saving up to 396 million EUR while gaining thousands of quality-adjusted life years (QALYs), making it a dominant choice for adults at moderate or high risk and those aged 65 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. Olsen, J., Schnack, H., Skovdal, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

New potential in pneumococcal immunization. Conjugate vaccine may improve disease protection, health of infants and young children. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pneumococcal vaccine. Health and Public Policy Committee, American College of Physicians. [2006]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of the Efficacy and Effectiveness of Pneumococcal Vaccines in Adults. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Next Generation Streptococcus pneumoniae Vaccines Conferring Broad Protection. [2020]

6. Brazil pubmed.ncbi.nlm.nih.gov

Adverse events after pneumococcal vaccination. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[Heptavalent pneumococcal conjugate vaccine immunogenicity and safety in Japanese infants: primary and booster immunization results]. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: a meta-analysis. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity of PCV24, an expanded pneumococcal conjugate vaccine, in adult monkeys and protection in mice. [2021]