AFX3772 Vaccine for Pneumococcal Infections

No longer recruiting at 76 trial locations

Overseen By Cathleen Jeffers

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, AFX3772, which aims to prevent pneumococcal disease in infants. Researchers seek to determine the safety and effectiveness of various doses of AFX3772 compared to existing vaccines like Prevnar 13 and Prevnar 20. Infants in the study will receive different doses of AFX3772 or the standard vaccines to observe their bodily responses. The trial seeks healthy, full-term infants around 2 months old who have not yet received any pneumococcal vaccines. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AFX3772 was safe in earlier studies. In toddlers aged 12 to 15 months, a similar vaccine was administered as a single dose and was well-tolerated, with side effects remaining consistent regardless of the dose. Additionally, in studies with healthy adults, AFX3772 triggered a strong immune response, which is promising. As this is a Phase 2 trial, early safety tests have been encouraging enough to warrant continuation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the AFX3772 vaccine for pneumococcal infections because it offers a potentially broader and more effective immune response compared to current vaccines like PCV13 and PCV20. Unlike existing options, AFX3772 is being tested at various doses (1 mcg, 2 mcg, and 5 mcg), which may allow for tailored immunity based on individual needs. This flexibility in dosing could lead to better protection against a wider range of pneumococcal strains, making it a promising candidate for enhanced prevention of these infections in infants.

What evidence suggests that this trial's treatments could be effective for pneumococcal infections?

Research shows that AFX3772 holds promise as a vaccine against pneumococcal infections. In earlier studies with healthy adults, AFX3772 triggered a strong immune response, producing more antibodies than some existing vaccines. It also did not cause serious side effects, indicating good tolerance. These findings suggest that AFX3772 could effectively prevent pneumococcal diseases, such as pneumonia and meningitis. Although most data comes from adult studies, the strong antibody response indicates potential use in infants. In this trial, infants will receive different dosages of AFX3772 in various treatment arms to evaluate its effectiveness and safety in this population. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Part 2 Group 6 Experimental Treatment 2 Interventions

Infants are scheduled to receive up to three doses of 5 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV20 as SOC.

Group II: Part 2 Group 5 Experimental Treatment 2 Interventions

Infants are scheduled to receive up to three doses of 2 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV20 as SOC.

Group III: Part 1 Group 3 Experimental Treatment 2 Interventions

Infants are scheduled to receive up to three doses of 5 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as SOC.

Group IV: Part 1 Group 2 Experimental Treatment 2 Interventions

Infants are scheduled to receive up to three doses of 2 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as SOC.

Group V: Part 1 Group 1 Experimental Treatment 2 Interventions

Infants are scheduled to receive up to three doses of 1 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as standard of care (SOC).

Group VI: Part 1 Group 4 Active Control 1 Intervention

PCV13 administered intramuscularly within 12 months.

Group VII: Part 2 Group 7 Active Control 1 Intervention

PCV20 administered intramuscularly within 12 months.

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X22007150

Phase 1/2 study of a novel 24-valent pneumococcal ... Conclusions. These results demonstrate that ASP3772 is well tolerated, highly immunogenic, and in adults may offer significantly broader ...

2. mdpi.com mdpi.com/2076-393X/13/5/498

The New Era of Pneumococcal Vaccination in Adults This review provides an updated overview of the pneumococcal disease burden, the evolution of pneumococcal vaccines, and the latest immunization strategies.

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/GSK/pressreleases/35734309/gsks-afx3772-vaccine-study-a-new-contender-in-infant-pneumococcal-prevention/

GSK's AFX3772 Vaccine Study: A New Contender in Infant ... The study aimed to assess the safety, tolerability, and immune response of the AFX3772 vaccine in preventing pneumococcal disease in infants, a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05412030

NCT05412030 | A Phase 2 Study to Evaluate the Safety, ... This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10435554/

Emerging vaccine strategies against the incessant ... In a combined Phase 1/2 study to evaluate safety and efficacy in healthy adults, AFX3772 exhibited a more robust antibody response than those ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24001452

Safety, tolerability and immunogenicity of a novel 24-valent ... In 12–15-month-old toddlers, a single dose of Pn-MAPS24v showed an acceptable safety profile, regardless of dose level; AEs were reported at similar ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05412030/a-phase-2-study-to-evaluate-the-safety-tolerability-and-immune-response-of-afx3772-vaccine-in-healthy-infants

A Phase 2 Study to Evaluate the Safety, Tolerability, and ... The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with ...

8. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/GSK-N/pressreleases/35734309/gsks-afx3772-vaccine-study-a-new-contender-in-infant-pneumococcal-prevention/

GSK's AFX3772 Vaccine Study: A New Contender in Infant ... The study aimed to assess the safety, tolerability, and immune response of the AFX3772 vaccine in preventing pneumococcal disease in infants, a ...