What is the mechanism of action of this treatment?

Pneumococcal vaccines, such as AFX3772, PCV13, and PCV15, work by inducing immunity against pneumococcal bacteria. They contain inactivated or attenuated forms of the bacteria or their components, which stimulate the immune system to produce antibodies. These antibodies recognize and neutralize the bacteria upon future exposure, preventing severe infections. This is crucial for patients as it reduces disease incidence, prevents severe complications, and decreases the reliance on antibiotics, thereby helping to combat antibiotic resistance.

What side effects are associated with this type of intervention?

The most common side effects of pneumococcal vaccines, including those similar to AFX3772 like PCV13, are generally mild and include local reactions at the injection site (such as pain, redness, and swelling), fever, irritability, and decreased appetite. Some individuals may experience more systemic reactions like fatigue, headache, and muscle pain. Serious side effects are rare but can include severe allergic reactions.

What prior FDA approvals exist?

The FDA has approved several pneumococcal vaccines for the prevention of pneumococcal infections. The 7-valent pneumococcal conjugate vaccine (PCV7) was licensed in 2000, followed by the 13-valent pneumococcal conjugate vaccine (PCV13), which offers broader protection against more serotypes of Streptococcus pneumoniae. Additionally, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) is approved for use in older children and adults, providing coverage against 23 different serotypes. More recently, the FDA approved the 15-valent (PCV15) and 20-valent (PCV20) pneumococcal conjugate vaccines, which further expand the serotype coverage and are recommended for use in adults. These vaccines are designed to induce immunity and reduce the incidence of pneumococcal diseases such as pneumonia, meningitis, and bacteremia.

What other types of research exist?

Promising alternatives to AFX3772 for pneumococcal infections include the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23). PCV13 has shown effectiveness in reducing invasive pneumococcal disease and is well-studied in both children and adults. Pneumovax 23 covers a broader range of serotypes and has been effective in various populations, including those with chronic conditions. Both vaccines have established safety profiles and are widely used in clinical practice.

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Cancer Vaccine

AFX3772 Vaccine for Pneumococcal Infections

Phase 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.

Be younger than 18 years old

Must not have

Had prior administration of any pneumococcal vaccine

Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site (like pain or swelling), fever, irritability, and loss of appetite. More serious allergic reactions are rare but possible due to ingredients in AFX3772 or Prevnar 13.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received a pneumococcal vaccine before.

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

Select...

I have received immunoglobulin treatment.

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I have a fever during my first visit.

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I have had a serious infection caused by S. pneumoniae.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with AEs

Percentage of participants with serious adverse events (SAEs)

Percentage of participants with solicited injection site events

+1 more

Secondary study objectives

Geometric mean concentration for serotype-specific IgG

Percentage of participants with a pneumococcal serotype-specific Immunoglobulin G (IgG) concentration of greater than or equal to (>=) 0.35 μg/mL

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Group 3Experimental Treatment1 Intervention

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

Group II: Group 2Experimental Treatment1 Intervention

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

Group III: Group 1Experimental Treatment1 Intervention

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

Group IV: Group 5Active Control1 Intervention

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

Group V: Group 4Active Control1 Intervention

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pneumococcal vaccines, such as AFX3772, PCV13, and PCV15, work by inducing immunity against pneumococcal bacteria. They contain inactivated or attenuated forms of the bacteria or their components, which stimulate the immune system to produce antibodies. These antibodies recognize and neutralize the bacteria upon future exposure, preventing severe infections. This is crucial for patients as it reduces disease incidence, prevents severe complications, and decreases the reliance on antibiotics, thereby helping to combat antibiotic resistance.