What is the mechanism of action of this treatment?

The most common treatments for Haemophilus influenzae infection, particularly type b (Hib), involve vaccination with vaccines like Vaxelis and PedvaxHIB. These vaccines work by stimulating the immune system to produce specific antibodies against the polysaccharide capsule of Haemophilus influenzae type b. This immune response is crucial as it provides long-term protection by enabling the body to recognize and combat the bacteria more effectively if exposed in the future. For patients, this means a significantly reduced risk of severe infections such as meningitis, pneumonia, and epiglottitis, which are associated with Hib.

What side effects are associated with this type of intervention?

The most common treatments for Haemophilus influenzae type b (Hib) infection, such as the vaccines Vaxelis and PedvaxHIB, are generally well-tolerated. Common side effects include mild reactions at the injection site (such as redness, swelling, and pain), fever, irritability, and fatigue. Serious side effects are rare but can include allergic reactions. These vaccines work by stimulating the immune system to produce antibodies against Hib, thereby providing protection against the infection.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Haemophilus influenzae type b (Hib) infections, which work by stimulating the immune system to produce antibodies against the bacteria. Notable vaccines include PedvaxHIB and Vaxelis. PedvaxHIB is a monovalent Hib conjugate vaccine, while Vaxelis is a combination vaccine that includes Hib along with other antigens. These vaccines are designed to protect infants and children from invasive diseases caused by Hib, such as meningitis and pneumonia, by inducing a robust immune response.

What other types of research exist?

As of now, there are no specific novel alternatives to Vaxelis and PedvaxHIB mentioned in the provided context. However, ongoing research in vaccine technology, such as mRNA vaccines and other conjugate vaccines, may offer new options in the near future. Patients should consult with their healthcare providers for the most current and personalized recommendations.

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Cancer Vaccine

Hib Vaccines for Haemophilus Influenzae Infection

Phase 4

Waitlist Available

Led By Laura Hammitt, MD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after dose 3 of vaxelis and 90 days after dose 2 of pedvaxhib

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to determine which of two vaccines better protects American Indian and Alaska Native infants from a bacterial infection. These infants are at higher risk and need early protection. The vaccines help the immune system recognize and fight the bacteria.

Who is the study for?

This trial is for healthy American Indian and Alaska Native infants aged 6 to 12 weeks, born at ≥35 weeks of gestation. They must be able to complete a 5-month follow-up and have parental consent. Infants with severe heart disease, immunocompromising conditions, or those who've received blood products or certain medications are excluded.

What is being tested?

The HibVax Study aims to compare the immune response in AI/AN infants given two different licensed vaccines: Vaxelis and PedvaxHIB. The study will monitor how well these vaccines stimulate defense against Haemophilus influenzae type b.

What are the potential side effects?

Potential side effects from the vaccines may include redness or swelling at the injection site, fever, irritability, sleepiness, allergic reactions to vaccine components like latex, or other mild symptoms typically associated with infant vaccinations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after dose 1 of vaxelis or pedvaxhib

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after dose 1 of vaxelis or pedvaxhib

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after dose 1 of vaxelis or pedvaxhib for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Anti-PRP IgG Geometric Mean Concentration (GMC)

Secondary study objectives

Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1

Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121

Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: VaxelisActive Control1 Intervention

165 infants will be randomized to the Vaxelis group, which is licensed for primary vaccination at 2, 4 and 6 months of age.

Group II: PedvaxHIB armActive Control1 Intervention

165 infants will be randomized to the PedvaxHIB group, which is licensed for primary vaccination at 2 and 4 months of age.

Do I qualify?Apply below to find out

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

The most common treatments for Haemophilus influenzae infection, particularly type b (Hib), involve vaccination with vaccines like Vaxelis and PedvaxHIB. These vaccines work by stimulating the immune system to produce specific antibodies against the polysaccharide capsule of Haemophilus influenzae type b. This immune response is crucial as it provides long-term protection by enabling the body to recognize and combat the bacteria more effectively if exposed in the future. For patients, this means a significantly reduced risk of severe infections such as meningitis, pneumonia, and epiglottitis, which are associated with Hib.