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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
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
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 moreTrial 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.
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.
Find a Location
Who is running the clinical trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
418 Previous Clinical Trials
2,116,454 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,650 Total Patients Enrolled
Laura Hammitt, MDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
3 Previous Clinical Trials
764 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition that you were born with, unless it is a simple and uncomplicated condition like a small hole in the heart.The baby's mother has HIV.You have a fever or are currently sick, but you can join the study once you feel better and meet all the other requirements.You have ongoing seizures or a changing or unstable neurological condition.Infants who are American Indian or Alaska Native and are between 6 and 12 weeks old when they receive their first vaccination.You were born after at least 35 weeks of pregnancy.The baby has a medical condition that weakens the immune system, including taking certain medications that affect the immune system for a long time.You have taken strong immunosuppressive medications, like prednisone, in the past week or plan to take them during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vaxelis
- Group 2: PedvaxHIB arm
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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