NCT04978818

Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)

Completed Phase 4 Results posted Last updated 24 June 2024

What this trial tests

Phase 4 trial testing Vaxelis in Haemophilus Influenzae Type B Infection in 333 participants. Completed in 26 October 2023.

Timeline

27 January 2022

Primary endpoint
26 October 2023

26 October 2023

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	333
Start date	27 January 2022
Primary completion	26 October 2023
Estimated completion	26 October 2023
Sites	5 locations across United States

Drugs / interventions tested

• Vaxelis — full drug profile →
• PedvaxHIB

Conditions studied

• Haemophilus Influenzae Type B Infection — all drugs for Haemophilus Influenzae Type B Infection →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 6 Weeks to 12 Weeks, any sex, with Haemophilus Influenzae Type B Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anti-PRP IgG Geometric Mean Concentration (GMC) Primary · 30 days after dose 1

The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB. GMC was modeled using constrained longitudinal analysis (cLDA) of anti-PRP IgG concentration at all study visits.

Group	Value	95% CI
PedvaxHIB Arm	0.40	0.31 – 0.5
Vaxelis	0.41	0.33 – 0.51

Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1 Secondary · 30 days after dose 1 of Vaxelis or PedvaxHIB

Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

Group	Value	95% CI
PedvaxHIB Arm	104
Vaxelis	115

Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1 Secondary · 30 days after dose 1 of Vaxelis or PedvaxHIB

Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

Group	Value	95% CI
PedvaxHIB Arm	40
Vaxelis	38

Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121 Secondary · 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB

Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

Group	Value	95% CI
PedvaxHIB Arm	115
Vaxelis	126

Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121 Secondary · 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB

Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

Group	Value	95% CI
PedvaxHIB Arm	100
Vaxelis	102

Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151 Secondary · 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB

Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.

Group	Value	95% CI
PedvaxHIB Arm	106
Vaxelis	122

Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 151 Secondary · 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB

Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.

Group	Value	95% CI
PedvaxHIB Arm	84
Vaxelis	107

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 7 months post first dose of study vaccine. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PedvaxHIB Arm

Serious: 12/166 (7%)

Deaths: 0/166

Vaxelis

Serious: 9/167 (5%)

Deaths: 0/167

Serious adverse events (9 terms)

Reaction	System	PedvaxHIB Arm	Vaxelis
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	—	—
COVID-19	Respiratory, thoracic and mediastinal disorders	—	—
Influenza	Respiratory, thoracic and mediastinal disorders	—	—
Serizure, or seizure-like activity	Nervous system disorders	—	—
Acute gastroenteritis	Gastrointestinal disorders	—	—
Broken Femur	Musculoskeletal and connective tissue disorders	—	—
Urinary Tract Infection	Renal and urinary disorders	—	—
Viral illness with hypoxia	Infections and infestations	—	—
Viral Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Bronchiolitis, COVID-19, Influenza, Serizure, or seizure-like activity, Acute gastroenteritis, Broken Femur, Urinary Tract Infection, Viral illness with hypoxia.

Data from ClinicalTrials.gov NCT04978818 adverse events section.

Sponsor's own description

The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Haemophilus influenzae Type b Vaccine Immunogenicity in American Indian/Alaska Native Infants.
   Jackson BD, Miernyk K, Steinberg J, Beaudry J, et al · · 2024 · cited 2× · PMID 39314177 · DOI 10.1542/peds.2024-066658