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

NCT04978818 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00011170
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Haemophilus Influenzae Type B Infection

Keywords

Native American; Vaccine

Outcome Measures

Primary Outcomes (1)

• Anti-PRP IgG Geometric Mean Concentration (GMC)

  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.

  30 days after dose 1

Secondary Outcomes (6)

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

  30 days after dose 1 of Vaxelis or PedvaxHIB

• Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1

  30 days after dose 1 of Vaxelis or PedvaxHIB

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

  60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB

• Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121

  60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB

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

  30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB

Study Arms (2)

Vaxelis

ACTIVE COMPARATOR

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

Drug: Vaxelis

PedvaxHIB arm

ACTIVE COMPARATOR

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

Drug: PedvaxHIB

Interventions

Vaxelis DRUG

Eligible infants will be block randomized to one of two study arms.

Also known as: Intervention

Vaxelis

PedvaxHIB DRUG

Eligible infants will be block randomized to one of two study arms.

Also known as: Comparator

PedvaxHIB arm

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at gestational age of ≥35 weeks
• AI/AN infant between 6 to 12 weeks of age (42-90 days) at the time of the first vaccination (i.e., Study Day 1)
• Written informed consent provided by parent(s)/Legally Authorized Representative(s) (LARs)
• Investigators believe that the parent(s)/LARs can and will comply with the requirements of the protocol (i.e., return for follow-up visits, recall of adverse events)
• Infant is available to complete the follow-up period of 5 months
• Healthy infant, as established by medical history and clinical examination before entering the study

You may not qualify if:

• History of receipt of blood, blood products, or immunoglobulin products since birth or expected receipt through the duration of the study
• Chronic seizure or evolving or unstable neurologic disorder
• Congenital Heart Disease, except for uncomplicated CHD (e.g., PDA, small septal defect)
• Infant of mother with HIV infection
• History of reaction or hypersensitivity likely to be exacerbated by any vaccine component, or to latex
• Infant with confirmed or suspected immunocompromising medical condition, based on medical history, including chronic administration (more than 14 days in the lifetime) of immunosuppressants or other immune-modifying drugs since birth
• Administration of infant vaccines other than birth dose Hepatitis B, prior to the time of enrollment
• Any condition which might interfere with the evaluation of the investigational product, or interpretation of subject safety or study results, in the opinion of the investigator
• Child of an employee of the sponsor, clinical study site, or any other individual involved with the conduct of the study, or an immediate family member of such individuals

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

Alaska Native Medical Center

Anchorage, Alaska, 99508, United States

Location

Chinle Center for Indigenous Health

Chinle, Arizona, 86503, United States

Location

Fort Defiance Center for Indigenous Health

Fort Defiance, Arizona, 86504, United States

Location

Gallup Center for Indigenous Health

Gallup, New Mexico, 87301, United States

Location

Shiprock Center for Indigenous Health

Shiprock, New Mexico, 87420, United States

Location

Related Publications (7)

• Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.

  PMID: 27846055 BACKGROUND

• Bulkow LR, Wainwright RB, Letson GW, Chang SJ, Ward JI. Comparative immunogenicity of four Haemophilus influenzae type b conjugate vaccines in Alaska Native infants. Pediatr Infect Dis J. 1993 Jun;12(6):484-92. doi: 10.1097/00006454-199306000-00006.

  PMID: 8345981 BACKGROUND

• Santosham M, Wolff M, Reid R, Hohenboken M, Bateman M, Goepp J, Cortese M, Sack D, Hill J, Newcomer W, et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenzae type b polysaccharide and Neisseria meningitidis outer-membrane protein complex. N Engl J Med. 1991 Jun 20;324(25):1767-72. doi: 10.1056/NEJM199106203242503.

  PMID: 1903846 BACKGROUND

• Singleton R, Bulkow LR, Levine OS, Butler JC, Hennessy TW, Parkinson A. Experience with the prevention of invasive Haemophilus influenzae type b disease by vaccination in Alaska: the impact of persistent oropharyngeal carriage. J Pediatr. 2000 Sep;137(3):313-20. doi: 10.1067/mpd.2000.107843.

  PMID: 10969253 BACKGROUND

• Diaz-Mitoma F, Halperin SA, Tapiero B, Hoffenbach A, Zappacosta PS, Radley D, Bradshaw S, Martin JC, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age. Vaccine. 2011 Feb 1;29(6):1324-31. doi: 10.1016/j.vaccine.2010.11.053. Epub 2010 Dec 4.

  PMID: 21134456 BACKGROUND

• Silfverdal SA, Icardi G, Vesikari T, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016 Jul 19;34(33):3810-6. doi: 10.1016/j.vaccine.2016.05.054. Epub 2016 Jun 18.

  PMID: 27288217 BACKGROUND

• State of Alaska Epidemiology Bulletin; Aug 11, 2009

  BACKGROUND

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Vaxelis; Methods; Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Laura Hammit
• Organization: Johns Hopkins School of Public Health

lhammitt@jhu.edu

4436510000

Study Officials

• Laura Hammitt, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an unblinded, post-licensure study; study staff will not be blinded to participant intervention status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization of participants will be done at the site level. Participants will be assigned randomly 1:1, to the Vaxelis arm or the PedvaxHIB arm. This is an unblinded study. Study staff will log into a secure system to randomize the participant. The study vaccine associated with that randomization will be selected. A verifier will confirm that the correct vaccine was selected. After verification, study staff will administer the dose.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 27, 2021
• Study Start: January 27, 2022
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)