Hia Vaccine for Haemophilus Infections

Not currently recruiting at 1 trial location

Overseen By Luis Barreto, MBBS, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: InventVacc Biologicals Inc.

Must not be taking: Glucocorticoids, Antihistamines, Prophylactic medications, others

Disqualifiers: Autoimmune diseases, Neurologic disorders, Cancer, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and immune response of a new vaccine designed to prevent infections caused by Haemophilus influenzae serotype a (Hia), a serious illness affecting Indigenous children in Canada and Alaska. Researchers will compare the vaccine's effects to a placebo (a harmless substance with no active ingredients) in healthy adults. This study could lead to a new vaccine that protects vulnerable populations from this dangerous disease. Individuals who are generally healthy, between 18 and 40 years old, and have a stable medical condition might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, if you have had any significant changes in chronic medication in the last three months due to uncontrolled symptoms or drug toxicity, you may be excluded. Also, certain medications like systemic glucocorticoids, immunosuppressants, and investigational products are restricted. Please discuss your specific medications with the trial investigator.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had any significant changes in your chronic medication recently, it might affect your eligibility. It's best to discuss your specific medications with the trial staff.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that vaccines like the new Haemophilus influenzae serotype a (Hia) vaccine have generally been well-tolerated. Studies on the similar Haemophilus influenzae type b (Hib) vaccine indicate that side effects are usually mild. Common reactions include redness, warmth, or swelling at the injection site. Some people might also experience a mild fever or feel slightly cranky.

More serious side effects, such as severe allergic reactions, are rare. Typically, about 5% to 30% of people report mild pain or swelling after receiving similar vaccines. This information suggests that the Hia vaccine is expected to be safe based on knowledge of similar vaccines. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Haemophilus infections, which often involve antibiotics, the Haemophilus Influenzae Serotype A (Hia) Vaccine uses a conjugate vaccine approach. This vaccine is unique because it combines a specific part of the Haemophilus bacteria with a protein carrier to enhance the immune response. Researchers are excited about this treatment because it has the potential to provide long-lasting immunity against Hia infections, reducing the need for repeated antibiotic courses and potentially curbing antibiotic resistance. Additionally, the use of an adjuvant like AdjuPhos may boost the vaccine's effectiveness, offering stronger and more durable protection.

What evidence suggests that this vaccine might be an effective treatment for Haemophilus infections?

Research has shown that the Hib (Haemophilus influenzae type b) vaccine effectively reduces serious diseases caused by Hib. Because Hib and Hia (Haemophilus influenzae serotype a) are similar, researchers hope a vaccine for Hia could work just as well. This trial will test the Hia vaccine, administered to participants in the vaccine arm. One study found that a potential Hia vaccine could be very cost-effective and significantly reduce the number of illnesses. These findings suggest that developing a vaccine for Hia could be a promising way to protect people in affected communities from serious diseases. ^{4 6 7 8 9}

Who Is on the Research Team?

Joanne M Langley, MD

Principal Investigator

Canadian Center for Vaccinology

Brian Ward, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Scott A. Halperin, MD

Principal Investigator

Canadian Center for Vaccinology

Are You a Good Fit for This Trial?

This trial is for healthy adults in the general population. It's focused on preventing serious illness caused by Haemophilus influenzae serotype a (Hia), which has been affecting Indigenous children in Canada and Alaska.

Inclusion Criteria

To be enrolled, subjects must have a body mass index (BMI) ≤ 32 kg/m2

The subject is considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study

The subject must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; the subject must agree to complete study-related procedures and communicate with the study staff at visits and by phone during the study

Exclusion Criteria

I have not received any vaccines 30 days before or plan to within 30 days after the Hia vaccine.

History of anaphylactic allergic reactions to Hia Conjugate Vaccine components

I haven't taken antihistamines in the last 48 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of the Hia Conjugate Vaccine or placebo, 28 days apart

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with adverse events collected for 28 days post each dose and immunogenicity assessed at multiple time points

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Haemophilus Influenzae Serotype A Vaccine

Trial Overview The study tests the safety and ability to provoke an immune response of a new Hia glycoconjugate vaccine using protein carrier CRM197. This first-in-human study will take place at two Canadian research centers.

How Is the Trial Designed?

Group I: Vaccine arm Active Control 1 Intervention

This arm receives 0.5 mL of a 10 µg dose of Hia Conjugate Vaccine with AdjuPhos.

Group II: Placebo arm Placebo Group 1 Intervention

This arm receives 0.5 mL placebo (normal saline).

Who Is Running the Clinical Trial?

InventVacc Biologicals Inc.

Lead Sponsor

Trials

1

Recruited

30+

Hia Consortium

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The International Outcome Inventory for Hearing Aids (IOI-HA) is a reliable seven-item questionnaire that effectively evaluates the effectiveness of hearing aid treatments across various research settings, ensuring comparability of data.

The original English version of the IOI-HA shows good internal consistency, suggesting that it can be summed to create a total outcome score, although generating two separate scores may enhance its reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. Cox, RM., Alexander, GC.[2022]

Children with mild hearing loss who consistently used hearing aids showed significantly better vocabulary and grammar skills compared to those who did not use them, highlighting the importance of regular HA use for language development.

The study found that the amount of daily hearing aid use was a key predictor of improvements in language skills, suggesting that consistent use is crucial for maximizing auditory benefits in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Hearing Aid Use on Outcomes of Children With Mild Hearing Loss. Walker, EA., Holte, L., McCreery, RW., et al.[2022]

Haemophilus influenzae serotype a (Hia) has become a significant pathogen in Canada following the success of vaccines against serotype b, with most cases belonging to clonal division I and the ST-23 clonal complex.

Surveillance for invasive H. influenzae disease should incorporate serotyping for Hia and multilocus sequence typing to identify hypervirulent clones, such as the ST-4 clone found in a recent Canadian isolate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population genetics of Haemophilus influenzae serotype a in three Canadian provinces. Tsang, RS., Shuel, M., Wylie, J., et al.[2020]

In a study of 133 children aged 3 months to 16 years, it was found that levels of antibodies (IgG and IgM) against Haemophilus influenzae type a (Hia) increased with age, indicating that older children have a stronger immune response to Hia.

The significantly higher concentrations of IgM compared to IgG suggest that natural exposure to environmental antigens may play a role in developing immunity, highlighting the need for immunization in younger children to prevent serious infections as Hia becomes more prevalent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seroprevalence of IgG and IgM antibodies to Haemophilus influenzae type a in Canadian children. Huska, B., Kubinec, C., Sadarangani, M., et al.[2022]

A study of 179 strains of Haemophilus influenzae isolated from 146 sick children in Argentina revealed a significant decrease in serotype b cases since the introduction of universal vaccination in 1998.

The research also noted a relative increase in other serotypes, indicating a shift in the serotype distribution of Hi infections following vaccination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Isolation of Haemophilus influenzae serotypes from deep sites in sick children]. Gatti, BM., Ramirez Gronda, GA., Etchevarría, M., et al.[2020]

Vaccination of only newborns against Haemophilus influenzae serotype a (Hia) is insufficient to eliminate the pathogen, even with a booster program, highlighting the need for broader vaccination strategies.

To effectively eradicate Hia, it is crucial to vaccinate not just newborns but also susceptible individuals, along with maintaining high vaccination coverage and timely booster doses to sustain herd immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modelling the impact of vaccination on curtailing Haemophilus influenzae serotype 'a'. Konini, A., Moghadas, SM.[2015]

The study involved 161 patients fitted with hearing aids, and it identified two key subscales in the International Outcome Inventory-Hearing Aids (IOI-HA): a 'benefit' subscale and a 'residual problems' subscale, which help measure the effectiveness of hearing aids.

The 'benefit' subscale correlated with improvements reported by patients on the Client-oriented Scale of Improvement (COSI), indicating that patients experienced significant benefits from their hearing aids, while the 'residual problems' subscale highlighted ongoing issues that some patients still faced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Outcome Inventory for Hearing Aids (IOI-HA) and its relationship to the Client-oriented Scale of Improvement (COSI). Stephens, D.[2019]

Among 28 children with congenital sensorineural hearing loss fitted with hearing aids, 18 also had a conductive component due to middle ear effusion or acute otitis media, which complicated the fitting process.

Children with both sensorineural and conductive hearing loss required significantly more fitting sessions and longer fitting periods, highlighting the need for early intervention and collaboration between audiologists and otolaryngologists to optimize hearing aid fitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Complexity of Hearing Aid Fitting: Children with Congenital Hearing Loss and Middle Ear Dysfunction. Priner, R., Brand, D.[2023]

In a 5-year study of 35 patients with H. influenzae meningitis, 12 cases were identified as serotype a, highlighting a concerning rise in invasive disease due to this serotype, particularly in young children.

Despite 83% of the patients having received at least one dose of the Haemophilus influenzae type b vaccine, the study reported significant complications, including a 16.6% mortality rate due to severe outcomes like cerebral damage and shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemophilus influenzae Serotype a as a Cause of Meningitis in Children in Brazil. Russo, DO., Torres, BR., Romanelli, RMC., et al.[2023]

Since the introduction of Hib vaccines, the majority of invasive Haemophilus influenzae infections are now caused by non-Hib strains, particularly Hia, which poses significant health risks.

The similarities between the virulence factors of Hia and Hib suggest that a combined vaccine targeting both serotypes could effectively prevent serious diseases caused by these pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemophilus influenzae serotype a as a cause of serious invasive infections. Ulanova, M., Tsang, RSW.[2022]

The Swedish translation of the International Outcome Inventory for Hearing Aids (IOI-HA) demonstrated reliable psychometric properties, similar to previous studies, based on a sample of 224 first-time hearing aid users.

The type of hearing loss significantly influenced the outcomes, with subjects having sensorineural hearing losses reporting poorer introspective scores compared to those with conductive or mixed hearing losses, indicating that the nature of hearing loss can affect the perceived effectiveness of hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing aid fitting outcome: clinical application and psychometric properties of a Swedish translation of the international outcome inventory for hearing aids (IOI-HA). Brännström, KJ., Wennerström, I.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8482018/

Hib Vaccines: Their Impact on Haemophilus influenzae ... Hib vaccine effectiveness against invasive Hib infection was only 44% among fully vaccinated, HIV-infected children in South Africa (only 1 of ...

2. cdc.gov cdc.gov/pinkbook/hcp/table-of-contents/chapter-8-haemophilus-influenzae.html

Chapter 8: Haemophilus influenzae | Pink Book Among children born during 2016–2017, 92.2% had received the Hib vaccine primary series (at least 2 or 3 doses, depending on product) and 79.9% ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40683138/

Increase in invasive Haemophilus influenzae type b ... Among those aged 6-11 months (n=60), 76.7% were correctly vaccinated with two doses. In children ≥12 months (n=65), 67.7% were correctly ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X18300963

Cost-effectiveness of a potential vaccine candidate for ... A potential vaccine candidate for Hia is highly cost-effective. An Hia vaccine can substantially reduce costs and burden of invasive disease.

5. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7336a4.htm

Use of Haemophilus influenzae Type b–Containing ... This report describes the Advisory Committe on Immunization Practices recommendation for use of Haemophilus influenzae type b (Hib) vaccine ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/hib.html

Haemophilus influenzae type b (Hib) Vaccine Safety Common side effects · Redness, warmth, or swelling at the site of injection. · Fever. · Irritability.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031280/

Adverse Events Following Haemophilus influenzae Type b ... Our study revealed that most Hib vaccine-related AEFIs were common adverse reactions, with the top three most common symptoms being fever (52.82 ...

8. fda.gov fda.gov/media/77017/download

Package Insert - Hiberix Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the ...

9. immunize.org immunize.org/wp-content/uploads/vis/hib.pdf

Haemophilus influenzae type b (Hib) Vaccine Hib vaccine can prevent Haemophilus influenzae type b (Hib) disease. Haemophilus influenzae type b can cause many different kinds of infections.