Phase 2 Trial of a Haemophilus Influenzae Serotype a (Hia) Glycoconjugate Vaccine

NCT07743008 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: IVB 816AC2501
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

This study is testing a vaccine designed to protect against Haemophilus influenzae type a (Hia), a bacterium that can cause serious infections.This is a phase 2 trial. The study will include healthy adults between the ages of 18 and 65. Participants will be randomly assigned to receive either the Hia vaccine or a placebo. The main goals of the study are to determine safety and measure immune response as it relates to protection against Hia.

Conditions

Haemophilus Influenzae; Haemophilus Influenzae Type a

Keywords

Hia; Randomized Controlled Trial; Vaccines; Haemophilus influenza type a

Outcome Measures

Primary Outcomes (6)

• Immediate Adverse Events Following Immunization

  Immediate adverse events are solicited local reactions of erythema (redness), swelling and fever.

  30 minutes post-vaccination

• Solicited local and systemic adverse events

  Solicited local adverse events: erythema, swelling, and pain at the injection site Solicited systemic adverse events: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort (malaise), swelling in the axilla, and swelling in the neck.

  From vaccination to day 7 post first vaccination

• Solicited local and systemic adverse events

  Solicited local adverse events: erythema, swelling, and pain at the injection site Solicited systemic adverse events: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort (malaise), swelling in the axilla, and swelling in the neck.

  From vaccination to day 7 post second vaccination

• Unsolicited Adverse Events

  Any unfavourable medical occurrence in a trial participant administered the investigational product. The adverse event does not necessarily have a causal relationship with the treatment.

  From vaccination to 28 days post first dose of vaccine

• Unsolicited Adverse Events

  Any unfavourable medical occurrence in a trial participant administered the investigational product. The adverse event does not necessarily have a causal relationship with the treatment.

  From vaccination to 28 days post second dose

• Serious Adverse Events and Medically Attended Adverse Events

  Any serious adverse events and/or medically attended adverse events reported by the participant.

  From vaccination up to 240 days after dose 2

Secondary Outcomes (3)

• Immunogenicity ELISA anti-CPS IgG titers

  Before and 28 days after each of two doses

• Immunogenicity (IgG titers )

  Day 0, 28, 88 and 240

• Immunogenicity Serum Bactericidal Assay (SBA) Titers

  Days 0, 28, 88, and 240

Study Arms (2)

Group 1: Hia vaccines (2 doses)

ACTIVE COMPARATOR

Participants randomly assigned to this group will receive 2 doses of Haemophilus influenzae serotype a (Hia) glycoconjugate vaccine with alum adjuvant, 60 days apart.

Biological: Haemophilus influenzae serotype a vaccine candidate

Group 2: Placebo (2 doses)

PLACEBO COMPARATOR

Participants randomly assigned to this group will receive 2 doses of placebo (normal saline), 60 days apart.

Other: Saline (as a placebo)

Interventions

Haemophilus influenzae serotype a vaccine candidate BIOLOGICAL

The Hia vaccine will be administered according to the Investigator Brochure.

Also known as: Hia vaccine

Group 1: Hia vaccines (2 doses)

Saline (as a placebo) OTHER

Normal saline will be administered as a placebo as per the product monograph.

Also known as: Normal saline

Group 2: Placebo (2 doses)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; the participant must agree to complete study-related procedures and communicate with the study staff at visits and by phone during the study;
• Participants must have a body mass index (BMI) ≤ 32 kg/m2 (https://www.cdc.gov/healthyweight/bmi/calculator.html).
• The participant 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;
• Participants must be between 18 and 65 years of age at the Vaccination visit (Day 0);
• Participants must be in stable health and with no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Principal Investigator or Sub-Investigator (thereafter referred to as Investigator) and determined by medical history, physical examination, and vital signs; Note: Participants with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination.
• Participants of childbearing potential must have a negative urine pregnancy test result at the Screening and Vaccination visits (Days 0 \& 60) and must not be lactating. Non-childbearing is defined as:
• Non-ovulating;
• Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to vaccination);
• Post-menopausal (absence of menstruations for 12 consecutive months and age consistent with natural cessation of ovulation);
• Participants of childbearing potential and who are sexually active must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, participants must have no plan to become pregnant for at least two months post-vaccination. Abstinent participants who are ovulating should be asked what method(s) they would use should their circumstances change, and participants without a well-defined plan should be excluded. The following methods of contraception are considered to be effective:
• Hormonal contraceptives (e.g., oral, injectable, topical \[patch\], or estrogenic vaginal ring);
• Intra-uterine device with or without hormonal release;
• Male partner using a condom plus spermicide or sterilized partner (at least one year prior to vaccination)\*;
• Credible self-reported history of heterosexual vaginal intercourse abstinence until at least 60 days post-vaccination;
• Female partner. \*Note: The overall similarity of the Hia candidate vaccine to Hib vaccines widely administered in multiple doses to infants for several decades and the absence of genotoxicity in the toxicity study provides further reassurance that a contraceptive requirement in males is not needed.

You may not qualify if:

• According to the Investigator's opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness. "Evolving" is defined as:
• Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse that would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting, including methadone (methadone as treatment for opioid dependence may be acceptable if the participant has been otherwise opioid-free for at least three years);
• A history of neurologic disorders or seizures;
• Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years (one or more episodes per year);
• Administration or planned administration of any vaccine (including routine vaccines) within 30 days prior to Hia immunization and up to 30 days post-second dose of vaccine. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
• Administration of any investigational vaccine or other product during the period starting 30 days prior to randomization through to completion of the study. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
• Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to randomization or planned use during the study period.
• Participants may not participate in any other investigational or marketed drug study while participating in this study;
• Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted;
• Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g., low-dose aspirin \[no more than 81 mg/day\]), and without a clinically apparent bleeding tendency are eligible. Participants treated with new generation drugs that do not increase the risk of IM bleeding (e.g., clopidogrel) are also eligible;
• History of allergy to any of the constituents of the Hia Conjugate Vaccine or a history of anaphylaxis to any vaccines;
• History of anaphylactic allergic reactions to Hia Conjugate Vaccine components;
• Use of antihistamines within 48 hours prior to study vaccination;
• Use of prophylactic medications (e.g., acetaminophen/paracetamol, aspirin, naproxen, or ibuprofen) within 24 hours of randomization to prevent or pre-empt symptoms due to vaccination or if they are on recurring doses of these medications for other reasons;
• Have a rash, dermatological condition, tattoos (a tattoo on one deltoid only is acceptable), muscle mass, or any other abnormalities at the injection site that may interfere with injection site reaction rating;

Sponsors & Collaborators

• InventVacc Biologicals Inc.: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Dalhousie University: collaborator
• Canadian Center for Vaccinology: collaborator
• Canadian Immunization Research Network: collaborator

Study Sites (2)

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Location

Vaccine Study Centre of the McGill University Health Centre

Montreal, Quebec, Canada

Location

Related Links

• Website with information about the vaccine trial

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Joanne M Langley, MD

  CIRN, Canadian Center for Vaccinology, Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): February 3, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CA (2)