Safety and Reactogenicity Trial of Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b

NCT05401305 | Completed Phase 1

• 1 other identifier: HIB-I-07/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Trial purpose is to evaluate the safety, tolerability and reactogenicity of the Vaccine for the prevention of infections caused by Haemophilus Influenzae Type b in volunteers aged 18-50.

Conditions

Haemophilus Influenzae Infection; Vaccines

Keywords

Haemophilus Influenzae; Haeophilus influenza type b; Vaccine; Hib vaccines; Hib; SPbSRIVS

Outcome Measures

Primary Outcomes (2)

• Incidence of local adverse events (AEs)

  * Pain at the injection site * Hyperemia at the injection site * Infiltrate at the injection site * Injection site edema Severity of an AE was established according to the following classification: 0 - none - No symptoms 1. \- mild - Mild symptoms 2. \- moderate - Symptoms that disrupt normal daily activities to a certain extent 3. \- severe - Symptoms that disrupt normal daily activities Hyperemia/infiltration/edema 0 - none - No symptoms 1. \- mild - Hyperemia with a diameter of up to 50 mm or infiltrate/edema with a diameter of up to 25 mm 2. \- moderate - Hyperemia with a diameter of up to 50 mm or infiltrate/edema with a diameter of 26-50 mm 3. \- severe - Infiltrate/edema more than 50 mm in diameter

  Days 1-7 post-vaccination

• Incidence of systemic adverse events (AEs)

  Fever, Irritability, Anxiety, Drowsiness, Fainting, Fatigue, Convulsions, Apnea, Arthralgia, Myalgia, Headache, Dizziness, Nausea, Abdominal pain, Loss of appetite, Vomiting, Diarrhea, Rash Severity of an AE was established according to the following classification: 0 - none - No symptoms 1. \- mild - Mild symptoms 2. \- moderate - Symptoms that disrupt normal daily activities to a certain extent 3. \- severe - Symptoms that disrupt normal daily activities Fever 0 - none \<=37.0°С 1. \- mild \> 37.0°С - \<=37.5°С 2. \- moderate \> 37.6°С - \<=38.5°С 3. \- severe \> 38.6°С

  Days 1-7 post-vaccination

Secondary Outcomes (15)

• Incidence of other adverse events (AEs)

  Days 8-28 post-vaccination

• Incidence of immediate adverse events (AEs) (allergic reactions)

  2 hours after vaccination

• Incidence of severe adverse events (SAEs)

  Days 0-28

• Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products

  Days 0-28

• Number of patients with abnormal results of assessment of vital signs - blood pressure (BP)

  Days 0-7, 14, 28

Study Arms (2)

Hib vaccine

EXPERIMENTAL

Volunteers will be vaccinated with Vaccine for the prevention of infections caused by Haemophilus influenza type b once intramuscularly at a dose of 0.5 mL. Stage I: 5 volunteers Stage II: 25 volunteers

Biological: Vaccine for the prevention of infections caused by Haemophilus influenza type b

Placebo

PLACEBO COMPARATOR

Volunteers will receive a placebo once intramuscularly at a dose of 0.5 mL. Stage I: 5 volunteers Stage II: 25 volunteers

Biological: Placebo

Interventions

Vaccine for the prevention of infections caused by Haemophilus influenza type b BIOLOGICAL

The vaccine is administered into the region of the deltoid muscle

Hib vaccine

Placebo BIOLOGICAL

The placebo is administered into the region of the deltoid muscle

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers (men and women) aged 18-50 years;
• Written informed consent of volunteers to participate in the clinical trial;
• Volunteers not previously vaccinated with any vaccine to prevent infections caused by Haemophilus influenza type b;
• Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
• For fertile women, a negative pregnancy test and consent to observe adequate methods of contraception (if hormonal contraceptives are used, they must be canceled at least 2 months before the start of the trial). All women with childbearing potential must have a negative pregnancy test result during the Data Collection Period. In the course of the trial women should use contraception methods with a reliability exceeding 90 %, or be sterile, or be in a postmenopausal state. Contraception methods with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals.
• For the men, are able to conceive - consent to use adequate contraception methods. In the course of the trial, men and their sexual partners should use contraception methods with a reliability exceeding 90 %, or be sterile. Contraception methods with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals.

You may not qualify if:

• A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
• Allergic reactions to vaccine components, especially to tetanus toxoid, or to any previous vaccination for the prevention of infections caused by Haemophilus influenza type b;
• Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
• Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
• Vaccination with any vaccine within one month before the vaccination;
• History of leukemia, tuberculosis, cancer, autoimmune diseases;
• Positive blood test results for HIV, syphilis, hepatitis B/C.
• Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
• History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory products for six months before the trial;
• History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
• History of chronic diseases of the cardiovascular, bronchopulmonary systems, gastrointestinal tract, liver, kidneys, blood in the acute or decompensation stage;
• History of progressive neurological pathology, convulsive syndrome;
• Diabetes, thyrotoxicosis or other diseases of the endocrine system;
• History of eczema;
• Treatment with glucocorticosteroids, including in small doses, as well as local use of products containing steroids;

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (1)

Federally Funded Healthcare Institution Primary Healthcare Unit No.163, Federal Medical-Biological Agency (FFHI PHU No.163, FMBA of Russia)

Коltsovo, Russia

Location

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Ellina Ruzanova, PhD

  St. Petersburg Research Institute of Vaccines and Sera

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: January 14, 2020
• Primary Completion: March 30, 2020
• Study Completion: June 17, 2020
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

RU (1)