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Haemophilus Influenzae InfectionPhase 1NCT05401305

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

A Phase 1 study testing Vaccine for the prevention of infections caused by Haemophilus influenza type b in people with Haemophilus Influenzae Infection and Vaccines, run by St. Petersburg Research Institute of Vaccines and Sera at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Haemophilus Influenzae Infection, Vaccines
What is being tested?
Vaccine for the prevention of infections caused by Haemophilus influenza type b
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteRussia
Study dates
14 Jan 2020to 17 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • According to the medical history, the volunteer was/is a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary and/or other;
  • Acute infectious diseases less than 4 weeks before the start of the trial according to the anamnesis;
  • Consumption of more than 10 units of alcohol per week or history of alcohol addiction, product addiction or abuse of pharmaceutical products;
  • Smoking of more than 10 cigarettes per day;
  • Participation in another clinical trial during the last 3 months;
  • Pregnancy or lactation;
  • Serious concurrent illnesses or pathological conditions not listed above which, in the opinion of the investigator, could complicate the assessment of the results of the trial including pathological deviations from age norms and laboratory norms of blood and urine parameters, which are clinically significant in the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Koltsovo

Other trials in Russia

About this study

Official title: Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of "Baby-Hib [Vaccine for the Prevention of Infections Caused by Haemophilus Influenzae Type b], Lyophilizate for Preparation of Intramuscular Injection Solution, 0.5 mL/Dose", FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-50

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.

Read the detailed description

The trial includes 2 stages (Stage I and Stage II). The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib vaccine in the first 10 volunteers during the first 7 days after vaccination.

The aim of the Stage I is to assess the tolerability, reactogenicity and safety of the Hib vaccine during 28 days after vaccination and also to conduct a comparative assessment of the safety and reactogenicity of the Hib vaccine and placebo during 28 days after vaccination.

Being tested
Vaccine for the prevention of infections caused by Haemophilus influenza type b, Placebo
Keywords
Haemophilus Influenzae, Haeophilus influenza type b, Vaccine, Hib vaccines, Hib, SPbSRIVS
Medical subject headings
Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccine for the prevention of infections caused by Haemophilus influenza type bBiological

    The vaccine is administered into the region of the deltoid muscle

  • PlaceboBiological

    The placebo is administered into the region of the deltoid muscle

Study groups in NCT05401305
Study groupRoleWhat they receive
Hib vaccineExperimentalVolunteers 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
Receives: Biological: Vaccine for the prevention of infections caused by Haemophilus influenza type b
PlaceboPlacebo comparatorVolunteers will receive a placebo once intramuscularly at a dose of 0.5 mL. Stage I: 5 volunteers Stage II: 25 volunteers
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Days 1-7 post-vaccination

  2. 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

    Measured: Days 1-7 post-vaccination

Secondary outcomes (15)

  1. Incidence of other adverse events (AEs)

    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

    Measured: Days 8-28 post-vaccination

  2. Incidence of immediate adverse events (AEs) (allergic reactions)

    • Anaphylaxis
    • Quincke's edema
    • Urticaria 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

    Measured: 2 hours after vaccination

  3. Incidence of severe adverse events (SAEs)

    Measured: Days 0-28

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

    Measured: Days 0-28

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

    BP measurements include the systolic and diastolic blood pressure, using tonometers

    Measured: Days 0-7, 14, 28

  6. Number of patients with abnormal results of assessment of vital signs - heart rate (HR)

    HR is measured using a phonendoscope at the apex of the heart (1.5 cm inwards from the left midclavicular line in the 5th intercostal space) during 1 minute.

    Measured: Days 0-7, 14, 28

  7. Number of patients with abnormal results of assessment of vital signs - respiratory rate (RR)

    RR is counted with a hand placed on the volunteer's chest or abdomen or by holding a stethoscope at the volunteer's nose. The measurement is carried out during one minute.

    Measured: Days 0-7, 14, 28

  8. Number of patients with abnormal results of assessment of vital signs - body temperature

    Body temperature is measured using a non-contact infrared electronic thermometer.

    Measured: 10 minutes before administration; 20 minutes, 2 hours, 5-8 hours after vaccination; Days 1-7, 14, 28

  9. Number of patients with abnormal results of physical examination

    Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion.

    It is necessary to conduct an examination and (when applicable) palpation, auscultation, percussion for the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system, thyroid gland. The palpation analysis of lymph nodes (submandibular, cervical, ulnar, inguinal) includes an assessment of their size, consistency, pain, mobility, adhesion between themselves and with surrounding tissues and skin.

    Measured: Days 0-7, 14, 28

  10. Number of patients with abnormal results of neurological status assessment

    Assessment of:

    • Cranial nerve function
    • Motor sphere
    • Reflex sphere
    • Sensitive sphere
    • Coordination sphere
    • Pelvic functions
    • Higher mental functions

    Measured: Days 0,1,3,28

  11. Number of patients with abnormal ECG findings

    Standard 12-lead ECG. Assessment of: PQ, QT,QTc intervals, QRS complex

    Measured: Days 0,3

  12. Number of patients with abnormal results of complete blood counts

    Red cells, Hemoglobin, ESR, White cells, Differential Leukocyte Count (segmented and rod neutrophils, lymphocytes, monocytes, eosinophils, basophils), Platelets

    Measured: Days 0,3,14,28

  13. Number of patients with abnormal results biochemical blood tests

    ALT, AST, LDH, Alkaline phosphatase, Bilirubin total, Total protein, Urea, Glucose, C-reactive protein, Creatinine, Prothrombin complex, Cholesterol, В-lipoproteins, Thymol

    Measured: Days 0,3,14,28

  14. Number of patients with abnormal results E immunoglobulin tests

    Total IgE

    Measured: Days 0,3,14,28

  15. Number of patients with abnormal Urinalysis results

    pH, Relative density / specific gravity, Protein, Glucose, Red cells, White cells

    Measured: Days 0,3,14,28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start14 Jan 2020
  3. Primary completion30 Mar 2020
  4. Study completion17 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05401305
Sponsor's protocol ID
HIB-I-07/19
Status last verified
May 2022
First submitted
27 May 2022
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vaccine for the prevention of infections caused by Haemophilus influenza type b in people with Haemophilus Influenzae Infection and Vaccines, run by St. Petersburg Research Institute of Vaccines and Sera at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of local adverse events (AEs) (time frame: Days 1-7 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05401305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022; AzTrials last refreshed its copy on 26 Oct 2026.

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