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Completed

NCT Number: NCT06177249

To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)

To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.

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Key information

Conditions

Age range

9 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Xia Shengli

Zhengzhou, Henan, 450000, China

About this study

The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 9 to 65 years old healthy residents;
  • volunteered for the experiment and signed informed consent;
  • the subjects or their guardians can comply with the requirements of the clinical trial protocol;
  • have not received rabies vaccination at any time;
  • nearly six months has not been mammals bite, scratch;
  • not participating in clinical trials of other drugs;
  • No use of human immunoglobulin or other products in the past six months.

Exclusion criteria

First needle exclusion:

  • have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;
  • Allergic to the main ingredient of the investigational vaccine;
  • known to people with poor immune function damage or the tumor, spleen;
  • Axillary temperature >38.0℃ within 7 days due to acute febrile illness;
  • Patients with axillary body temperature > 37.0℃;
  • Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors;
  • patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases;
  • pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial.

Subsequent needle exclusions:

  • any serious adverse event causally related to vaccination;
  • new findings that meet the "first dose exclusion criteria";
  • the researchers think that may affect test evaluation of any situation.

Treatment and study plan

Control Vaccine

Biological

A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.

Experimental vaccine

Biological

A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.

Primary outcomes

  1. 1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention

    Time frame: Every needle 30 days after vaccination

    Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site

  2. 1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention

    Time frame: Vaccinations 31 days to 180 days

    Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site

  3. 1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.

    Time frame: Every needle 30 days after vaccination

    Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed

  4. 1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.

    Time frame: Vaccinations 31 days to 180 days

    Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed

Secondary outcomes

  1. The immunogenicity was tested by immunofluorescence staining

    Time frame: 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples

    The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml

  2. The immunogenicity was tested by immunofluorescence staining

    Time frame: Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group

    The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml

Sponsors and collaborators

Lead sponsor

Hualan Biological Bacterin Co. Ltd.

Industry

Collaborators

  • Henan Center for Disease Control and Prevention

Registry information

Official study title

Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials

Acronym: rabies

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 20, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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