Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers

NCT05621655
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
1,512
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Lead sponsor
MAXVAX Biotechnology Limited Liability Company
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Start date
2023-01-08
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Number of sites
2
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Summary
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
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Short title
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
clinicaltrials.gov
Official title
A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Subunit Rotavirus Vaccine in Healthy Infants Aged 6-12 Weeks and Healthy Toddlers Aged 7-71 Months
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-12-01
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First posted
2022-11-18
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Registry last updated
2024-11-20
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Primary completion date
2023-04-29
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Start date
2023-01-08
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Actual participants
1,512
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Participants
1,512
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
1:1:1
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
MAXVAX Biotechnology Limited Liability Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05621655
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ClinicalTrials.gov ID
NCT05621655
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. The incidence of adverse events

    Timeframe: Within 30 minutes after each vaccination

    Incidence of adverse events within 30 minutes after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  2. The incidence of adverse events

    Timeframe: Within 14 days after each vaccination

    Incidence of adverse events within 14 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  3. The incidence of adverse events

    Timeframe: Day 15 to 28/30 after each vaccination

    Incidence of adverse events Day 15 to 28/30 after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  4. The incidence of adverse events

    Timeframe: Within 28/30 days after each vaccination

    Incidence of adverse events within 28/30 days after each dose. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

  5. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin A (IgA)

    Timeframe: Day 30 after the last vaccination

    Measured by ELISA at baseline and 30 days after the last vaccination.

  6. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus Immunoglobulin G (IgG)

    Timeframe: Day 30 after the last vaccination

    Measured by ELISA at baseline and 30 days after the last vaccination.

  7. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 30 after the last vaccination

    Neutralizing antibodies will be measured by Micro serum neutralization test at baseline and 30 days after the last vaccination.

  8. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 30 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.

  9. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 30 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.

  10. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 30 after the last vaccination

    Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.

  1. Incidence of serious adverse events (SAE)

    Timeframe: From the first vaccination to 12 months after the last vaccination.

    Incidence of serious adverse events throughout the study.

  2. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 90 after the last vaccination

    Measured by ELISA.

  3. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 180 after the last vaccination

    Measured by ELISA.

  4. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 360 after the last vaccination

    Measured by ELISA.

  5. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 90 after the last vaccination

    Measured by ELISA.

  6. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 180 after the last vaccination

    Measured by ELISA.

  7. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 360 after the last vaccination

    Measured by ELISA.

  8. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 90 after the last vaccination

    Neutralizing antibodies will be measured by Micro serum neutralization test.

  9. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 180 after the last vaccination

    Neutralizing antibodies will be measured by Micro serum neutralization test.

  10. Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 360 after the last vaccination

    Neutralizing antibodies will be measured by Micro serum neutralization test.

  11. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 90 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.

  12. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 180 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.

  13. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA

    Timeframe: Day 360 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgA titer compared with Baseline.

  14. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 90 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.

  15. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 180 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.

  16. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG

    Timeframe: Day 360 after the last vaccination

    Seroconversion is defined as a ≥ 4-fold rise in IgG titer compared with Baseline.

  17. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 90 after the last vaccination

    Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.

  18. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 180 after the last vaccination

    Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.

  19. Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody

    Timeframe: Day 360 after the last vaccination

    Seroconversion is defined as a ≥ 2.7-fold rise in neutralizing antibody titer compared with Baseline.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
6 Weeks
Maximum age
71 Months
Healthy volunteers
Yes

  1. Healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months;
  2. Legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF).

First dose exclusion criteria:

  1. Axillary temperature >37.0℃ before vaccination;

  2. Recepit of any rotavirus vaccine in the past;

  3. History of intussusception or suffering from intussusception or history of any chronic gastrointestinal disease, including congenital malformations of the gastrointestinal tract that are likely to cause intussusception (such as Meckel's diverticulum);

  4. Congenital malformations, developmental disorders, genetic defect, severe malnutrition, etc.;

  5. Subjects aged 2 years or younger with history of dystocia, suffocation rescue, or nervous system damage;

  6. Subjects aged 2 years or younger with history of premature birth (<37 weeks' gestation) or low birth weight (weight at birth of<2500 g);

  7. History of convulsions, epilepsy and cerebral palsy, or mental illness and family history;

  8. History of severe anaphylactic reaction to vaccination, or allergy to any components of the study vaccine;

  9. Acute diseases (such as fever>39.0℃) or acute exacerbation of chronic disease within 3 days before vaccination;

  10. Receipt of immune enhancement (including oral or intravenous immunoglobulin, but hepatitis B immunoglobulin is acceptable) or immunosuppressive therapy (continuous oral or intravenous infusion for more than 14 days) within 3 months;

  11. Recepit of live attenuated vaccines within 14 days, or other vaccines within 7 days;

  12. Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;

  13. History of coagulation abnormalities (such as lack of blood coagulation factors, blood coagulopathy);

  14. Primary and secondary impairment of immune function (history of thyroid, pancreas, liver, spleen resection, or treatment due to thyroid disease within the past 12 months);

  15. Concurrent participation or plan to participate in another clinical trial throughout the study;

  16. According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

    Subsequent vaccination exclusion criteria:

  17. Severe allergic reaction after the previous injection of study vaccine;

  18. Serious adverse reactions that are causally related to the previous vaccination;

  19. After the first vaccination, subjects with newly discovered or newly happened diseases that meet the first dose exclusion criteria will be determined by the investigator whether to continue participating the study;

  20. Other reasons for exclusion judged by the investigator.

Sources for eligibility
clinicaltrials.gov

  • Shangqiu Liangyuan District Center for Disease Control and PreventionShangqiu, China
  • Ningling County Center for Disease Control and PreventionShangqiu, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (4)