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

NCT05621655 | Active Not Recruiting Phase 2

• 1 other identifier: MKKCT2021002
• Study Type: interventional
• Target: 1,512
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rotavirus Infections; Rotavirus Gastroenteritis

Keywords

Rotavirus; Gastroenteritis

Outcome Measures

Primary Outcomes (10)

• The incidence of adverse events

  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.

  Within 30 minutes after each vaccination

• The incidence of adverse events

  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.

  Within 14 days after each vaccination

• The incidence of adverse events

  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.

  Day 15 to 28/30 after each vaccination

• The incidence of adverse events

  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.

  Within 28/30 days after each vaccination

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

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

  Day 30 after the last vaccination

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

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

  Day 30 after the last vaccination

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

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

  Day 30 after the last vaccination

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

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

  Day 30 after the last vaccination

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

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

  Day 30 after the last vaccination

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

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

  Day 30 after the last vaccination

Secondary Outcomes (19)

• Incidence of serious adverse events (SAE)

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

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

  Day 90 after the last vaccination

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

  Day 180 after the last vaccination

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

  Day 360 after the last vaccination

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

  Day 90 after the last vaccination

Study Arms (12)

Mid dose in toddlers (7-71 months old, 3 doses)

EXPERIMENTAL

Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.

Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine

Mid dose in toddlers (7-71 months old, 2 doses)

EXPERIMENTAL

Mid dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.

Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine

High dose in toddlers (7-71 months old, 3 doses)

EXPERIMENTAL

High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.

Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine

High dose in toddlers (7-71 months old, 2 doses)

EXPERIMENTAL

High dose recombinant trivalent rotavirus subunit vaccine in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.

Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine

Placebo in toddlers (7-71 months old, 3 doses)

PLACEBO COMPARATOR

Placebo in toddlers aged 7-71 months on Day 0, 28 and 56, intramuscularly injected.

Biological: Placebo

Placebo in toddlers (7-71 months old, 2 doses)

PLACEBO COMPARATOR

Placebo in toddlers aged 7-71 months on Day 0 and 28, intramuscularly injected.

Biological: Placebo

Mid dose in infants (6-12 weeks of age, 3 doses at 4-week intervals)

EXPERIMENTAL

Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.

Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine

Mid dose in infants (6-12 weeks of age, 3 doses at 8-week intervals)

EXPERIMENTAL

Mid dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.

Biological: Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine

High dose in infants (6-12 weeks of age, 3 doses at 4-week intervals)

EXPERIMENTAL

High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.

Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine

High dose in infants (6-12 weeks of age, 3 doses at 8-week intervals)

EXPERIMENTAL

High dose recombinant trivalent rotavirus subunit vaccine in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.

Biological: High dose Recombinant Trivalent Subunit Rotavirus Vaccine

Placebo in infants (6-12 weeks of age, 3 doses at 4-week intervals)

PLACEBO COMPARATOR

Placebo in infants aged 6-12 weeks on Day 0, 28 and 56, intramuscularly injected.

Biological: Placebo

Placebo in infants (6-12 weeks of age, 3 doses at 8-week intervals)

PLACEBO COMPARATOR

Placebo in infants aged 6-12 weeks on Day 0, 56 and 112, intramuscularly injected.

Biological: Placebo

Interventions

Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine BIOLOGICAL

0.5 mL of vaccine containing a total of 60 µg of protein (20 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.

Mid dose in infants (6-12 weeks of age, 3 doses at 4-week intervals); Mid dose in infants (6-12 weeks of age, 3 doses at 8-week intervals); Mid dose in toddlers (7-71 months old, 2 doses); Mid dose in toddlers (7-71 months old, 3 doses)

High dose Recombinant Trivalent Subunit Rotavirus Vaccine BIOLOGICAL

0.5 mL of vaccine containing a total of 90 µg of protein (30 µg of each P type) adjuvanted with 0.5 mg aluminum hydroxide.

High dose in infants (6-12 weeks of age, 3 doses at 4-week intervals); High dose in infants (6-12 weeks of age, 3 doses at 8-week intervals); High dose in toddlers (7-71 months old, 2 doses); High dose in toddlers (7-71 months old, 3 doses)

Placebo BIOLOGICAL

0.5 mL per dose, containing 0.5 mg aluminium hydroxide adjuvant.

Placebo in infants (6-12 weeks of age, 3 doses at 4-week intervals); Placebo in infants (6-12 weeks of age, 3 doses at 8-week intervals); Placebo in toddlers (7-71 months old, 2 doses); Placebo in toddlers (7-71 months old, 3 doses)

Eligibility Criteria

• Age: 6 Weeks - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Axillary temperature \>37.0℃ before vaccination;
• Recepit of any rotavirus vaccine in the past;
• 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);
• Congenital malformations, developmental disorders, genetic defect, severe malnutrition, etc.;
• Subjects aged 2 years or younger with history of dystocia, suffocation rescue, or nervous system damage;
• Subjects aged 2 years or younger with history of premature birth (\<37 weeks' gestation) or low birth weight (weight at birth of\<2500 g);
• History of convulsions, epilepsy and cerebral palsy, or mental illness and family history;
• History of severe anaphylactic reaction to vaccination, or allergy to any components of the study vaccine;
• Acute diseases (such as fever\>39.0℃) or acute exacerbation of chronic disease within 3 days before vaccination;
• 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;
• Recepit of live attenuated vaccines within 14 days, or other vaccines within 7 days;
• Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
• History of coagulation abnormalities (such as lack of blood coagulation factors, blood coagulopathy);
• 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);
• Concurrent participation or plan to participate in another clinical trial throughout the study;

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (2)

Shangqiu Liangyuan District Center for Disease Control and Prevention

Shangqiu, Henan, 476000, China

Location

Ningling County Center for Disease Control and Prevention

Shangqiu, Henan, 476700, China

Location

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yanxia Wang

  Henan Center for Disease Control and Prevention

  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: November 7, 2022
• First Posted: November 18, 2022
• Study Start: January 8, 2023
• Primary Completion: April 29, 2023
• Study Completion: December 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)