Clinical trial NCT05621655: Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Rotavirus Infections
Rotavirus Gastroenteritis
Keywords: Rotavirus
Gastroenteritis
Lead sponsor: MAXVAX Biotechnology Limited Liability Company
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2022-11-18
Enrollment: 1512
Sex: ALL
Minimum age (years): 6
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This clinical trial is aimed to evaluate the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in Chinese healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.The subjects will be divided into 12 subgroups. Two different immune regimens and two dose levels will be evaluated in each age group. Toddlers aged 7-71 months will receive two intramuscular injections on Day 0 and 28 or three intramuscular injections on Day 0, 28 and 56. Infants aged 6-12 weeks will receive three intramuscular injections on Day 0, 28 and 56 or Day 0, 56 and 112. Two dose (mid dose and high dose) will be included in each age group. To maintain blindness in the trial, in each age group with fixed immune regimen, subjects will be randomized in a 1:1:1 ratio to receive mid dose vaccine, high dose vaccine, or placebo.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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.

Primary outcomes:
measure: The incidence of adverse events
timeFrame: Within 30 minutes after each vaccination
measure: The incidence of adverse events
timeFrame: Within 14 days after each vaccination
measure: The incidence of adverse events
timeFrame: Day 15 to 28/30 after each vaccination
measure: The incidence of adverse events
timeFrame: Within 28/30 days after each vaccination
measure: 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
measure: 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
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 30 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 30 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 30 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 30 after the last vaccination
Secondary outcomes:
measure: Incidence of serious adverse events (SAE)
timeFrame: From the first vaccination to 12 months after the last vaccination.
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 90 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 180 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 360 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 90 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 180 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 360 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 90 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 180 after the last vaccination
measure: Geometric Mean Titers (GMT) of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 360 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 90 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 180 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgA
timeFrame: Day 360 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 90 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 180 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus IgG
timeFrame: Day 360 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 90 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 180 after the last vaccination
measure: Seroconversion rates of anti-P[4], anti-P[6], anti-P[8] rotavirus neutralizing antibody
timeFrame: Day 360 after the last vaccination
Other outcomes:
Locations:
city: Shangqiu
country: China
facility: Shangqiu Liangyuan District Center for Disease Control and Prevention
state: Henan
city: Shangqiu
country: China
facility: Ningling County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Center for Disease Control and Prevention
name: Yanxia Wang
role: PRINCIPAL_INVESTIGATOR
References: