Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.

NCT05037435 | Completed Phase 3

• 1 other identifier: RTB 001/18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the presented study was to evaluate the safety and immunological efficacy in preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45 years old) by using the pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried).

Conditions

Rotavirus Infections; Rotavirus Vaccines

Outcome Measures

Primary Outcomes (4)

• Geometric Mean Titer (GMT) of antibody

  28 days post-Dose 1

• Seroconversion level

  28 days after Dose 1 of vaccine

• Seroconversion factor (The increase in the geometric mean antibody titer on day 28 compared to the initial level is expressed in the fold increase.).

  The seroconversion factor after administration of the study vaccine was 1.20, after administration of placebo - 0.97.

  28 days post-Dose 1

• Frequency and expressiveness of AE /SAE.

  From the time of Dose 1 to 28 days

Study Arms (2)

The pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried)

EXPERIMENTAL

Live attenuated bovine-human \[UK\] reassortant rotavirus vaccine manufactured by the Serum Institute of India, Limited (SIIL). The pentavalent vaccine contains rotavirus serotypes G1, G2, G3, G4, and G9 (≥5.6 log10 FFU/serotype/dose). The vaccine is lyophilized and supplied with 2.5 ml of citrate bicarbonate buffer added for reconstitution before oral administration.

Biological: The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)

Diluent is a sterile solution (Citrate Bicarbonate Buffer)

PLACEBO COMPARATOR

Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL.

Other: Placebo

Interventions

The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) BIOLOGICAL

Group 1 (20 participants) - received the pentavalent live vaccine to prevent rotavirus infection Single-use orally 2.5 ml (1 dose).

Also known as: Rota-V-Aid™

The pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried)

Placebo OTHER

Group 2 (20 participants ) - received placebo orally once of 2.5 ml (1 dose).

Also known as: Diluent is a sterile solution (Citrate Bicarbonate Buffer)

Diluent is a sterile solution (Citrate Bicarbonate Buffer)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The signed informed consent;
• Healthy participants, men's and females aged from 18 up to 45 years inclusive;
• Readiness of participants and their sexual partners to use reliable methods of contraception (a combination of at least two modes, including one barrier method, for example, use of a spermicide and condom) from the moment of signing of the informed consent (that is in 3 days before administration of drugs) and before the expiration of 1 month after completion of participation in the study;
• The verified diagnosis "is healthy," established according to collecting the anamnesis and physical inspection:
• absence in the anamnesis and at the time of screening clinically significant dysfunctions cardiovascular, respiratory, nervous, hemopoietic, endocrine, gastrointestinal systems, liver, and kidneys;
• absence of persistent infections (HIV, hepatitis B, C, syphilis);
• absence of the mental disorders and any other states capable to affectability of the participant to follow requirements of the protocol;
• hemodynamic indicators within norm: systolic arterial blood pressure - within 100 - 130 mm Hg., diastolic arterial blood pressure - within 60 - 90 mm Hg;
• The Body Mass Index (BMI) is in normal limits (≥18.5 kg/sq.m and ≤30 kg/sq.m);
• The participant's Ability, according to the study, to fulfill the requirements of the protocol.

You may not qualify if:

• The severe vaccine-challenged reactions/complications connected with the previous vaccination;
• Allergic reactions to components of vaccine or any previous vaccination;
• Any carried-out vaccination less than in 2 months before the present study;
• In the chronic anamnesis diseases of the digestive tract, causes intestinal invagination, gastrointestinal pathology, surgical interventions on abdominal organs;
• Clinically significant deviations of laboratory and tool indicators (including standard pathological changes on the ECG) overstepping the bounds of the range of normal values revealed on screening and capable of negatively impacting the safety of participants of the volunteer in the study;
• Any diseases within four weeks preceding screening;
• Presence of any oncological diseases (including in the anamnesis);
• Any disease demands continuous therapy, including vegetable drugs or the expected concurrent therapy during the study;
• Donor blood donation (450 ml of blood or plasma and more) or loss of 500 or more ml of blood in 3 months before the study;
• Positive analysis on HIV, Hepatitis B and C, and syphilis (RW);
• Impossibility to give the written informed consent or to follow requirements of the protocol;
• Probability to refuse to follow the protocol's requirements, instructions and restrictions; for example, unwillingness to cooperate, impossibility to return to clinical center for the subsequent visits, and the probability not of completion of participation in a clinical trial;
• Participation in clinical trials of drugs less than in 3 months before the study;
• Smoking more than ten cigarettes in a day;
• Drug addiction in the anamnesis. The positive analysis of urine on psychotropic and narcotic substances, psychoactive medicines;

Sponsors & Collaborators

• Limited Liability Company Pharm Aid: lead

Study Sites (1)

Perm State Medical University named after Academician E.A. Wagner

Perm, 614990, Russia

Location

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Freeze Drying

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Irina V. Feldblium, Dr. Sci

  Perm State Medical University named after Academician E.A. Wagner

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized double-blind placebo-controllable.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 8, 2021
• Study Start: June 25, 2018
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

RU (1)