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Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia (ROTAVAC)

Primary Purpose

Diarrhea, Diarrhea Rotavirus

Status

Completed

Phase

Phase 2

Locations

Zambia

Study Type

Interventional

Intervention

ROTAVAC®

ROTAVAC 5D

Rotarix®

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring diarrhea, Rotavirus, ROTAVAC, Rotavirus vaccine

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy infant as established by medical history and clinical examination before entering the study.
Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
Infants received age-appropriate EPI vaccines till enrolment.
Ability and willingness to provide informed consent as per local consenting procedures.
Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.

Exclusion Criteria:

Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
Presence of fever on the day of enrolment (temporary exclusion).
Acute disease at the time of enrolment (temporary exclusion).
Concurrent participation in another clinical trial throughout the entire timeframe of this study.
Presence of severe malnutrition (weight-for-height z-score < -3SD median).
Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.
History of congenital abdominal disorders, intussusception, abdominal surgery
Known or suspected impairment of immunological function based on medical history and physical examination.
Prior receipt or intent to receive rotavirus and other age specified EPI vaccines outside of the study center and during study participation.
A known sensitivity or allergy to any component of the study vaccine.
Clinically detectable significant congenital or genetic defect.
History of persistent diarrhea (defined as diarrhea more than 14 days).
Participant's parents not able, available or willing to accept active follow-up by the study staff.
Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
History of any neurologic disorders or seizures.
Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
Participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the PI or study site personnel.

Sites / Locations

George Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

ROTAVAC 5D

ROTAVAC®

Rotarix®

Arm Description

Bharat Biotech International Ltd's new Rotavirus vaccine, ROTAVAC 5D is a live, attenuated G9P[11] monovalent vaccine at a dose of 0.5mL containing NLT log 10^5.0 focus forming units (FFU) per dose. 5D is in liquid form.

Bharat Biotech International Ltd's licensed rotavirus vaccine, ROTAVAC® is a live, attenuated G9P[11] monovalent vaccine at a dose of 0.5mL containing NLT log 10^5.0 focus forming units (FFU) per dose. ROTAVAC® is in frozen form and is thawed till fully liquid prior to administration.

GSK Biologicals' licensed rotavirus vaccine, Rotarix® is a live attenuated RIX4414 strain of human rotavirus of the G1P[8] type containing not less than 106.0 CCID50 (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus.

Outcomes

Primary Outcome Measures

Geometric Mean Concentration Using WC3 as the Viral Lysate

GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) using WC3 (heterologous to vaccine strain) as the viral lysate. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC 5D® and ROTAVAC®.

Secondary Outcome Measures

Immediate Adverse Events

Percentage of participants reporting immediate adverse events after each vaccination

Solicited Adverse Events

Percentage of participants reporting solicited post-vaccination reactogenicity (fever, diarrhea, vomiting, decreased appetite, irritability, decreased activity level)

Unsolicited Adverse Events

Percentage of participants reporting unsolicited AEs at a rate >5%.

Serious Adverse Events

Percentage of participants reporting SAEs

Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate

Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if a baseline concentration is < 20 U/mL or a post-vaccination serum anti-rotavirus IgA antibody concentration of ≥ 2-fold baseline level if a baseline concentration is ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.

Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate

Seropositivity is defined as serum anti-rotavirus IgA antibody concentration ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.

Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate

Seroresponse will be assessed as a four-fold, three-fold and two- fold rise in antibody concentration from baseline. Seroresponse will be assessed as a four-fold, three-fold and two-fold rise in antibody concentration from baseline. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.

Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate

GMFR in each of the ROTAVAC 5D®, ROTAVAC® and Rotarix® vaccine arms. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.

Full Information

NCT ID

NCT03602053

First Posted

July 18, 2018

Last Updated

December 17, 2020

Sponsor

Centre for Infectious Disease Research in Zambia

Collaborators

PATH, Christian Medical College, Vellore, India, Children's Hospital Medical Center, Cincinnati, Bharat Biotech International Limited

1. Study Identification

Unique Protocol Identification Number

NCT03602053

Brief Title

Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

Acronym

ROTAVAC

Official Title

An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 22, 2019 (Actual)

Primary Completion Date

October 4, 2019 (Actual)

Study Completion Date

October 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Infectious Disease Research in Zambia

Collaborators

PATH, Christian Medical College, Vellore, India, Children's Hospital Medical Center, Cincinnati, Bharat Biotech International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.

Detailed Description

This study is designed as a Phase IIb, single center, randomized, controlled, open label study with 3 groups of infants (n=150 per group) receiving either three doses of ROTAVAC® three doses of ROTAVAC 5D or two doses of Rotarix®. 450 participants will be randomized (1:1:1) to receive ROTAVAC®, ROTAVAC 5D or Rotarix®. The three doses of ROTAVAC® and ROTAVAC 5D will be administered at 6, 10 and 14 weeks of age whereas two doses of Rotarix® will be administered at 6 and 10 weeks of age. All vaccines will be administered concomitantly with EPI vaccines including Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and Hepatitis B vaccine (DTwP-Hib-HepB), Pneumococcal conjugate vaccine and OPV at 6, 10 and 14 weeks and IPV at week 14 (when switched to in Zambia). The participants will be monitored for 30 minutes following vaccine administration for immediate adverse events. A blood sample will be obtained from all the participating infants before first vaccination and four weeks after the last vaccine dose. This would mean that the blood sample will be collected at approximately 14 weeks of age for infants in the Rotarix® arm and 18 weeks for infants in the ROTAVAC® groups. Enhanced passive/Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination will be conducted on all infants. In addition, surveillance for unsolicited AEs, SAEs including intussusception will be carried out over the period between first vaccination and four weeks after the last vaccination on all infants. The study will compare the immunogenicity of the two formulations of ROTAVAC® i.e. ROTAVAC® vs. ROTAVAC 5D and will descriptively analyze the immune response to Rotarix®. Primary immunogenicity analysis of all samples will be based on a validated ELISA which uses strain WC3 as a substrate. A subset of the samples (50 pairs/arms) collected will also be tested by a validated ELISA which uses strain 89-12 (G1P8 virus) as a substrate. This trial will generate immunogenicity and safety data on ROTAVAC® and ROTAVAC 5D outside of India. Presentation of data to Zambian Ministry of Health, WHO and in peer reviewed open access publications will be key audiences targeted for communication of results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea, Diarrhea Rotavirus

Keywords

diarrhea, Rotavirus, ROTAVAC, Rotavirus vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Phase IIb, single center, randomized, controlled, open label study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ROTAVAC 5D

Arm Type

Experimental

Arm Description

Arm Title

ROTAVAC®

Arm Type

Experimental

Arm Description

Arm Title

Rotarix®

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

ROTAVAC®

Intervention Description

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

Intervention Type

Biological

Intervention Name(s)

ROTAVAC 5D

Intervention Description

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

Intervention Type

Biological

Intervention Name(s)

Rotarix®

Intervention Description

1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.

Primary Outcome Measure Information:

Title

Geometric Mean Concentration Using WC3 as the Viral Lysate

Description

Time Frame

28 day after last dose of the study vaccine

Secondary Outcome Measure Information:

Title

Immediate Adverse Events

Description

Percentage of participants reporting immediate adverse events after each vaccination

Time Frame

within 30 minutes' post-vaccination.

Title

Solicited Adverse Events

Description

Percentage of participants reporting solicited post-vaccination reactogenicity (fever, diarrhea, vomiting, decreased appetite, irritability, decreased activity level)

Time Frame

7 day period after each vaccination.

Title

Unsolicited Adverse Events

Description

Percentage of participants reporting unsolicited AEs at a rate >5%.

Time Frame

From first vaccination through 4 weeks after the last vaccination.

Title

Serious Adverse Events

Description

Percentage of participants reporting SAEs

Time Frame

From first vaccination through 4 weeks after the last vaccination of each study participant. Immunogenicity

Title

Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate

Description

Time Frame

28 days after last dose of study vaccine.

Title

Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate

Description

Time Frame

28 days after last dose of study vaccine

Title

Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate

Description

Time Frame

28 days after last dose of study vaccine

Title

Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate

Description

Time Frame

At 28 days after last dose of study vaccine in reference to baseline.

Other Pre-specified Outcome Measures:

Title

Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate

Description

GMCs of serum anti-rotavirus IgA antibodies in each of the three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.

Time Frame

28 days after the last dose of a study vaccine.

Title

Seroconversion Using Strain 89-12 as the Viral Lysate

Description

Seroconversion rate in three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.

Time Frame

28 days after the last dose of a study vaccine.

Title

Seropositivity Using Strain 89-12 as the Viral Lysate

Description

Seropositivity rate in three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.

Time Frame

at baseline and 28 days after last dose of study vaccine

Title

Geometric Mean Fold Rise (GMFR) Using Strain 89-12 as the Viral Lysate

Description

GMFR in the three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.

Time Frame

at 28 days after last dose of study vaccine in reference to baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy infant as established by medical history and clinical examination before entering the study. Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record. Infants received age-appropriate EPI vaccines till enrolment. Ability and willingness to provide informed consent as per local consenting procedures. Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period. Exclusion Criteria: Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion). Presence of fever on the day of enrolment (temporary exclusion). Acute disease at the time of enrolment (temporary exclusion). Concurrent participation in another clinical trial throughout the entire timeframe of this study. Presence of severe malnutrition (weight-for-height z-score < -3SD median). Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol. History of congenital abdominal disorders, intussusception, abdominal surgery Known or suspected impairment of immunological function based on medical history and physical examination. Prior receipt or intent to receive rotavirus and other age specified EPI vaccines outside of the study center and during study participation. A known sensitivity or allergy to any component of the study vaccine. Clinically detectable significant congenital or genetic defect. History of persistent diarrhea (defined as diarrhea more than 14 days). Participant's parents not able, available or willing to accept active follow-up by the study staff. Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. History of any neurologic disorders or seizures. Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent. Participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the PI or study site personnel.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Niraj Rathi, MD

Organizational Affiliation

PATH

Official's Role

Study Director

Facility Information:

Facility Name

George Research Centre

City

Lusaka

ZIP/Postal Code

10101

Country

Zambia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Links:

URL

https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Rotarix/pdf/ROTARIX-PI-PIL.PDF

Description

Rotarix (Product Information).

URL

https://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_ppi.pdf

Description

Rotateq (Product Information).

URL

https://www.path.org/media-center/path-welcomes-new-promising-study-results-for-rotavirus-vaccine-candidate/

Description

PATH welcomes new promising study results for rotavirus vaccine candidate.

URL

http://www.pharmabiz.com/NewsDetails.aspx?aid=108851&sid=2

Description

Bharat Biotech receives National Technology Award for Rotavac from President of India

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Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

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