Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

NCT02286895 | Completed Phase 4 Results

• 1 other identifier: PATH-RVI-PRV-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.

Conditions

Diarrhea Rotavirus

Keywords

rotavirus; rotavirus vaccine; Mali; EPI vaccines

Outcome Measures

Primary Outcomes (2)

• Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody

  Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline

  28 days post-vaccination

• Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody

  Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value.

  28 days post-vaccination

Secondary Outcomes (17)

• Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody

  3 months post-vaccination

• Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine

  28 days post-vaccination

• Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA)

  28 days post-vaccination

• Geometric Mean of Meningitis Serum Bactericidal Antibody Titer

  Baseline to Day 28

• Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value

  28 days post-vaccination

Study Arms (2)

Group A (without rotavirus vaccine)

ACTIVE COMPARATOR

Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg).

Biological: measles vaccine (MV); Biological: yellow fever vaccine (YFV); Biological: meningitis conjugate vaccine (PsA-TT-5μg)

Group B (with rotavirus vaccine)

EXPERIMENTAL

Group A will receive measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine (PsA-TT-5μg) plus one oral dose of pentavalent rotavirus vaccine (PRV).

Biological: pentavalent rotavirus vaccine (PRV); Biological: measles vaccine (MV); Biological: yellow fever vaccine (YFV); Biological: meningitis conjugate vaccine (PsA-TT-5μg)

Interventions

pentavalent rotavirus vaccine (PRV) BIOLOGICAL

Each two-ml dose contains 5 live human-bovine reassortant rotaviruses with a minimum of 2.0 - 2.8 x 106 infectious units (IU) per reassortant, depending on the serotype, and not greater than 116 x 106 IU per aggregate dose. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq is a pale yellow clear liquid that may have a pink tint. This vaccine was administered orally.

Also known as: RotaTeq

Group B (with rotavirus vaccine)

measles vaccine (MV) BIOLOGICAL

A lyophilized vaccine in a pack containing one vial plus one ampoule of sterile water for injection. After reconstitution, each 0.5 ml/dose of MV contains active substances not less than 1000 units of 50% cell culture infectious doses (CCID50) of MV. Measles Vaccine Live Attenuated virus is propagated on Human Diploid Cells. This MV is currently part of the local EPI program in Mali. This vaccine was administered subcutaneously to the right deltoid.

Group A (without rotavirus vaccine); Group B (with rotavirus vaccine)

yellow fever vaccine (YFV) BIOLOGICAL

A freeze-dried live attenuated yellow fever virus of the 17D strain for injection. After reconstitution, one dose (0.5 ml) contains active substances not less than 1000 units of 50% lethal doses (LD50) of yellow fever virus. This YFV is currently part of the local EPI program in Mali. This vaccine was administered intramuscularly to the left deltoid.

Group A (without rotavirus vaccine); Group B (with rotavirus vaccine)

meningitis conjugate vaccine (PsA-TT-5μg) BIOLOGICAL

A meningococcal A vaccine, with meningococcal A polysaccharide (PsA) conjugated to the carrier protein, tetanus toxoid (TT). After reconstitution, one dose (0.5 ml) contains 5μg meningococcal A polysaccharide and 5-16 μg tetanus toxoid as a carrier protein. PsA-TT-5μg was considered experimental at the initiation of this study, but received approval from the WHO for infants on 30 December 2014. For all participants enrolled January 1st, 2015 or later, PsA-TT-5μg was not included in Group A or Group B, due to its December 2014 expiration date. This vaccine was administered intramuscularly to the right thigh.

Also known as: PsA-TT

Group A (without rotavirus vaccine); Group B (with rotavirus vaccine)

Eligibility Criteria

• Age: 9 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At least 9 months of age through 11 months of age (has not yet reached 1st birthday) at the time of administration of study vaccines.
• Residence in the study area.
• At least one parent or guardian who is at least 18 years of age and is willing to provide written informed consent.
• Generally healthy and free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator.
• A child who is fully vaccinated according to the local EPI schedule (exclusive of oral polio vaccine birth dose).
• A parent or guardian is willing to attend all planned study visits or allow home visits and mobile phone contacts, as required by the protocol.

You may not qualify if:

• Previous receipt any measles-containing vaccine.
• Previous receipt of any yellow fever vaccine.
• Previous receipt of any meningitis vaccine.
• Receipt of rotavirus vaccine within the past 90 days.
• Administration of any other vaccine within 8 weeks prior to administration of study vaccines or planned vaccination during the 4 weeks after study vaccination.
• History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization
• Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines.
• Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the vaccine period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic corticosteroids, this means prednisone, or equivalent, ≥0.5 mg/kg/day; topical steroids including inhaled steroids are allowed).
• A family history of congenital or hereditary immunodeficiency.
• History of intussusception.
• Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which in the opinion of the investigator, might interfere with the study objectives.
• Any condition or criterion that in the opinion of the investigator might compromise the well-being of the subject or the compliance with study procedures or interfere with the outcome of the study.

Sponsors & Collaborators

• PATH: lead
• Center for Vaccine Development - Mali: collaborator
• University of Maryland: collaborator

Study Sites (1)

CVD-Mali

Bamako, Mali

Location

Related Publications (1)

• Haidara FC, Tapia MD, Sow SO, Doumbia M, Coulibaly F, Diallo F, Traore A, Kodio M, Kelly CL, Fitzpatrick M, Kotloff K, Victor JC, Neuzil K. Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants. J Infect Dis. 2018 Jul 13;218(4):606-613. doi: 10.1093/infdis/jiy215.

  PMID: 29659924 DERIVED

MeSH Terms

Interventions

RotaTeq; Measles Vaccine; Yellow Fever Vaccine

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• Samba O Sow, MD, Msc

  Center for Vaccine Development - Mali

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: November 10, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 2, 2019
• Results First Posted: December 7, 2018

Record last verified: 2018-12

Locations

MA (1)