Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings

NCT06667206 | Recruiting Phase 2 DMC

• 1 other identifier: OVG2022/06
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IIb clinical trial investigating the non-inferiority of immune responses in children given two doses of measles vaccine at different timepoints. The study will randomise 450 children to 3 groups: group A will receive measles containing vaccine (MCV) at 6 and 12 months ; group B at 9 and 18 months; Group C at 6 and 18 months.

Conditions

Measles

Keywords

measles-rubella vaccine

Outcome Measures

Primary Outcomes (3)

• Protective measles antibody concentrations at 2.5 years of age

  Proportion of participants with protective levels of measles neutralising antibodies (PRNT\>120mIUL)

  2.5 years of age

• Local and systemic reactions

  Reactogenicity profile from diary cards

  7 days post each vaccination

• Serious Adverse Events

  2 years: (from baseline vaccination until 2 year follow up visit)

Secondary Outcomes (4)

• Measles plaque reduction neutralisation titre (PRNT) and immunoglobulin G (IgG) concentration

  one month after first dose

• The effect of maternal human immunodeficiency virus (HIV) infection

  one month after first dose and second dose

• The effect of maternal antibodies on infant immune response

  pre-vaccination, 4 weeks after the first dose, 4 weeks after the second dose

• Immune response to rubella component of the vaccine

  4 weeks after a first and second dose

Other Outcomes (1)

• Public perceptions of measles immunisation

  Baseline until 2 year follow up visit

Study Arms (3)

Group A: 6 and 12 months

EXPERIMENTAL

Early Prime-Boost schedule: Measles vaccines given at 6 and 12 months of age

Biological: Licenced Measles-Rubella vaccine

Group B: 9 and 18 months (standard schedule)

EXPERIMENTAL

Standard schedule: Measles vaccines given at 9 and 18 months of age

Biological: Licenced Measles-Rubella vaccine

Group C: 6 and 18 months

EXPERIMENTAL

Early Prime schedule: Measles vaccines given at 6 and 18 months of age

Biological: Licenced Measles-Rubella vaccine

Interventions

Licenced Measles-Rubella vaccine BIOLOGICAL

Licenced Measles-Rubella vaccine provided by the Ugandan EPI programme

Group A: 6 and 12 months; Group B: 9 and 18 months (standard schedule); Group C: 6 and 18 months

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 months (23 - 28 weeks) at time of screening
• Received all previous vaccines as per country Expanded Programme of Immunization (EPI) schedule, verified by child health card
• Parents/caretakers willing to give informed consent for their and their children's participation and stay in the geographical area where the study would be conducted

You may not qualify if:

• The participant may not enter the trial if any of the following apply:
• Child not healthy enough to be vaccinated in the opinion of the investigator
• Recent family history of measles infection (since birth)
• Previous receipt of any measles vaccination
• A family history of congenital or hereditary immunodeficiency other than HIV
• Receipt of more than 1 week of immunosuppressant or immune modifying drugs e.g. high dose steroids.
• Major congenital defects or serious chronic illness that in the opinion of the investigator are likely to modify immune responses or the ability to comply with the requirements of the study.
• History of any neurological disorders or seizures
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
• Other abnormalities or medical history that contraindicated measles vaccination

Sponsors & Collaborators

• University of Oxford: lead
• St George's, University of London: collaborator
• MU-JHU CARE: collaborator

Study Sites (1)

Makarere University - Johns Hopkins University Collaboration

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Measles

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Oxford Vaccine Group

CONTACT

01865 611400; info@ovg.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All participants receive the same vaccines but are randomised to the timing of administration of the vaccines.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Equal numbers of participants are randomised to 3 arms.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: October 31, 2024
• Study Start: November 15, 2023
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: October 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

UG (1)