The Interaction Between Measles and DTP Vaccination

NCT02710045 | Completed Results

• 1 other identifier: SCC 1085
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate for the broad immunological effects of administering measles vaccine (MV) and diphtheria-tetanus-whole cell pertussis vaccine (DTP) to 9 month old Gambian infants, either alone or together. Effects on vaccine-specific immune responses, innate immunity, and immune memory were studied. The hypothesis is that when MV and DTP are given together there will be more inflammation and this will interfere with generation of immunity to the vaccine and to other non-vaccine related stimuli.

Conditions

Non-target Heterologous Effects of Vaccines; Vaccine Interactions

Keywords

Immunity, Innate; Immunity, Non-Specific; Antibodies; Cytokines; Immunity, Cellular

Outcome Measures

Primary Outcomes (2)

• Effect on Interferon (IFN)-Gamma : Interleukin (IL)-4 Ratio in Plasma

  The IFN-gamma:IL-4 cytokine ratio in plasma samples taken 4 weeks after vaccination measured by multiplex assay using the Bio-Plex 200 Suspension Array system. Ratio compared between the 3 intervention groups with the hypothesis that the MV+DTP group will have a higher ratio than the other 2 groups.

  4 weeks after vaccination

• Effect on CD4+FOXP3+CD127- Regulatory T Cell Frequencies

  Regulatory T cell (Treg) frequencies (among all gated CD4+ T cells) at 9 and 10 months of age determined by flow cytometry and compared between the 3 intervention groups with the primary hypothesis that the MV+DTP group will have lower Treg frequencies than the MV group.

  4 weeks (9 months and 10 months of age)

Secondary Outcomes (5)

• Effect of Vaccine Group on Measles Antibody Levels

  4 weeks (9 and 10 months of age)

• Effect of Vaccine Group on Effector Memory T Cells (TEM)

  4 weeks (9 and 10 months of age)

• Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels

  4 weeks (9 and 10 months of age)

• Effect of Vaccine Group on Pertussis Toxoid Antibody Levels

  4 weeks (9 and 10 months of age)

• Measles Antibody Levels at 19 Months of Age

  10 months (19 months of age)

Study Arms (3)

MV at 9 months

ACTIVE COMPARATOR

Measles Vaccine at 9 months of age. Measles Vaccine at 18 months of age. All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.

Biological: Measles Vaccine at 9 months of age; Biological: Measles Vaccine at 18 months of age

DTP + MV at 9 months

ACTIVE COMPARATOR

Measles Vaccine at 9 months of age. DTP Vaccine at 9 months of age. Measles Vaccine at 18 months of age. DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.

Biological: Measles Vaccine at 9 months of age; Biological: DTP Vaccine at 9 months of age; Biological: Measles Vaccine at 18 months of age

DTP at 9 months

ACTIVE COMPARATOR

DTP Vaccine at 9 months of age. Measles Vaccine at 18 months of age. DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.

Biological: DTP Vaccine at 9 months of age; Biological: Measles Vaccine at 18 months of age

Interventions

Measles Vaccine at 9 months of age BIOLOGICAL

Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age

Also known as: MV

DTP + MV at 9 months; MV at 9 months

DTP Vaccine at 9 months of age BIOLOGICAL

Single intramuscular (i.m.) dose of diphtheria-tetanus-whole cell pertussis vaccine (Serum Institute of India Ltd.) into the thigh at 9 months of age

Also known as: DTP

DTP + MV at 9 months; DTP at 9 months

Measles Vaccine at 18 months of age BIOLOGICAL

Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age

Also known as: MV

DTP + MV at 9 months; DTP at 9 months; MV at 9 months

Eligibility Criteria

• Age: 16 Weeks - 22 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy 4 month old infants
• All EPI vaccines received to date according to current Gambia government schedule
• Normal weight for age according to growth chart

You may not qualify if:

• Temperature \>37.5°C
• Any history of ongoing chronic illness

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia: lead

Related Publications (28)

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MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Results Point of Contact

• Title: Katie Flanagan
• Organization: University of Tasmania

katie.flanagan@ths.tas.gov.au

+61 3 6777 4081

Study Officials

• Katie L Flanagan, PhD

  University of Tasmania, Australia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 16, 2016
• Study Start: November 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2011
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share