Non-Specific Effects of Standard Titre Measles Vaccination

NCT00168662 | Completed Phase 4

• 2 other identifiers: IC18-CT95-0011-Twodose1EU grant: IC18-CT95-0011
• Study Type: interventional
• Target: 7,800
• Locations: 1 country
• Sites: 1

Brief Summary

The general objectives of the proposed research work are: A1) to reduce childhood mortality in developing countries through better control of measles infection by finding the best immunization strategy, and A2) to investigate the hypothesis that standard titre measles immunization is associated with non targeted beneficial effects on childhood morbidity and mortality in developing countries. The measurable, specific objectives of the present proposal are: B1) to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age can reduce measles incidence by 50% through better coverage or improved seroconversion, and B2) to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age can reduce childhood mortality by 20% through better coverage, better protection against measles or non targeted beneficial effects, and B3) to determine the magnitude and duration of non-measles related changes in morbidity patterns after standard titre measles immunization, in particular to test whether measles immunization is associated with a 15% reduction in the risk of diarrhoea, and B4) to determine non-measles related immunological changes among recipients of measles vaccine in order to establish possible pathways for the non targeted effects of standard titre measles immunization.

Conditions

Measles

Keywords

Non-specific effects of vaccines; Infant mortality; Child mortality; Mortality; Morbidity; Measles vaccine; Measles; Immunisation; Low income country; Guinea-Bissau; Bandim Health Project; Immunology

Outcome Measures

Primary Outcomes (4)

• Vaccination coverage

• Vaccine efficacy

• Measles specific mortality

• All cause mortality until 3 years of age

Secondary Outcomes (11)

• Measles antibodies at 6, 7½, 9, 10½ and 18 months of age

• T-cells at 6, 7½, 9, 10½ and 18 months of age

• Thymus size at 6, 7½, 9, 10½ months of age

• Neopterin level at 7½ months of age

• Beta-2-microglobulin level at 7½ months of age

Interventions

Measles and inactivated polio vaccine BIOLOGICAL

Eligibility Criteria

• Age: 6 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Bandim Health Project: lead
• International Cooperation with Developing Countries: collaborator
• Danish Council for Development Research: collaborator
• Medical Research Council Unit, The Gambia: collaborator

Study Sites (1)

Bandim Health Project

Bissau, Apartado 861, 1004 Bissau Codex, Guinea-Bissau

Location

Related Publications (10)

• Veirum JE, Sodemann M, Biai S, Jakobsen M, Garly ML, Hedegaard K, Jensen H, Aaby P. Routine vaccinations associated with divergent effects on female and male mortality at the paediatric ward in Bissau, Guinea-Bissau. Vaccine. 2005 Jan 19;23(9):1197-204. doi: 10.1016/j.vaccine.2004.02.053.

  PMID: 15629363 BACKGROUND

• Garly ML, Martins CL, Bale C, da Costa F, Dias F, Whittle H, Aaby P. Early two-dose measles vaccination schedule in Guinea-Bissau: good protection and coverage in infancy. Int J Epidemiol. 1999 Apr;28(2):347-52. doi: 10.1093/ije/28.2.347.

  PMID: 10342702 RESULT

• Garly ML, Bale C, Martins CL, Monteiro M, George E, Kidd M, Dias F, Aaby P, Whittle HC. Measles antibody responses after early two dose trials in Guinea-Bissau with Edmonston-Zagreb and Schwarz standard-titre measles vaccine: better antibody increase from booster dose of the Edmonston-Zagreb vaccine. Vaccine. 2001 Feb 28;19(15-16):1951-9. doi: 10.1016/s0264-410x(00)00431-x.

  PMID: 11228365 RESULT

• Garly ML, Bale C, Martins CL, Balde MA, Hedegaard KL, Whittle HC, Aaby P. BCG vaccination among West African infants is associated with less anergy to tuberculin and diphtheria-tetanus antigens. Vaccine. 2001 Nov 12;20(3-4):468-74. doi: 10.1016/s0264-410x(01)00339-5.

  PMID: 11672911 RESULT

• Aaby P, Jensen H, Garly ML, Bale C, Martins C, Lisse I. Routine vaccinations and child survival in a war situation with high mortality: effect of gender. Vaccine. 2002 Nov 22;21(1-2):15-20. doi: 10.1016/s0264-410x(02)00441-3.

  PMID: 12443658 RESULT

• Garly ML, Martins CL, Bale C, Balde MA, Hedegaard KL, Gustafson P, Lisse IM, Whittle HC, Aaby P. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG? Vaccine. 2003 Jun 20;21(21-22):2782-90. doi: 10.1016/s0264-410x(03)00181-6.

  PMID: 12798618 RESULT

• Aaby P, Garly ML, Bale C, Martins C, Jensen H, Lisse I, Whittle H. Survival of previously measles-vaccinated and measles-unvaccinated children in an emergency situation: an unplanned study. Pediatr Infect Dis J. 2003 Sep;22(9):798-805. doi: 10.1097/01.inf.0000083821.33187.b5.

  PMID: 14506371 RESULT

• Aaby P, Jensen H, Rodrigues A, Garly ML, Benn CS, Lisse IM, Simondon F. Divergent female-male mortality ratios associated with different routine vaccinations among female-male twin pairs. Int J Epidemiol. 2004 Apr;33(2):367-73. doi: 10.1093/ije/dyh004.

  PMID: 15082642 RESULT

• Garly ML, Jensen H, Martins CL, Bale C, Balde MA, Lisse IM, Aaby P. Hepatitis B vaccination associated with higher female than male mortality in Guinea-bissau: an observational study. Pediatr Infect Dis J. 2004 Dec;23(12):1086-92.

  PMID: 15626943 RESULT

• Roth A, Gustafson P, Nhaga A, Djana Q, Poulsen A, Garly ML, Jensen H, Sodemann M, Rodriques A, Aaby P. BCG vaccination scar associated with better childhood survival in Guinea-Bissau. Int J Epidemiol. 2005 Jun;34(3):540-7. doi: 10.1093/ije/dyh392. Epub 2005 Jan 19.

  PMID: 15659474 RESULT

Related Links

• Statens Serum Institut, Denmark

MeSH Terms

Conditions

Measles; Infant Death

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• PETER AABY, MSc, Dr. Med

  Bandim Health Project

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 1995
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: February 26, 2008

Record last verified: 2008-02

Locations

GU (1)