NCT01691820

A Study in Adolescent Females to Explore Cytomegalovirus Infection

Completed NA Results posted Last updated 27 April 2021

What this trial tests

NA trial testing Blood collection in Infections, Cytomegalovirus in 369 participants. Completed in 8 April 2017.

Timeline

5 October 2012

Primary endpoint
8 April 2017

8 April 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	369
Start date	5 October 2012
Primary completion	8 April 2017
Estimated completion	8 April 2017
Sites	5 locations across Finland, United States, Mexico

Drugs / interventions tested

• Blood collection — full drug profile →
• Urine collection — full drug profile →
• Saliva collection — full drug profile →

Conditions studied

• Infections, Cytomegalovirus — all drugs for Infections, Cytomegalovirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 10 to 17, female only, with Infections, Cytomegalovirus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 4

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a vir

anti-Teg IgG - Two-fold and above increases

Group	Value	95% CI
Group S+	5

anti-Teg IgG -Four-fold and above increases

Group	Value	95% CI
Group S+	2

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 8

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	5

Four-fold and above increases

Group	Value	95% CI
Group S+	1

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 12

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	6

Four-fold and above increases

Group	Value	95% CI
Group S+	3

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 16

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	1

Four-fold and above increases

Group	Value	95% CI
Group S+	0

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 20

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	5

Four-fold and above increases

Group	Value	95% CI
Group S+	2

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 24

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	6

Four-fold and above increases

Group	Value	95% CI
Group S+	2

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 28

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	5

Four-fold and above increases

Group	Value	95% CI
Group S+	1

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 32

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	1

Four-fold and above increases

Group	Value	95% CI
Group S+	1

Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. Primary · At Month 36

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases" category = subjects that had two-fold and above increases of anti-CMV IgG concentration. "Four-fold and above increases" = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 1.136 ELISA unit (EU)/mL. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or

Two-fold and above increases

Group	Value	95% CI
Group S+	3

Four-fold and above increases

Group	Value	95% CI
Group S+	0

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). Primary · At Month 0

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL.

Group	Value	95% CI
Group S+	5.4	4.9 – 6.1

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). Primary · At Month 4

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that

Group	Value	95% CI
Group S+	32.2	14.4 – 72.0

Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA). Primary · At Month 8

This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were tabulated as geometric mean concentrations (GMC) and expressed as ELISA units (EU)/mL. The cut-off of the assay = 1.136 EU/mL. GMC was calculated on subjects meeting a two-fold increase or above (i.e.: subjects that

Group	Value	95% CI
Group S+	10.3	2.8 – 38.0

Sponsor's own description

The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary infections (re-infections/re-activations) and the incidence of CMV primary infections in adolescent females.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Incidence of Cytomegalovirus Primary and Secondary Infection in Adolescent Girls: Results From a Prospective Study.
   Paris R, Apter D, Boppana S, D'Aloia M, et al · · 2023 · cited 4× · PMID 37340664 · DOI 10.1093/infdis/jiad182