Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose M. Ramirez-Aranda, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01445743
First received: September 23, 2011
Last updated: February 12, 2014
Last verified: February 2014

September 23, 2011
February 12, 2014
September 2011
August 2012   (final data collection date for primary outcome measure)
Elevation of specific pertussis antibody levels in children of women who were administered the immunization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Elevation of at least three antibodies against either pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), or filamentous hemagglutinin (FHA).
Elevation of total pertussis antibody levels in children of women who were administered the immunization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01445743 on ClinicalTrials.gov Archive Site
Non interference of acellular vaccine in children [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To demonstrate the acellular pertussis immunization non interference in the effective development of pertussis antibodies in children at 2, 4, and 6 months of age.
Not Provided
Not Provided
Not Provided
 
Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy
Immunogenicity and Safety of an Acellular DPT Vaccine in Pregnant Women in Nuevo Leon, Mexico

That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine.

The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.

Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects: Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in Nuevo Leon State.

The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel.

For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. Infant: collected at delivery (cord), 2, 4 and 6 months of age.

Immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2 FIM 2).

Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Pregnancy
Biological: Biological/Vaccine: Tdap Vaccine
Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.
Other Name: ADACEL
  • Experimental: Biological/Vaccine: Tdap Vaccine
    Biological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL)
    Intervention: Biological: Biological/Vaccine: Tdap Vaccine
  • Placebo Comparator: Placebo Comparator: Physiologic Saline solution
    Administration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution
    Intervention: Biological: Biological/Vaccine: Tdap Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
February 2014
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 38 years
  • Pregnancy between 22 and 32 weeks of gestation
  • Covered by Ministry of Health medical security
  • Definitive residency in Guadalupe and Benito Juarez cities
  • Pregnancy termination in the study`s hospital.
  • At low risk for complication as determined by the obstetrical risk assessment form (ORAF)
  • Second trimester or later ultrasound with no significant abnormalities
  • Intend to be available for follow up visits and phone calls access through 6 months following delivery
  • Willing to give written informed consent

Exclusion criteria:

  • Serious mental illness. (Schizophrenia, psychosis, major depression).
  • Serious underlying medical condition (e.g Degenerative diseases: Diabetes Mellitus,Hypertension and so on.
  • Current smoking or use of drugs.
  • Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
  • Be considered as a high risk pregnancy for serious obstetrical complication according to the local Obstetrical Risk Assessment Form.
Female
18 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01445743
EN11-009
Yes
Jose M. Ramirez-Aranda, Hospital Universitario Dr. Jose E. Gonzalez
Hospital Universitario Dr. Jose E. Gonzalez
Not Provided
Principal Investigator: Jose M Ramirez, MD; PhD Proffesor of Family Medicine
Hospital Universitario Dr. Jose E. Gonzalez
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP